Diabetes

Two studies published this week in BMJ provide support for eating more fruits, vegetables, and whole grain foods to lower the risk of developing diabetes.

Lisovskaya/iStock/Getty Images Plus

In a pooled analysis of three large prospective American cohorts, people with the highest versus lowest total consumption of whole grain foods had a significantly lower risk of type 2 diabetes.

“These findings provide further support for the current recommendations of increasing whole grain consumption as part of a healthy diet for the prevention of type 2 diabetes,” wrote the authors led by Yang Hu, a doctoral student at Harvard School of Public Health, Boston.

Similarly, in a large European case-cohort study, people with higher values for plasma vitamin C and carotenoids (fruit and vegetable intake) had a lower incidence of type 2 diabetes.

“This study suggests that even a modest increase in fruit and vegetable intake could help to prevent type 2 diabetes ... regardless of whether the increase is among people with initially low or high intake,” wrote Ju-Sheng Zheng, PhD, University of Cambridge (England), and colleagues.
 

Individual whole grain foods

Previous studies have shown that high consumption of whole grains is associated with a lower risk of developing chronic diseases, including type 2 diabetes, cardiovascular disease, obesity, and some types of cancer, Mr. Hu and colleagues wrote.

Although research has shown that whole grain breakfast cereal and brown rice are linked with a lower risk of type 2 diabetes, the effect of other commonly consumed whole grain foods – which contain different amounts of dietary fiber, antioxidants, magnesium, and phytochemicals – has not been established.

Mr. Hu and colleagues analyzed pooled data from 158,259 U.S. women who participated in the Nurses’ Health Study (1984-2014) or the Nurses’ Health Study II (1991-2017) and 36,525 U.S. men who took part in the Health Professionals Follow-Up Study (1986-2016), who were free of diabetes, cardiovascular disease, and cancer.

Participants’ baseline consumption of seven types of whole grain foods – whole grain breakfast cereal, oatmeal, dark bread, brown rice, added bran, wheat germ, and popcorn – was based on self-replies to food frequency questionnaires.

During an average 24-year follow-up, 18,629 participants developed type 2 diabetes.

After adjusting for body mass index, lifestyle, and dietary risk factors, participants in the highest quintile of total whole grain consumption had a 29% lower risk of incident type 2 diabetes than those in the lowest quintile.

The most commonly consumed whole grain foods were whole grain cold breakfast cereal, dark bread, and popcorn.

Compared with eating less than one serving a month of whole grain cold breakfast cereal or dark bread, eating one or more servings a day was associated with a 19% and 21% lower risk of developing diabetes, respectively.

For popcorn, a J-shaped association was found for intake, where the risk of type 2 diabetes was not significantly raised until consumption exceeded about one serving a day, which led to about an 8% increased risk of developing diabetes – likely related to fat and sugar added to the popcorn, the researchers wrote.

For the less frequently consumed whole grain foods, compared with eating less than one serving a month of oatmeal, brown rice, added bran, or wheat germ, participants who ate two or more servings a week had a 21%, 12%, 15%, and 12% lower risk of developing type 2 diabetes, respectively.

Lean or overweight individuals had a greater decreased risk of diabetes with increased consumption of whole grain foods; however, because individuals with obesity have a higher risk of diabetes, even a small decrease in risk is still meaningful.

Limitations include the study was observational and may have had unknown confounders, and the results may not be generalizable to other populations, the authors note.
 

‘Five a day’ fruits and vegetables

Only one previous small published study from the United Kingdom has examined how blood levels of vitamin C and carotenoids are associated with incident type 2 diabetes, Dr. Zheng and colleagues wrote.

They investigated the relationship in 9,754 adults who developed new-onset type 2 diabetes and a comparison group of 13,662 adults who remained diabetes free during an average 9.7-year follow-up, from 340,234 participants in the European Prospective Investigation Into Cancer and Nutrition–InterAct study.

Participants were from Denmark, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom, and incident type 2 diabetes occurred between 1991 and 2007.

The researchers used high-performance liquid chromatography–ultraviolet methods to determine participants’ plasma levels of vitamin C and six carotenoids (alphta-carotene, beta-carotene, lycopene, lutein, zeaxanthin, beta-cryptoxanthin), which they used to calculate a composite biomarker score.

The recommendation to eat at least five fruits and vegetables a day corresponds to eating ≥400 g/day, according to Dr. Zheng and colleagues. The self-reported median fruit and vegetable intake in the current study was 274, 357, 396, 452, and 508 g/day from lowest to highest quintile.

After multivariable adjustment, higher levels of plasma vitamin C and carotenoids were associated with an 18% and 25% lower risk of incident type 2 diabetes per standard deviation, respectively.

Compared with patients whose vitamin C and carotenoid composite biomarker scores were in the lowest 20%, those with scores in the top 20% had half the risk of incident diabetes. Increasing fruit and vegetable consumption by 66 g/day was associated with a 25% lower risk of developing diabetes.

“These findings provide strong evidence from objectively measured biomarkers for the recommendation that fruit and vegetable intake should be increased to prevent type 2 diabetes,” according to the researchers.

However, consumption of fruits and vegetables remains far below guideline recommendations, they observed. “Although five portions a day of fruit and vegetables have been recommended for decades, in 2014-2015, 69% of U.K. adults ate fewer than this number, and this proportion is even higher in European adults (86%).”

Dr. Zheng and colleagues acknowledged that study limitations include those that are inherent with observational studies.

Although they could not distinguish between juice, fortified products, or whole foods, the analyses “were adjusted for vitamin supplement use, and suggest that as biomarkers of fruit and vegetable intake these findings endorse the consumption of fruit and vegetables, not that of supplements,” they maintained.

The study by Mr. Hu and colleagues was funded by the National Institutes of Health. The InterAct project was funded by the EU FP6 program. Biomarker measurements for vitamin C and carotenoids were funded by the InterAct project, EPIC-CVD project, MRC Cambridge Initiative, European Commission Framework Program 7, European Research Council, and National Institute for Health Research. Dr. Zheng has reported receiving funding from Westlake University and the EU Horizon 2020 program.

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

Two studies published this week in BMJ provide support for eating more fruits, vegetables, and whole grain foods to lower the risk of developing diabetes.

Lisovskaya/iStock/Getty Images Plus

In a pooled analysis of three large prospective American cohorts, people with the highest versus lowest total consumption of whole grain foods had a significantly lower risk of type 2 diabetes.

“These findings provide further support for the current recommendations of increasing whole grain consumption as part of a healthy diet for the prevention of type 2 diabetes,” wrote the authors led by Yang Hu, a doctoral student at Harvard School of Public Health, Boston.

Similarly, in a large European case-cohort study, people with higher values for plasma vitamin C and carotenoids (fruit and vegetable intake) had a lower incidence of type 2 diabetes.

“This study suggests that even a modest increase in fruit and vegetable intake could help to prevent type 2 diabetes ... regardless of whether the increase is among people with initially low or high intake,” wrote Ju-Sheng Zheng, PhD, University of Cambridge (England), and colleagues.
 

Individual whole grain foods

Previous studies have shown that high consumption of whole grains is associated with a lower risk of developing chronic diseases, including type 2 diabetes, cardiovascular disease, obesity, and some types of cancer, Mr. Hu and colleagues wrote.

Although research has shown that whole grain breakfast cereal and brown rice are linked with a lower risk of type 2 diabetes, the effect of other commonly consumed whole grain foods – which contain different amounts of dietary fiber, antioxidants, magnesium, and phytochemicals – has not been established.

Mr. Hu and colleagues analyzed pooled data from 158,259 U.S. women who participated in the Nurses’ Health Study (1984-2014) or the Nurses’ Health Study II (1991-2017) and 36,525 U.S. men who took part in the Health Professionals Follow-Up Study (1986-2016), who were free of diabetes, cardiovascular disease, and cancer.

Participants’ baseline consumption of seven types of whole grain foods – whole grain breakfast cereal, oatmeal, dark bread, brown rice, added bran, wheat germ, and popcorn – was based on self-replies to food frequency questionnaires.

During an average 24-year follow-up, 18,629 participants developed type 2 diabetes.

After adjusting for body mass index, lifestyle, and dietary risk factors, participants in the highest quintile of total whole grain consumption had a 29% lower risk of incident type 2 diabetes than those in the lowest quintile.

The most commonly consumed whole grain foods were whole grain cold breakfast cereal, dark bread, and popcorn.

Compared with eating less than one serving a month of whole grain cold breakfast cereal or dark bread, eating one or more servings a day was associated with a 19% and 21% lower risk of developing diabetes, respectively.

For popcorn, a J-shaped association was found for intake, where the risk of type 2 diabetes was not significantly raised until consumption exceeded about one serving a day, which led to about an 8% increased risk of developing diabetes – likely related to fat and sugar added to the popcorn, the researchers wrote.

For the less frequently consumed whole grain foods, compared with eating less than one serving a month of oatmeal, brown rice, added bran, or wheat germ, participants who ate two or more servings a week had a 21%, 12%, 15%, and 12% lower risk of developing type 2 diabetes, respectively.

Lean or overweight individuals had a greater decreased risk of diabetes with increased consumption of whole grain foods; however, because individuals with obesity have a higher risk of diabetes, even a small decrease in risk is still meaningful.

Limitations include the study was observational and may have had unknown confounders, and the results may not be generalizable to other populations, the authors note.
 

‘Five a day’ fruits and vegetables

Only one previous small published study from the United Kingdom has examined how blood levels of vitamin C and carotenoids are associated with incident type 2 diabetes, Dr. Zheng and colleagues wrote.

They investigated the relationship in 9,754 adults who developed new-onset type 2 diabetes and a comparison group of 13,662 adults who remained diabetes free during an average 9.7-year follow-up, from 340,234 participants in the European Prospective Investigation Into Cancer and Nutrition–InterAct study.

Participants were from Denmark, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom, and incident type 2 diabetes occurred between 1991 and 2007.

The researchers used high-performance liquid chromatography–ultraviolet methods to determine participants’ plasma levels of vitamin C and six carotenoids (alphta-carotene, beta-carotene, lycopene, lutein, zeaxanthin, beta-cryptoxanthin), which they used to calculate a composite biomarker score.

