Clinician Reviews

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

Artificial intelligence (AI) has proven of value in the COVID-19 pandemic and shows promise for mitigating future health care crises. During the pandemic’s first wave in New York, for example, Mount Sinai Health System used an algorithm to help identify patients ready for discharge. Such systems can help overburdened hospitals manage personnel and the flow of supplies in a medical crisis so they can continue to provide superior patient care.¹

Pandemic applications have demonstrated AI’s potential not only to lift administrative burdens, but also to give physicians back what Eric Topol, MD, founder and director of Scripps Research Translational Institute and author of Deep Medicine, calls “the gift of time.”² More time with patients contributes to clear communication and positive relationships, which lower the odds of medical errors, enhance patient safety, and potentially reduce physicians’ risks of certain types of litigation.³

However, physicians and health systems will need to approach AI with caution. Many unknowns remain – including potential liability risks and the potential for worsening preexisting bias. The law will need to evolve to account for AI-related liability scenarios, some of which are yet to be imagined.

Like any emerging technology, AI brings risk, but its promise of benefit should outweigh the probability of negative consequences – provided we remain aware of and mitigate the potential for AI-induced adverse events.
 

AI’s pandemic success limited due to fragmented data

Innovation is the key to success in any crisis, and many health care providers have shown their ability to innovate with AI during the pandemic. For example, researchers at the University of California, San Diego, health system who were designing an AI program to help doctors spot pneumonia on a chest x-ray retooled their application to assist physicians fighting coronavirus.⁴

Meanwhile, AI has been used to distinguish COVID-19–specific symptoms: It was a computer sifting medical records that took anosmia, loss of the sense of smell, from an anecdotal connection to an officially recognized early symptom of the virus.⁵ This information now helps physicians distinguish COVID-19 from influenza.

However, holding back more innovation is the fragmentation of health care data in the United States. Most AI applications for medicine rely on machine learning; that is, they train on historical patient data to recognize patterns. Therefore, “Everything that we’re doing gets better with a lot more annotated datasets,” Dr. Topol says. Unfortunately, because of our disparate systems, we don’t have centralized data.⁶ And even if our data were centralized, researchers lack enough reliable COVID-19 data to perfect algorithms in the short term.

Or, put in bleaker terms by the Washington Post: “One of the biggest challenges has been that much data remains siloed inside incompatible computer systems, hoarded by business interests and tangled in geopolitics.”⁷

The good news is that machine learning and data science platform Kaggle is hosting the COVID-19 Open Research Dataset, or CORD-19, which contains well over 100,000 scholarly articles on COVID-19, SARS, and other relevant infections.⁸ In lieu of a true central repository of anonymized health data, such large datasets can help train new AI applications in search of new diagnostic tools and therapies.
 

AI introduces new questions around liability

While AI may eventually be assigned legal personhood, it is not, in fact, a person: It is a tool wielded by individual clinicians, by teams, by health systems, even multiple systems collaborating. Our current liability laws are not ready for the era of digital medicine.

AI algorithms are not perfect. Because we know that diagnostic error is already a major allegation in malpractice claims, we must ask: What happens when a patient alleges that diagnostic error occurred because a physician or physicians leaned too heavily on AI?

In the United States, testing delays have threatened the safety of patients, physicians, and the public by delaying diagnosis of COVID-19. But again, health care providers have applied real innovation – generating novel and useful ideas and applying those ideas – to this problem. For example, researchers at Mount Sinai became the first in the country to combine AI with imaging and clinical data to produce an algorithm that can detect COVID-19 based on computed tomography scans of the chest, in combination with patient information and exposure history.⁹
 

AI in health care can help mitigate bias – or worsen it

Machine learning is only as good as the information provided to train the machine. Models trained on partial datasets can skew toward demographics that turned up more often in the data – for example, White race or men over 60. There is concern that “analyses based on faulty or biased algorithms could exacerbate existing racial gaps and other disparities in health care.”¹⁰ Already during the pandemic’s first waves, multiple AI systems used to classify x-rays have been found to show racial, gender, and socioeconomic biases.¹¹

Such bias could create high potential for poor recommendations, including false positives and false negatives. It’s critical that system builders are able to explain and qualify their training data and that those who best understand AI-related system risks are the ones who influence health care systems or alter applications to mitigate AI-related harms.¹²

AI can help spot the next outbreak

More than a week before the World Health Organization released its first warning about a novel coronavirus, the AI platform BlueDot, created in Toronto, spotted an unusual cluster of pneumonia cases in Wuhan, China. Meanwhile, at Boston Children’s Hospital, the AI application Healthmap was scanning social media and news sites for signs of disease cluster, and it, too, flagged the first signs of what would become the COVID-19 outbreak – days before the WHO’s first formal alert.¹³

These innovative applications of AI in health care demonstrate real promise in detecting future outbreaks of new viruses early. This will allow health care providers and public health officials to get information out sooner, reducing the load on health systems, and ultimately, saving lives.
 

Dr. Anderson is chairman and chief executive officer, The Doctors Company and TDC Group.

References

1. Gold A. “Coronavirus tests the value of artificial intelligence in medicine” Fierce Biotech. 2020 May 22.

2. Topol E. “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again” (New York: Hachette Book Group; 2019:285).

3. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

4. Gold A. Coronavirus tests the value of artificial intelligence in medicine. Fierce Biotech. 2020 May 22.

5. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

6. Reuter E. Hundreds of AI solutions proposed for pandemic, but few are proven. MedCity News. 2020 May 28.

7. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

8. Lee K. COVID-19 will accelerate the AI health care revolution. Wired. 2020 May 22.

9. Mei X et al. Artificial intelligence–enabled rapid diagnosis of patients with COVID-19. Nat Med. 2020 May 19;26:1224-8. doi: 10.1038/s41591-020-0931-3.

10. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

11. Wiggers K. Researchers find evidence of racial, gender, and socioeconomic bias in chest X-ray classifiers. The Machine: Making Sense of AI. 2020 Oct 21.

12. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

13. Sewalk K. Innovative disease surveillance platforms detected early warning signs for novel coronavirus outbreak (nCoV-2019). The Disease Daily. 2020 Jan 31.
 

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

Artificial intelligence (AI) has proven of value in the COVID-19 pandemic and shows promise for mitigating future health care crises. During the pandemic’s first wave in New York, for example, Mount Sinai Health System used an algorithm to help identify patients ready for discharge. Such systems can help overburdened hospitals manage personnel and the flow of supplies in a medical crisis so they can continue to provide superior patient care.¹

Pandemic applications have demonstrated AI’s potential not only to lift administrative burdens, but also to give physicians back what Eric Topol, MD, founder and director of Scripps Research Translational Institute and author of Deep Medicine, calls “the gift of time.”² More time with patients contributes to clear communication and positive relationships, which lower the odds of medical errors, enhance patient safety, and potentially reduce physicians’ risks of certain types of litigation.³

However, physicians and health systems will need to approach AI with caution. Many unknowns remain – including potential liability risks and the potential for worsening preexisting bias. The law will need to evolve to account for AI-related liability scenarios, some of which are yet to be imagined.

Like any emerging technology, AI brings risk, but its promise of benefit should outweigh the probability of negative consequences – provided we remain aware of and mitigate the potential for AI-induced adverse events.
 

AI’s pandemic success limited due to fragmented data

Innovation is the key to success in any crisis, and many health care providers have shown their ability to innovate with AI during the pandemic. For example, researchers at the University of California, San Diego, health system who were designing an AI program to help doctors spot pneumonia on a chest x-ray retooled their application to assist physicians fighting coronavirus.⁴

Meanwhile, AI has been used to distinguish COVID-19–specific symptoms: It was a computer sifting medical records that took anosmia, loss of the sense of smell, from an anecdotal connection to an officially recognized early symptom of the virus.⁵ This information now helps physicians distinguish COVID-19 from influenza.

However, holding back more innovation is the fragmentation of health care data in the United States. Most AI applications for medicine rely on machine learning; that is, they train on historical patient data to recognize patterns. Therefore, “Everything that we’re doing gets better with a lot more annotated datasets,” Dr. Topol says. Unfortunately, because of our disparate systems, we don’t have centralized data.⁶ And even if our data were centralized, researchers lack enough reliable COVID-19 data to perfect algorithms in the short term.

Or, put in bleaker terms by the Washington Post: “One of the biggest challenges has been that much data remains siloed inside incompatible computer systems, hoarded by business interests and tangled in geopolitics.”⁷

The good news is that machine learning and data science platform Kaggle is hosting the COVID-19 Open Research Dataset, or CORD-19, which contains well over 100,000 scholarly articles on COVID-19, SARS, and other relevant infections.⁸ In lieu of a true central repository of anonymized health data, such large datasets can help train new AI applications in search of new diagnostic tools and therapies.
 

AI introduces new questions around liability

While AI may eventually be assigned legal personhood, it is not, in fact, a person: It is a tool wielded by individual clinicians, by teams, by health systems, even multiple systems collaborating. Our current liability laws are not ready for the era of digital medicine.

AI algorithms are not perfect. Because we know that diagnostic error is already a major allegation in malpractice claims, we must ask: What happens when a patient alleges that diagnostic error occurred because a physician or physicians leaned too heavily on AI?

In the United States, testing delays have threatened the safety of patients, physicians, and the public by delaying diagnosis of COVID-19. But again, health care providers have applied real innovation – generating novel and useful ideas and applying those ideas – to this problem. For example, researchers at Mount Sinai became the first in the country to combine AI with imaging and clinical data to produce an algorithm that can detect COVID-19 based on computed tomography scans of the chest, in combination with patient information and exposure history.⁹
 

AI in health care can help mitigate bias – or worsen it

Machine learning is only as good as the information provided to train the machine. Models trained on partial datasets can skew toward demographics that turned up more often in the data – for example, White race or men over 60. There is concern that “analyses based on faulty or biased algorithms could exacerbate existing racial gaps and other disparities in health care.”¹⁰ Already during the pandemic’s first waves, multiple AI systems used to classify x-rays have been found to show racial, gender, and socioeconomic biases.¹¹

Such bias could create high potential for poor recommendations, including false positives and false negatives. It’s critical that system builders are able to explain and qualify their training data and that those who best understand AI-related system risks are the ones who influence health care systems or alter applications to mitigate AI-related harms.¹²

AI can help spot the next outbreak

More than a week before the World Health Organization released its first warning about a novel coronavirus, the AI platform BlueDot, created in Toronto, spotted an unusual cluster of pneumonia cases in Wuhan, China. Meanwhile, at Boston Children’s Hospital, the AI application Healthmap was scanning social media and news sites for signs of disease cluster, and it, too, flagged the first signs of what would become the COVID-19 outbreak – days before the WHO’s first formal alert.¹³

These innovative applications of AI in health care demonstrate real promise in detecting future outbreaks of new viruses early. This will allow health care providers and public health officials to get information out sooner, reducing the load on health systems, and ultimately, saving lives.
 

Dr. Anderson is chairman and chief executive officer, The Doctors Company and TDC Group.

References

1. Gold A. “Coronavirus tests the value of artificial intelligence in medicine” Fierce Biotech. 2020 May 22.

2. Topol E. “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again” (New York: Hachette Book Group; 2019:285).

3. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

4. Gold A. Coronavirus tests the value of artificial intelligence in medicine. Fierce Biotech. 2020 May 22.

5. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

6. Reuter E. Hundreds of AI solutions proposed for pandemic, but few are proven. MedCity News. 2020 May 28.

7. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

8. Lee K. COVID-19 will accelerate the AI health care revolution. Wired. 2020 May 22.

9. Mei X et al. Artificial intelligence–enabled rapid diagnosis of patients with COVID-19. Nat Med. 2020 May 19;26:1224-8. doi: 10.1038/s41591-020-0931-3.

10. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

11. Wiggers K. Researchers find evidence of racial, gender, and socioeconomic bias in chest X-ray classifiers. The Machine: Making Sense of AI. 2020 Oct 21.

12. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

13. Sewalk K. Innovative disease surveillance platforms detected early warning signs for novel coronavirus outbreak (nCoV-2019). The Disease Daily. 2020 Jan 31.
 

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

Artificial intelligence (AI) has proven of value in the COVID-19 pandemic and shows promise for mitigating future health care crises. During the pandemic’s first wave in New York, for example, Mount Sinai Health System used an algorithm to help identify patients ready for discharge. Such systems can help overburdened hospitals manage personnel and the flow of supplies in a medical crisis so they can continue to provide superior patient care.¹

Pandemic applications have demonstrated AI’s potential not only to lift administrative burdens, but also to give physicians back what Eric Topol, MD, founder and director of Scripps Research Translational Institute and author of Deep Medicine, calls “the gift of time.”² More time with patients contributes to clear communication and positive relationships, which lower the odds of medical errors, enhance patient safety, and potentially reduce physicians’ risks of certain types of litigation.³

However, physicians and health systems will need to approach AI with caution. Many unknowns remain – including potential liability risks and the potential for worsening preexisting bias. The law will need to evolve to account for AI-related liability scenarios, some of which are yet to be imagined.

Like any emerging technology, AI brings risk, but its promise of benefit should outweigh the probability of negative consequences – provided we remain aware of and mitigate the potential for AI-induced adverse events.
 

AI’s pandemic success limited due to fragmented data

Innovation is the key to success in any crisis, and many health care providers have shown their ability to innovate with AI during the pandemic. For example, researchers at the University of California, San Diego, health system who were designing an AI program to help doctors spot pneumonia on a chest x-ray retooled their application to assist physicians fighting coronavirus.⁴

Meanwhile, AI has been used to distinguish COVID-19–specific symptoms: It was a computer sifting medical records that took anosmia, loss of the sense of smell, from an anecdotal connection to an officially recognized early symptom of the virus.⁵ This information now helps physicians distinguish COVID-19 from influenza.

However, holding back more innovation is the fragmentation of health care data in the United States. Most AI applications for medicine rely on machine learning; that is, they train on historical patient data to recognize patterns. Therefore, “Everything that we’re doing gets better with a lot more annotated datasets,” Dr. Topol says. Unfortunately, because of our disparate systems, we don’t have centralized data.⁶ And even if our data were centralized, researchers lack enough reliable COVID-19 data to perfect algorithms in the short term.

Or, put in bleaker terms by the Washington Post: “One of the biggest challenges has been that much data remains siloed inside incompatible computer systems, hoarded by business interests and tangled in geopolitics.”⁷

The good news is that machine learning and data science platform Kaggle is hosting the COVID-19 Open Research Dataset, or CORD-19, which contains well over 100,000 scholarly articles on COVID-19, SARS, and other relevant infections.⁸ In lieu of a true central repository of anonymized health data, such large datasets can help train new AI applications in search of new diagnostic tools and therapies.
 

AI introduces new questions around liability

While AI may eventually be assigned legal personhood, it is not, in fact, a person: It is a tool wielded by individual clinicians, by teams, by health systems, even multiple systems collaborating. Our current liability laws are not ready for the era of digital medicine.

AI algorithms are not perfect. Because we know that diagnostic error is already a major allegation in malpractice claims, we must ask: What happens when a patient alleges that diagnostic error occurred because a physician or physicians leaned too heavily on AI?

In the United States, testing delays have threatened the safety of patients, physicians, and the public by delaying diagnosis of COVID-19. But again, health care providers have applied real innovation – generating novel and useful ideas and applying those ideas – to this problem. For example, researchers at Mount Sinai became the first in the country to combine AI with imaging and clinical data to produce an algorithm that can detect COVID-19 based on computed tomography scans of the chest, in combination with patient information and exposure history.⁹
 

AI in health care can help mitigate bias – or worsen it

Machine learning is only as good as the information provided to train the machine. Models trained on partial datasets can skew toward demographics that turned up more often in the data – for example, White race or men over 60. There is concern that “analyses based on faulty or biased algorithms could exacerbate existing racial gaps and other disparities in health care.”¹⁰ Already during the pandemic’s first waves, multiple AI systems used to classify x-rays have been found to show racial, gender, and socioeconomic biases.¹¹

Such bias could create high potential for poor recommendations, including false positives and false negatives. It’s critical that system builders are able to explain and qualify their training data and that those who best understand AI-related system risks are the ones who influence health care systems or alter applications to mitigate AI-related harms.¹²

AI can help spot the next outbreak

More than a week before the World Health Organization released its first warning about a novel coronavirus, the AI platform BlueDot, created in Toronto, spotted an unusual cluster of pneumonia cases in Wuhan, China. Meanwhile, at Boston Children’s Hospital, the AI application Healthmap was scanning social media and news sites for signs of disease cluster, and it, too, flagged the first signs of what would become the COVID-19 outbreak – days before the WHO’s first formal alert.¹³

These innovative applications of AI in health care demonstrate real promise in detecting future outbreaks of new viruses early. This will allow health care providers and public health officials to get information out sooner, reducing the load on health systems, and ultimately, saving lives.
 

Dr. Anderson is chairman and chief executive officer, The Doctors Company and TDC Group.

References

1. Gold A. “Coronavirus tests the value of artificial intelligence in medicine” Fierce Biotech. 2020 May 22.

2. Topol E. “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again” (New York: Hachette Book Group; 2019:285).

3. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

4. Gold A. Coronavirus tests the value of artificial intelligence in medicine. Fierce Biotech. 2020 May 22.

5. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

6. Reuter E. Hundreds of AI solutions proposed for pandemic, but few are proven. MedCity News. 2020 May 28.

7. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

8. Lee K. COVID-19 will accelerate the AI health care revolution. Wired. 2020 May 22.

9. Mei X et al. Artificial intelligence–enabled rapid diagnosis of patients with COVID-19. Nat Med. 2020 May 19;26:1224-8. doi: 10.1038/s41591-020-0931-3.

10. Cha AE. Artificial intelligence and COVID-19: Can the machines save us? Washington Post. 2020 Nov 1.

11. Wiggers K. Researchers find evidence of racial, gender, and socioeconomic bias in chest X-ray classifiers. The Machine: Making Sense of AI. 2020 Oct 21.

12. The Doctors Company. “The Algorithm Will See You Now: How AI’s Healthcare Potential Outweighs Its Risk” 2020 Jan.

13. Sewalk K. Innovative disease surveillance platforms detected early warning signs for novel coronavirus outbreak (nCoV-2019). The Disease Daily. 2020 Jan 31.
 

The incidence of type 2 diabetes in children appears to have doubled during the COVID-19 pandemic, data from two new U.S. studies suggest, with the lead investigator of one saying she was “surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”

Anetta_R/Thinkstock

Findings from the two separate retrospective chart reviews – one conducted in Washington, D.C., and the other in Baton Rouge, La. – were presented June 25 at the annual scientific sessions of the American Diabetes Association.

Although the two studies differed somewhat in the clinical parameters examined, both revealed a similar doubling of the rates of hospitalizations for type 2 diabetes among youth during 2020, compared with the same time period in 2019, as well as greater severity of metabolic disturbance.

And, as has been previously described with type 2 diabetes in youth, African American ethnicity predominated in both cohorts.

“Although we could not assess the cause of the increases in type 2 diabetes from our data, these disparities suggest that indirect effects of social distancing measures, including school closure and unemployment, are placing undue burden on underserved communities. Decreases in well-child care and fears of seeking medical care during the pandemic may have also contributed,” lead investigator of one of the studies, pediatric endocrinologist Brynn E. Marks, MD, Children’s National Hospital, Washington, said in an interview.
 