The recommendation to eat at least five fruits and vegetables a day corresponds to eating ≥400 g/day, according to Dr. Zheng and colleagues. The self-reported median fruit and vegetable intake in the current study was 274, 357, 396, 452, and 508 g/day from lowest to highest quintile.

After multivariable adjustment, higher levels of plasma vitamin C and carotenoids were associated with an 18% and 25% lower risk of incident type 2 diabetes per standard deviation, respectively.

Compared with patients whose vitamin C and carotenoid composite biomarker scores were in the lowest 20%, those with scores in the top 20% had half the risk of incident diabetes. Increasing fruit and vegetable consumption by 66 g/day was associated with a 25% lower risk of developing diabetes.

“These findings provide strong evidence from objectively measured biomarkers for the recommendation that fruit and vegetable intake should be increased to prevent type 2 diabetes,” according to the researchers.

However, consumption of fruits and vegetables remains far below guideline recommendations, they observed. “Although five portions a day of fruit and vegetables have been recommended for decades, in 2014-2015, 69% of U.K. adults ate fewer than this number, and this proportion is even higher in European adults (86%).”

Dr. Zheng and colleagues acknowledged that study limitations include those that are inherent with observational studies.

Although they could not distinguish between juice, fortified products, or whole foods, the analyses “were adjusted for vitamin supplement use, and suggest that as biomarkers of fruit and vegetable intake these findings endorse the consumption of fruit and vegetables, not that of supplements,” they maintained.

The study by Mr. Hu and colleagues was funded by the National Institutes of Health. The InterAct project was funded by the EU FP6 program. Biomarker measurements for vitamin C and carotenoids were funded by the InterAct project, EPIC-CVD project, MRC Cambridge Initiative, European Commission Framework Program 7, European Research Council, and National Institute for Health Research. Dr. Zheng has reported receiving funding from Westlake University and the EU Horizon 2020 program.

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

Two studies published this week in BMJ provide support for eating more fruits, vegetables, and whole grain foods to lower the risk of developing diabetes.

Lisovskaya/iStock/Getty Images Plus

In a pooled analysis of three large prospective American cohorts, people with the highest versus lowest total consumption of whole grain foods had a significantly lower risk of type 2 diabetes.

“These findings provide further support for the current recommendations of increasing whole grain consumption as part of a healthy diet for the prevention of type 2 diabetes,” wrote the authors led by Yang Hu, a doctoral student at Harvard School of Public Health, Boston.

Similarly, in a large European case-cohort study, people with higher values for plasma vitamin C and carotenoids (fruit and vegetable intake) had a lower incidence of type 2 diabetes.

“This study suggests that even a modest increase in fruit and vegetable intake could help to prevent type 2 diabetes ... regardless of whether the increase is among people with initially low or high intake,” wrote Ju-Sheng Zheng, PhD, University of Cambridge (England), and colleagues.
 

Individual whole grain foods

Previous studies have shown that high consumption of whole grains is associated with a lower risk of developing chronic diseases, including type 2 diabetes, cardiovascular disease, obesity, and some types of cancer, Mr. Hu and colleagues wrote.

Although research has shown that whole grain breakfast cereal and brown rice are linked with a lower risk of type 2 diabetes, the effect of other commonly consumed whole grain foods – which contain different amounts of dietary fiber, antioxidants, magnesium, and phytochemicals – has not been established.

Mr. Hu and colleagues analyzed pooled data from 158,259 U.S. women who participated in the Nurses’ Health Study (1984-2014) or the Nurses’ Health Study II (1991-2017) and 36,525 U.S. men who took part in the Health Professionals Follow-Up Study (1986-2016), who were free of diabetes, cardiovascular disease, and cancer.

Participants’ baseline consumption of seven types of whole grain foods – whole grain breakfast cereal, oatmeal, dark bread, brown rice, added bran, wheat germ, and popcorn – was based on self-replies to food frequency questionnaires.

During an average 24-year follow-up, 18,629 participants developed type 2 diabetes.

After adjusting for body mass index, lifestyle, and dietary risk factors, participants in the highest quintile of total whole grain consumption had a 29% lower risk of incident type 2 diabetes than those in the lowest quintile.

The most commonly consumed whole grain foods were whole grain cold breakfast cereal, dark bread, and popcorn.

Compared with eating less than one serving a month of whole grain cold breakfast cereal or dark bread, eating one or more servings a day was associated with a 19% and 21% lower risk of developing diabetes, respectively.

For popcorn, a J-shaped association was found for intake, where the risk of type 2 diabetes was not significantly raised until consumption exceeded about one serving a day, which led to about an 8% increased risk of developing diabetes – likely related to fat and sugar added to the popcorn, the researchers wrote.

For the less frequently consumed whole grain foods, compared with eating less than one serving a month of oatmeal, brown rice, added bran, or wheat germ, participants who ate two or more servings a week had a 21%, 12%, 15%, and 12% lower risk of developing type 2 diabetes, respectively.

Lean or overweight individuals had a greater decreased risk of diabetes with increased consumption of whole grain foods; however, because individuals with obesity have a higher risk of diabetes, even a small decrease in risk is still meaningful.

Limitations include the study was observational and may have had unknown confounders, and the results may not be generalizable to other populations, the authors note.
 

‘Five a day’ fruits and vegetables

Only one previous small published study from the United Kingdom has examined how blood levels of vitamin C and carotenoids are associated with incident type 2 diabetes, Dr. Zheng and colleagues wrote.

They investigated the relationship in 9,754 adults who developed new-onset type 2 diabetes and a comparison group of 13,662 adults who remained diabetes free during an average 9.7-year follow-up, from 340,234 participants in the European Prospective Investigation Into Cancer and Nutrition–InterAct study.

Participants were from Denmark, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom, and incident type 2 diabetes occurred between 1991 and 2007.

The researchers used high-performance liquid chromatography–ultraviolet methods to determine participants’ plasma levels of vitamin C and six carotenoids (alphta-carotene, beta-carotene, lycopene, lutein, zeaxanthin, beta-cryptoxanthin), which they used to calculate a composite biomarker score.

The recommendation to eat at least five fruits and vegetables a day corresponds to eating ≥400 g/day, according to Dr. Zheng and colleagues. The self-reported median fruit and vegetable intake in the current study was 274, 357, 396, 452, and 508 g/day from lowest to highest quintile.

After multivariable adjustment, higher levels of plasma vitamin C and carotenoids were associated with an 18% and 25% lower risk of incident type 2 diabetes per standard deviation, respectively.

Compared with patients whose vitamin C and carotenoid composite biomarker scores were in the lowest 20%, those with scores in the top 20% had half the risk of incident diabetes. Increasing fruit and vegetable consumption by 66 g/day was associated with a 25% lower risk of developing diabetes.

“These findings provide strong evidence from objectively measured biomarkers for the recommendation that fruit and vegetable intake should be increased to prevent type 2 diabetes,” according to the researchers.

However, consumption of fruits and vegetables remains far below guideline recommendations, they observed. “Although five portions a day of fruit and vegetables have been recommended for decades, in 2014-2015, 69% of U.K. adults ate fewer than this number, and this proportion is even higher in European adults (86%).”

Dr. Zheng and colleagues acknowledged that study limitations include those that are inherent with observational studies.

Although they could not distinguish between juice, fortified products, or whole foods, the analyses “were adjusted for vitamin supplement use, and suggest that as biomarkers of fruit and vegetable intake these findings endorse the consumption of fruit and vegetables, not that of supplements,” they maintained.

The study by Mr. Hu and colleagues was funded by the National Institutes of Health. The InterAct project was funded by the EU FP6 program. Biomarker measurements for vitamin C and carotenoids were funded by the InterAct project, EPIC-CVD project, MRC Cambridge Initiative, European Commission Framework Program 7, European Research Council, and National Institute for Health Research. Dr. Zheng has reported receiving funding from Westlake University and the EU Horizon 2020 program.

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

Diabetes was by far the most common delayed pediatric presentation in emergency care during the COVID-19 pandemic, according to a snapshot survey of nearly 2,500 pediatricians in the United Kingdom and Ireland.

There were also nine deaths where delayed presentation was considered a contributing factor, resulting mainly from sepsis and malignancy.

By comparison, over the same 2-week period of the survey there were three child deaths from COVID-19 directly, according to senior study author Shamez Ladhani, MRCPCH, PhD, chair of the British Paediatric Surveillance Unit (BPSU), Royal College of Paediatrics and Child Health, London.

“The unintended consequences of COVID are far greater, in children, than the disease itself. The way we are trying to prevent this is causing more harm than the disease,” he lamented.

One-third of senior U.K. pediatric specialists who responded to the survey reported dealing with so-called emergency delayed presentations in children who they would normally have expected to present much earlier.

After diabetes, the most commonly reported delayed diagnoses were sepsis and child protection issues. Cancer also featured prominently.

“We’ve found that there is great concern that children are not accessing healthcare as they should during lockdown and after,” Dr. Ladhani stressed. “Our emergency departments saw a 50% reduction during the peak, and now it is still 40% less than expected. The problem is improving but it remains.”

The survey findings were recently published online in Archives of Disease in Childhood, by first author Richard M. Lynn, MSc, of the Institute of Child Health, department of epidemiology and public health, University College London Research, and colleagues.
 

New diabetes cases presented very late during lockdown

Over the 2-week reporting period in mid-April 2020, type 1 diabetes was the most frequently reported delayed diagnosis, with 44 cases overall, 23 of which involved diabetic ketoacidosis.

“If you talk to the diabetes specialists, they tell us that generally, most cases of new diabetes arrive late because it has very nonspecific symptoms,” Dr. Ladhani explained.

However, he added, “pediatricians on the frontline know what to expect with diabetes. Those children who would have come in late prior to the pandemic are now arriving very late. Those consultants surveyed were not junior doctors but consultant pediatricians with many years of experience.”

In a recent article looking at pediatric delayed presentations, one patient with diabetes entered intensive care, and the BPSU report recorded one death possibly associated with diabetes, Dr. Ladhani pointed out.

“Pediatricians are worried that children are coming in late. We need to raise awareness that parents need to access healthcare and this message needs to go out now,” he said. “We can’t wait until a second wave. It has to be now because A&E [accident and emergency] attendance is still 40% [lower than] ... expected.”
 

BPSU survey covers over 90% of pediatricians in U.K. and Ireland

After numerous anecdotal reports of delayed presentations in the United Kingdom and abroad, the snapshot survey was conducted as part of routine monthly reports where pediatricians are asked to document any cases of rare conditions seen.