More hospitalizations, racial disparities aggravated by COVID-19

Lead author of the other study, Daniel S. Hsia, MD, Pennington Biomedical Research Center, Baton Rouge, said in an interview: “Since the pandemic, our data suggest that more children may be diagnosed with type 2 diabetes and may require hospitalization when they are diagnosed. Looking at both datasets, there appears to be a racial disparity in type 2 diabetes diagnoses that has only been exacerbated by the COVID-19 pandemic.”

Of concern, Dr. Hsia said, “The incidence rate of type 2 diabetes in children was already on the rise before the pandemic. While there may be a brief leveling off now that children are getting regular health care and going back to school in person, I believe these rates will continue to rise especially in light of the childhood obesity rates not improving.”

Their dataset captured all youth who were newly diagnosed with type 2 diabetes during the first full year of the COVID-19 pandemic, from March 11, 2020, to March 10, 2021, and compared those data with the time period from March 11, 2019, to March 10, 2020.

During the pandemic, the number of cases of type 2 diabetes increased by 182%, from 50 in 2019 to 141 in 2020. The average age at diagnosis was about 14 years in both time periods.

In the prepandemic period, 18 (36%) diagnosed with type 2 diabetes required inpatient admission, compared with 85 (60.3%) during the pandemic. At Children’s National, youth with suspected new-onset type 2 diabetes aren’t typically hospitalized unless they have severe hyperglycemia, ketosis, or are unable to schedule urgent outpatient follow-up, Dr. Marks noted.

The proportions of youth with new-onset type 2 diabetes who presented in diabetic ketoacidosis (DKA) rose from 2 (4%) prepandemic to 33 (23.4%) during the pandemic. Presentation with hyperosmolar DKA rose from 0 to 13 (9.2%).

However, during the pandemic only five youth were actively infected with SARS-CoV-2 at the time of type 2 diabetes diagnosis among the 90 tested.

Dr. Marks said: “We believe the increase in inpatient admissions was due to more severe presentation during the pandemic. ...We were surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”
 

Shift in diagnoses to type 2 diabetes

The pandemic also appears to have shifted the proportion of youth diagnosed with type 2 diabetes, compared with type 1 diabetes. Whereas 24% of youth with new-onset diabetes prepandemic had type 2 diabetes and the rest had type 1 diabetes, during pandemic the proportion with type 2 diabetes rose to 44%.

“Rates of type 2 diabetes rose steadily at a rate of 1.45 cases per month throughout the course of the pandemic, suggesting a cumulative effect of the indirect effects of social distancing measures,” Dr. Marks said.

Furthermore, she added, whereas 60% of youth diagnosed with type 2 diabetes before the pandemic were female, the rate fell to 40% during the pandemic. This trend might be because of activity levels in that, while male adolescents are typically more active, rates of exercise fell in both sexes during the pandemic but declined more sharply in males such that activity levels between the sexes became equal.  

Although type 2 diabetes in youth has always been more common in ethnic minorities, the pandemic appears to have exacerbated these disparities.

While 58% of youth diagnosed with type 2 diabetes prepandemic identified as non-Hispanic Black, that proportion rose to 76.7% during the pandemic. Among Black youth with new-onset type 2 diabetes, 31 of 33 presented in DKA, and 12 of the 13 who presented in hyperosmolar DKA during the pandemic were Black.

“Strategies to promote health equity and address the undue burden of the COVID-19 pandemic on underserved communities must be developed to avoid worsening disparities and long-term health outcomes,” Dr. Marks said.
 

‘A microcosm’: Similar findings in a smaller population

Dr. Hsia and colleagues looked at a smaller number of patients in a shorter time period. In March–December 2019, the hospitalization rate for new-onset type 2 diabetes was 0.27% (8 out of 2,964 hospitalizations), compared with 0.62% (17 out of 2,729 hospitalizations) during the same period in 2020 (P < .048) – also more than a doubling. Age at admission, sex, and body mass index didn’t differ between the two groups.

Criteria for DKA were met by three children in 2019 versus eight in 2020, and hyperosmolar hyperglycemic syndrome in zero versus two, respectively. Mean hemoglobin A1c on admission was 12.4% in 2019 versus 13.1% in 2020 (P = .59), and mean serum glucose was 441 mg/dL versus 669 mg/dL (P = .14), respectively. Serum osmolality on admission was 314 mmol/kg in 2019 versus 335 mmol/kg in 2020 (P = .19).

“Clinically speaking the differences in the lab values were significant, but we did not have enough numbers ... to see a statistically significant difference. I think by looking at more centers, our site likely represents a microcosm of what is happening across the country,” Dr. Hsia said.

In 2019, 7 of the 8 children were African American, as were 16 of the 17 children in 2020. The other single child in each group was White.

Dr. Hsia said: “Larger studies that include more patients are needed to confirm our initial findings. More research is needed to understand why this increasing trend of type 2 diabetes diagnoses in children may be occurring [and] to better understand how stay-at-home orders and other restrictions due to COVID-19 have worsened risk factors for type 2 diabetes.”

“These include decreased physical activity, more screen time, disturbed sleep, and increased intake of processed foods, which can all lead to weight gain,” he concluded.

Dr. Marks reported receiving research support from Tandem, Dexcom, and the Cystic Fibrosis Foundation. Dr. Hsia reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The incidence of type 2 diabetes in children appears to have doubled during the COVID-19 pandemic, data from two new U.S. studies suggest, with the lead investigator of one saying she was “surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”

Anetta_R/Thinkstock

Findings from the two separate retrospective chart reviews – one conducted in Washington, D.C., and the other in Baton Rouge, La. – were presented June 25 at the annual scientific sessions of the American Diabetes Association.

Although the two studies differed somewhat in the clinical parameters examined, both revealed a similar doubling of the rates of hospitalizations for type 2 diabetes among youth during 2020, compared with the same time period in 2019, as well as greater severity of metabolic disturbance.

And, as has been previously described with type 2 diabetes in youth, African American ethnicity predominated in both cohorts.

“Although we could not assess the cause of the increases in type 2 diabetes from our data, these disparities suggest that indirect effects of social distancing measures, including school closure and unemployment, are placing undue burden on underserved communities. Decreases in well-child care and fears of seeking medical care during the pandemic may have also contributed,” lead investigator of one of the studies, pediatric endocrinologist Brynn E. Marks, MD, Children’s National Hospital, Washington, said in an interview.
 

More hospitalizations, racial disparities aggravated by COVID-19

Lead author of the other study, Daniel S. Hsia, MD, Pennington Biomedical Research Center, Baton Rouge, said in an interview: “Since the pandemic, our data suggest that more children may be diagnosed with type 2 diabetes and may require hospitalization when they are diagnosed. Looking at both datasets, there appears to be a racial disparity in type 2 diabetes diagnoses that has only been exacerbated by the COVID-19 pandemic.”

Of concern, Dr. Hsia said, “The incidence rate of type 2 diabetes in children was already on the rise before the pandemic. While there may be a brief leveling off now that children are getting regular health care and going back to school in person, I believe these rates will continue to rise especially in light of the childhood obesity rates not improving.”

Their dataset captured all youth who were newly diagnosed with type 2 diabetes during the first full year of the COVID-19 pandemic, from March 11, 2020, to March 10, 2021, and compared those data with the time period from March 11, 2019, to March 10, 2020.

During the pandemic, the number of cases of type 2 diabetes increased by 182%, from 50 in 2019 to 141 in 2020. The average age at diagnosis was about 14 years in both time periods.

In the prepandemic period, 18 (36%) diagnosed with type 2 diabetes required inpatient admission, compared with 85 (60.3%) during the pandemic. At Children’s National, youth with suspected new-onset type 2 diabetes aren’t typically hospitalized unless they have severe hyperglycemia, ketosis, or are unable to schedule urgent outpatient follow-up, Dr. Marks noted.

The proportions of youth with new-onset type 2 diabetes who presented in diabetic ketoacidosis (DKA) rose from 2 (4%) prepandemic to 33 (23.4%) during the pandemic. Presentation with hyperosmolar DKA rose from 0 to 13 (9.2%).

However, during the pandemic only five youth were actively infected with SARS-CoV-2 at the time of type 2 diabetes diagnosis among the 90 tested.

Dr. Marks said: “We believe the increase in inpatient admissions was due to more severe presentation during the pandemic. ...We were surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”
 

Shift in diagnoses to type 2 diabetes

The pandemic also appears to have shifted the proportion of youth diagnosed with type 2 diabetes, compared with type 1 diabetes. Whereas 24% of youth with new-onset diabetes prepandemic had type 2 diabetes and the rest had type 1 diabetes, during pandemic the proportion with type 2 diabetes rose to 44%.

“Rates of type 2 diabetes rose steadily at a rate of 1.45 cases per month throughout the course of the pandemic, suggesting a cumulative effect of the indirect effects of social distancing measures,” Dr. Marks said.

Furthermore, she added, whereas 60% of youth diagnosed with type 2 diabetes before the pandemic were female, the rate fell to 40% during the pandemic. This trend might be because of activity levels in that, while male adolescents are typically more active, rates of exercise fell in both sexes during the pandemic but declined more sharply in males such that activity levels between the sexes became equal.  

Although type 2 diabetes in youth has always been more common in ethnic minorities, the pandemic appears to have exacerbated these disparities.

While 58% of youth diagnosed with type 2 diabetes prepandemic identified as non-Hispanic Black, that proportion rose to 76.7% during the pandemic. Among Black youth with new-onset type 2 diabetes, 31 of 33 presented in DKA, and 12 of the 13 who presented in hyperosmolar DKA during the pandemic were Black.

“Strategies to promote health equity and address the undue burden of the COVID-19 pandemic on underserved communities must be developed to avoid worsening disparities and long-term health outcomes,” Dr. Marks said.
 

‘A microcosm’: Similar findings in a smaller population

Dr. Hsia and colleagues looked at a smaller number of patients in a shorter time period. In March–December 2019, the hospitalization rate for new-onset type 2 diabetes was 0.27% (8 out of 2,964 hospitalizations), compared with 0.62% (17 out of 2,729 hospitalizations) during the same period in 2020 (P < .048) – also more than a doubling. Age at admission, sex, and body mass index didn’t differ between the two groups.

Criteria for DKA were met by three children in 2019 versus eight in 2020, and hyperosmolar hyperglycemic syndrome in zero versus two, respectively. Mean hemoglobin A1c on admission was 12.4% in 2019 versus 13.1% in 2020 (P = .59), and mean serum glucose was 441 mg/dL versus 669 mg/dL (P = .14), respectively. Serum osmolality on admission was 314 mmol/kg in 2019 versus 335 mmol/kg in 2020 (P = .19).

“Clinically speaking the differences in the lab values were significant, but we did not have enough numbers ... to see a statistically significant difference. I think by looking at more centers, our site likely represents a microcosm of what is happening across the country,” Dr. Hsia said.

In 2019, 7 of the 8 children were African American, as were 16 of the 17 children in 2020. The other single child in each group was White.

Dr. Hsia said: “Larger studies that include more patients are needed to confirm our initial findings. More research is needed to understand why this increasing trend of type 2 diabetes diagnoses in children may be occurring [and] to better understand how stay-at-home orders and other restrictions due to COVID-19 have worsened risk factors for type 2 diabetes.”

“These include decreased physical activity, more screen time, disturbed sleep, and increased intake of processed foods, which can all lead to weight gain,” he concluded.

Dr. Marks reported receiving research support from Tandem, Dexcom, and the Cystic Fibrosis Foundation. Dr. Hsia reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The incidence of type 2 diabetes in children appears to have doubled during the COVID-19 pandemic, data from two new U.S. studies suggest, with the lead investigator of one saying she was “surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”

Anetta_R/Thinkstock

Findings from the two separate retrospective chart reviews – one conducted in Washington, D.C., and the other in Baton Rouge, La. – were presented June 25 at the annual scientific sessions of the American Diabetes Association.

Although the two studies differed somewhat in the clinical parameters examined, both revealed a similar doubling of the rates of hospitalizations for type 2 diabetes among youth during 2020, compared with the same time period in 2019, as well as greater severity of metabolic disturbance.

And, as has been previously described with type 2 diabetes in youth, African American ethnicity predominated in both cohorts.

“Although we could not assess the cause of the increases in type 2 diabetes from our data, these disparities suggest that indirect effects of social distancing measures, including school closure and unemployment, are placing undue burden on underserved communities. Decreases in well-child care and fears of seeking medical care during the pandemic may have also contributed,” lead investigator of one of the studies, pediatric endocrinologist Brynn E. Marks, MD, Children’s National Hospital, Washington, said in an interview.
 

More hospitalizations, racial disparities aggravated by COVID-19

Lead author of the other study, Daniel S. Hsia, MD, Pennington Biomedical Research Center, Baton Rouge, said in an interview: “Since the pandemic, our data suggest that more children may be diagnosed with type 2 diabetes and may require hospitalization when they are diagnosed. Looking at both datasets, there appears to be a racial disparity in type 2 diabetes diagnoses that has only been exacerbated by the COVID-19 pandemic.”

Of concern, Dr. Hsia said, “The incidence rate of type 2 diabetes in children was already on the rise before the pandemic. While there may be a brief leveling off now that children are getting regular health care and going back to school in person, I believe these rates will continue to rise especially in light of the childhood obesity rates not improving.”

Their dataset captured all youth who were newly diagnosed with type 2 diabetes during the first full year of the COVID-19 pandemic, from March 11, 2020, to March 10, 2021, and compared those data with the time period from March 11, 2019, to March 10, 2020.

During the pandemic, the number of cases of type 2 diabetes increased by 182%, from 50 in 2019 to 141 in 2020. The average age at diagnosis was about 14 years in both time periods.

In the prepandemic period, 18 (36%) diagnosed with type 2 diabetes required inpatient admission, compared with 85 (60.3%) during the pandemic. At Children’s National, youth with suspected new-onset type 2 diabetes aren’t typically hospitalized unless they have severe hyperglycemia, ketosis, or are unable to schedule urgent outpatient follow-up, Dr. Marks noted.

The proportions of youth with new-onset type 2 diabetes who presented in diabetic ketoacidosis (DKA) rose from 2 (4%) prepandemic to 33 (23.4%) during the pandemic. Presentation with hyperosmolar DKA rose from 0 to 13 (9.2%).

However, during the pandemic only five youth were actively infected with SARS-CoV-2 at the time of type 2 diabetes diagnosis among the 90 tested.

Dr. Marks said: “We believe the increase in inpatient admissions was due to more severe presentation during the pandemic. ...We were surprised by the staggering increase in cases of type 2 diabetes ... and the increase in severity of presentation.”
 

Shift in diagnoses to type 2 diabetes

The pandemic also appears to have shifted the proportion of youth diagnosed with type 2 diabetes, compared with type 1 diabetes. Whereas 24% of youth with new-onset diabetes prepandemic had type 2 diabetes and the rest had type 1 diabetes, during pandemic the proportion with type 2 diabetes rose to 44%.

“Rates of type 2 diabetes rose steadily at a rate of 1.45 cases per month throughout the course of the pandemic, suggesting a cumulative effect of the indirect effects of social distancing measures,” Dr. Marks said.

Furthermore, she added, whereas 60% of youth diagnosed with type 2 diabetes before the pandemic were female, the rate fell to 40% during the pandemic. This trend might be because of activity levels in that, while male adolescents are typically more active, rates of exercise fell in both sexes during the pandemic but declined more sharply in males such that activity levels between the sexes became equal.  

Although type 2 diabetes in youth has always been more common in ethnic minorities, the pandemic appears to have exacerbated these disparities.

While 58% of youth diagnosed with type 2 diabetes prepandemic identified as non-Hispanic Black, that proportion rose to 76.7% during the pandemic. Among Black youth with new-onset type 2 diabetes, 31 of 33 presented in DKA, and 12 of the 13 who presented in hyperosmolar DKA during the pandemic were Black.

“Strategies to promote health equity and address the undue burden of the COVID-19 pandemic on underserved communities must be developed to avoid worsening disparities and long-term health outcomes,” Dr. Marks said.
 

‘A microcosm’: Similar findings in a smaller population

Dr. Hsia and colleagues looked at a smaller number of patients in a shorter time period. In March–December 2019, the hospitalization rate for new-onset type 2 diabetes was 0.27% (8 out of 2,964 hospitalizations), compared with 0.62% (17 out of 2,729 hospitalizations) during the same period in 2020 (P < .048) – also more than a doubling. Age at admission, sex, and body mass index didn’t differ between the two groups.

Criteria for DKA were met by three children in 2019 versus eight in 2020, and hyperosmolar hyperglycemic syndrome in zero versus two, respectively. Mean hemoglobin A1c on admission was 12.4% in 2019 versus 13.1% in 2020 (P = .59), and mean serum glucose was 441 mg/dL versus 669 mg/dL (P = .14), respectively. Serum osmolality on admission was 314 mmol/kg in 2019 versus 335 mmol/kg in 2020 (P = .19).

“Clinically speaking the differences in the lab values were significant, but we did not have enough numbers ... to see a statistically significant difference. I think by looking at more centers, our site likely represents a microcosm of what is happening across the country,” Dr. Hsia said.

In 2019, 7 of the 8 children were African American, as were 16 of the 17 children in 2020. The other single child in each group was White.

Dr. Hsia said: “Larger studies that include more patients are needed to confirm our initial findings. More research is needed to understand why this increasing trend of type 2 diabetes diagnoses in children may be occurring [and] to better understand how stay-at-home orders and other restrictions due to COVID-19 have worsened risk factors for type 2 diabetes.”

“These include decreased physical activity, more screen time, disturbed sleep, and increased intake of processed foods, which can all lead to weight gain,” he concluded.

Dr. Marks reported receiving research support from Tandem, Dexcom, and the Cystic Fibrosis Foundation. Dr. Hsia reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Tirzepatide, a novel “twincretin” agent, was superior to 1-mg semaglutide treatments for reducing both hemoglobin A1c levels and body weight in patients with type 2 diabetes in a pivotal, 40-week, head-to-head trial with nearly 1,900 randomized patients, one of four positive pivotal trial results reported for tirzepatide at the annual scientific sessions of the American Diabetes Association.

“Across all four studies we see a significant and clinically meaningful decrease in A1c, and robust weight loss. The results exceeded our expectations” for both these outcomes, said Laura Fernández Landó, MD, senior medical director for tirzepatide at Lilly, the company developing the agent, and a coauthor on the semaglutide comparison study as well as on other tirzepatide reports at the meeting.

“This opens up a new avenue for results in diabetes therapy,” Jens Juul Holst, MD, remarked in a press conference.

SURPASS-2 compared three different tirzepatide doses delivered once weekly by subcutaneous injection against a 1-mg weekly, subcutaneous dose of semaglutide (Ozempic) in 1,879 adults who had been diagnosed with type 2 diabetes for an average of almost 9 years. All patients were already on metformin treatment that had proved inadequate for controlling their hyperglycemia; enrolled patients had an average A1c of 8.28%. The trial’s primary endpoint was change from baseline in A1c levels after 40 weeks.
 

Significant differences at each dose level

Patients on each of the three tirzepatide doses – 5 mg, 10 mg, or 15 mg once weekly – showed dose-dependent reductions in A1c that, for each dose, were significantly better than the reduction achieved with semaglutide. The highest tirzepatide dose reduced A1c levels by an average of 0.45% more than what semaglutide achieved, reported first author Juan P. Frias, MD; Dr. Landó; and their coauthors.

One key secondary endpoint was weight reduction, and each of the three tirzepatide doses again produced significant incremental loss beyond what semaglutide produced. The 5-mg weekly dose of tirzepatide produced an average 1.9-kg additional weight loss, compared with semaglutide, while the 15-mg dose resulted in an average 5.5-kg loss beyond what semaglutide achieved and a total average weight loss of 11.2 kg from baseline.

The study’s additional key secondary endpoints, the percentages of patients reaching an A1c of less than 7%, and less than 5.7%, also showed significantly better numbers with tirzepatide. The highest tirzepatide dose pushed 86% of patients below the 7% mark, compared with 79% on semaglutide, and the top tirzepatide dose resulted in 46% of patients getting their A1c below 5.7%, compared with 19% of patients on semaglutide.

The findings are “stunning, I must stay, and those results included that up to half of the patients treated with high doses of tirzepatide may reach A1c levels of less than 5.7%, which is really, really unheard of,” said Dr. Holst, professor of endocrinology and metabolism at the University of Copenhagen. Along with the “weight losses at the same time of up to 12% in that patient group, we are seeing some completely unexpected and really shocking and wonderful new advances in the therapy,” added Dr. Holst.

The safety profile of tirzepatide was roughly similar to semaglutide’s and to that other agents in the glucagonlike peptide-1 receptor agonist (GLP-1 RA) class. Concurrently with the report at the meeting, the results also appeared in an article published online in the New England Journal of Medicine.
 

An ‘impressive’ weight loss effect

Weight loss on tirzepatide was “impressive,” commented Katherine R. Tuttle, MD, a nephrologist affiliated with the University of Washington and executive director for research at Providence Health Care in Spokane, Wash. Another striking feature of tirzepatide’s weight-loss effect was that it did not plateau during the 40 weeks of the study, Dr. Tuttle noted in an accompanying editorial that accompanied the published report, a finding that suggests the potential for additional weight loss from continued treatment .

“The weight loss is remarkable,” commented Rodolfo J. Galindo, MD, an endocrinologist at Emory University, Atlanta. While incremental reduction of A1c on the order of less than 0.5% is helpful, incremental weight loss of more than 10 lbs on tirzepatide, compared with semaglutide “will likely be a tie-breaker” for many clinicians and patients to favor tirzepatide over semaglutide or another GLP-1 RA agent, he said in an interview. Dr. Galindo also cited other important factors that he predicted will drive decisions on using tirzepatide or a GLP-1 RA once tirzepatide reaches the U.S. market: relative cost, access, and tolerability.
 

The important issue of dose

But the edge that tirzepatide showed over semaglutide for weight loss did not occur on a completely level playing field. The 1 mg/week dose of semaglutide used as the comparator in SURPASS-2 was the maximum dose available at the time the study began, but in June 2021 the Food and Drug Administration approved a 2.4 mg/week dose (Wegovy) labeled specifically for weight loss. Dr. Tuttle cited the limitation this introduces in her editorial.

“The dose issue is important,” she wrote. The doses of tirzepatide and semaglutide compared in SURPASS-2 “were not comparable in terms of weight outcomes” given that prior evidence showed that the 2.4 mg/week semaglutide dose is more appropriate for weight loss.

Dr. Tuttle also cited other factors to consider when assessing tirzepatide compared with agents in the GLP-1 RA class.

Several GLP-1 RA agents, including semaglutide, have proven efficacy for reducing rates of atherosclerotic cardiovascular events and albuminuria, and they also slow decline in kidney function and progression of diabetic kidney disease. No details on the renal effects of tirzepatide appeared in the SURPASS-2 report. A press release from Lilly in May 2021 briefly mentioned results from a meta-analysis of several clinical studies of tirzepatide that showed a nonsignificant effect from tirzepatide on the incidence of major cardiovascular adverse events (death from cardiovascular or undetermined causes, MI, stroke, and hospitalization for unstable angina) relative to comparator groups. Results from a dedicated cardiovascular outcomes trial in high-risk patients treated with tirzepatide, SURPASS-CVOT, are not expected until 2024.

A further limitation of SURPASS-2 was the demographics of the enrolled population, which had a low (0.4%) enrollment rate of Black patients, and a high proportion (70%) of Hispanic patients, Dr. Tuttle observed.
 

Low rates of hypoglycemia

Another notable finding from SURPASS-2 was the low incidence of clinically significant hypoglycemic events (blood glucose levels less than 54 mg/dL), which occurred in 0.2%-1.7% of patients on tirzepatide, depending on their dose, and in 0.4% of patients on semaglutide. Two patients in the tirzepatide cohort had severe hypoglycemia.

These numbers are reassuring, said Dr. Galindo, and reflect the safety of tirzepatide’s dual, incretin-like mechanisms of action that make it a “twincretin.” The molecule acts as both a GLP-1 RA, and as glucose-dependent insulinotropic polypeptide, an incretin that stimulates insulin release when blood sugar is high but also increases glucagon levels when blood sugar levels are normal or low. This dual action may help explain the apparent increased potency tirzepatide showed for both A1c reduction and weight loss, compared with semaglutide, which acts only as a GLP-1 RA.

Some experts have cited the uncertainty introduced by the open-label design of SURPASS-2, a decision necessitated by the distinctly different delivery devices used for tirzepatide and semaglutide, explained Dr. Landó. But she highlighted that double blinding applied to the three different tirzepatide dosages tested in the trial. Dr. Landó said that Lilly plans to seek FDA approval for all three tested tirzepatide doses to give clinicians and patients flexibility in applying the treatment.

SURPASS-2 used a prolonged dose-escalation protocol designed to minimize gastrointestinal adverse effects that started patients on a 2.5 mg weekly dose that then increased by 2.5 mg increments every 4 weeks until patients reached their assigned target dose. This meant that patients did not begin receiving the 15-mg/week dose until halfway through the trial.
 

Several more tirzepatide trials

Reports from two other pivotal trials for tirzepatide also appeared as posters at the meeting. SURPASS-5 compared tirzepatide with placebo in 475 patients inadequately controlled with titrated insulin glargine (Lantus). SURPASS-3 randomized 1,444 patients to tirzepatide or titrated insulin degludec (Tresiba). In both studies treatment with tirzepatide led to significantly better reductions in A1c and in weight loss than the comparator treatments. Results from a third pivotal trial, SURPASS-1 which compared tirzepatide against placebo in 478 treatment-naive patients, will come in a report scheduled for the second day of the meeting.

The results from all the recent tirzepatide trials show a consistent benefit across the continuum of patients with type 2 diabetes regardless of whether it’s recent onset or well-established disease, said Dr. Landó.

The SURPASS studies were sponsored by Lilly, the company developing tirzepatide, and the reports include several authors who are Lilly employees. Dr. Landó is a Lilly employee and stockholder. Dr. Tuttle has been a consultant to Lilly and to Novo Nordisk, the company that markets semaglutide, as well as to AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, and Janssen. She has also received travel expenses from Kyokawa Hakko Kirin, and research funding from Bayer, Goldfinch Bio, and Lilly. Dr. Galindo has been a consultant to Lilly and to Novo Nordisk, as well as to Abbott Diabetes Care, Sanofi, Valeritas, and Weight Watchers, and his institution has received grant support on his behalf from Lilly, Novo Nordisk and Dexcom. Dr. Holst had no disclosures.

[email protected]

Tirzepatide, a novel “twincretin” agent, was superior to 1-mg semaglutide treatments for reducing both hemoglobin A1c levels and body weight in patients with type 2 diabetes in a pivotal, 40-week, head-to-head trial with nearly 1,900 randomized patients, one of four positive pivotal trial results reported for tirzepatide at the annual scientific sessions of the American Diabetes Association.

“Across all four studies we see a significant and clinically meaningful decrease in A1c, and robust weight loss. The results exceeded our expectations” for both these outcomes, said Laura Fernández Landó, MD, senior medical director for tirzepatide at Lilly, the company developing the agent, and a coauthor on the semaglutide comparison study as well as on other tirzepatide reports at the meeting.

“This opens up a new avenue for results in diabetes therapy,” Jens Juul Holst, MD, remarked in a press conference.

SURPASS-2 compared three different tirzepatide doses delivered once weekly by subcutaneous injection against a 1-mg weekly, subcutaneous dose of semaglutide (Ozempic) in 1,879 adults who had been diagnosed with type 2 diabetes for an average of almost 9 years. All patients were already on metformin treatment that had proved inadequate for controlling their hyperglycemia; enrolled patients had an average A1c of 8.28%. The trial’s primary endpoint was change from baseline in A1c levels after 40 weeks.
 

Significant differences at each dose level

Patients on each of the three tirzepatide doses – 5 mg, 10 mg, or 15 mg once weekly – showed dose-dependent reductions in A1c that, for each dose, were significantly better than the reduction achieved with semaglutide. The highest tirzepatide dose reduced A1c levels by an average of 0.45% more than what semaglutide achieved, reported first author Juan P. Frias, MD; Dr. Landó; and their coauthors.

One key secondary endpoint was weight reduction, and each of the three tirzepatide doses again produced significant incremental loss beyond what semaglutide produced. The 5-mg weekly dose of tirzepatide produced an average 1.9-kg additional weight loss, compared with semaglutide, while the 15-mg dose resulted in an average 5.5-kg loss beyond what semaglutide achieved and a total average weight loss of 11.2 kg from baseline.

The study’s additional key secondary endpoints, the percentages of patients reaching an A1c of less than 7%, and less than 5.7%, also showed significantly better numbers with tirzepatide. The highest tirzepatide dose pushed 86% of patients below the 7% mark, compared with 79% on semaglutide, and the top tirzepatide dose resulted in 46% of patients getting their A1c below 5.7%, compared with 19% of patients on semaglutide.

The findings are “stunning, I must stay, and those results included that up to half of the patients treated with high doses of tirzepatide may reach A1c levels of less than 5.7%, which is really, really unheard of,” said Dr. Holst, professor of endocrinology and metabolism at the University of Copenhagen. Along with the “weight losses at the same time of up to 12% in that patient group, we are seeing some completely unexpected and really shocking and wonderful new advances in the therapy,” added Dr. Holst.

The safety profile of tirzepatide was roughly similar to semaglutide’s and to that other agents in the glucagonlike peptide-1 receptor agonist (GLP-1 RA) class. Concurrently with the report at the meeting, the results also appeared in an article published online in the New England Journal of Medicine.
 

An ‘impressive’ weight loss effect

Weight loss on tirzepatide was “impressive,” commented Katherine R. Tuttle, MD, a nephrologist affiliated with the University of Washington and executive director for research at Providence Health Care in Spokane, Wash. Another striking feature of tirzepatide’s weight-loss effect was that it did not plateau during the 40 weeks of the study, Dr. Tuttle noted in an accompanying editorial that accompanied the published report, a finding that suggests the potential for additional weight loss from continued treatment .

“The weight loss is remarkable,” commented Rodolfo J. Galindo, MD, an endocrinologist at Emory University, Atlanta. While incremental reduction of A1c on the order of less than 0.5% is helpful, incremental weight loss of more than 10 lbs on tirzepatide, compared with semaglutide “will likely be a tie-breaker” for many clinicians and patients to favor tirzepatide over semaglutide or another GLP-1 RA agent, he said in an interview. Dr. Galindo also cited other important factors that he predicted will drive decisions on using tirzepatide or a GLP-1 RA once tirzepatide reaches the U.S. market: relative cost, access, and tolerability.
 

The important issue of dose

But the edge that tirzepatide showed over semaglutide for weight loss did not occur on a completely level playing field. The 1 mg/week dose of semaglutide used as the comparator in SURPASS-2 was the maximum dose available at the time the study began, but in June 2021 the Food and Drug Administration approved a 2.4 mg/week dose (Wegovy) labeled specifically for weight loss. Dr. Tuttle cited the limitation this introduces in her editorial.

“The dose issue is important,” she wrote. The doses of tirzepatide and semaglutide compared in SURPASS-2 “were not comparable in terms of weight outcomes” given that prior evidence showed that the 2.4 mg/week semaglutide dose is more appropriate for weight loss.

Dr. Tuttle also cited other factors to consider when assessing tirzepatide compared with agents in the GLP-1 RA class.

Several GLP-1 RA agents, including semaglutide, have proven efficacy for reducing rates of atherosclerotic cardiovascular events and albuminuria, and they also slow decline in kidney function and progression of diabetic kidney disease. No details on the renal effects of tirzepatide appeared in the SURPASS-2 report. A press release from Lilly in May 2021 briefly mentioned results from a meta-analysis of several clinical studies of tirzepatide that showed a nonsignificant effect from tirzepatide on the incidence of major cardiovascular adverse events (death from cardiovascular or undetermined causes, MI, stroke, and hospitalization for unstable angina) relative to comparator groups. Results from a dedicated cardiovascular outcomes trial in high-risk patients treated with tirzepatide, SURPASS-CVOT, are not expected until 2024.

A further limitation of SURPASS-2 was the demographics of the enrolled population, which had a low (0.4%) enrollment rate of Black patients, and a high proportion (70%) of Hispanic patients, Dr. Tuttle observed.
 

Low rates of hypoglycemia

Another notable finding from SURPASS-2 was the low incidence of clinically significant hypoglycemic events (blood glucose levels less than 54 mg/dL), which occurred in 0.2%-1.7% of patients on tirzepatide, depending on their dose, and in 0.4% of patients on semaglutide. Two patients in the tirzepatide cohort had severe hypoglycemia.

These numbers are reassuring, said Dr. Galindo, and reflect the safety of tirzepatide’s dual, incretin-like mechanisms of action that make it a “twincretin.” The molecule acts as both a GLP-1 RA, and as glucose-dependent insulinotropic polypeptide, an incretin that stimulates insulin release when blood sugar is high but also increases glucagon levels when blood sugar levels are normal or low. This dual action may help explain the apparent increased potency tirzepatide showed for both A1c reduction and weight loss, compared with semaglutide, which acts only as a GLP-1 RA.

Some experts have cited the uncertainty introduced by the open-label design of SURPASS-2, a decision necessitated by the distinctly different delivery devices used for tirzepatide and semaglutide, explained Dr. Landó. But she highlighted that double blinding applied to the three different tirzepatide dosages tested in the trial. Dr. Landó said that Lilly plans to seek FDA approval for all three tested tirzepatide doses to give clinicians and patients flexibility in applying the treatment.

SURPASS-2 used a prolonged dose-escalation protocol designed to minimize gastrointestinal adverse effects that started patients on a 2.5 mg weekly dose that then increased by 2.5 mg increments every 4 weeks until patients reached their assigned target dose. This meant that patients did not begin receiving the 15-mg/week dose until halfway through the trial.
 

Several more tirzepatide trials

Reports from two other pivotal trials for tirzepatide also appeared as posters at the meeting. SURPASS-5 compared tirzepatide with placebo in 475 patients inadequately controlled with titrated insulin glargine (Lantus). SURPASS-3 randomized 1,444 patients to tirzepatide or titrated insulin degludec (Tresiba). In both studies treatment with tirzepatide led to significantly better reductions in A1c and in weight loss than the comparator treatments. Results from a third pivotal trial, SURPASS-1 which compared tirzepatide against placebo in 478 treatment-naive patients, will come in a report scheduled for the second day of the meeting.

The results from all the recent tirzepatide trials show a consistent benefit across the continuum of patients with type 2 diabetes regardless of whether it’s recent onset or well-established disease, said Dr. Landó.

The SURPASS studies were sponsored by Lilly, the company developing tirzepatide, and the reports include several authors who are Lilly employees. Dr. Landó is a Lilly employee and stockholder. Dr. Tuttle has been a consultant to Lilly and to Novo Nordisk, the company that markets semaglutide, as well as to AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, and Janssen. She has also received travel expenses from Kyokawa Hakko Kirin, and research funding from Bayer, Goldfinch Bio, and Lilly. Dr. Galindo has been a consultant to Lilly and to Novo Nordisk, as well as to Abbott Diabetes Care, Sanofi, Valeritas, and Weight Watchers, and his institution has received grant support on his behalf from Lilly, Novo Nordisk and Dexcom. Dr. Holst had no disclosures.

[email protected]

Tirzepatide, a novel “twincretin” agent, was superior to 1-mg semaglutide treatments for reducing both hemoglobin A1c levels and body weight in patients with type 2 diabetes in a pivotal, 40-week, head-to-head trial with nearly 1,900 randomized patients, one of four positive pivotal trial results reported for tirzepatide at the annual scientific sessions of the American Diabetes Association.

“Across all four studies we see a significant and clinically meaningful decrease in A1c, and robust weight loss. The results exceeded our expectations” for both these outcomes, said Laura Fernández Landó, MD, senior medical director for tirzepatide at Lilly, the company developing the agent, and a coauthor on the semaglutide comparison study as well as on other tirzepatide reports at the meeting.

“This opens up a new avenue for results in diabetes therapy,” Jens Juul Holst, MD, remarked in a press conference.

SURPASS-2 compared three different tirzepatide doses delivered once weekly by subcutaneous injection against a 1-mg weekly, subcutaneous dose of semaglutide (Ozempic) in 1,879 adults who had been diagnosed with type 2 diabetes for an average of almost 9 years. All patients were already on metformin treatment that had proved inadequate for controlling their hyperglycemia; enrolled patients had an average A1c of 8.28%. The trial’s primary endpoint was change from baseline in A1c levels after 40 weeks.
 

Significant differences at each dose level

Patients on each of the three tirzepatide doses – 5 mg, 10 mg, or 15 mg once weekly – showed dose-dependent reductions in A1c that, for each dose, were significantly better than the reduction achieved with semaglutide. The highest tirzepatide dose reduced A1c levels by an average of 0.45% more than what semaglutide achieved, reported first author Juan P. Frias, MD; Dr. Landó; and their coauthors.

One key secondary endpoint was weight reduction, and each of the three tirzepatide doses again produced significant incremental loss beyond what semaglutide produced. The 5-mg weekly dose of tirzepatide produced an average 1.9-kg additional weight loss, compared with semaglutide, while the 15-mg dose resulted in an average 5.5-kg loss beyond what semaglutide achieved and a total average weight loss of 11.2 kg from baseline.

The study’s additional key secondary endpoints, the percentages of patients reaching an A1c of less than 7%, and less than 5.7%, also showed significantly better numbers with tirzepatide. The highest tirzepatide dose pushed 86% of patients below the 7% mark, compared with 79% on semaglutide, and the top tirzepatide dose resulted in 46% of patients getting their A1c below 5.7%, compared with 19% of patients on semaglutide.

The findings are “stunning, I must stay, and those results included that up to half of the patients treated with high doses of tirzepatide may reach A1c levels of less than 5.7%, which is really, really unheard of,” said Dr. Holst, professor of endocrinology and metabolism at the University of Copenhagen. Along with the “weight losses at the same time of up to 12% in that patient group, we are seeing some completely unexpected and really shocking and wonderful new advances in the therapy,” added Dr. Holst.

The safety profile of tirzepatide was roughly similar to semaglutide’s and to that other agents in the glucagonlike peptide-1 receptor agonist (GLP-1 RA) class. Concurrently with the report at the meeting, the results also appeared in an article published online in the New England Journal of Medicine.
 

An ‘impressive’ weight loss effect

Weight loss on tirzepatide was “impressive,” commented Katherine R. Tuttle, MD, a nephrologist affiliated with the University of Washington and executive director for research at Providence Health Care in Spokane, Wash. Another striking feature of tirzepatide’s weight-loss effect was that it did not plateau during the 40 weeks of the study, Dr. Tuttle noted in an accompanying editorial that accompanied the published report, a finding that suggests the potential for additional weight loss from continued treatment .