“We had heard stories of delayed presentations, but we wanted to know was this a real problem or just anecdotal?” Dr. Ladhani said.

The regular BPSU survey covers over 90% of U.K.- and Ireland-based pediatric consultants (numbering 4,075). On the back of this established communication, the BPSU decided to gauge the extent of delayed presentations during the peak weeks of the COVID-19 pandemic.

Over the next 7 days, 2,433 pediatricians, representing 60% of BPSU participants, responded.

“This response rate in 7 days highlights the importance given to the survey by pediatricians ... and the widespread professional concern about delayed presentations,” the authors wrote.

Participants were asked whether they had seen any children during the previous 14 days who, in their opinion, presented later than they would have expected prior to the COVID-19 pandemic.

“There’s no one definition for this but these senior clinicians know when something is unusual,” said Dr. Ladhani.

ED attendances were compared with figures for the same period last year. Overall, a total of 32% of 752 pediatricians working in EDs and pediatric assessment units reported witnessing delayed presentations, with 57 (8%) reporting at least three patients with delayed presentation.

“It was clear that those doctors on the frontline were seeing a lot of delayed presentations. Also, neonatologists reported women arriving late for labor, and community physicians said they just weren’t witnessing child protection cases anymore,” added Dr. Ladhani.

Other issues included early discharges following births because of COVID-19 concerns, before feeding had been established, prompting return visits because of feeding problems and dehydration.

The top five delayed diagnoses were diabetes (n = 44), sepsis (n = 21), child protection (n = 14), malignancy (n = 8), and appendicitis (n = 6). There were 10 delayed perinatal presentations.

Of the nine deaths, for which delayed presentation was considered to play a role, three were caused by sepsis, three were caused by new malignancy diagnoses, one was caused by new diagnosis of metabolic disease, and two did not have the cause reported.

The delays in presentation are likely to have been influenced by the U.K. government’s message to “stay at home” during the strict lockdown period, which perhaps was sometimes interpreted too literally, Dr. Ladhani suggested. “It was the right message socially, but not medically.”

Russell Viner, MB, PhD, president of the Royal College of Paediatrics and Child Health, said in a statement: “The impact for children is what we call ‘collateral damage’, including long absences from school and delays or interruptions to vital services. We know that parents adhered very strongly to the ‘stay at home’ [message] and we need to say clearly that this doesn’t apply if your child is very sick. Should we experience a second wave or regional outbreaks, it is vital that we get the message out to parents that we want to see unwell children at the earliest possible stage.”

Dr. Ladhani reported no relevant financial relationships.

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

Diabetes was by far the most common delayed pediatric presentation in emergency care during the COVID-19 pandemic, according to a snapshot survey of nearly 2,500 pediatricians in the United Kingdom and Ireland.

There were also nine deaths where delayed presentation was considered a contributing factor, resulting mainly from sepsis and malignancy.

By comparison, over the same 2-week period of the survey there were three child deaths from COVID-19 directly, according to senior study author Shamez Ladhani, MRCPCH, PhD, chair of the British Paediatric Surveillance Unit (BPSU), Royal College of Paediatrics and Child Health, London.

“The unintended consequences of COVID are far greater, in children, than the disease itself. The way we are trying to prevent this is causing more harm than the disease,” he lamented.

One-third of senior U.K. pediatric specialists who responded to the survey reported dealing with so-called emergency delayed presentations in children who they would normally have expected to present much earlier.

After diabetes, the most commonly reported delayed diagnoses were sepsis and child protection issues. Cancer also featured prominently.

“We’ve found that there is great concern that children are not accessing healthcare as they should during lockdown and after,” Dr. Ladhani stressed. “Our emergency departments saw a 50% reduction during the peak, and now it is still 40% less than expected. The problem is improving but it remains.”

The survey findings were recently published online in Archives of Disease in Childhood, by first author Richard M. Lynn, MSc, of the Institute of Child Health, department of epidemiology and public health, University College London Research, and colleagues.
 

New diabetes cases presented very late during lockdown

Over the 2-week reporting period in mid-April 2020, type 1 diabetes was the most frequently reported delayed diagnosis, with 44 cases overall, 23 of which involved diabetic ketoacidosis.

“If you talk to the diabetes specialists, they tell us that generally, most cases of new diabetes arrive late because it has very nonspecific symptoms,” Dr. Ladhani explained.

However, he added, “pediatricians on the frontline know what to expect with diabetes. Those children who would have come in late prior to the pandemic are now arriving very late. Those consultants surveyed were not junior doctors but consultant pediatricians with many years of experience.”

In a recent article looking at pediatric delayed presentations, one patient with diabetes entered intensive care, and the BPSU report recorded one death possibly associated with diabetes, Dr. Ladhani pointed out.

“Pediatricians are worried that children are coming in late. We need to raise awareness that parents need to access healthcare and this message needs to go out now,” he said. “We can’t wait until a second wave. It has to be now because A&E [accident and emergency] attendance is still 40% [lower than] ... expected.”
 

BPSU survey covers over 90% of pediatricians in U.K. and Ireland

After numerous anecdotal reports of delayed presentations in the United Kingdom and abroad, the snapshot survey was conducted as part of routine monthly reports where pediatricians are asked to document any cases of rare conditions seen.

“We had heard stories of delayed presentations, but we wanted to know was this a real problem or just anecdotal?” Dr. Ladhani said.

The regular BPSU survey covers over 90% of U.K.- and Ireland-based pediatric consultants (numbering 4,075). On the back of this established communication, the BPSU decided to gauge the extent of delayed presentations during the peak weeks of the COVID-19 pandemic.

Over the next 7 days, 2,433 pediatricians, representing 60% of BPSU participants, responded.

“This response rate in 7 days highlights the importance given to the survey by pediatricians ... and the widespread professional concern about delayed presentations,” the authors wrote.

Participants were asked whether they had seen any children during the previous 14 days who, in their opinion, presented later than they would have expected prior to the COVID-19 pandemic.

“There’s no one definition for this but these senior clinicians know when something is unusual,” said Dr. Ladhani.

ED attendances were compared with figures for the same period last year. Overall, a total of 32% of 752 pediatricians working in EDs and pediatric assessment units reported witnessing delayed presentations, with 57 (8%) reporting at least three patients with delayed presentation.

“It was clear that those doctors on the frontline were seeing a lot of delayed presentations. Also, neonatologists reported women arriving late for labor, and community physicians said they just weren’t witnessing child protection cases anymore,” added Dr. Ladhani.

Other issues included early discharges following births because of COVID-19 concerns, before feeding had been established, prompting return visits because of feeding problems and dehydration.

The top five delayed diagnoses were diabetes (n = 44), sepsis (n = 21), child protection (n = 14), malignancy (n = 8), and appendicitis (n = 6). There were 10 delayed perinatal presentations.

Of the nine deaths, for which delayed presentation was considered to play a role, three were caused by sepsis, three were caused by new malignancy diagnoses, one was caused by new diagnosis of metabolic disease, and two did not have the cause reported.

The delays in presentation are likely to have been influenced by the U.K. government’s message to “stay at home” during the strict lockdown period, which perhaps was sometimes interpreted too literally, Dr. Ladhani suggested. “It was the right message socially, but not medically.”

Russell Viner, MB, PhD, president of the Royal College of Paediatrics and Child Health, said in a statement: “The impact for children is what we call ‘collateral damage’, including long absences from school and delays or interruptions to vital services. We know that parents adhered very strongly to the ‘stay at home’ [message] and we need to say clearly that this doesn’t apply if your child is very sick. Should we experience a second wave or regional outbreaks, it is vital that we get the message out to parents that we want to see unwell children at the earliest possible stage.”

Dr. Ladhani reported no relevant financial relationships.

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

Diabetes was by far the most common delayed pediatric presentation in emergency care during the COVID-19 pandemic, according to a snapshot survey of nearly 2,500 pediatricians in the United Kingdom and Ireland.

There were also nine deaths where delayed presentation was considered a contributing factor, resulting mainly from sepsis and malignancy.

By comparison, over the same 2-week period of the survey there were three child deaths from COVID-19 directly, according to senior study author Shamez Ladhani, MRCPCH, PhD, chair of the British Paediatric Surveillance Unit (BPSU), Royal College of Paediatrics and Child Health, London.

“The unintended consequences of COVID are far greater, in children, than the disease itself. The way we are trying to prevent this is causing more harm than the disease,” he lamented.

One-third of senior U.K. pediatric specialists who responded to the survey reported dealing with so-called emergency delayed presentations in children who they would normally have expected to present much earlier.

After diabetes, the most commonly reported delayed diagnoses were sepsis and child protection issues. Cancer also featured prominently.

“We’ve found that there is great concern that children are not accessing healthcare as they should during lockdown and after,” Dr. Ladhani stressed. “Our emergency departments saw a 50% reduction during the peak, and now it is still 40% less than expected. The problem is improving but it remains.”

The survey findings were recently published online in Archives of Disease in Childhood, by first author Richard M. Lynn, MSc, of the Institute of Child Health, department of epidemiology and public health, University College London Research, and colleagues.
 

New diabetes cases presented very late during lockdown

Over the 2-week reporting period in mid-April 2020, type 1 diabetes was the most frequently reported delayed diagnosis, with 44 cases overall, 23 of which involved diabetic ketoacidosis.

“If you talk to the diabetes specialists, they tell us that generally, most cases of new diabetes arrive late because it has very nonspecific symptoms,” Dr. Ladhani explained.

However, he added, “pediatricians on the frontline know what to expect with diabetes. Those children who would have come in late prior to the pandemic are now arriving very late. Those consultants surveyed were not junior doctors but consultant pediatricians with many years of experience.”

In a recent article looking at pediatric delayed presentations, one patient with diabetes entered intensive care, and the BPSU report recorded one death possibly associated with diabetes, Dr. Ladhani pointed out.

“Pediatricians are worried that children are coming in late. We need to raise awareness that parents need to access healthcare and this message needs to go out now,” he said. “We can’t wait until a second wave. It has to be now because A&E [accident and emergency] attendance is still 40% [lower than] ... expected.”
 