“The weight loss is remarkable,” commented Rodolfo J. Galindo, MD, an endocrinologist at Emory University, Atlanta. While incremental reduction of A1c on the order of less than 0.5% is helpful, incremental weight loss of more than 10 lbs on tirzepatide, compared with semaglutide “will likely be a tie-breaker” for many clinicians and patients to favor tirzepatide over semaglutide or another GLP-1 RA agent, he said in an interview. Dr. Galindo also cited other important factors that he predicted will drive decisions on using tirzepatide or a GLP-1 RA once tirzepatide reaches the U.S. market: relative cost, access, and tolerability.
 

The important issue of dose

But the edge that tirzepatide showed over semaglutide for weight loss did not occur on a completely level playing field. The 1 mg/week dose of semaglutide used as the comparator in SURPASS-2 was the maximum dose available at the time the study began, but in June 2021 the Food and Drug Administration approved a 2.4 mg/week dose (Wegovy) labeled specifically for weight loss. Dr. Tuttle cited the limitation this introduces in her editorial.

“The dose issue is important,” she wrote. The doses of tirzepatide and semaglutide compared in SURPASS-2 “were not comparable in terms of weight outcomes” given that prior evidence showed that the 2.4 mg/week semaglutide dose is more appropriate for weight loss.

Dr. Tuttle also cited other factors to consider when assessing tirzepatide compared with agents in the GLP-1 RA class.

Several GLP-1 RA agents, including semaglutide, have proven efficacy for reducing rates of atherosclerotic cardiovascular events and albuminuria, and they also slow decline in kidney function and progression of diabetic kidney disease. No details on the renal effects of tirzepatide appeared in the SURPASS-2 report. A press release from Lilly in May 2021 briefly mentioned results from a meta-analysis of several clinical studies of tirzepatide that showed a nonsignificant effect from tirzepatide on the incidence of major cardiovascular adverse events (death from cardiovascular or undetermined causes, MI, stroke, and hospitalization for unstable angina) relative to comparator groups. Results from a dedicated cardiovascular outcomes trial in high-risk patients treated with tirzepatide, SURPASS-CVOT, are not expected until 2024.

A further limitation of SURPASS-2 was the demographics of the enrolled population, which had a low (0.4%) enrollment rate of Black patients, and a high proportion (70%) of Hispanic patients, Dr. Tuttle observed.
 

Low rates of hypoglycemia

Another notable finding from SURPASS-2 was the low incidence of clinically significant hypoglycemic events (blood glucose levels less than 54 mg/dL), which occurred in 0.2%-1.7% of patients on tirzepatide, depending on their dose, and in 0.4% of patients on semaglutide. Two patients in the tirzepatide cohort had severe hypoglycemia.

These numbers are reassuring, said Dr. Galindo, and reflect the safety of tirzepatide’s dual, incretin-like mechanisms of action that make it a “twincretin.” The molecule acts as both a GLP-1 RA, and as glucose-dependent insulinotropic polypeptide, an incretin that stimulates insulin release when blood sugar is high but also increases glucagon levels when blood sugar levels are normal or low. This dual action may help explain the apparent increased potency tirzepatide showed for both A1c reduction and weight loss, compared with semaglutide, which acts only as a GLP-1 RA.

Some experts have cited the uncertainty introduced by the open-label design of SURPASS-2, a decision necessitated by the distinctly different delivery devices used for tirzepatide and semaglutide, explained Dr. Landó. But she highlighted that double blinding applied to the three different tirzepatide dosages tested in the trial. Dr. Landó said that Lilly plans to seek FDA approval for all three tested tirzepatide doses to give clinicians and patients flexibility in applying the treatment.

SURPASS-2 used a prolonged dose-escalation protocol designed to minimize gastrointestinal adverse effects that started patients on a 2.5 mg weekly dose that then increased by 2.5 mg increments every 4 weeks until patients reached their assigned target dose. This meant that patients did not begin receiving the 15-mg/week dose until halfway through the trial.
 

Several more tirzepatide trials

Reports from two other pivotal trials for tirzepatide also appeared as posters at the meeting. SURPASS-5 compared tirzepatide with placebo in 475 patients inadequately controlled with titrated insulin glargine (Lantus). SURPASS-3 randomized 1,444 patients to tirzepatide or titrated insulin degludec (Tresiba). In both studies treatment with tirzepatide led to significantly better reductions in A1c and in weight loss than the comparator treatments. Results from a third pivotal trial, SURPASS-1 which compared tirzepatide against placebo in 478 treatment-naive patients, will come in a report scheduled for the second day of the meeting.

The results from all the recent tirzepatide trials show a consistent benefit across the continuum of patients with type 2 diabetes regardless of whether it’s recent onset or well-established disease, said Dr. Landó.

The SURPASS studies were sponsored by Lilly, the company developing tirzepatide, and the reports include several authors who are Lilly employees. Dr. Landó is a Lilly employee and stockholder. Dr. Tuttle has been a consultant to Lilly and to Novo Nordisk, the company that markets semaglutide, as well as to AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, and Janssen. She has also received travel expenses from Kyokawa Hakko Kirin, and research funding from Bayer, Goldfinch Bio, and Lilly. Dr. Galindo has been a consultant to Lilly and to Novo Nordisk, as well as to Abbott Diabetes Care, Sanofi, Valeritas, and Weight Watchers, and his institution has received grant support on his behalf from Lilly, Novo Nordisk and Dexcom. Dr. Holst had no disclosures.

[email protected]

Unmanaged diabetes and high blood glucose levels are linked to more severe COVID-19 and worse rates of recovery, according to results of a retrospective study.

Patients not managing their diabetes with medication had more severe COVID-19 and length of hospitalization, compared with those who were taking medication, investigator Sudip Bajpeyi, PhD, said at the annual scientific sessions of the American Diabetes Association.

In addition, patients with higher blood glucose levels had more severe COVID-19 and longer hospital stays.

Those findings underscore the need to assess, monitor, and control blood glucose, especially in vulnerable populations, said Dr. Bajpeyi, director of the Metabolic, Nutrition, and Exercise Research Laboratory in the University of Texas, El Paso, who added that nearly 90% of the study subjects were Hispanic.

“As public health decisions are made, we think fasting blood glucose should be considered in the treatment of hospitalized COVID-19 patients,” he said in a press conference.
 

Links between diabetes and COVID-19

There are now many reports in medical literature that link diabetes to increased risk of COVID-19 severity, according to Ali Mossayebi, a master’s student who worked on the study. However, there are fewer studies that have looked specifically at the implications of poor diabetes management or acute glycemic control, the investigators said.

It’s known that poorly controlled diabetes can have severe health consequences, including higher risks for life-threatening comorbidities, they added.

Their retrospective study focused on medical records from 364 patients with COVID-19 admitted to a medical center in El Paso. Their mean age was 60 years, and their mean body mass index was 30.3 kg/m²; 87% were Hispanic.

Acute glycemic control was assessed by fasting blood glucose at the time of hospitalization, while chronic glycemic control was assessed by hemoglobin A1c, the investigators said. Severity of COVID-19 was measured with the Sequential (Sepsis-Related) Organ Failure Assessment (qSOFA), which is based on the patient’s respiratory rate, blood pressure, and mental status.
 

Impact of unmanaged diabetes and high blood glucose

Severity of COVID-19 severity and length of hospital stay were significantly greater in patients with unmanaged diabetes, as compared with those who reported that they managed their diabetes with medication, Dr. Bajpeyi and coinvestigators found.

Among patients with unmanaged diabetes, the mean qSOFA score was 0.22, as compared with 0.44 for patients with managed diabetes. The mean length of hospital stay was 10.8 days for patients with unmanaged diabetes and 8.2 days for those with medication-managed diabetes, according to the abstract.

COVID-19 severity and hospital stay length were highest among patients with acute glycemia, the investigators further reported in an electronic poster that was part of the ADA meeting proceedings.

The mean qSOFA score was about 0.6 for patients with blood glucose levels of at least 126 mg/dL and A1c below 6.5%, and roughly 0.2 for those with normal blood glucose and normal A1c. Similarly, duration of hospital stay was significantly higher for patients with high blood glucose and A1c as compared with those with normal blood glucose and A1c.
 

Aggressive treatment needed

Findings of this study are in line with previous research showing that in-hospital hyperglycemia is a common and important marker of poor clinical outcome and mortality, with or without diabetes, according to Rodolfo J. Galindo, MD, FACE, medical chair of the hospital diabetes task force at Emory Healthcare System, Atlanta.

“These patients need aggressive treatment of hyperglycemia, regardless of the diagnosis of diabetes or A1c value,” said Dr. Galindo, who was not involved in the study. “They also need outpatient follow-up after discharge, because they may develop diabetes soon after.”

Follow-up within is important because roughly 30% of patients with stress hyperglycemia (increases in blood glucose during an acute illness) will develop diabetes within a year, according to Dr. Galindo.

“We do not know in COVID-10 patients if it is only 30%,” he said, “Our thinking in our group is that it’s probably higher.”

Dr. Bajpeyi and coauthors reported no disclosures. Dr. Galindo reported disclosures related to Abbott Diabetes, Boehringer Ingelheim International, Eli Lilly, Novo Nordisk, Sanofi US, Valeritas, and Dexcom.

Unmanaged diabetes and high blood glucose levels are linked to more severe COVID-19 and worse rates of recovery, according to results of a retrospective study.

Patients not managing their diabetes with medication had more severe COVID-19 and length of hospitalization, compared with those who were taking medication, investigator Sudip Bajpeyi, PhD, said at the annual scientific sessions of the American Diabetes Association.

In addition, patients with higher blood glucose levels had more severe COVID-19 and longer hospital stays.

Those findings underscore the need to assess, monitor, and control blood glucose, especially in vulnerable populations, said Dr. Bajpeyi, director of the Metabolic, Nutrition, and Exercise Research Laboratory in the University of Texas, El Paso, who added that nearly 90% of the study subjects were Hispanic.

“As public health decisions are made, we think fasting blood glucose should be considered in the treatment of hospitalized COVID-19 patients,” he said in a press conference.
 

Links between diabetes and COVID-19

There are now many reports in medical literature that link diabetes to increased risk of COVID-19 severity, according to Ali Mossayebi, a master’s student who worked on the study. However, there are fewer studies that have looked specifically at the implications of poor diabetes management or acute glycemic control, the investigators said.

It’s known that poorly controlled diabetes can have severe health consequences, including higher risks for life-threatening comorbidities, they added.

Their retrospective study focused on medical records from 364 patients with COVID-19 admitted to a medical center in El Paso. Their mean age was 60 years, and their mean body mass index was 30.3 kg/m²; 87% were Hispanic.

Acute glycemic control was assessed by fasting blood glucose at the time of hospitalization, while chronic glycemic control was assessed by hemoglobin A1c, the investigators said. Severity of COVID-19 was measured with the Sequential (Sepsis-Related) Organ Failure Assessment (qSOFA), which is based on the patient’s respiratory rate, blood pressure, and mental status.
 

Impact of unmanaged diabetes and high blood glucose

Severity of COVID-19 severity and length of hospital stay were significantly greater in patients with unmanaged diabetes, as compared with those who reported that they managed their diabetes with medication, Dr. Bajpeyi and coinvestigators found.

Among patients with unmanaged diabetes, the mean qSOFA score was 0.22, as compared with 0.44 for patients with managed diabetes. The mean length of hospital stay was 10.8 days for patients with unmanaged diabetes and 8.2 days for those with medication-managed diabetes, according to the abstract.

COVID-19 severity and hospital stay length were highest among patients with acute glycemia, the investigators further reported in an electronic poster that was part of the ADA meeting proceedings.

The mean qSOFA score was about 0.6 for patients with blood glucose levels of at least 126 mg/dL and A1c below 6.5%, and roughly 0.2 for those with normal blood glucose and normal A1c. Similarly, duration of hospital stay was significantly higher for patients with high blood glucose and A1c as compared with those with normal blood glucose and A1c.
 

Aggressive treatment needed

Findings of this study are in line with previous research showing that in-hospital hyperglycemia is a common and important marker of poor clinical outcome and mortality, with or without diabetes, according to Rodolfo J. Galindo, MD, FACE, medical chair of the hospital diabetes task force at Emory Healthcare System, Atlanta.

“These patients need aggressive treatment of hyperglycemia, regardless of the diagnosis of diabetes or A1c value,” said Dr. Galindo, who was not involved in the study. “They also need outpatient follow-up after discharge, because they may develop diabetes soon after.”

Follow-up within is important because roughly 30% of patients with stress hyperglycemia (increases in blood glucose during an acute illness) will develop diabetes within a year, according to Dr. Galindo.

“We do not know in COVID-10 patients if it is only 30%,” he said, “Our thinking in our group is that it’s probably higher.”

Dr. Bajpeyi and coauthors reported no disclosures. Dr. Galindo reported disclosures related to Abbott Diabetes, Boehringer Ingelheim International, Eli Lilly, Novo Nordisk, Sanofi US, Valeritas, and Dexcom.

Unmanaged diabetes and high blood glucose levels are linked to more severe COVID-19 and worse rates of recovery, according to results of a retrospective study.

Patients not managing their diabetes with medication had more severe COVID-19 and length of hospitalization, compared with those who were taking medication, investigator Sudip Bajpeyi, PhD, said at the annual scientific sessions of the American Diabetes Association.

In addition, patients with higher blood glucose levels had more severe COVID-19 and longer hospital stays.

Those findings underscore the need to assess, monitor, and control blood glucose, especially in vulnerable populations, said Dr. Bajpeyi, director of the Metabolic, Nutrition, and Exercise Research Laboratory in the University of Texas, El Paso, who added that nearly 90% of the study subjects were Hispanic.

“As public health decisions are made, we think fasting blood glucose should be considered in the treatment of hospitalized COVID-19 patients,” he said in a press conference.
 

Links between diabetes and COVID-19

There are now many reports in medical literature that link diabetes to increased risk of COVID-19 severity, according to Ali Mossayebi, a master’s student who worked on the study. However, there are fewer studies that have looked specifically at the implications of poor diabetes management or acute glycemic control, the investigators said.

It’s known that poorly controlled diabetes can have severe health consequences, including higher risks for life-threatening comorbidities, they added.

Their retrospective study focused on medical records from 364 patients with COVID-19 admitted to a medical center in El Paso. Their mean age was 60 years, and their mean body mass index was 30.3 kg/m²; 87% were Hispanic.

Acute glycemic control was assessed by fasting blood glucose at the time of hospitalization, while chronic glycemic control was assessed by hemoglobin A1c, the investigators said. Severity of COVID-19 was measured with the Sequential (Sepsis-Related) Organ Failure Assessment (qSOFA), which is based on the patient’s respiratory rate, blood pressure, and mental status.
 

Impact of unmanaged diabetes and high blood glucose

Severity of COVID-19 severity and length of hospital stay were significantly greater in patients with unmanaged diabetes, as compared with those who reported that they managed their diabetes with medication, Dr. Bajpeyi and coinvestigators found.

Among patients with unmanaged diabetes, the mean qSOFA score was 0.22, as compared with 0.44 for patients with managed diabetes. The mean length of hospital stay was 10.8 days for patients with unmanaged diabetes and 8.2 days for those with medication-managed diabetes, according to the abstract.

COVID-19 severity and hospital stay length were highest among patients with acute glycemia, the investigators further reported in an electronic poster that was part of the ADA meeting proceedings.

The mean qSOFA score was about 0.6 for patients with blood glucose levels of at least 126 mg/dL and A1c below 6.5%, and roughly 0.2 for those with normal blood glucose and normal A1c. Similarly, duration of hospital stay was significantly higher for patients with high blood glucose and A1c as compared with those with normal blood glucose and A1c.
 

Aggressive treatment needed

Findings of this study are in line with previous research showing that in-hospital hyperglycemia is a common and important marker of poor clinical outcome and mortality, with or without diabetes, according to Rodolfo J. Galindo, MD, FACE, medical chair of the hospital diabetes task force at Emory Healthcare System, Atlanta.

“These patients need aggressive treatment of hyperglycemia, regardless of the diagnosis of diabetes or A1c value,” said Dr. Galindo, who was not involved in the study. “They also need outpatient follow-up after discharge, because they may develop diabetes soon after.”

Follow-up within is important because roughly 30% of patients with stress hyperglycemia (increases in blood glucose during an acute illness) will develop diabetes within a year, according to Dr. Galindo.

“We do not know in COVID-10 patients if it is only 30%,” he said, “Our thinking in our group is that it’s probably higher.”

Dr. Bajpeyi and coauthors reported no disclosures. Dr. Galindo reported disclosures related to Abbott Diabetes, Boehringer Ingelheim International, Eli Lilly, Novo Nordisk, Sanofi US, Valeritas, and Dexcom.

Waxy loose scale with associated erythema on the face and scalp is a classic sign of seborrheic dermatitis (SD).

SD is caused by inflammation related to the presence of Malassezia, which proliferates on sebum-rich areas of skin. Malassezia is normally present on the skin, but some individuals have a heightened sensitivity to it, leading to erythema and scale. It is prudent to examine the scalp, nasolabial folds, and around the ears where it often occurs concomitantly.

There are multiple topical and systemic options which treat the fungal involvement, the subsequent inflammation, and reduce the scale.¹ Topical azole antifungals are effective for reducing the amount of Malassezia present. Topical steroids work well to reduce the erythema. Fortunately, low-potency steroids, including hydrocortisone and desonide, are adequate. This is important since SD frequently involves the face and higher-potency steroids can cause skin atrophy or rebound erythema.

Salicylic acid products exfoliate the scale and topical tar products suppress the scale, both leading to clinical improvement. Sunlight and narrow beam UVB light therapy are also effective treatments. As was true with this patient, SD often improves during the summer months (when there is more sunlight) and when patients shave, as this allows for additional sun exposure to the skin.

The patient in this case was told to use ketoconazole shampoo for his scalp, beard, and mustache. He was instructed to use it at least 3 times per week, applying it to the scalp as the first part of his bathing routine and then waiting until the end to rinse it off. This technique maximizes the antifungal shampoo’s contact time on the skin. He was also given a prescription for ketoconazole cream to apply twice daily to the areas of facial erythema and scale. He was counseled that shaving his beard and mustache might help reduce the SD in those areas.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

Waxy loose scale with associated erythema on the face and scalp is a classic sign of seborrheic dermatitis (SD).

SD is caused by inflammation related to the presence of Malassezia, which proliferates on sebum-rich areas of skin. Malassezia is normally present on the skin, but some individuals have a heightened sensitivity to it, leading to erythema and scale. It is prudent to examine the scalp, nasolabial folds, and around the ears where it often occurs concomitantly.

There are multiple topical and systemic options which treat the fungal involvement, the subsequent inflammation, and reduce the scale.¹ Topical azole antifungals are effective for reducing the amount of Malassezia present. Topical steroids work well to reduce the erythema. Fortunately, low-potency steroids, including hydrocortisone and desonide, are adequate. This is important since SD frequently involves the face and higher-potency steroids can cause skin atrophy or rebound erythema.

Salicylic acid products exfoliate the scale and topical tar products suppress the scale, both leading to clinical improvement. Sunlight and narrow beam UVB light therapy are also effective treatments. As was true with this patient, SD often improves during the summer months (when there is more sunlight) and when patients shave, as this allows for additional sun exposure to the skin.

The patient in this case was told to use ketoconazole shampoo for his scalp, beard, and mustache. He was instructed to use it at least 3 times per week, applying it to the scalp as the first part of his bathing routine and then waiting until the end to rinse it off. This technique maximizes the antifungal shampoo’s contact time on the skin. He was also given a prescription for ketoconazole cream to apply twice daily to the areas of facial erythema and scale. He was counseled that shaving his beard and mustache might help reduce the SD in those areas.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

Waxy loose scale with associated erythema on the face and scalp is a classic sign of seborrheic dermatitis (SD).

SD is caused by inflammation related to the presence of Malassezia, which proliferates on sebum-rich areas of skin. Malassezia is normally present on the skin, but some individuals have a heightened sensitivity to it, leading to erythema and scale. It is prudent to examine the scalp, nasolabial folds, and around the ears where it often occurs concomitantly.

There are multiple topical and systemic options which treat the fungal involvement, the subsequent inflammation, and reduce the scale.¹ Topical azole antifungals are effective for reducing the amount of Malassezia present. Topical steroids work well to reduce the erythema. Fortunately, low-potency steroids, including hydrocortisone and desonide, are adequate. This is important since SD frequently involves the face and higher-potency steroids can cause skin atrophy or rebound erythema.

Salicylic acid products exfoliate the scale and topical tar products suppress the scale, both leading to clinical improvement. Sunlight and narrow beam UVB light therapy are also effective treatments. As was true with this patient, SD often improves during the summer months (when there is more sunlight) and when patients shave, as this allows for additional sun exposure to the skin.

The patient in this case was told to use ketoconazole shampoo for his scalp, beard, and mustache. He was instructed to use it at least 3 times per week, applying it to the scalp as the first part of his bathing routine and then waiting until the end to rinse it off. This technique maximizes the antifungal shampoo’s contact time on the skin. He was also given a prescription for ketoconazole cream to apply twice daily to the areas of facial erythema and scale. He was counseled that shaving his beard and mustache might help reduce the SD in those areas.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

The Diagnosis: Platelike Osteoma Cutis 

Histopathologic examination revealed extensive cutaneous ossification in the dermis and subcutis with dermal fibrosis and minimal surrounding inflammation (Figure 1). There was no evidence of infection or neoplasm. Further evaluation did not demonstrate any additional physical dysmorphia, and there were no imbalances of calcium-phosphate metabolism or abnormalities in parathyroid hormone or thyroid hormone function. A diagnosis of platelike osteoma cutis (PLOC) was favored. Computed tomography of the head showed material at the posterior skull of similar density to the adjacent calvarial skull and centered within the dermis, consistent with osteoma cutis (Figure 2). 

Osteoma cutis describes the formation of bone within the skin. It occurs when hydroxyapatite crystals in a proteinaceous matrix are deposited within the skin, ultimately leading to the formation of bone ultrastructure. Ossification of the skin most often occurs secondary to trauma, inflammation, or neoplasm; however, it rarely may be a primary event.^1,2 

Platelike osteoma cutis is a rare form of primary cutaneous ossification in which bone forms within the skin in a platelike manner. It most frequently affects the scalp but also has been observed on the trunk and extremities.¹ A driving metabolic or endocrine abnormality typically is not identified.² 

Platelike osteoma cutis can occur as an isolated finding or as a feature of Albright hereditary osteodystrophy (AHO) or progressive osseous heteroplasia (POH). In addition to cutaneous ossification, AHO involves short stature, endocrinopathy, obesity, shortened fourth and fifth metacarpals, and mental retardation. Progressive osseous heteroplasia is characterized by progressive ossification of the skin and deeper tissues such as muscle and fascia, leading to severe movement restriction; it is believed to be a localized nonprogressive variant of POH.^3,4 Mutations in the guanine nucleotide binding protein, alpha stimulating activity polypeptide 1 gene, GNAS1, a key regulatory gene involved in AHO and POH, have been found in several cases of PLOC.³ Our patient lacked any dysmorphic features or laboratory abnormalities suggestive of AHO or POH. Moreover, testing of the tissue and blood for the GNAS1 mutation was negative. Treatment of PLOC often is difficult. Our patient underwent a trial of ablative fractional laser resurfacing, which failed to lead to perceivable improvement.  

The differential diagnoses include a kerion, dissecting cellulitis of the scalp, folliculitis decalvans, and acne keloidalis nuchae. A kerion is a manifestation of tinea capitis characterized by an inflammatory plaque, often with pain or tenderness. Kerions most frequently occur in children aged 5 to 10 years.⁵ Failure to treat a kerion may result in scarring alopecia. Treatment consists of oral antifungals.  

Dissecting cellulitis of the scalp is thought to occur secondary to follicular occlusion. It is characterized by boggy suppurative nodules primarily on the posterior and vertex scalp. Patchy hair loss is present and typically progresses to cicatricial alopecia. Histology characteristically shows areas of dense, predominantly neutrophilic, perifollicular dermal infiltrates.⁶ 

Folliculitis decalvans is a primary neutrophilic cicatricial alopecia that primarily occurs in adults. Patients with folliculitis decalvans tend to have multiple pustules on the periphery of confluent areas of scarring alopecia. It is theorized that an immune response to staphylococcal superantigens contributes to this disease process.⁷  

The clinical findings of acne keloidalis nuchae include inflammatory pustules and papules with keloidlike plaques on the posterior neck and scalp. It occurs predominantly in teenaged and adult males of African ancestry.⁸ Treatment is aimed at reducing inflammation and preventing exacerbating factors. Severe disease courses may lead to scarring alopecia.

The Diagnosis: Platelike Osteoma Cutis 

Histopathologic examination revealed extensive cutaneous ossification in the dermis and subcutis with dermal fibrosis and minimal surrounding inflammation (Figure 1). There was no evidence of infection or neoplasm. Further evaluation did not demonstrate any additional physical dysmorphia, and there were no imbalances of calcium-phosphate metabolism or abnormalities in parathyroid hormone or thyroid hormone function. A diagnosis of platelike osteoma cutis (PLOC) was favored. Computed tomography of the head showed material at the posterior skull of similar density to the adjacent calvarial skull and centered within the dermis, consistent with osteoma cutis (Figure 2). 

Osteoma cutis describes the formation of bone within the skin. It occurs when hydroxyapatite crystals in a proteinaceous matrix are deposited within the skin, ultimately leading to the formation of bone ultrastructure. Ossification of the skin most often occurs secondary to trauma, inflammation, or neoplasm; however, it rarely may be a primary event.^1,2 

Platelike osteoma cutis is a rare form of primary cutaneous ossification in which bone forms within the skin in a platelike manner. It most frequently affects the scalp but also has been observed on the trunk and extremities.¹ A driving metabolic or endocrine abnormality typically is not identified.² 

Platelike osteoma cutis can occur as an isolated finding or as a feature of Albright hereditary osteodystrophy (AHO) or progressive osseous heteroplasia (POH). In addition to cutaneous ossification, AHO involves short stature, endocrinopathy, obesity, shortened fourth and fifth metacarpals, and mental retardation. Progressive osseous heteroplasia is characterized by progressive ossification of the skin and deeper tissues such as muscle and fascia, leading to severe movement restriction; it is believed to be a localized nonprogressive variant of POH.^3,4 Mutations in the guanine nucleotide binding protein, alpha stimulating activity polypeptide 1 gene, GNAS1, a key regulatory gene involved in AHO and POH, have been found in several cases of PLOC.³ Our patient lacked any dysmorphic features or laboratory abnormalities suggestive of AHO or POH. Moreover, testing of the tissue and blood for the GNAS1 mutation was negative. Treatment of PLOC often is difficult. Our patient underwent a trial of ablative fractional laser resurfacing, which failed to lead to perceivable improvement.  

The differential diagnoses include a kerion, dissecting cellulitis of the scalp, folliculitis decalvans, and acne keloidalis nuchae. A kerion is a manifestation of tinea capitis characterized by an inflammatory plaque, often with pain or tenderness. Kerions most frequently occur in children aged 5 to 10 years.⁵ Failure to treat a kerion may result in scarring alopecia. Treatment consists of oral antifungals.  

Dissecting cellulitis of the scalp is thought to occur secondary to follicular occlusion. It is characterized by boggy suppurative nodules primarily on the posterior and vertex scalp. Patchy hair loss is present and typically progresses to cicatricial alopecia. Histology characteristically shows areas of dense, predominantly neutrophilic, perifollicular dermal infiltrates.⁶ 

Folliculitis decalvans is a primary neutrophilic cicatricial alopecia that primarily occurs in adults. Patients with folliculitis decalvans tend to have multiple pustules on the periphery of confluent areas of scarring alopecia. It is theorized that an immune response to staphylococcal superantigens contributes to this disease process.⁷  

The clinical findings of acne keloidalis nuchae include inflammatory pustules and papules with keloidlike plaques on the posterior neck and scalp. It occurs predominantly in teenaged and adult males of African ancestry.⁸ Treatment is aimed at reducing inflammation and preventing exacerbating factors. Severe disease courses may lead to scarring alopecia.

The Diagnosis: Platelike Osteoma Cutis 

Histopathologic examination revealed extensive cutaneous ossification in the dermis and subcutis with dermal fibrosis and minimal surrounding inflammation (Figure 1). There was no evidence of infection or neoplasm. Further evaluation did not demonstrate any additional physical dysmorphia, and there were no imbalances of calcium-phosphate metabolism or abnormalities in parathyroid hormone or thyroid hormone function. A diagnosis of platelike osteoma cutis (PLOC) was favored. Computed tomography of the head showed material at the posterior skull of similar density to the adjacent calvarial skull and centered within the dermis, consistent with osteoma cutis (Figure 2). 

Osteoma cutis describes the formation of bone within the skin. It occurs when hydroxyapatite crystals in a proteinaceous matrix are deposited within the skin, ultimately leading to the formation of bone ultrastructure. Ossification of the skin most often occurs secondary to trauma, inflammation, or neoplasm; however, it rarely may be a primary event.^1,2 

Platelike osteoma cutis is a rare form of primary cutaneous ossification in which bone forms within the skin in a platelike manner. It most frequently affects the scalp but also has been observed on the trunk and extremities.¹ A driving metabolic or endocrine abnormality typically is not identified.² 

Platelike osteoma cutis can occur as an isolated finding or as a feature of Albright hereditary osteodystrophy (AHO) or progressive osseous heteroplasia (POH). In addition to cutaneous ossification, AHO involves short stature, endocrinopathy, obesity, shortened fourth and fifth metacarpals, and mental retardation. Progressive osseous heteroplasia is characterized by progressive ossification of the skin and deeper tissues such as muscle and fascia, leading to severe movement restriction; it is believed to be a localized nonprogressive variant of POH.^3,4 Mutations in the guanine nucleotide binding protein, alpha stimulating activity polypeptide 1 gene, GNAS1, a key regulatory gene involved in AHO and POH, have been found in several cases of PLOC.³ Our patient lacked any dysmorphic features or laboratory abnormalities suggestive of AHO or POH. Moreover, testing of the tissue and blood for the GNAS1 mutation was negative. Treatment of PLOC often is difficult. Our patient underwent a trial of ablative fractional laser resurfacing, which failed to lead to perceivable improvement.  

The differential diagnoses include a kerion, dissecting cellulitis of the scalp, folliculitis decalvans, and acne keloidalis nuchae. A kerion is a manifestation of tinea capitis characterized by an inflammatory plaque, often with pain or tenderness. Kerions most frequently occur in children aged 5 to 10 years.⁵ Failure to treat a kerion may result in scarring alopecia. Treatment consists of oral antifungals.  

Dissecting cellulitis of the scalp is thought to occur secondary to follicular occlusion. It is characterized by boggy suppurative nodules primarily on the posterior and vertex scalp. Patchy hair loss is present and typically progresses to cicatricial alopecia. Histology characteristically shows areas of dense, predominantly neutrophilic, perifollicular dermal infiltrates.⁶ 

Folliculitis decalvans is a primary neutrophilic cicatricial alopecia that primarily occurs in adults. Patients with folliculitis decalvans tend to have multiple pustules on the periphery of confluent areas of scarring alopecia. It is theorized that an immune response to staphylococcal superantigens contributes to this disease process.⁷  

The clinical findings of acne keloidalis nuchae include inflammatory pustules and papules with keloidlike plaques on the posterior neck and scalp. It occurs predominantly in teenaged and adult males of African ancestry.⁸ Treatment is aimed at reducing inflammation and preventing exacerbating factors. Severe disease courses may lead to scarring alopecia.

A delaying tactic used by some U.S. health insurers to limit coverage of bariatric surgery does not jibe with the clinical experience at one U.S. center with 461 patients who underwent primary or revisional bariatric surgery.

PhotoDisk

The tactic applies to patients with a baseline body mass index (BMI) of 35-39 kg/m² who usually also need at least one comorbidity to qualify for insurance coverage for bariatric surgery, and specifically to the subgroup for whom hypertension is the qualifying comorbidity.

Some insurers limit surgery coverage to patients with hypertension who fail to reach their goal blood pressure on agents from three different drug classes, a policy that is “extremely frustrating and dangerous,” said Yannis Raftopoulos, MD, PhD, in his presentation at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

Using number of antihypertensive drugs ‘is not correct’

“Using the number of antihypertensive medications to justify surgery is not correct because blood pressure control is not [always] better when patients take two or three medications, compared with when they are taking one. This harms patients because the more severe their hypertension, the worse their control,” said Dr. Raftopoulos, director of the weight management program at Holyoke (Mass.) Medical Center.

He presented findings from a retrospective study of 461 patients who underwent either sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass at his center, including 213 (46%) diagnosed with hypertension at the time of their surgery. Within this group were 68 patients with a BMI of 35-39, which meant that they could get insurance coverage for bariatric surgery only if they also had a relevant comorbidity such as hypertension, diabetes, or severe sleep apnea.

Among these patients, 36 (17% of those with hypertension) had only hypertension as their relevant comorbidity and would not have qualified for bariatric surgery under the strictest criteria applied by some insurers that require patients to remain hypertensive despite treatment with at least three different antihypertensive medications. (These 36 patients underwent bariatric surgery because their insurance coverage did not have this restriction.)

The analyses Dr. Raftopoulos presented also documented the rate of hypertension resolution among patients in the series who had hypertension at baseline and 1-year follow-up results. Among 65 patients on one antihypertensive drug at baseline, 43 (66%) had complete resolution of their hypertension after 1 year, defined as blood pressure of less than 130/90 mm Hg while completely off antihypertensive treatment. In contrast, among 55 patients on two antihypertensive medications at baseline, 28 (51%) had complete resolution after 1 year, and among 24 patients on three or more antihypertensive medications at baseline, 3 (13%) had complete resolution 1 year after bariatric surgery, he reported.

“Patients who were treated with one oral antihypertensive medication preoperatively had a higher likelihood of postoperative hypertension resolution,” concluded Dr. Raftopoulos.

Restricting access to bariatric surgery to patients with a BMI of less than 40 based on the preoperative intensity of their antihypertensive treatment “is not supported by our data, and can be potentially harmful,” he declared.

“This study was the result of discussions about this problem with multiple insurers in my area,” he added. “This affects a good number of patients.”

Waiting for hypertension to become less treatable

The results Dr. Raftopoulos presented “are not surprising, because they confirm the hypothesis that earlier intervention in the course of a disease like hypertension is more likely to be successful,” commented Bruce D. Schirmer, MD, a professor of surgery at the University of Virginia, Charlottesville, and designated discussant for the report.

The policy followed by some health insurers to delay coverage for bariatric surgery until patients fail three medications “forces patients with more treatable hypertension to wait until their disease worsens and becomes less treatable before they can receive appropriate treatment,” he said.

Dr. Schirmer attributed the motivation for this approach to a “despicable” and “reprehensible” reason: “Actuarial calculations that show paying for curative therapy is not cost effective in the short term. The duration of a patient’s policy may not be long enough to yield a positive financial outcome, so it becomes more appropriate to deny optimal care and have patients become sicker from their disease.”

“I applaud the authors for accumulating the data that point out this unfortunate rule of some insurance companies,” Dr. Schirmer added.

The practice is comparable with an insurer requiring that a patient’s cancer must be metastatic before allowing coverage for treatment, commented Ann M. Rogers, MD, professor and director of the Penn State University surgical weight loss program in Hershey, Penn., and a moderator of the session.

Dr. Raftopoulos, Dr. Schirmer, and Dr. Rogers had no disclosures.

[email protected]

A delaying tactic used by some U.S. health insurers to limit coverage of bariatric surgery does not jibe with the clinical experience at one U.S. center with 461 patients who underwent primary or revisional bariatric surgery.

PhotoDisk

The tactic applies to patients with a baseline body mass index (BMI) of 35-39 kg/m² who usually also need at least one comorbidity to qualify for insurance coverage for bariatric surgery, and specifically to the subgroup for whom hypertension is the qualifying comorbidity.

Some insurers limit surgery coverage to patients with hypertension who fail to reach their goal blood pressure on agents from three different drug classes, a policy that is “extremely frustrating and dangerous,” said Yannis Raftopoulos, MD, PhD, in his presentation at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

Using number of antihypertensive drugs ‘is not correct’

“Using the number of antihypertensive medications to justify surgery is not correct because blood pressure control is not [always] better when patients take two or three medications, compared with when they are taking one. This harms patients because the more severe their hypertension, the worse their control,” said Dr. Raftopoulos, director of the weight management program at Holyoke (Mass.) Medical Center.

He presented findings from a retrospective study of 461 patients who underwent either sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass at his center, including 213 (46%) diagnosed with hypertension at the time of their surgery. Within this group were 68 patients with a BMI of 35-39, which meant that they could get insurance coverage for bariatric surgery only if they also had a relevant comorbidity such as hypertension, diabetes, or severe sleep apnea.

Among these patients, 36 (17% of those with hypertension) had only hypertension as their relevant comorbidity and would not have qualified for bariatric surgery under the strictest criteria applied by some insurers that require patients to remain hypertensive despite treatment with at least three different antihypertensive medications. (These 36 patients underwent bariatric surgery because their insurance coverage did not have this restriction.)

The analyses Dr. Raftopoulos presented also documented the rate of hypertension resolution among patients in the series who had hypertension at baseline and 1-year follow-up results. Among 65 patients on one antihypertensive drug at baseline, 43 (66%) had complete resolution of their hypertension after 1 year, defined as blood pressure of less than 130/90 mm Hg while completely off antihypertensive treatment. In contrast, among 55 patients on two antihypertensive medications at baseline, 28 (51%) had complete resolution after 1 year, and among 24 patients on three or more antihypertensive medications at baseline, 3 (13%) had complete resolution 1 year after bariatric surgery, he reported.

“Patients who were treated with one oral antihypertensive medication preoperatively had a higher likelihood of postoperative hypertension resolution,” concluded Dr. Raftopoulos.

Restricting access to bariatric surgery to patients with a BMI of less than 40 based on the preoperative intensity of their antihypertensive treatment “is not supported by our data, and can be potentially harmful,” he declared.

“This study was the result of discussions about this problem with multiple insurers in my area,” he added. “This affects a good number of patients.”

Waiting for hypertension to become less treatable

The results Dr. Raftopoulos presented “are not surprising, because they confirm the hypothesis that earlier intervention in the course of a disease like hypertension is more likely to be successful,” commented Bruce D. Schirmer, MD, a professor of surgery at the University of Virginia, Charlottesville, and designated discussant for the report.