BPSU survey covers over 90% of pediatricians in U.K. and Ireland

After numerous anecdotal reports of delayed presentations in the United Kingdom and abroad, the snapshot survey was conducted as part of routine monthly reports where pediatricians are asked to document any cases of rare conditions seen.

“We had heard stories of delayed presentations, but we wanted to know was this a real problem or just anecdotal?” Dr. Ladhani said.

The regular BPSU survey covers over 90% of U.K.- and Ireland-based pediatric consultants (numbering 4,075). On the back of this established communication, the BPSU decided to gauge the extent of delayed presentations during the peak weeks of the COVID-19 pandemic.

Over the next 7 days, 2,433 pediatricians, representing 60% of BPSU participants, responded.

“This response rate in 7 days highlights the importance given to the survey by pediatricians ... and the widespread professional concern about delayed presentations,” the authors wrote.

Participants were asked whether they had seen any children during the previous 14 days who, in their opinion, presented later than they would have expected prior to the COVID-19 pandemic.

“There’s no one definition for this but these senior clinicians know when something is unusual,” said Dr. Ladhani.

ED attendances were compared with figures for the same period last year. Overall, a total of 32% of 752 pediatricians working in EDs and pediatric assessment units reported witnessing delayed presentations, with 57 (8%) reporting at least three patients with delayed presentation.

“It was clear that those doctors on the frontline were seeing a lot of delayed presentations. Also, neonatologists reported women arriving late for labor, and community physicians said they just weren’t witnessing child protection cases anymore,” added Dr. Ladhani.

Other issues included early discharges following births because of COVID-19 concerns, before feeding had been established, prompting return visits because of feeding problems and dehydration.

The top five delayed diagnoses were diabetes (n = 44), sepsis (n = 21), child protection (n = 14), malignancy (n = 8), and appendicitis (n = 6). There were 10 delayed perinatal presentations.

Of the nine deaths, for which delayed presentation was considered to play a role, three were caused by sepsis, three were caused by new malignancy diagnoses, one was caused by new diagnosis of metabolic disease, and two did not have the cause reported.

The delays in presentation are likely to have been influenced by the U.K. government’s message to “stay at home” during the strict lockdown period, which perhaps was sometimes interpreted too literally, Dr. Ladhani suggested. “It was the right message socially, but not medically.”

Russell Viner, MB, PhD, president of the Royal College of Paediatrics and Child Health, said in a statement: “The impact for children is what we call ‘collateral damage’, including long absences from school and delays or interruptions to vital services. We know that parents adhered very strongly to the ‘stay at home’ [message] and we need to say clearly that this doesn’t apply if your child is very sick. Should we experience a second wave or regional outbreaks, it is vital that we get the message out to parents that we want to see unwell children at the earliest possible stage.”

Dr. Ladhani reported no relevant financial relationships.

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

“Patients with type 2 diabetes should consider intermittent fasting carefully” and “not undertake it without the involvement of their physician,” stress the authors of a new viewpoint published online July 2 in JAMA.

This is because intermittent fasting in patients with type 2 diabetes has only been studied in seven small, short published trials of very different regimens, with limited evidence of benefit. In addition, some concerns arose from these studies.

Weight loss with intermittent fasting appears to be similar to that attained with caloric restriction, but in the case of those with diabetes, the best way to adjust glucose-lowering medicines to reduce the risk of hypoglycemia while practicing intermittent fasting has not been established, and there is potential for such fasting to cause glycemic variability.

The viewpoint’s lead author Benjamin D. Horne, PhD, MStat, MPH, from Intermountain Medical Center, Salt Lake City, and Stanford (Calif.) University, expanded on the issues in a podcast interview with JAMA editor in chief Howard C. Bauchner, MD.

Asked if he would advise intermittent fasting for patients with type 2 diabetes, Dr. Horne replied that he would recommend it, with caveats, “because of the safety issues – some of which are fairly benign for people who are apparently healthy but may be not quite as benign for people with type 2 diabetes.

“Things such as low blood pressure, weakness, headaches, [and] dizziness are considerations,” he continued, but “the big issue” is hypoglycemia, so caloric restriction may be a better choice for some patients with diabetes.

Dr. Horne said he likes to give patients options. “I’ve met quite a number of people who are very behind time-restricted feeding – eating during a 6- to 8-hour window,” he said. “If they are able to stay on it, they tend to really love it.”

The most popular regimen that results in some weight loss is fasting for 24 hours – with or without a 500-calorie meal – on 2 nonconsecutive days a week, the so-called 5:2 diet. And “as someone who’s in cardiovascular research,” Dr. Horne added, “the one that I’m thinking for long term is once-a-week fasting for a 24-hour period.”
 

Intermittent fasting: Less safe than calorie restriction in diabetes?

Patients who already have diabetes and lose weight benefit from improved glucose, blood pressure, and lipid levels, Dr. Horne and colleagues wrote.

Currently, intermittent fasting is popular in the lay press and on social media with claims of potential benefits for diabetes “that are as yet untested or unproven,” they added. In fact, “whether a patient with type 2 diabetes should engage in intermittent fasting involves a variety of concerns over safety and efficacy.”

Thus, they examined the existing evidence for the health effects and safety of intermittent fasting – defined as time-restricted feeding, or fasting on alternate days or during 1-4 days a week, with only water or also juice and bone broth, or no more than 700 calories allowed on fasting days – in patients with type 2 diabetes.

They found seven published studies of intermittent fasting in patients with type 2 diabetes, including five randomized clinical trials, of which only one study had more than 63 patients.

Intermittent fasting regimens in the studies included five fasting frequencies and most follow-up durations were 4 months or less, including 18-20 hours a day for 2 weeks; 2 days a week for 12 weeks (two studies) or for 12 months (one study); 3-4 days a week for 7-11 months; 4 days a week for 12 weeks; and 17 days in 4 months.

They all reported that intermittent fasting was tied to weight loss, and most (but not all) of the studies also found that it was associated with decreases in A1c and improved glucose levels, quality of life, and blood pressure, but not insulin resistance.

But this “heterogeneity of designs and regimens and the variance in results make it difficult to draw clinically meaningful direction,” Dr. Horne and colleagues observed.

Moreover, only one study addressed the relative safety of two intermittent fasting regimens, and it found that both regimens increased hypoglycemic events despite the use of a medication dose-change protocol.

Only one study explicitly compared intermittent fasting with caloric restriction, which found “that a twice-weekly intermittent fasting regimen improved [A1c] levels is promising,” the authors wrote.

However, that study showed only noninferiority for change in A1c level (–0.3% for intermittent fasting vs. –0.5% for caloric restriction).

The major implication, according to the viewpoint authors, is that “intermittent fasting may be less safe than caloric restriction although approximately equivalently effective.”

“Therefore,” they summarized, “until intermittent fasting is shown to be more effective than caloric restriction for reducing [A1c] or otherwise controlling diabetes, that study – and the limited other high-quality data – suggest that intermittent fasting regimens for patients with type 2 diabetes recommended by health professionals or promoted to the public should be limited to individuals for whom the risk of hypoglycemia is closely monitored and medications are carefully adjusted to ensure safety.”

Should continuous glucose monitoring to detect glycemic variability be considered?

Intermittent fasting may also bring wider fluctuations of glycemic control than simple calorie restriction, with hypoglycemia during fasting times and hyperglycemia during feeding times, which would not be reflected in A1c levels, Dr. Horne and colleagues pointed out.

“Studies have raised concern that glycemic variability leads to both microvascular (e.g., retinopathy) and macrovascular (e.g., coronary disease) complications in patients with type 2 diabetes,” they cautioned.

Therefore, “continuous glucose monitoring should be considered for studies of ... clinical interventions using intermittent fasting in patients with type 2 diabetes,” they concluded.

Dr. Horne has reported serving as principal investigator of grants for studies on intermittent fasting from the Intermountain Research and Medical Foundation. Disclosures of the other two authors are listed with the viewpoint.

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

“Patients with type 2 diabetes should consider intermittent fasting carefully” and “not undertake it without the involvement of their physician,” stress the authors of a new viewpoint published online July 2 in JAMA.

This is because intermittent fasting in patients with type 2 diabetes has only been studied in seven small, short published trials of very different regimens, with limited evidence of benefit. In addition, some concerns arose from these studies.

Weight loss with intermittent fasting appears to be similar to that attained with caloric restriction, but in the case of those with diabetes, the best way to adjust glucose-lowering medicines to reduce the risk of hypoglycemia while practicing intermittent fasting has not been established, and there is potential for such fasting to cause glycemic variability.

The viewpoint’s lead author Benjamin D. Horne, PhD, MStat, MPH, from Intermountain Medical Center, Salt Lake City, and Stanford (Calif.) University, expanded on the issues in a podcast interview with JAMA editor in chief Howard C. Bauchner, MD.

Asked if he would advise intermittent fasting for patients with type 2 diabetes, Dr. Horne replied that he would recommend it, with caveats, “because of the safety issues – some of which are fairly benign for people who are apparently healthy but may be not quite as benign for people with type 2 diabetes.

“Things such as low blood pressure, weakness, headaches, [and] dizziness are considerations,” he continued, but “the big issue” is hypoglycemia, so caloric restriction may be a better choice for some patients with diabetes.

Dr. Horne said he likes to give patients options. “I’ve met quite a number of people who are very behind time-restricted feeding – eating during a 6- to 8-hour window,” he said. “If they are able to stay on it, they tend to really love it.”

The most popular regimen that results in some weight loss is fasting for 24 hours – with or without a 500-calorie meal – on 2 nonconsecutive days a week, the so-called 5:2 diet. And “as someone who’s in cardiovascular research,” Dr. Horne added, “the one that I’m thinking for long term is once-a-week fasting for a 24-hour period.”
 

Intermittent fasting: Less safe than calorie restriction in diabetes?

Patients who already have diabetes and lose weight benefit from improved glucose, blood pressure, and lipid levels, Dr. Horne and colleagues wrote.

Currently, intermittent fasting is popular in the lay press and on social media with claims of potential benefits for diabetes “that are as yet untested or unproven,” they added. In fact, “whether a patient with type 2 diabetes should engage in intermittent fasting involves a variety of concerns over safety and efficacy.”

Thus, they examined the existing evidence for the health effects and safety of intermittent fasting – defined as time-restricted feeding, or fasting on alternate days or during 1-4 days a week, with only water or also juice and bone broth, or no more than 700 calories allowed on fasting days – in patients with type 2 diabetes.

They found seven published studies of intermittent fasting in patients with type 2 diabetes, including five randomized clinical trials, of which only one study had more than 63 patients.

Intermittent fasting regimens in the studies included five fasting frequencies and most follow-up durations were 4 months or less, including 18-20 hours a day for 2 weeks; 2 days a week for 12 weeks (two studies) or for 12 months (one study); 3-4 days a week for 7-11 months; 4 days a week for 12 weeks; and 17 days in 4 months.

They all reported that intermittent fasting was tied to weight loss, and most (but not all) of the studies also found that it was associated with decreases in A1c and improved glucose levels, quality of life, and blood pressure, but not insulin resistance.

But this “heterogeneity of designs and regimens and the variance in results make it difficult to draw clinically meaningful direction,” Dr. Horne and colleagues observed.

Moreover, only one study addressed the relative safety of two intermittent fasting regimens, and it found that both regimens increased hypoglycemic events despite the use of a medication dose-change protocol.

Only one study explicitly compared intermittent fasting with caloric restriction, which found “that a twice-weekly intermittent fasting regimen improved [A1c] levels is promising,” the authors wrote.

However, that study showed only noninferiority for change in A1c level (–0.3% for intermittent fasting vs. –0.5% for caloric restriction).

The major implication, according to the viewpoint authors, is that “intermittent fasting may be less safe than caloric restriction although approximately equivalently effective.”

“Therefore,” they summarized, “until intermittent fasting is shown to be more effective than caloric restriction for reducing [A1c] or otherwise controlling diabetes, that study – and the limited other high-quality data – suggest that intermittent fasting regimens for patients with type 2 diabetes recommended by health professionals or promoted to the public should be limited to individuals for whom the risk of hypoglycemia is closely monitored and medications are carefully adjusted to ensure safety.”

Should continuous glucose monitoring to detect glycemic variability be considered?

Intermittent fasting may also bring wider fluctuations of glycemic control than simple calorie restriction, with hypoglycemia during fasting times and hyperglycemia during feeding times, which would not be reflected in A1c levels, Dr. Horne and colleagues pointed out.

“Studies have raised concern that glycemic variability leads to both microvascular (e.g., retinopathy) and macrovascular (e.g., coronary disease) complications in patients with type 2 diabetes,” they cautioned.

Therefore, “continuous glucose monitoring should be considered for studies of ... clinical interventions using intermittent fasting in patients with type 2 diabetes,” they concluded.

Dr. Horne has reported serving as principal investigator of grants for studies on intermittent fasting from the Intermountain Research and Medical Foundation. Disclosures of the other two authors are listed with the viewpoint.

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

“Patients with type 2 diabetes should consider intermittent fasting carefully” and “not undertake it without the involvement of their physician,” stress the authors of a new viewpoint published online July 2 in JAMA.

This is because intermittent fasting in patients with type 2 diabetes has only been studied in seven small, short published trials of very different regimens, with limited evidence of benefit. In addition, some concerns arose from these studies.

Weight loss with intermittent fasting appears to be similar to that attained with caloric restriction, but in the case of those with diabetes, the best way to adjust glucose-lowering medicines to reduce the risk of hypoglycemia while practicing intermittent fasting has not been established, and there is potential for such fasting to cause glycemic variability.

The viewpoint’s lead author Benjamin D. Horne, PhD, MStat, MPH, from Intermountain Medical Center, Salt Lake City, and Stanford (Calif.) University, expanded on the issues in a podcast interview with JAMA editor in chief Howard C. Bauchner, MD.

Asked if he would advise intermittent fasting for patients with type 2 diabetes, Dr. Horne replied that he would recommend it, with caveats, “because of the safety issues – some of which are fairly benign for people who are apparently healthy but may be not quite as benign for people with type 2 diabetes.

“Things such as low blood pressure, weakness, headaches, [and] dizziness are considerations,” he continued, but “the big issue” is hypoglycemia, so caloric restriction may be a better choice for some patients with diabetes.

Dr. Horne said he likes to give patients options. “I’ve met quite a number of people who are very behind time-restricted feeding – eating during a 6- to 8-hour window,” he said. “If they are able to stay on it, they tend to really love it.”

The most popular regimen that results in some weight loss is fasting for 24 hours – with or without a 500-calorie meal – on 2 nonconsecutive days a week, the so-called 5:2 diet. And “as someone who’s in cardiovascular research,” Dr. Horne added, “the one that I’m thinking for long term is once-a-week fasting for a 24-hour period.”
 

Intermittent fasting: Less safe than calorie restriction in diabetes?

Patients who already have diabetes and lose weight benefit from improved glucose, blood pressure, and lipid levels, Dr. Horne and colleagues wrote.

Currently, intermittent fasting is popular in the lay press and on social media with claims of potential benefits for diabetes “that are as yet untested or unproven,” they added. In fact, “whether a patient with type 2 diabetes should engage in intermittent fasting involves a variety of concerns over safety and efficacy.”

Thus, they examined the existing evidence for the health effects and safety of intermittent fasting – defined as time-restricted feeding, or fasting on alternate days or during 1-4 days a week, with only water or also juice and bone broth, or no more than 700 calories allowed on fasting days – in patients with type 2 diabetes.

They found seven published studies of intermittent fasting in patients with type 2 diabetes, including five randomized clinical trials, of which only one study had more than 63 patients.

Intermittent fasting regimens in the studies included five fasting frequencies and most follow-up durations were 4 months or less, including 18-20 hours a day for 2 weeks; 2 days a week for 12 weeks (two studies) or for 12 months (one study); 3-4 days a week for 7-11 months; 4 days a week for 12 weeks; and 17 days in 4 months.

They all reported that intermittent fasting was tied to weight loss, and most (but not all) of the studies also found that it was associated with decreases in A1c and improved glucose levels, quality of life, and blood pressure, but not insulin resistance.

But this “heterogeneity of designs and regimens and the variance in results make it difficult to draw clinically meaningful direction,” Dr. Horne and colleagues observed.

Moreover, only one study addressed the relative safety of two intermittent fasting regimens, and it found that both regimens increased hypoglycemic events despite the use of a medication dose-change protocol.

Only one study explicitly compared intermittent fasting with caloric restriction, which found “that a twice-weekly intermittent fasting regimen improved [A1c] levels is promising,” the authors wrote.

However, that study showed only noninferiority for change in A1c level (–0.3% for intermittent fasting vs. –0.5% for caloric restriction).

The major implication, according to the viewpoint authors, is that “intermittent fasting may be less safe than caloric restriction although approximately equivalently effective.”

“Therefore,” they summarized, “until intermittent fasting is shown to be more effective than caloric restriction for reducing [A1c] or otherwise controlling diabetes, that study – and the limited other high-quality data – suggest that intermittent fasting regimens for patients with type 2 diabetes recommended by health professionals or promoted to the public should be limited to individuals for whom the risk of hypoglycemia is closely monitored and medications are carefully adjusted to ensure safety.”

Should continuous glucose monitoring to detect glycemic variability be considered?

Intermittent fasting may also bring wider fluctuations of glycemic control than simple calorie restriction, with hypoglycemia during fasting times and hyperglycemia during feeding times, which would not be reflected in A1c levels, Dr. Horne and colleagues pointed out.

“Studies have raised concern that glycemic variability leads to both microvascular (e.g., retinopathy) and macrovascular (e.g., coronary disease) complications in patients with type 2 diabetes,” they cautioned.

Therefore, “continuous glucose monitoring should be considered for studies of ... clinical interventions using intermittent fasting in patients with type 2 diabetes,” they concluded.

Dr. Horne has reported serving as principal investigator of grants for studies on intermittent fasting from the Intermountain Research and Medical Foundation. Disclosures of the other two authors are listed with the viewpoint.

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

Here are the stories our MDedge editors across specialties think you need to know about today:

Lifestyle choices may reduce breast cancer risk regardless of genetics

A “favorable” lifestyle was associated with a reduced risk of breast cancer even among women at high genetic risk for the disease in a study of more than 90,000 women, researchers reported.

The findings suggest that, regardless of genetic risk, women may be able to reduce their risk of developing breast cancer by getting adequate levels of exercise; maintaining a healthy weight; and limiting or eliminating use of alcohol, oral contraceptives, and hormone replacement therapy.

“These data should empower patients that they can impact on their overall health and reduce the risk of developing breast cancer,” said William Gradishar, MD, who was not invovled with the study. Read more.

Primary care practices may lose $68K per physician this year

Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.

Dermatology and rheumatology visits have recovered, but some specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15, and pulmonology visits were down 45% in that time.

This primary care estimate is without a potential second wave of COVID-19, noted Sanjay Basu, MD, director of research and population health at Collective Health in San Francisco, and colleagues.

“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview. Read more.

Big pharma sues to block Minnesota insulin affordability law

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

In the July 1 filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“There is nothing in the U.S. Constitution that prevents states from saving the lives of its citizens who are in imminent danger,” said Mayo Clinic hematologist S. Vincent Rajkumar, MD. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.” Read more.

Despite guidelines, kids get opioids & steroids for pneumonia, sinusitis

A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.

Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.

“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.” Read more.

Study supports changing classification of RCC

The definition of stage IV renal cell carcinoma (RCC) should be expanded to include lymph node–positive stage III disease, according to a population-level cohort study published in Cancer.

While patients with lymph node–negative stage III disease had superior overall survival at 5 years, survival rates were similar between patients with node–positive stage III disease and stage IV disease. This supports reclassifying stage III node-positive RCC to stage IV, according to researchers.

“Prior institutional studies have indicated that, among patients with stage III disease, those with lymph node disease have worse oncologic outcomes and experience survival that is similar to that of patients with American Joint Committee on Cancer (AJCC) stage IV disease,” wrote Arnav Srivastava, MD, of Rutgers Cancer Institute of New Jersey, New Brunswick, and colleagues. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Lifestyle choices may reduce breast cancer risk regardless of genetics

A “favorable” lifestyle was associated with a reduced risk of breast cancer even among women at high genetic risk for the disease in a study of more than 90,000 women, researchers reported.

The findings suggest that, regardless of genetic risk, women may be able to reduce their risk of developing breast cancer by getting adequate levels of exercise; maintaining a healthy weight; and limiting or eliminating use of alcohol, oral contraceptives, and hormone replacement therapy.