The policy followed by some health insurers to delay coverage for bariatric surgery until patients fail three medications “forces patients with more treatable hypertension to wait until their disease worsens and becomes less treatable before they can receive appropriate treatment,” he said.

Dr. Schirmer attributed the motivation for this approach to a “despicable” and “reprehensible” reason: “Actuarial calculations that show paying for curative therapy is not cost effective in the short term. The duration of a patient’s policy may not be long enough to yield a positive financial outcome, so it becomes more appropriate to deny optimal care and have patients become sicker from their disease.”

“I applaud the authors for accumulating the data that point out this unfortunate rule of some insurance companies,” Dr. Schirmer added.

The practice is comparable with an insurer requiring that a patient’s cancer must be metastatic before allowing coverage for treatment, commented Ann M. Rogers, MD, professor and director of the Penn State University surgical weight loss program in Hershey, Penn., and a moderator of the session.

Dr. Raftopoulos, Dr. Schirmer, and Dr. Rogers had no disclosures.

[email protected]

A delaying tactic used by some U.S. health insurers to limit coverage of bariatric surgery does not jibe with the clinical experience at one U.S. center with 461 patients who underwent primary or revisional bariatric surgery.

PhotoDisk

The tactic applies to patients with a baseline body mass index (BMI) of 35-39 kg/m² who usually also need at least one comorbidity to qualify for insurance coverage for bariatric surgery, and specifically to the subgroup for whom hypertension is the qualifying comorbidity.

Some insurers limit surgery coverage to patients with hypertension who fail to reach their goal blood pressure on agents from three different drug classes, a policy that is “extremely frustrating and dangerous,” said Yannis Raftopoulos, MD, PhD, in his presentation at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

Using number of antihypertensive drugs ‘is not correct’

“Using the number of antihypertensive medications to justify surgery is not correct because blood pressure control is not [always] better when patients take two or three medications, compared with when they are taking one. This harms patients because the more severe their hypertension, the worse their control,” said Dr. Raftopoulos, director of the weight management program at Holyoke (Mass.) Medical Center.

He presented findings from a retrospective study of 461 patients who underwent either sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass at his center, including 213 (46%) diagnosed with hypertension at the time of their surgery. Within this group were 68 patients with a BMI of 35-39, which meant that they could get insurance coverage for bariatric surgery only if they also had a relevant comorbidity such as hypertension, diabetes, or severe sleep apnea.

Among these patients, 36 (17% of those with hypertension) had only hypertension as their relevant comorbidity and would not have qualified for bariatric surgery under the strictest criteria applied by some insurers that require patients to remain hypertensive despite treatment with at least three different antihypertensive medications. (These 36 patients underwent bariatric surgery because their insurance coverage did not have this restriction.)

The analyses Dr. Raftopoulos presented also documented the rate of hypertension resolution among patients in the series who had hypertension at baseline and 1-year follow-up results. Among 65 patients on one antihypertensive drug at baseline, 43 (66%) had complete resolution of their hypertension after 1 year, defined as blood pressure of less than 130/90 mm Hg while completely off antihypertensive treatment. In contrast, among 55 patients on two antihypertensive medications at baseline, 28 (51%) had complete resolution after 1 year, and among 24 patients on three or more antihypertensive medications at baseline, 3 (13%) had complete resolution 1 year after bariatric surgery, he reported.

“Patients who were treated with one oral antihypertensive medication preoperatively had a higher likelihood of postoperative hypertension resolution,” concluded Dr. Raftopoulos.

Restricting access to bariatric surgery to patients with a BMI of less than 40 based on the preoperative intensity of their antihypertensive treatment “is not supported by our data, and can be potentially harmful,” he declared.

“This study was the result of discussions about this problem with multiple insurers in my area,” he added. “This affects a good number of patients.”

Waiting for hypertension to become less treatable

The results Dr. Raftopoulos presented “are not surprising, because they confirm the hypothesis that earlier intervention in the course of a disease like hypertension is more likely to be successful,” commented Bruce D. Schirmer, MD, a professor of surgery at the University of Virginia, Charlottesville, and designated discussant for the report.

The policy followed by some health insurers to delay coverage for bariatric surgery until patients fail three medications “forces patients with more treatable hypertension to wait until their disease worsens and becomes less treatable before they can receive appropriate treatment,” he said.

Dr. Schirmer attributed the motivation for this approach to a “despicable” and “reprehensible” reason: “Actuarial calculations that show paying for curative therapy is not cost effective in the short term. The duration of a patient’s policy may not be long enough to yield a positive financial outcome, so it becomes more appropriate to deny optimal care and have patients become sicker from their disease.”

“I applaud the authors for accumulating the data that point out this unfortunate rule of some insurance companies,” Dr. Schirmer added.

The practice is comparable with an insurer requiring that a patient’s cancer must be metastatic before allowing coverage for treatment, commented Ann M. Rogers, MD, professor and director of the Penn State University surgical weight loss program in Hershey, Penn., and a moderator of the session.

Dr. Raftopoulos, Dr. Schirmer, and Dr. Rogers had no disclosures.

[email protected]

A 21-year-old man presented to the emergency department (ED) with a 2-month history of joint pain, swelling, and difficulty walking that began with swelling of his right knee (FIGURE 1A). The patient said that over the course of several weeks, the swelling and joint pain spread to his left knee, followed by bilateral elbows and ankles. Nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin produced only modest improvement.

Two weeks prior to presentation, the patient also experienced widespread pruritus and conjunctivitis. His past medical history was significant for a sexual encounter that resulted in urinary tract infection (UTI)–like symptoms approximately 1 month prior to the onset of his joint symptoms. He did not seek care for the UTI-like symptoms.

In the ED, the patient was febrile (102.1 °F) and tachycardic. Skin examination revealed erythematous papules, intact vesicles, and pustules with background hyperkeratosis and desquamation on his right foot (FIGURE 1B). The patient had spotty erythema on his palate and a 4-mm superficial erosion on the right penile shaft. Swelling and tenderness were noted over the elbows, knees, hands, and ankles. No inguinal lymphadenopathy was noted.

An arthrocentesis was performed on the right knee that demonstrated no organisms on Gram stain and a normal joint fluid cell count. A complete blood count (CBC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and urinalysis were ordered. A punch biopsy was performed on a scaly patch on the right elbow.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

 

 

Dx: Keratoderma blenorrhagicum

The patient’s history, clinical findings, and lab results, including a positive Chlamydia trachomatis polymerase chain reaction (PCR) test from a urethral swab, pointed to a diagnosis of keratoderma blenorrhagicum in association with reactive arthritis (following infection with C trachomatis).

Reactive arthritis features a triad of conjunctivitis, urethritis, and arthritis that follows either gastrointestinal or urogenital infection.

Relevant diagnostic findings included an elevated CRP of 26.5 mg/L (normal range, < 10 mg/L), an elevated ESR of 116 mm/h (normal range, < 15 mm/h) and as noted, a positive C trachomatis PCR test. The patient’s white blood cell count was 9.7/μL (normal range, 4.5-11 μL) and the rest of the CBC was within normal limits. Urinalysis was positive for leukocytes and rare bacteria. A treponemal antibody test was negative.

Additionally, the punch biopsy from the right elbow revealed acanthosis, intercellular spongiosis, and subcorneal pustules consistent with localized pustular psoriasis or keratoderma blenorrhagicum. After the diagnosis was made, human leukocyte antigen B27 allele (HLA-B27) testing was conducted and was positive.

A predisposition exacerbates the infection

Reactive arthritis, a type of spondyloarthropathy, features a triad of conjunctivitis, urethritis, and arthritis that follows either gastrointestinal or urogenital infection.¹ Reactive arthritis occurs with a male predominance of 3:1, and the worldwide prevalence is 1 in 3000.¹ Causative bacteria include C trachomatis, Yersinia, Salmonella, ­Shigella, and Campylobacter, Escherichia coli, Clostridioides (formerly Clostridium) difficile, and C pneumoniae.² Patients with the HLA-B27 allele are 50 times more likely to develop reactive arthritis following infection with the aforementioned bacteria.¹

Findings consistent with a diagnosis of reactive arthritis include a recent history of gastrointestinal or urogenital illness, joint pain, conjunctivitis, oral lesions, cutaneous changes, and genital lesions.³ Diagnostic tests should include arthrocentesis with cultures or PCR and cell count, ESR, CRP, CBC, and urinalysis. HLA-B27 can be used to support the diagnosis but is not routinely recommended.²

Pustules and psoriasiform scaling characterize this diagnosis

The differential diagnosis for the signs and symptoms seen in this patient include disseminated gonococcal arthritis, psoriatic arthritis, rheumatoid arthritis, and secondary syphilis.

Gonococcal arthritis manifests with painful, sterile joints as well as pustules on the palms and soles, but not with the psoriasiform scaling and desquamation that was seen in this case. A culture or PCR from urethral discharge or pustules on the palms and soles could be used to confirm this diagnosis.³

Continue to: Psoriasis in association with psoriatic arthritis

Psoriasis in association with psoriatic arthritis and the psoriasiform rashing of reactive arthritis (keratoderma blenorrhagicum) show similar histopathology; however, patients with psoriatic arthritis generally exhibit fewer constitutional symptoms.⁴

Rheumatoid arthritis also manifests with joint pain and swelling, especially in the hands, wrists, and knees. This diagnosis was unlikely in this patient, where small joints were largely uninvolved.⁴

Secondary syphilis also manifests with papular, scaly, erythematous lesions on the palms and soles along with pityriasis rosea–like rashing on the trunk. However, it rarely produces pustules or hyperkeratotic keratoderma.⁵ As noted earlier, a treponemal antibody test in this patient was negative.

Drug therapy is the best option

First-line therapy for reactive arthritis consists of NSAIDs. If the patient exhibits an inadequate response after a 2-week trial, intra-­articular or systemic glucocorticoids may be considered.³ If the patient fails to respond to the steroids, disease-modifying antirheumatic drugs (DMARDs) may be considered. Reactive arthritis is considered chronic if the disease lasts longer than 6 months, at which point, DMARDs or tumor necrosis factor-α inhibitors may be utilized.³ For cutaneous manifestations, such as keratoderma blenorrhagicum, topical glucocorticoids twice daily may be used along with keratolytic agents.

Our patient received 2 doses of azithromycin (500 mg IV) and 1 dose of ceftriaxone (2 g IV) to treat his infection while in the ED. Over the course of his hospital stay, he received ceftriaxone (1 g IV daily) for 6 days and naproxen (500 mg tid po) which was tapered. Additionally, he received a week of methylprednisolone (60 mg IM daily) before tapering to oral prednisone. His taper consisted of 40 mg po for 1 week and was decreased by 10 mg each week. Augmented betamethasone dipropionate 0.05% cream and urea 20% cream were prescribed for twice-daily application for the hyperkeratotic scale on both of his feet.

A 21-year-old man presented to the emergency department (ED) with a 2-month history of joint pain, swelling, and difficulty walking that began with swelling of his right knee (FIGURE 1A). The patient said that over the course of several weeks, the swelling and joint pain spread to his left knee, followed by bilateral elbows and ankles. Nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin produced only modest improvement.

Two weeks prior to presentation, the patient also experienced widespread pruritus and conjunctivitis. His past medical history was significant for a sexual encounter that resulted in urinary tract infection (UTI)–like symptoms approximately 1 month prior to the onset of his joint symptoms. He did not seek care for the UTI-like symptoms.

In the ED, the patient was febrile (102.1 °F) and tachycardic. Skin examination revealed erythematous papules, intact vesicles, and pustules with background hyperkeratosis and desquamation on his right foot (FIGURE 1B). The patient had spotty erythema on his palate and a 4-mm superficial erosion on the right penile shaft. Swelling and tenderness were noted over the elbows, knees, hands, and ankles. No inguinal lymphadenopathy was noted.

An arthrocentesis was performed on the right knee that demonstrated no organisms on Gram stain and a normal joint fluid cell count. A complete blood count (CBC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and urinalysis were ordered. A punch biopsy was performed on a scaly patch on the right elbow.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

 

 

Dx: Keratoderma blenorrhagicum

The patient’s history, clinical findings, and lab results, including a positive Chlamydia trachomatis polymerase chain reaction (PCR) test from a urethral swab, pointed to a diagnosis of keratoderma blenorrhagicum in association with reactive arthritis (following infection with C trachomatis).

Reactive arthritis features a triad of conjunctivitis, urethritis, and arthritis that follows either gastrointestinal or urogenital infection.

Relevant diagnostic findings included an elevated CRP of 26.5 mg/L (normal range, < 10 mg/L), an elevated ESR of 116 mm/h (normal range, < 15 mm/h) and as noted, a positive C trachomatis PCR test. The patient’s white blood cell count was 9.7/μL (normal range, 4.5-11 μL) and the rest of the CBC was within normal limits. Urinalysis was positive for leukocytes and rare bacteria. A treponemal antibody test was negative.

Additionally, the punch biopsy from the right elbow revealed acanthosis, intercellular spongiosis, and subcorneal pustules consistent with localized pustular psoriasis or keratoderma blenorrhagicum. After the diagnosis was made, human leukocyte antigen B27 allele (HLA-B27) testing was conducted and was positive.

A predisposition exacerbates the infection

Reactive arthritis, a type of spondyloarthropathy, features a triad of conjunctivitis, urethritis, and arthritis that follows either gastrointestinal or urogenital infection.¹ Reactive arthritis occurs with a male predominance of 3:1, and the worldwide prevalence is 1 in 3000.¹ Causative bacteria include C trachomatis, Yersinia, Salmonella, ­Shigella, and Campylobacter, Escherichia coli, Clostridioides (formerly Clostridium) difficile, and C pneumoniae.² Patients with the HLA-B27 allele are 50 times more likely to develop reactive arthritis following infection with the aforementioned bacteria.¹

Findings consistent with a diagnosis of reactive arthritis include a recent history of gastrointestinal or urogenital illness, joint pain, conjunctivitis, oral lesions, cutaneous changes, and genital lesions.³ Diagnostic tests should include arthrocentesis with cultures or PCR and cell count, ESR, CRP, CBC, and urinalysis. HLA-B27 can be used to support the diagnosis but is not routinely recommended.²

Pustules and psoriasiform scaling characterize this diagnosis

The differential diagnosis for the signs and symptoms seen in this patient include disseminated gonococcal arthritis, psoriatic arthritis, rheumatoid arthritis, and secondary syphilis.

Gonococcal arthritis manifests with painful, sterile joints as well as pustules on the palms and soles, but not with the psoriasiform scaling and desquamation that was seen in this case. A culture or PCR from urethral discharge or pustules on the palms and soles could be used to confirm this diagnosis.³

Continue to: Psoriasis in association with psoriatic arthritis

Psoriasis in association with psoriatic arthritis and the psoriasiform rashing of reactive arthritis (keratoderma blenorrhagicum) show similar histopathology; however, patients with psoriatic arthritis generally exhibit fewer constitutional symptoms.⁴

Rheumatoid arthritis also manifests with joint pain and swelling, especially in the hands, wrists, and knees. This diagnosis was unlikely in this patient, where small joints were largely uninvolved.⁴

Secondary syphilis also manifests with papular, scaly, erythematous lesions on the palms and soles along with pityriasis rosea–like rashing on the trunk. However, it rarely produces pustules or hyperkeratotic keratoderma.⁵ As noted earlier, a treponemal antibody test in this patient was negative.

Drug therapy is the best option

First-line therapy for reactive arthritis consists of NSAIDs. If the patient exhibits an inadequate response after a 2-week trial, intra-­articular or systemic glucocorticoids may be considered.³ If the patient fails to respond to the steroids, disease-modifying antirheumatic drugs (DMARDs) may be considered. Reactive arthritis is considered chronic if the disease lasts longer than 6 months, at which point, DMARDs or tumor necrosis factor-α inhibitors may be utilized.³ For cutaneous manifestations, such as keratoderma blenorrhagicum, topical glucocorticoids twice daily may be used along with keratolytic agents.

Our patient received 2 doses of azithromycin (500 mg IV) and 1 dose of ceftriaxone (2 g IV) to treat his infection while in the ED. Over the course of his hospital stay, he received ceftriaxone (1 g IV daily) for 6 days and naproxen (500 mg tid po) which was tapered. Additionally, he received a week of methylprednisolone (60 mg IM daily) before tapering to oral prednisone. His taper consisted of 40 mg po for 1 week and was decreased by 10 mg each week. Augmented betamethasone dipropionate 0.05% cream and urea 20% cream were prescribed for twice-daily application for the hyperkeratotic scale on both of his feet.

A 21-year-old man presented to the emergency department (ED) with a 2-month history of joint pain, swelling, and difficulty walking that began with swelling of his right knee (FIGURE 1A). The patient said that over the course of several weeks, the swelling and joint pain spread to his left knee, followed by bilateral elbows and ankles. Nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin produced only modest improvement.

Two weeks prior to presentation, the patient also experienced widespread pruritus and conjunctivitis. His past medical history was significant for a sexual encounter that resulted in urinary tract infection (UTI)–like symptoms approximately 1 month prior to the onset of his joint symptoms. He did not seek care for the UTI-like symptoms.

In the ED, the patient was febrile (102.1 °F) and tachycardic. Skin examination revealed erythematous papules, intact vesicles, and pustules with background hyperkeratosis and desquamation on his right foot (FIGURE 1B). The patient had spotty erythema on his palate and a 4-mm superficial erosion on the right penile shaft. Swelling and tenderness were noted over the elbows, knees, hands, and ankles. No inguinal lymphadenopathy was noted.

An arthrocentesis was performed on the right knee that demonstrated no organisms on Gram stain and a normal joint fluid cell count. A complete blood count (CBC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and urinalysis were ordered. A punch biopsy was performed on a scaly patch on the right elbow.

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

 

 

Dx: Keratoderma blenorrhagicum

The patient’s history, clinical findings, and lab results, including a positive Chlamydia trachomatis polymerase chain reaction (PCR) test from a urethral swab, pointed to a diagnosis of keratoderma blenorrhagicum in association with reactive arthritis (following infection with C trachomatis).

Reactive arthritis features a triad of conjunctivitis, urethritis, and arthritis that follows either gastrointestinal or urogenital infection.

Relevant diagnostic findings included an elevated CRP of 26.5 mg/L (normal range, < 10 mg/L), an elevated ESR of 116 mm/h (normal range, < 15 mm/h) and as noted, a positive C trachomatis PCR test. The patient’s white blood cell count was 9.7/μL (normal range, 4.5-11 μL) and the rest of the CBC was within normal limits. Urinalysis was positive for leukocytes and rare bacteria. A treponemal antibody test was negative.

Additionally, the punch biopsy from the right elbow revealed acanthosis, intercellular spongiosis, and subcorneal pustules consistent with localized pustular psoriasis or keratoderma blenorrhagicum. After the diagnosis was made, human leukocyte antigen B27 allele (HLA-B27) testing was conducted and was positive.