“These data should empower patients that they can impact on their overall health and reduce the risk of developing breast cancer,” said William Gradishar, MD, who was not invovled with the study. Read more.

Primary care practices may lose $68K per physician this year

Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.

Dermatology and rheumatology visits have recovered, but some specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15, and pulmonology visits were down 45% in that time.

This primary care estimate is without a potential second wave of COVID-19, noted Sanjay Basu, MD, director of research and population health at Collective Health in San Francisco, and colleagues.

“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview. Read more.

Big pharma sues to block Minnesota insulin affordability law

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

In the July 1 filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“There is nothing in the U.S. Constitution that prevents states from saving the lives of its citizens who are in imminent danger,” said Mayo Clinic hematologist S. Vincent Rajkumar, MD. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.” Read more.

Despite guidelines, kids get opioids & steroids for pneumonia, sinusitis

A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.

Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.

“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.” Read more.

Study supports changing classification of RCC

The definition of stage IV renal cell carcinoma (RCC) should be expanded to include lymph node–positive stage III disease, according to a population-level cohort study published in Cancer.

While patients with lymph node–negative stage III disease had superior overall survival at 5 years, survival rates were similar between patients with node–positive stage III disease and stage IV disease. This supports reclassifying stage III node-positive RCC to stage IV, according to researchers.

“Prior institutional studies have indicated that, among patients with stage III disease, those with lymph node disease have worse oncologic outcomes and experience survival that is similar to that of patients with American Joint Committee on Cancer (AJCC) stage IV disease,” wrote Arnav Srivastava, MD, of Rutgers Cancer Institute of New Jersey, New Brunswick, and colleagues. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Lifestyle choices may reduce breast cancer risk regardless of genetics

A “favorable” lifestyle was associated with a reduced risk of breast cancer even among women at high genetic risk for the disease in a study of more than 90,000 women, researchers reported.

The findings suggest that, regardless of genetic risk, women may be able to reduce their risk of developing breast cancer by getting adequate levels of exercise; maintaining a healthy weight; and limiting or eliminating use of alcohol, oral contraceptives, and hormone replacement therapy.

“These data should empower patients that they can impact on their overall health and reduce the risk of developing breast cancer,” said William Gradishar, MD, who was not invovled with the study. Read more.

Primary care practices may lose $68K per physician this year

Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.

Dermatology and rheumatology visits have recovered, but some specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15, and pulmonology visits were down 45% in that time.

This primary care estimate is without a potential second wave of COVID-19, noted Sanjay Basu, MD, director of research and population health at Collective Health in San Francisco, and colleagues.

“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview. Read more.

Big pharma sues to block Minnesota insulin affordability law

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

In the July 1 filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“There is nothing in the U.S. Constitution that prevents states from saving the lives of its citizens who are in imminent danger,” said Mayo Clinic hematologist S. Vincent Rajkumar, MD. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.” Read more.

Despite guidelines, kids get opioids & steroids for pneumonia, sinusitis

A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.

Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.

“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.” Read more.

Study supports changing classification of RCC

The definition of stage IV renal cell carcinoma (RCC) should be expanded to include lymph node–positive stage III disease, according to a population-level cohort study published in Cancer.

While patients with lymph node–negative stage III disease had superior overall survival at 5 years, survival rates were similar between patients with node–positive stage III disease and stage IV disease. This supports reclassifying stage III node-positive RCC to stage IV, according to researchers.

“Prior institutional studies have indicated that, among patients with stage III disease, those with lymph node disease have worse oncologic outcomes and experience survival that is similar to that of patients with American Joint Committee on Cancer (AJCC) stage IV disease,” wrote Arnav Srivastava, MD, of Rutgers Cancer Institute of New Jersey, New Brunswick, and colleagues. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.

Advocates said they were appalled by the PhRMA action.
 

PhRMA says law is unconstitutional

In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.

The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.

The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
 

Advocates decry suit

Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.

It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.

Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”

Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.

“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”

Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.

“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”

T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.

“We will not stop showing them the real price we pay for their greed,” said the organization.

Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.

“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”

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

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.

Advocates said they were appalled by the PhRMA action.
 

PhRMA says law is unconstitutional

In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.

The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.

The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
 

Advocates decry suit

Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.

It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.

Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”

Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.

“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”

Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.

“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”

T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.

“We will not stop showing them the real price we pay for their greed,” said the organization.

Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.

“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”

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

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.

Advocates said they were appalled by the PhRMA action.
 

PhRMA says law is unconstitutional

In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.

The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.

The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
 

Advocates decry suit

Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.

It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.

Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”

Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.

“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”

Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.

“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”

T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.

“We will not stop showing them the real price we pay for their greed,” said the organization.

Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.

“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”

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

Some automated insulin delivery systems currently in development add glucagon and/or pramlintide to insulin, but whether the extra hormones are worth the additional cost and effort is a subject of debate.

Sara Freeman/MDedge News

Also called closed-loop or artificial pancreas systems, they are comprised of an insulin pump and a continuous glucose monitor (CGM) that communicate via a built-in algorithm to deliver insulin based on glucose levels. Currently available systems are called hybrid closed loops because they still require user input for meals, exercise, illness, and other special circumstances.

Two hybrid closed-loop systems available in the United States, the Medtronic Minimed 670G and the Tandem Control-IQ, as well as the Medtronic Minimed 780G that was just approved in Europe, use insulin only.

Of all ongoing active closed-loop clinical studies, 44 involve insulin-only systems, as of May 2020.

However, two such systems in development add a glucagon analogue to insulin in the same pump (in separate cartridges), with the aim of minimizing the risk of hypoglycemia. And four investigational systems combine insulin with pramlintide (Symlin, AstraZeneca), an amylin analogue that reduces postmeal glucose spikes. Three systems in development combine all three hormones. 

In a debate during the virtual American Diabetes Association 80th Scientific Sessions, Roman Hovorka, PhD, of the University of Cambridge (England) argued in favor of insulin-only systems on the basis of efficacy, less burden and complexity, and lower cost.

But Steven J. Russell, MD, PhD, of Massachusetts General Hospital, Boston, countered that glucagon adds safety and value to the system by allowing for more aggressive insulin dosing with lower hypoglycemia risk, benefits which he said would overcome any downsides.
 

Insulin-only systems are good enough

Dr. Hovorka began by defining a “good” artificial pancreas as one that produces consensus time-in-range targets of at least 70% of glucose values between 3.9 to 10 mmol/L (70-180 mg/dL) and less than 3% below 3.9 mmol/L (70 mg/dL). At the same time, he said, the burden should be low, which he suggested means no more than 10-20 minutes a day spent managing the system, low “alarm burden,” and minimal technical issues.

“We need to balance glucose control and the burden. For some people, reducing the burden is sometimes even more important than the glucose control,” Dr. Hovorka commented.

He pointed out that, in addition to Medtronic’s and Tandem’s systems, two other insulin-only hybrid closed-loop systems are marketed outside the United States. These are the CamDiab system, available in the United Kingdom, which uses his group’s Cambridge control algorithm in a Dana pump with the Dexcom G6 sensor, and the Diabeloop algorithm, available in Europe, that combines a patch pump with the Dexcom G6.

“Lots of energy and resources are going to taking [insulin-only] systems into clinic use,” Dr. Hovorka observed.

He reviewed recently published data for both the Tandem Control-IQ and the Cambridge control algorithm showing similar results meeting the “good artificial pancreas” definition.

In his current clinic population of 160 patients aged 2-80 years using the Cambridge algorithm, 69% of users have achieved 70% or greater time in range and 28% have achieved 80% or greater time in range.

“So, the insulin-only system can achieve acceptable, and in some instances very good, glucose control,” Dr. Hovorka said.

He acknowledged that there are still challenges with insulin-only systems, including exercise-related dysglycemia and postprandial hyperglycemia related to slow insulin absorption, missed or incorrect boluses, or large meals.

But, Dr. Hovorka said, downsides of dual-hormone systems include the need for room-temperature stable glucagon and for dual-chamber pumps with two cannulas and two infusion sites (in addition to the sensor site), and the unknown long-term biological risks of chronic subcutaneous glucagon or pramlintide delivery.

Moreover, he said, costs are expected to be higher for a two-chamber versus single-chamber pump, as well as for the second hormone, reservoir, and infusion set.

Data thus far from short-term studies suggest that insulin-only systems are sufficient in eliminating nocturnal hypoglycemia, while the addition of glucagon potentially reduces daytime hypoglycemia, especially during exercise.

However, longer-term head-to-head studies will be needed, Dr. Hovorka said, noting, “Comparative benefits of the single- and dual-hormone system for improving hemoglobin A1c and preventing severe hypoglycemia remain unknown.”

He suggested that glucagon dual-hormone closed-loop systems might be suitable for patients who are particularly prone to hypoglycemia, whereas pramlintide dual-hormone systems have the potential to more fully close the loop when used with ultra rapid-acting insulin analogues.

Nonetheless, he said, “Many, if not most, users may achieve acceptable control with insulin-only systems.”

Dual-hormone systems: Extra benefit worth it?

Dr. Russell, who is an investigator in multicenter pivotal studies of both insulin-only and bihormonal configurations of the Beta Bionics iLet bionic pancreas, began his debate presentation by endorsing the effectiveness of insulin-only hybrid systems and stating that he encourages his patients with type 1 diabetes to use them.

Michele G. Sullivan/MDedge News

But, he said, adding glucagon can allow for better automation of hypoglycemia prevention and treatment in situations such as exercise.

“A bihormonal system achieves lower glucose, higher time-in-range, and less hypoglycemia than a well-functioning insulin-only system.”

Moreover, Dr. Russell said, “Glucagon reduces the need for medicinal carbohydrates, promotes satiety, and increases energy expenditure. ... Combined, these three factors may oppose weight gain or encourage weight loss as opposed to a system that uses insulin only.”

He pointed to a 2017 meta-analysis that showed improved time-in-range and greater reductions in hypoglycemia with dual- versus single-hormone systems. 

And, in unpublished data from a randomized random-order crossover study of 23 patients with type 1 diabetes who each spent a week with usual care (insulin pump with or without CGM), insulin-only iLet, and bihormonal iLet, mean glucose levels were 165, 148, and 139 mg/dL, respectively. Time-in-range was 60%, 72%, and 79%, and median time with glucose below 54 mg/dL was 0.6%, 0.6%, and 0.2%, respectively.

Dr. Russell also addressed each of the arguments made by Dr. Hovorka and others against glucagon use.

Regarding the need for a stable glucagon formulation, he said that the analogue being developed for the iLet, dasiglucagon (Zealand pharma), is stable for more than a month at 40º C, with higher bioavailability and slightly slower absorption than glucagon.

And while he acknowledged the need for two separate hormone cartridges, Dr. Russell said that the Gen4 version of the iLet is fairly simple and intuitive, and the device itself is about the same size as the Tandem t:slim.

Use of glucagon didn’t increase insulin use in iLet trials, nor was it associated with increased reported nausea or liver glycogen depletion.

And users universally reported preferring the bihormonal system.

Long-term safety of chronic glucagon exposure has yet to be addressed, but animal data are reassuring, Dr. Russell said.

Regarding increased cost, he pointed to 2018 data showing that the incremental improvement in glycemic control from no automation to single-hormone automation is the same as from single to dual (mean glucose reductions of 7.4 and 13.6 mg/dL, respectively, and decreases in time spent in hypoglycemia of 1.28% vs. 2.95%).

“I would argue that, if one can justify adding automation, one could justify some additional expense to add the cost of glucagon.” And, he said, the cost would likely be based on a negotiation around the extra value offered by the dual-hormone system.

“The addition of glucagon, I believe, will be justified by the improved outcomes and improved quality of life,” he concluded.

Dr. Hovorka has reported receiving research support from MiniMed Medtronic, Abbott Diabetes Care, and Dexcom; being a speaker for Novo Nordisk, Eli Lilly, and Dexcom; holding license fees from B. Braun and Medtronic; and being director of CamDiab. Dr. Russell has reported holding patents on aspects of the bionic pancreas; receiving honoraria, travel expenses, and/or research support from Dexcom, Eli Lilly, Tandem Diabetes, Sanofi, Novo Nordisk, Roche, Ascensia, Zealand Pharma, and Beta Bionics; being a consultant for Flexion Therapeutics, Senseonics, and Beta Bionics; and participating in scientific advisory boards for Companion Medical, Tandem Diabetes, and Unomedical.

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

Some automated insulin delivery systems currently in development add glucagon and/or pramlintide to insulin, but whether the extra hormones are worth the additional cost and effort is a subject of debate.

Sara Freeman/MDedge News

Also called closed-loop or artificial pancreas systems, they are comprised of an insulin pump and a continuous glucose monitor (CGM) that communicate via a built-in algorithm to deliver insulin based on glucose levels. Currently available systems are called hybrid closed loops because they still require user input for meals, exercise, illness, and other special circumstances.

Two hybrid closed-loop systems available in the United States, the Medtronic Minimed 670G and the Tandem Control-IQ, as well as the Medtronic Minimed 780G that was just approved in Europe, use insulin only.

Of all ongoing active closed-loop clinical studies, 44 involve insulin-only systems, as of May 2020.

However, two such systems in development add a glucagon analogue to insulin in the same pump (in separate cartridges), with the aim of minimizing the risk of hypoglycemia. And four investigational systems combine insulin with pramlintide (Symlin, AstraZeneca), an amylin analogue that reduces postmeal glucose spikes. Three systems in development combine all three hormones. 

In a debate during the virtual American Diabetes Association 80th Scientific Sessions, Roman Hovorka, PhD, of the University of Cambridge (England) argued in favor of insulin-only systems on the basis of efficacy, less burden and complexity, and lower cost.

But Steven J. Russell, MD, PhD, of Massachusetts General Hospital, Boston, countered that glucagon adds safety and value to the system by allowing for more aggressive insulin dosing with lower hypoglycemia risk, benefits which he said would overcome any downsides.
 

Insulin-only systems are good enough

Dr. Hovorka began by defining a “good” artificial pancreas as one that produces consensus time-in-range targets of at least 70% of glucose values between 3.9 to 10 mmol/L (70-180 mg/dL) and less than 3% below 3.9 mmol/L (70 mg/dL). At the same time, he said, the burden should be low, which he suggested means no more than 10-20 minutes a day spent managing the system, low “alarm burden,” and minimal technical issues.

“We need to balance glucose control and the burden. For some people, reducing the burden is sometimes even more important than the glucose control,” Dr. Hovorka commented.

He pointed out that, in addition to Medtronic’s and Tandem’s systems, two other insulin-only hybrid closed-loop systems are marketed outside the United States. These are the CamDiab system, available in the United Kingdom, which uses his group’s Cambridge control algorithm in a Dana pump with the Dexcom G6 sensor, and the Diabeloop algorithm, available in Europe, that combines a patch pump with the Dexcom G6.

“Lots of energy and resources are going to taking [insulin-only] systems into clinic use,” Dr. Hovorka observed.

He reviewed recently published data for both the Tandem Control-IQ and the Cambridge control algorithm showing similar results meeting the “good artificial pancreas” definition.

In his current clinic population of 160 patients aged 2-80 years using the Cambridge algorithm, 69% of users have achieved 70% or greater time in range and 28% have achieved 80% or greater time in range.

“So, the insulin-only system can achieve acceptable, and in some instances very good, glucose control,” Dr. Hovorka said.

He acknowledged that there are still challenges with insulin-only systems, including exercise-related dysglycemia and postprandial hyperglycemia related to slow insulin absorption, missed or incorrect boluses, or large meals.

But, Dr. Hovorka said, downsides of dual-hormone systems include the need for room-temperature stable glucagon and for dual-chamber pumps with two cannulas and two infusion sites (in addition to the sensor site), and the unknown long-term biological risks of chronic subcutaneous glucagon or pramlintide delivery.

Moreover, he said, costs are expected to be higher for a two-chamber versus single-chamber pump, as well as for the second hormone, reservoir, and infusion set.

Data thus far from short-term studies suggest that insulin-only systems are sufficient in eliminating nocturnal hypoglycemia, while the addition of glucagon potentially reduces daytime hypoglycemia, especially during exercise.

However, longer-term head-to-head studies will be needed, Dr. Hovorka said, noting, “Comparative benefits of the single- and dual-hormone system for improving hemoglobin A1c and preventing severe hypoglycemia remain unknown.”

He suggested that glucagon dual-hormone closed-loop systems might be suitable for patients who are particularly prone to hypoglycemia, whereas pramlintide dual-hormone systems have the potential to more fully close the loop when used with ultra rapid-acting insulin analogues.

Nonetheless, he said, “Many, if not most, users may achieve acceptable control with insulin-only systems.”

Dual-hormone systems: Extra benefit worth it?

Dr. Russell, who is an investigator in multicenter pivotal studies of both insulin-only and bihormonal configurations of the Beta Bionics iLet bionic pancreas, began his debate presentation by endorsing the effectiveness of insulin-only hybrid systems and stating that he encourages his patients with type 1 diabetes to use them.

Michele G. Sullivan/MDedge News

But, he said, adding glucagon can allow for better automation of hypoglycemia prevention and treatment in situations such as exercise.

“A bihormonal system achieves lower glucose, higher time-in-range, and less hypoglycemia than a well-functioning insulin-only system.”

Moreover, Dr. Russell said, “Glucagon reduces the need for medicinal carbohydrates, promotes satiety, and increases energy expenditure. ... Combined, these three factors may oppose weight gain or encourage weight loss as opposed to a system that uses insulin only.”

He pointed to a 2017 meta-analysis that showed improved time-in-range and greater reductions in hypoglycemia with dual- versus single-hormone systems. 

And, in unpublished data from a randomized random-order crossover study of 23 patients with type 1 diabetes who each spent a week with usual care (insulin pump with or without CGM), insulin-only iLet, and bihormonal iLet, mean glucose levels were 165, 148, and 139 mg/dL, respectively. Time-in-range was 60%, 72%, and 79%, and median time with glucose below 54 mg/dL was 0.6%, 0.6%, and 0.2%, respectively.

Dr. Russell also addressed each of the arguments made by Dr. Hovorka and others against glucagon use.

Regarding the need for a stable glucagon formulation, he said that the analogue being developed for the iLet, dasiglucagon (Zealand pharma), is stable for more than a month at 40º C, with higher bioavailability and slightly slower absorption than glucagon.

And while he acknowledged the need for two separate hormone cartridges, Dr. Russell said that the Gen4 version of the iLet is fairly simple and intuitive, and the device itself is about the same size as the Tandem t:slim.

Use of glucagon didn’t increase insulin use in iLet trials, nor was it associated with increased reported nausea or liver glycogen depletion.

And users universally reported preferring the bihormonal system.

Long-term safety of chronic glucagon exposure has yet to be addressed, but animal data are reassuring, Dr. Russell said.

Regarding increased cost, he pointed to 2018 data showing that the incremental improvement in glycemic control from no automation to single-hormone automation is the same as from single to dual (mean glucose reductions of 7.4 and 13.6 mg/dL, respectively, and decreases in time spent in hypoglycemia of 1.28% vs. 2.95%).

“I would argue that, if one can justify adding automation, one could justify some additional expense to add the cost of glucagon.” And, he said, the cost would likely be based on a negotiation around the extra value offered by the dual-hormone system.

“The addition of glucagon, I believe, will be justified by the improved outcomes and improved quality of life,” he concluded.

Dr. Hovorka has reported receiving research support from MiniMed Medtronic, Abbott Diabetes Care, and Dexcom; being a speaker for Novo Nordisk, Eli Lilly, and Dexcom; holding license fees from B. Braun and Medtronic; and being director of CamDiab. Dr. Russell has reported holding patents on aspects of the bionic pancreas; receiving honoraria, travel expenses, and/or research support from Dexcom, Eli Lilly, Tandem Diabetes, Sanofi, Novo Nordisk, Roche, Ascensia, Zealand Pharma, and Beta Bionics; being a consultant for Flexion Therapeutics, Senseonics, and Beta Bionics; and participating in scientific advisory boards for Companion Medical, Tandem Diabetes, and Unomedical.

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

Some automated insulin delivery systems currently in development add glucagon and/or pramlintide to insulin, but whether the extra hormones are worth the additional cost and effort is a subject of debate.

Sara Freeman/MDedge News

Also called closed-loop or artificial pancreas systems, they are comprised of an insulin pump and a continuous glucose monitor (CGM) that communicate via a built-in algorithm to deliver insulin based on glucose levels. Currently available systems are called hybrid closed loops because they still require user input for meals, exercise, illness, and other special circumstances.