A predisposition exacerbates the infection

Reactive arthritis, a type of spondyloarthropathy, features a triad of conjunctivitis, urethritis, and arthritis that follows either gastrointestinal or urogenital infection.¹ Reactive arthritis occurs with a male predominance of 3:1, and the worldwide prevalence is 1 in 3000.¹ Causative bacteria include C trachomatis, Yersinia, Salmonella, ­Shigella, and Campylobacter, Escherichia coli, Clostridioides (formerly Clostridium) difficile, and C pneumoniae.² Patients with the HLA-B27 allele are 50 times more likely to develop reactive arthritis following infection with the aforementioned bacteria.¹

Findings consistent with a diagnosis of reactive arthritis include a recent history of gastrointestinal or urogenital illness, joint pain, conjunctivitis, oral lesions, cutaneous changes, and genital lesions.³ Diagnostic tests should include arthrocentesis with cultures or PCR and cell count, ESR, CRP, CBC, and urinalysis. HLA-B27 can be used to support the diagnosis but is not routinely recommended.²

Pustules and psoriasiform scaling characterize this diagnosis

The differential diagnosis for the signs and symptoms seen in this patient include disseminated gonococcal arthritis, psoriatic arthritis, rheumatoid arthritis, and secondary syphilis.

Gonococcal arthritis manifests with painful, sterile joints as well as pustules on the palms and soles, but not with the psoriasiform scaling and desquamation that was seen in this case. A culture or PCR from urethral discharge or pustules on the palms and soles could be used to confirm this diagnosis.³

Continue to: Psoriasis in association with psoriatic arthritis

Psoriasis in association with psoriatic arthritis and the psoriasiform rashing of reactive arthritis (keratoderma blenorrhagicum) show similar histopathology; however, patients with psoriatic arthritis generally exhibit fewer constitutional symptoms.⁴

Rheumatoid arthritis also manifests with joint pain and swelling, especially in the hands, wrists, and knees. This diagnosis was unlikely in this patient, where small joints were largely uninvolved.⁴

Secondary syphilis also manifests with papular, scaly, erythematous lesions on the palms and soles along with pityriasis rosea–like rashing on the trunk. However, it rarely produces pustules or hyperkeratotic keratoderma.⁵ As noted earlier, a treponemal antibody test in this patient was negative.

Drug therapy is the best option

First-line therapy for reactive arthritis consists of NSAIDs. If the patient exhibits an inadequate response after a 2-week trial, intra-­articular or systemic glucocorticoids may be considered.³ If the patient fails to respond to the steroids, disease-modifying antirheumatic drugs (DMARDs) may be considered. Reactive arthritis is considered chronic if the disease lasts longer than 6 months, at which point, DMARDs or tumor necrosis factor-α inhibitors may be utilized.³ For cutaneous manifestations, such as keratoderma blenorrhagicum, topical glucocorticoids twice daily may be used along with keratolytic agents.

Our patient received 2 doses of azithromycin (500 mg IV) and 1 dose of ceftriaxone (2 g IV) to treat his infection while in the ED. Over the course of his hospital stay, he received ceftriaxone (1 g IV daily) for 6 days and naproxen (500 mg tid po) which was tapered. Additionally, he received a week of methylprednisolone (60 mg IM daily) before tapering to oral prednisone. His taper consisted of 40 mg po for 1 week and was decreased by 10 mg each week. Augmented betamethasone dipropionate 0.05% cream and urea 20% cream were prescribed for twice-daily application for the hyperkeratotic scale on both of his feet.

A new study supports the recommendation of eating two servings of fruit a day for health benefits – in this case a lower risk of diabetes.

Adults who ate two servings of fruit a day had 36% lower odds of developing diabetes within 5 years compared to those who ate less than a half serving of fruit a day, after adjusting for confounders, in a population-based Australian study.

The findings by Nicola P. Bondonno, PhD, and colleagues, based on data from the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab), were published online June 2 in the Journal of Clinical Endocrinology & Metabolism.

The study also showed that a higher fruit intake was associated with higher insulin sensitivity and lower pancreatic beta-cell function in a dose-response manner.

And a higher intake of apples – but not citrus fruit or bananas, the two other fruits studied – was associated with lower post-load serum insulin levels.

“This indicates that people who consumed more fruit [especially apples] had to produce less insulin to lower their blood glucose levels,” Dr. Bondonno, from the Institute for Nutrition Research, Edith Cowan University, Perth, Australia, explained in a statement from the Endocrine Society.

“This is important since high levels of circulating insulin (hyperinsulinemia) can damage blood vessels” and this is “related not only to diabetes, but also to high blood pressure, obesity, and heart disease,” she observed.
 

Fruit juice doesn’t have same effect

The study supports the recommendation of the Australian Dietary Guidelines – 2 servings of fruit a day, where one serving is 150 grams, which corresponds to a medium-sized apple, orange, or banana – Dr. Bondonno clarified in an email.

However, fruit juice was not associated with better glucose or insulin levels, or lower risk of diabetes, possibly because of its relatively high glycemic load and fewer beneficial fibers, the researchers speculate; added data suggest that even juice with added fiber does not trigger satiety.

The study findings “support encouragement of the consumption of whole fruits, but not fruit juice, to preserve insulin sensitivity and mitigate [type 2 diabetes] risk,” Dr. Bondonno and colleagues summarize.

“Promoting a healthy diet and lifestyle which includes the consumption of popular fruits such as apples, bananas, and oranges, with widespread geographical availability, may lower [type 2 diabetes] incidence,” they conclude.
 

Lower 5-year odds of diabetes

It is not clear how eating fruit may confer protection against developing diabetes, the researchers write.

They aimed to examine how consumption of total fruit, individual fruit, and fruit juice is related to glucose tolerance, insulin sensitivity, and incident diabetes at 5 years and 12 years in participants in the nationally representative AusDiab study.  

They identified 7,675 adults aged 25 and older without diabetes who had undergone blood tests and completed a food frequency questionnaire in 1999-2000.

Participants had indicated how often they ate 10 different types of fruit, any type of fruit juice, and other foods on a scale of 0 (never) to 10 (three or more times/day).

Researchers divided participants into quartiles based on their median fruit consumption: 62 (range 0-95) g/day, 122 (95-162) g/day, 230 (162-283) g/day, and 372 (283-961) g/day.

The most commonly consumed fruit was apples (23% of total fruit intake), followed by bananas (20%) and citrus fruit (18%). Other fruits each accounted for less than 8% of total fruit intake, so they were not studied separately.

Participants in each quartile had a similar mean age (54 years) and body mass index (27 kg/m²).

However, compared with participants in quartile 1 (low fruit intake), those in quartiles 3 and 4 (moderate and high fruit intakes, respectively) were more likely to be female, do at least 150 minutes of physical activity a week, and less likely to smoke. They also ate more vegetables and less red meat and processed meat, but they consumed more sugar.

Of 4,674 participants who had 5-year follow-up, 179 participants developed diabetes.

Compared to participants with a low fruit intake (quartile 1), those with a moderate fruit intake (quartile 3) had a 36% lower odds of developing diabetes within 5 years (odds ratio, 0.64; 95% confidence interval, 0.44-0.92) after adjusting for age, sex, physical activity, education, socioeconomic status, income, body mass index, smoking, cardiovascular disease, parental history of diabetes, and consumption of alcohol, vegetables, red meat, processed meat, and calories.

Of the 3,518 participants with 12-year follow-up, 247 participants had diabetes, but there were no significant associations between fruit consumption and this longer-term risk of diabetes, possibly due to the small number of participants and events.

The study was supported by grants from the National Health and Medical Research Council of Australia and the National Heart Foundation of Australia. Dr. Bondonno has reported no relevant financial disclosures. Disclosures of the other authors are listed with the article.

A version of this article first appeared on Medscape.com.

A new study supports the recommendation of eating two servings of fruit a day for health benefits – in this case a lower risk of diabetes.

Adults who ate two servings of fruit a day had 36% lower odds of developing diabetes within 5 years compared to those who ate less than a half serving of fruit a day, after adjusting for confounders, in a population-based Australian study.

The findings by Nicola P. Bondonno, PhD, and colleagues, based on data from the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab), were published online June 2 in the Journal of Clinical Endocrinology & Metabolism.

The study also showed that a higher fruit intake was associated with higher insulin sensitivity and lower pancreatic beta-cell function in a dose-response manner.

And a higher intake of apples – but not citrus fruit or bananas, the two other fruits studied – was associated with lower post-load serum insulin levels.

“This indicates that people who consumed more fruit [especially apples] had to produce less insulin to lower their blood glucose levels,” Dr. Bondonno, from the Institute for Nutrition Research, Edith Cowan University, Perth, Australia, explained in a statement from the Endocrine Society.

“This is important since high levels of circulating insulin (hyperinsulinemia) can damage blood vessels” and this is “related not only to diabetes, but also to high blood pressure, obesity, and heart disease,” she observed.
 

Fruit juice doesn’t have same effect

The study supports the recommendation of the Australian Dietary Guidelines – 2 servings of fruit a day, where one serving is 150 grams, which corresponds to a medium-sized apple, orange, or banana – Dr. Bondonno clarified in an email.

However, fruit juice was not associated with better glucose or insulin levels, or lower risk of diabetes, possibly because of its relatively high glycemic load and fewer beneficial fibers, the researchers speculate; added data suggest that even juice with added fiber does not trigger satiety.

The study findings “support encouragement of the consumption of whole fruits, but not fruit juice, to preserve insulin sensitivity and mitigate [type 2 diabetes] risk,” Dr. Bondonno and colleagues summarize.

“Promoting a healthy diet and lifestyle which includes the consumption of popular fruits such as apples, bananas, and oranges, with widespread geographical availability, may lower [type 2 diabetes] incidence,” they conclude.
 

Lower 5-year odds of diabetes

It is not clear how eating fruit may confer protection against developing diabetes, the researchers write.

They aimed to examine how consumption of total fruit, individual fruit, and fruit juice is related to glucose tolerance, insulin sensitivity, and incident diabetes at 5 years and 12 years in participants in the nationally representative AusDiab study.  

They identified 7,675 adults aged 25 and older without diabetes who had undergone blood tests and completed a food frequency questionnaire in 1999-2000.

Participants had indicated how often they ate 10 different types of fruit, any type of fruit juice, and other foods on a scale of 0 (never) to 10 (three or more times/day).

Researchers divided participants into quartiles based on their median fruit consumption: 62 (range 0-95) g/day, 122 (95-162) g/day, 230 (162-283) g/day, and 372 (283-961) g/day.

The most commonly consumed fruit was apples (23% of total fruit intake), followed by bananas (20%) and citrus fruit (18%). Other fruits each accounted for less than 8% of total fruit intake, so they were not studied separately.

Participants in each quartile had a similar mean age (54 years) and body mass index (27 kg/m²).

However, compared with participants in quartile 1 (low fruit intake), those in quartiles 3 and 4 (moderate and high fruit intakes, respectively) were more likely to be female, do at least 150 minutes of physical activity a week, and less likely to smoke. They also ate more vegetables and less red meat and processed meat, but they consumed more sugar.

Of 4,674 participants who had 5-year follow-up, 179 participants developed diabetes.

Compared to participants with a low fruit intake (quartile 1), those with a moderate fruit intake (quartile 3) had a 36% lower odds of developing diabetes within 5 years (odds ratio, 0.64; 95% confidence interval, 0.44-0.92) after adjusting for age, sex, physical activity, education, socioeconomic status, income, body mass index, smoking, cardiovascular disease, parental history of diabetes, and consumption of alcohol, vegetables, red meat, processed meat, and calories.

Of the 3,518 participants with 12-year follow-up, 247 participants had diabetes, but there were no significant associations between fruit consumption and this longer-term risk of diabetes, possibly due to the small number of participants and events.

The study was supported by grants from the National Health and Medical Research Council of Australia and the National Heart Foundation of Australia. Dr. Bondonno has reported no relevant financial disclosures. Disclosures of the other authors are listed with the article.

A version of this article first appeared on Medscape.com.

A new study supports the recommendation of eating two servings of fruit a day for health benefits – in this case a lower risk of diabetes.

Adults who ate two servings of fruit a day had 36% lower odds of developing diabetes within 5 years compared to those who ate less than a half serving of fruit a day, after adjusting for confounders, in a population-based Australian study.

The findings by Nicola P. Bondonno, PhD, and colleagues, based on data from the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab), were published online June 2 in the Journal of Clinical Endocrinology & Metabolism.

The study also showed that a higher fruit intake was associated with higher insulin sensitivity and lower pancreatic beta-cell function in a dose-response manner.

And a higher intake of apples – but not citrus fruit or bananas, the two other fruits studied – was associated with lower post-load serum insulin levels.

“This indicates that people who consumed more fruit [especially apples] had to produce less insulin to lower their blood glucose levels,” Dr. Bondonno, from the Institute for Nutrition Research, Edith Cowan University, Perth, Australia, explained in a statement from the Endocrine Society.

“This is important since high levels of circulating insulin (hyperinsulinemia) can damage blood vessels” and this is “related not only to diabetes, but also to high blood pressure, obesity, and heart disease,” she observed.
 

Fruit juice doesn’t have same effect

The study supports the recommendation of the Australian Dietary Guidelines – 2 servings of fruit a day, where one serving is 150 grams, which corresponds to a medium-sized apple, orange, or banana – Dr. Bondonno clarified in an email.

However, fruit juice was not associated with better glucose or insulin levels, or lower risk of diabetes, possibly because of its relatively high glycemic load and fewer beneficial fibers, the researchers speculate; added data suggest that even juice with added fiber does not trigger satiety.

The study findings “support encouragement of the consumption of whole fruits, but not fruit juice, to preserve insulin sensitivity and mitigate [type 2 diabetes] risk,” Dr. Bondonno and colleagues summarize.

“Promoting a healthy diet and lifestyle which includes the consumption of popular fruits such as apples, bananas, and oranges, with widespread geographical availability, may lower [type 2 diabetes] incidence,” they conclude.
 

Lower 5-year odds of diabetes

It is not clear how eating fruit may confer protection against developing diabetes, the researchers write.

They aimed to examine how consumption of total fruit, individual fruit, and fruit juice is related to glucose tolerance, insulin sensitivity, and incident diabetes at 5 years and 12 years in participants in the nationally representative AusDiab study.  

They identified 7,675 adults aged 25 and older without diabetes who had undergone blood tests and completed a food frequency questionnaire in 1999-2000.

Participants had indicated how often they ate 10 different types of fruit, any type of fruit juice, and other foods on a scale of 0 (never) to 10 (three or more times/day).

Researchers divided participants into quartiles based on their median fruit consumption: 62 (range 0-95) g/day, 122 (95-162) g/day, 230 (162-283) g/day, and 372 (283-961) g/day.

The most commonly consumed fruit was apples (23% of total fruit intake), followed by bananas (20%) and citrus fruit (18%). Other fruits each accounted for less than 8% of total fruit intake, so they were not studied separately.

Participants in each quartile had a similar mean age (54 years) and body mass index (27 kg/m²).

However, compared with participants in quartile 1 (low fruit intake), those in quartiles 3 and 4 (moderate and high fruit intakes, respectively) were more likely to be female, do at least 150 minutes of physical activity a week, and less likely to smoke. They also ate more vegetables and less red meat and processed meat, but they consumed more sugar.

Of 4,674 participants who had 5-year follow-up, 179 participants developed diabetes.

Compared to participants with a low fruit intake (quartile 1), those with a moderate fruit intake (quartile 3) had a 36% lower odds of developing diabetes within 5 years (odds ratio, 0.64; 95% confidence interval, 0.44-0.92) after adjusting for age, sex, physical activity, education, socioeconomic status, income, body mass index, smoking, cardiovascular disease, parental history of diabetes, and consumption of alcohol, vegetables, red meat, processed meat, and calories.

Of the 3,518 participants with 12-year follow-up, 247 participants had diabetes, but there were no significant associations between fruit consumption and this longer-term risk of diabetes, possibly due to the small number of participants and events.

The study was supported by grants from the National Health and Medical Research Council of Australia and the National Heart Foundation of Australia. Dr. Bondonno has reported no relevant financial disclosures. Disclosures of the other authors are listed with the article.

A version of this article first appeared on Medscape.com.

Highly trained nurse practitioners (NPs) and physician assistants (PAs) are just as capable of performing screening colonoscopies as gastroenterologists: This is the conclusion from a number of studies conducted across both the United States and Europe. 

So, why aren’t more NPs and PAs doing them?

“We wanted it to take off, but we haven’t been able to do it,” said San Diego gastroenterologist Daniel “Stony” Anderson, MD. He spent decades working to expand access to colorectal cancer screening at Kaiser Permanente and other health care organizations, and he has now been doing the same as president of the California Colorectal Cancer Coalition.

Anderson told this news organization that he isn’t sure why the practice did not catch on but added, “I don’t see a groundswell for this.”

One explanation has been that the centers abandoned the practice because there were enough gastroenterologists to handle the demand.

Or perhaps it was one battle too many for NPs and PAs, who are fighting at the state level and at Veterans Affairs (VA) for permission to deliver more primary care and anesthesia services.

In addition, doctors are fighting back.

The American Medical Association runs a Stop Scope Creep campaign that opposes attempts by NPs and PAs “to inappropriately expand their scope of practice.” Along with anesthesiologists, the AMA is fighting the extension of a COVID-19 waiver at the VA that allows NPs and PAs to continue delivering anesthesia without a physician’s supervision. Other groups have joined in the battle against practice expansion via social media under the hashtags #stopscopecreep and #patientsafetymatters.

The battle is ongoing and ugly at times.

Proponents describe NPs and PAs as “advanced practice providers” but opponents call them “midlevel practitioners.” One website called Midlevel WTF argues that the health care system is declining, in part, because of “the proliferation of poorly supervised or completely unsupervised midlevels across the health care spectrum.” 
 

NPs perform colonoscopies ‘safely and effectively’ 

One of the studies to examine the issue of NPs performing screening colonoscopies, and how this compares with gastroenterologists performing the procedure, was published in Endoscopy International Open in October 2020.

In a retrospective analysis from Johns Hopkins Hospital in Baltimore, the authors concluded that three fellowship-trained NPs satisfied the American College of Gastroenterology’s quality indicators and “demonstrated that adequately trained NPs can perform colonoscopy safely and effectively.”

There was little reaction to this conclusion when the study was published. But some months later, several gastroenterologists on social media began questioning the high percentage of African Americans in the study and suggested that the research exploited Black patients, according to a story in STAT, a national health news website.

In a written statement, Hopkins said in an interview, from 2010 to 2016, patients were given the option to have an NP or physician provide a screening colonoscopy. However, they are no longer offered that option. The project has been discontinued: The gastroenterologist who was overseeing the clinical program, Anthony Kalloo, MD, director of the division of gastroenterology and hepatology, left John Hopkins earlier this year, and two of the three NPs involved in the program have also left.

Dr. Kalloo declined to comment but was quoted at length in the STAT article. He noted that NPs regularly perform colonoscopies in the United Kingdom and that the John Hopkins study showed, for the first time, “that we could do this in the United States, and the implication of that is cost savings.”

Dr. Kalloo also defended his work against claims of racial exploitation. In fact, he said, “I found those comments to be amusing. ... Obviously, they saw that I was the lead author from Hopkins, but they obviously didn’t know what I look like.” Dr. Kalloo is Black.

Dr. Kalloo is now chair of the department of medicine at Maimonides Medical Center, New York City, and he told STAT that he was interested in starting up a similar project there to train NPs to perform colonoscopies.

Other centers that explored the practice have also not continued with it.

A 2008 study at the University of California, Davis, notes: “Several barriers to colorectal cancer screening have been identified, including limited access to trained endoscopists and highlight insufficient capacity to meet projected demand for colonoscopies. ... Training NPs to perform colonoscopy may be an effective strategy to increase access.”

The study compared 100 screening colonoscopies performed by board certified gastroenterologists (GI-MD) and 50 performed by a gastroenterology-trained NP (GI-NP). There were no complications reported among the 150 cases, and “the GI-NP in our study performed screening colonoscopy as safely, accurately, and satisfactorily as the GI-MDs,” the authors conclude. 

But it’s not a strategy the hospital adopted. The nurse who conducted the study said in an interview that she is no longer doing them and declined further comment. The University of California, Davis could not confirm whether anyone else is.
 

An uncommon practice

The American Gastroenterological Association (AGA) referred questions from this news organization to the American Society for Gastrointestinal Endoscopy (ASGE).

It is very uncommon to have NPs do coloscopies, commented Douglas K. Rex, MD, director of endoscopy at Indiana University, Indianapolis, and incoming ASGE president.

“There was more of a movement the United Kingdom, but not in the United States,” he said. “I can’t tell you the reason. It’s a combination of minimal data and also the fact that there are plenty of gastroenterologists.”

The ASGE guidelines for endoscopy by nonphysicians concludes: “There are insufficient data to support nonphysician endoscopists to perform colonoscopy.”

Asked about concerns that the demand for colonoscopies will increase now that the recommendation is to start colorectal cancer screening at 45 years old, Dr. Rex said he thinks the system has enough capacity.

But will it continue to be sufficient? In a 2020 white paper on colorectal cancer screening, the AGA noted that lowering the starting age to 45 years will add 21 million people to the current pool of 94 million eligible for screening, an increase of 22%.

Lukejohn Day, MD, a gastroenterologist at the University of California, San Francisco, has reviewed the data collected on nonphysicians performing colorectal cancer screening. He led a meta-analysis of 24 studies conducted from 1997 to 2011, and the team concluded that “nonphysicians can safely perform endoscopic procedures with similar quality, especially with respect to screening flexible sigmoidoscopy. Far fewer data was reported for nonphysicians performing colonoscopy and upper endoscopy, but among this data nonphysicians perform both procedures within accepted national benchmarks for quality measures used in endoscopy.”

Dr. Day told this news organization that he had trained two NPs to do colonoscopies and did the study to get a better sense of the practice. Even still, he said the NPs required extensive training before they could perform the procedure. 

“It’s not like someone could finish school and become an endoscopist. It requires a very rigorous training program – a lot of education and mentoring,” he said. “Their program is very similar to what our GI fellows go through.”

Dr. Day said they faced opposition from the gastroenterologists, but they “had enough guardrails” in place to convince skeptics.

One of those guardrails was the requirement that an attending physician be in the building. But when San Francisco General Hospital moved to a new facility, they were unable to guarantee that coverage and the program ended, Dr. Day said.
 

Quality and depth of training hard to replicate

One place where both NPs and PAs do colonoscopies is at the VA. However, the administration doesn’t keep track of how many work there, according to a VA spokesperson. Regulations on physician providers also vary from state to state, and that is reflected in its workforce.

At the St. Louis VA Medical Center, PAs have been performing diagnostic and colorectal cancer screening colonoscopies for nearly 20 years, according to a 2020 article on the quality of care delivered by PAs. The researchers looked at data from more than 700 patients treated over a year. They had colonoscopies performed by one of seven gastroenterologists, five PAs, or 32 GI fellows from two academic affiliates. The PAs performed better than the fellows and just as well as the gastroenterologists, they concluded. 

Samir Gupta, MD, chief of gastroenterology at the VA San Diego Healthcare System, California, said in an email that he thinks a range of clinically licensed health care providers can be trained to do high-quality colonoscopy.

“The challenge has been ensuring training structure and volume of cases sufficient to consistently enable high-quality colonoscopy practice, including achieving adequate rates of polyp detection and removal and complete exams,” he wrote.

This is a challenge for gastroenterologists, but they receive ongoing medical education, and, in many settings, quality is closely monitored and managed, he wrote. He added that in a 3-year training program, most fellows do hundreds of colonoscopies.

“It is really hard to replicate this quality and depth of training outside of a GI fellowship,” Dr. Gupta said.

A version of this article first appeared on Medscape.com.

Highly trained nurse practitioners (NPs) and physician assistants (PAs) are just as capable of performing screening colonoscopies as gastroenterologists: This is the conclusion from a number of studies conducted across both the United States and Europe. 

So, why aren’t more NPs and PAs doing them?

“We wanted it to take off, but we haven’t been able to do it,” said San Diego gastroenterologist Daniel “Stony” Anderson, MD. He spent decades working to expand access to colorectal cancer screening at Kaiser Permanente and other health care organizations, and he has now been doing the same as president of the California Colorectal Cancer Coalition.

Anderson told this news organization that he isn’t sure why the practice did not catch on but added, “I don’t see a groundswell for this.”

One explanation has been that the centers abandoned the practice because there were enough gastroenterologists to handle the demand.

Or perhaps it was one battle too many for NPs and PAs, who are fighting at the state level and at Veterans Affairs (VA) for permission to deliver more primary care and anesthesia services.

In addition, doctors are fighting back.

The American Medical Association runs a Stop Scope Creep campaign that opposes attempts by NPs and PAs “to inappropriately expand their scope of practice.” Along with anesthesiologists, the AMA is fighting the extension of a COVID-19 waiver at the VA that allows NPs and PAs to continue delivering anesthesia without a physician’s supervision. Other groups have joined in the battle against practice expansion via social media under the hashtags #stopscopecreep and #patientsafetymatters.

The battle is ongoing and ugly at times.

Proponents describe NPs and PAs as “advanced practice providers” but opponents call them “midlevel practitioners.” One website called Midlevel WTF argues that the health care system is declining, in part, because of “the proliferation of poorly supervised or completely unsupervised midlevels across the health care spectrum.” 
 

NPs perform colonoscopies ‘safely and effectively’ 

One of the studies to examine the issue of NPs performing screening colonoscopies, and how this compares with gastroenterologists performing the procedure, was published in Endoscopy International Open in October 2020.

In a retrospective analysis from Johns Hopkins Hospital in Baltimore, the authors concluded that three fellowship-trained NPs satisfied the American College of Gastroenterology’s quality indicators and “demonstrated that adequately trained NPs can perform colonoscopy safely and effectively.”

There was little reaction to this conclusion when the study was published. But some months later, several gastroenterologists on social media began questioning the high percentage of African Americans in the study and suggested that the research exploited Black patients, according to a story in STAT, a national health news website.

In a written statement, Hopkins said in an interview, from 2010 to 2016, patients were given the option to have an NP or physician provide a screening colonoscopy. However, they are no longer offered that option. The project has been discontinued: The gastroenterologist who was overseeing the clinical program, Anthony Kalloo, MD, director of the division of gastroenterology and hepatology, left John Hopkins earlier this year, and two of the three NPs involved in the program have also left.

Dr. Kalloo declined to comment but was quoted at length in the STAT article. He noted that NPs regularly perform colonoscopies in the United Kingdom and that the John Hopkins study showed, for the first time, “that we could do this in the United States, and the implication of that is cost savings.”

Dr. Kalloo also defended his work against claims of racial exploitation. In fact, he said, “I found those comments to be amusing. ... Obviously, they saw that I was the lead author from Hopkins, but they obviously didn’t know what I look like.” Dr. Kalloo is Black.

Dr. Kalloo is now chair of the department of medicine at Maimonides Medical Center, New York City, and he told STAT that he was interested in starting up a similar project there to train NPs to perform colonoscopies.

Other centers that explored the practice have also not continued with it.

A 2008 study at the University of California, Davis, notes: “Several barriers to colorectal cancer screening have been identified, including limited access to trained endoscopists and highlight insufficient capacity to meet projected demand for colonoscopies. ... Training NPs to perform colonoscopy may be an effective strategy to increase access.”

The study compared 100 screening colonoscopies performed by board certified gastroenterologists (GI-MD) and 50 performed by a gastroenterology-trained NP (GI-NP). There were no complications reported among the 150 cases, and “the GI-NP in our study performed screening colonoscopy as safely, accurately, and satisfactorily as the GI-MDs,” the authors conclude. 

But it’s not a strategy the hospital adopted. The nurse who conducted the study said in an interview that she is no longer doing them and declined further comment. The University of California, Davis could not confirm whether anyone else is.
 

An uncommon practice

The American Gastroenterological Association (AGA) referred questions from this news organization to the American Society for Gastrointestinal Endoscopy (ASGE).

It is very uncommon to have NPs do coloscopies, commented Douglas K. Rex, MD, director of endoscopy at Indiana University, Indianapolis, and incoming ASGE president.

“There was more of a movement the United Kingdom, but not in the United States,” he said. “I can’t tell you the reason. It’s a combination of minimal data and also the fact that there are plenty of gastroenterologists.”

The ASGE guidelines for endoscopy by nonphysicians concludes: “There are insufficient data to support nonphysician endoscopists to perform colonoscopy.”

Asked about concerns that the demand for colonoscopies will increase now that the recommendation is to start colorectal cancer screening at 45 years old, Dr. Rex said he thinks the system has enough capacity.

But will it continue to be sufficient? In a 2020 white paper on colorectal cancer screening, the AGA noted that lowering the starting age to 45 years will add 21 million people to the current pool of 94 million eligible for screening, an increase of 22%.

Lukejohn Day, MD, a gastroenterologist at the University of California, San Francisco, has reviewed the data collected on nonphysicians performing colorectal cancer screening. He led a meta-analysis of 24 studies conducted from 1997 to 2011, and the team concluded that “nonphysicians can safely perform endoscopic procedures with similar quality, especially with respect to screening flexible sigmoidoscopy. Far fewer data was reported for nonphysicians performing colonoscopy and upper endoscopy, but among this data nonphysicians perform both procedures within accepted national benchmarks for quality measures used in endoscopy.”

Dr. Day told this news organization that he had trained two NPs to do colonoscopies and did the study to get a better sense of the practice. Even still, he said the NPs required extensive training before they could perform the procedure. 

“It’s not like someone could finish school and become an endoscopist. It requires a very rigorous training program – a lot of education and mentoring,” he said. “Their program is very similar to what our GI fellows go through.”

Dr. Day said they faced opposition from the gastroenterologists, but they “had enough guardrails” in place to convince skeptics.

One of those guardrails was the requirement that an attending physician be in the building. But when San Francisco General Hospital moved to a new facility, they were unable to guarantee that coverage and the program ended, Dr. Day said.
 

Quality and depth of training hard to replicate

One place where both NPs and PAs do colonoscopies is at the VA. However, the administration doesn’t keep track of how many work there, according to a VA spokesperson. Regulations on physician providers also vary from state to state, and that is reflected in its workforce.

At the St. Louis VA Medical Center, PAs have been performing diagnostic and colorectal cancer screening colonoscopies for nearly 20 years, according to a 2020 article on the quality of care delivered by PAs. The researchers looked at data from more than 700 patients treated over a year. They had colonoscopies performed by one of seven gastroenterologists, five PAs, or 32 GI fellows from two academic affiliates. The PAs performed better than the fellows and just as well as the gastroenterologists, they concluded. 

Samir Gupta, MD, chief of gastroenterology at the VA San Diego Healthcare System, California, said in an email that he thinks a range of clinically licensed health care providers can be trained to do high-quality colonoscopy.

“The challenge has been ensuring training structure and volume of cases sufficient to consistently enable high-quality colonoscopy practice, including achieving adequate rates of polyp detection and removal and complete exams,” he wrote.

This is a challenge for gastroenterologists, but they receive ongoing medical education, and, in many settings, quality is closely monitored and managed, he wrote. He added that in a 3-year training program, most fellows do hundreds of colonoscopies.

“It is really hard to replicate this quality and depth of training outside of a GI fellowship,” Dr. Gupta said.

A version of this article first appeared on Medscape.com.

Highly trained nurse practitioners (NPs) and physician assistants (PAs) are just as capable of performing screening colonoscopies as gastroenterologists: This is the conclusion from a number of studies conducted across both the United States and Europe. 

So, why aren’t more NPs and PAs doing them?

“We wanted it to take off, but we haven’t been able to do it,” said San Diego gastroenterologist Daniel “Stony” Anderson, MD. He spent decades working to expand access to colorectal cancer screening at Kaiser Permanente and other health care organizations, and he has now been doing the same as president of the California Colorectal Cancer Coalition.

Anderson told this news organization that he isn’t sure why the practice did not catch on but added, “I don’t see a groundswell for this.”

One explanation has been that the centers abandoned the practice because there were enough gastroenterologists to handle the demand.

Or perhaps it was one battle too many for NPs and PAs, who are fighting at the state level and at Veterans Affairs (VA) for permission to deliver more primary care and anesthesia services.

In addition, doctors are fighting back.

The American Medical Association runs a Stop Scope Creep campaign that opposes attempts by NPs and PAs “to inappropriately expand their scope of practice.” Along with anesthesiologists, the AMA is fighting the extension of a COVID-19 waiver at the VA that allows NPs and PAs to continue delivering anesthesia without a physician’s supervision. Other groups have joined in the battle against practice expansion via social media under the hashtags #stopscopecreep and #patientsafetymatters.

The battle is ongoing and ugly at times.

Proponents describe NPs and PAs as “advanced practice providers” but opponents call them “midlevel practitioners.” One website called Midlevel WTF argues that the health care system is declining, in part, because of “the proliferation of poorly supervised or completely unsupervised midlevels across the health care spectrum.” 
 

NPs perform colonoscopies ‘safely and effectively’ 

One of the studies to examine the issue of NPs performing screening colonoscopies, and how this compares with gastroenterologists performing the procedure, was published in Endoscopy International Open in October 2020.

In a retrospective analysis from Johns Hopkins Hospital in Baltimore, the authors concluded that three fellowship-trained NPs satisfied the American College of Gastroenterology’s quality indicators and “demonstrated that adequately trained NPs can perform colonoscopy safely and effectively.”

There was little reaction to this conclusion when the study was published. But some months later, several gastroenterologists on social media began questioning the high percentage of African Americans in the study and suggested that the research exploited Black patients, according to a story in STAT, a national health news website.

In a written statement, Hopkins said in an interview, from 2010 to 2016, patients were given the option to have an NP or physician provide a screening colonoscopy. However, they are no longer offered that option. The project has been discontinued: The gastroenterologist who was overseeing the clinical program, Anthony Kalloo, MD, director of the division of gastroenterology and hepatology, left John Hopkins earlier this year, and two of the three NPs involved in the program have also left.

Dr. Kalloo declined to comment but was quoted at length in the STAT article. He noted that NPs regularly perform colonoscopies in the United Kingdom and that the John Hopkins study showed, for the first time, “that we could do this in the United States, and the implication of that is cost savings.”

Dr. Kalloo also defended his work against claims of racial exploitation. In fact, he said, “I found those comments to be amusing. ... Obviously, they saw that I was the lead author from Hopkins, but they obviously didn’t know what I look like.” Dr. Kalloo is Black.

Dr. Kalloo is now chair of the department of medicine at Maimonides Medical Center, New York City, and he told STAT that he was interested in starting up a similar project there to train NPs to perform colonoscopies.

Other centers that explored the practice have also not continued with it.

A 2008 study at the University of California, Davis, notes: “Several barriers to colorectal cancer screening have been identified, including limited access to trained endoscopists and highlight insufficient capacity to meet projected demand for colonoscopies. ... Training NPs to perform colonoscopy may be an effective strategy to increase access.”

The study compared 100 screening colonoscopies performed by board certified gastroenterologists (GI-MD) and 50 performed by a gastroenterology-trained NP (GI-NP). There were no complications reported among the 150 cases, and “the GI-NP in our study performed screening colonoscopy as safely, accurately, and satisfactorily as the GI-MDs,” the authors conclude. 

But it’s not a strategy the hospital adopted. The nurse who conducted the study said in an interview that she is no longer doing them and declined further comment. The University of California, Davis could not confirm whether anyone else is.
 

An uncommon practice

The American Gastroenterological Association (AGA) referred questions from this news organization to the American Society for Gastrointestinal Endoscopy (ASGE).

It is very uncommon to have NPs do coloscopies, commented Douglas K. Rex, MD, director of endoscopy at Indiana University, Indianapolis, and incoming ASGE president.

“There was more of a movement the United Kingdom, but not in the United States,” he said. “I can’t tell you the reason. It’s a combination of minimal data and also the fact that there are plenty of gastroenterologists.”

The ASGE guidelines for endoscopy by nonphysicians concludes: “There are insufficient data to support nonphysician endoscopists to perform colonoscopy.”

Asked about concerns that the demand for colonoscopies will increase now that the recommendation is to start colorectal cancer screening at 45 years old, Dr. Rex said he thinks the system has enough capacity.

But will it continue to be sufficient? In a 2020 white paper on colorectal cancer screening, the AGA noted that lowering the starting age to 45 years will add 21 million people to the current pool of 94 million eligible for screening, an increase of 22%.

Lukejohn Day, MD, a gastroenterologist at the University of California, San Francisco, has reviewed the data collected on nonphysicians performing colorectal cancer screening. He led a meta-analysis of 24 studies conducted from 1997 to 2011, and the team concluded that “nonphysicians can safely perform endoscopic procedures with similar quality, especially with respect to screening flexible sigmoidoscopy. Far fewer data was reported for nonphysicians performing colonoscopy and upper endoscopy, but among this data nonphysicians perform both procedures within accepted national benchmarks for quality measures used in endoscopy.”

Dr. Day told this news organization that he had trained two NPs to do colonoscopies and did the study to get a better sense of the practice. Even still, he said the NPs required extensive training before they could perform the procedure. 

“It’s not like someone could finish school and become an endoscopist. It requires a very rigorous training program – a lot of education and mentoring,” he said. “Their program is very similar to what our GI fellows go through.”

Dr. Day said they faced opposition from the gastroenterologists, but they “had enough guardrails” in place to convince skeptics.

One of those guardrails was the requirement that an attending physician be in the building. But when San Francisco General Hospital moved to a new facility, they were unable to guarantee that coverage and the program ended, Dr. Day said.
 

Quality and depth of training hard to replicate

One place where both NPs and PAs do colonoscopies is at the VA. However, the administration doesn’t keep track of how many work there, according to a VA spokesperson. Regulations on physician providers also vary from state to state, and that is reflected in its workforce.

At the St. Louis VA Medical Center, PAs have been performing diagnostic and colorectal cancer screening colonoscopies for nearly 20 years, according to a 2020 article on the quality of care delivered by PAs. The researchers looked at data from more than 700 patients treated over a year. They had colonoscopies performed by one of seven gastroenterologists, five PAs, or 32 GI fellows from two academic affiliates. The PAs performed better than the fellows and just as well as the gastroenterologists, they concluded. 

Samir Gupta, MD, chief of gastroenterology at the VA San Diego Healthcare System, California, said in an email that he thinks a range of clinically licensed health care providers can be trained to do high-quality colonoscopy.

“The challenge has been ensuring training structure and volume of cases sufficient to consistently enable high-quality colonoscopy practice, including achieving adequate rates of polyp detection and removal and complete exams,” he wrote.

This is a challenge for gastroenterologists, but they receive ongoing medical education, and, in many settings, quality is closely monitored and managed, he wrote. He added that in a 3-year training program, most fellows do hundreds of colonoscopies.

“It is really hard to replicate this quality and depth of training outside of a GI fellowship,” Dr. Gupta said.

A version of this article first appeared on Medscape.com.