Two hybrid closed-loop systems available in the United States, the Medtronic Minimed 670G and the Tandem Control-IQ, as well as the Medtronic Minimed 780G that was just approved in Europe, use insulin only.

Of all ongoing active closed-loop clinical studies, 44 involve insulin-only systems, as of May 2020.

However, two such systems in development add a glucagon analogue to insulin in the same pump (in separate cartridges), with the aim of minimizing the risk of hypoglycemia. And four investigational systems combine insulin with pramlintide (Symlin, AstraZeneca), an amylin analogue that reduces postmeal glucose spikes. Three systems in development combine all three hormones. 

In a debate during the virtual American Diabetes Association 80th Scientific Sessions, Roman Hovorka, PhD, of the University of Cambridge (England) argued in favor of insulin-only systems on the basis of efficacy, less burden and complexity, and lower cost.

But Steven J. Russell, MD, PhD, of Massachusetts General Hospital, Boston, countered that glucagon adds safety and value to the system by allowing for more aggressive insulin dosing with lower hypoglycemia risk, benefits which he said would overcome any downsides.
 

Insulin-only systems are good enough

Dr. Hovorka began by defining a “good” artificial pancreas as one that produces consensus time-in-range targets of at least 70% of glucose values between 3.9 to 10 mmol/L (70-180 mg/dL) and less than 3% below 3.9 mmol/L (70 mg/dL). At the same time, he said, the burden should be low, which he suggested means no more than 10-20 minutes a day spent managing the system, low “alarm burden,” and minimal technical issues.

“We need to balance glucose control and the burden. For some people, reducing the burden is sometimes even more important than the glucose control,” Dr. Hovorka commented.

He pointed out that, in addition to Medtronic’s and Tandem’s systems, two other insulin-only hybrid closed-loop systems are marketed outside the United States. These are the CamDiab system, available in the United Kingdom, which uses his group’s Cambridge control algorithm in a Dana pump with the Dexcom G6 sensor, and the Diabeloop algorithm, available in Europe, that combines a patch pump with the Dexcom G6.

“Lots of energy and resources are going to taking [insulin-only] systems into clinic use,” Dr. Hovorka observed.

He reviewed recently published data for both the Tandem Control-IQ and the Cambridge control algorithm showing similar results meeting the “good artificial pancreas” definition.

In his current clinic population of 160 patients aged 2-80 years using the Cambridge algorithm, 69% of users have achieved 70% or greater time in range and 28% have achieved 80% or greater time in range.

“So, the insulin-only system can achieve acceptable, and in some instances very good, glucose control,” Dr. Hovorka said.

He acknowledged that there are still challenges with insulin-only systems, including exercise-related dysglycemia and postprandial hyperglycemia related to slow insulin absorption, missed or incorrect boluses, or large meals.

But, Dr. Hovorka said, downsides of dual-hormone systems include the need for room-temperature stable glucagon and for dual-chamber pumps with two cannulas and two infusion sites (in addition to the sensor site), and the unknown long-term biological risks of chronic subcutaneous glucagon or pramlintide delivery.

Moreover, he said, costs are expected to be higher for a two-chamber versus single-chamber pump, as well as for the second hormone, reservoir, and infusion set.

Data thus far from short-term studies suggest that insulin-only systems are sufficient in eliminating nocturnal hypoglycemia, while the addition of glucagon potentially reduces daytime hypoglycemia, especially during exercise.

However, longer-term head-to-head studies will be needed, Dr. Hovorka said, noting, “Comparative benefits of the single- and dual-hormone system for improving hemoglobin A1c and preventing severe hypoglycemia remain unknown.”

He suggested that glucagon dual-hormone closed-loop systems might be suitable for patients who are particularly prone to hypoglycemia, whereas pramlintide dual-hormone systems have the potential to more fully close the loop when used with ultra rapid-acting insulin analogues.

Nonetheless, he said, “Many, if not most, users may achieve acceptable control with insulin-only systems.”

Dual-hormone systems: Extra benefit worth it?

Dr. Russell, who is an investigator in multicenter pivotal studies of both insulin-only and bihormonal configurations of the Beta Bionics iLet bionic pancreas, began his debate presentation by endorsing the effectiveness of insulin-only hybrid systems and stating that he encourages his patients with type 1 diabetes to use them.

Michele G. Sullivan/MDedge News

But, he said, adding glucagon can allow for better automation of hypoglycemia prevention and treatment in situations such as exercise.

“A bihormonal system achieves lower glucose, higher time-in-range, and less hypoglycemia than a well-functioning insulin-only system.”

Moreover, Dr. Russell said, “Glucagon reduces the need for medicinal carbohydrates, promotes satiety, and increases energy expenditure. ... Combined, these three factors may oppose weight gain or encourage weight loss as opposed to a system that uses insulin only.”

He pointed to a 2017 meta-analysis that showed improved time-in-range and greater reductions in hypoglycemia with dual- versus single-hormone systems. 

And, in unpublished data from a randomized random-order crossover study of 23 patients with type 1 diabetes who each spent a week with usual care (insulin pump with or without CGM), insulin-only iLet, and bihormonal iLet, mean glucose levels were 165, 148, and 139 mg/dL, respectively. Time-in-range was 60%, 72%, and 79%, and median time with glucose below 54 mg/dL was 0.6%, 0.6%, and 0.2%, respectively.

Dr. Russell also addressed each of the arguments made by Dr. Hovorka and others against glucagon use.

Regarding the need for a stable glucagon formulation, he said that the analogue being developed for the iLet, dasiglucagon (Zealand pharma), is stable for more than a month at 40º C, with higher bioavailability and slightly slower absorption than glucagon.

And while he acknowledged the need for two separate hormone cartridges, Dr. Russell said that the Gen4 version of the iLet is fairly simple and intuitive, and the device itself is about the same size as the Tandem t:slim.

Use of glucagon didn’t increase insulin use in iLet trials, nor was it associated with increased reported nausea or liver glycogen depletion.

And users universally reported preferring the bihormonal system.

Long-term safety of chronic glucagon exposure has yet to be addressed, but animal data are reassuring, Dr. Russell said.

Regarding increased cost, he pointed to 2018 data showing that the incremental improvement in glycemic control from no automation to single-hormone automation is the same as from single to dual (mean glucose reductions of 7.4 and 13.6 mg/dL, respectively, and decreases in time spent in hypoglycemia of 1.28% vs. 2.95%).

“I would argue that, if one can justify adding automation, one could justify some additional expense to add the cost of glucagon.” And, he said, the cost would likely be based on a negotiation around the extra value offered by the dual-hormone system.

“The addition of glucagon, I believe, will be justified by the improved outcomes and improved quality of life,” he concluded.

Dr. Hovorka has reported receiving research support from MiniMed Medtronic, Abbott Diabetes Care, and Dexcom; being a speaker for Novo Nordisk, Eli Lilly, and Dexcom; holding license fees from B. Braun and Medtronic; and being director of CamDiab. Dr. Russell has reported holding patents on aspects of the bionic pancreas; receiving honoraria, travel expenses, and/or research support from Dexcom, Eli Lilly, Tandem Diabetes, Sanofi, Novo Nordisk, Roche, Ascensia, Zealand Pharma, and Beta Bionics; being a consultant for Flexion Therapeutics, Senseonics, and Beta Bionics; and participating in scientific advisory boards for Companion Medical, Tandem Diabetes, and Unomedical.

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

Captopril appears to be associated with a higher rate of pulmonary adverse reactions in patients with diabetes than that of other ACE inhibitors or angiotensin receptor blockers (ARBs) and therefore may not be the best choice for patients with diabetes and COVID-19, a new study suggests.

The study was published online in the Journal of the American Pharmacists Association.

The authors, led by Emma G. Stafford, PharmD, University of Missouri-Kansas City School of Pharmacy, note that diabetes seems to confer a higher risk of adverse outcomes in COVID-19 infection and there is conflicting data on the contribution of ACE inhibitors and ARBs, commonly used medications in diabetes, on the mortality and morbidity of COVID-19.

“In light of the recent COVID-19 outbreak, more research is needed to understand the effects that diabetes (and its medications) may have on the respiratory system and how that could affect the management of diseases such as COVID-19,” they say.

“Although ACE inhibitors and ARBs are generally considered to have similar adverse event profiles, evaluation of postmarketing adverse events may shed light on minute differences that could have important clinical impacts,” they add.

For the current study, the researchers analyzed data from multiple publicly available data sources on adverse drug reactions in patients with diabetes taking ACE inhibitors or ARBs. The data included all adverse drug events (ADEs) reported nationally to the US Food and Drug Administration and internationally to the Medical Dictionary for Regulatory Activities (MedDRA).

Results showed that captopril, the first ACE inhibitor approved back in 1981, has a higher incidence of pulmonary ADEs in patients with diabetes as compared with other ACE-inhibitor drugs (P = .005) as well as a statistically significant difference in pulmonary events compared with ARBs (P = .012).

“These analyses suggest that pharmacists and clinicians will need to consider the specific medication’s adverse event profile, particularly captopril, on how it may affect infections and other acute disease states that alter pulmonary function, such as COVID-19,” the authors conclude.

They say that the high incidence of pulmonary adverse drug effects with captopril “highlights the fact that the drugs belonging in one class are not identical and that its pharmacokinetics and pharmacodynamics can affect the patients’ health especially during acute processes like COVID-19.”

“This is especially important as current observational studies of COVID-19 patients tend to group drugs within a class and are not analyzing the potential differences within each class,” they add.

They note that ACE inhibitors can be broadly classified into 3 structural classes: sulfhydryl-, dicarboxyl-, and phosphorous- containing molecules. Notably, captopril is the only currently available ACE inhibitor belonging to the sulfhydryl-containing class and may explain the higher incidence of adverse drug effects observed, they comment.

“Health care providers have been left with many questions when treating patients with COVID-19, including how ACE inhibitors or ARBs may affect their clinical course. Results from this study may be helpful when prescribing or continuing ACE inhibitors or ARBs for patients with diabetes and infections or illnesses that may affect pulmonary function, such as COVID-19,” they conclude.

Questioning safety in COVID-19 an “overreach”

Commenting for Medscape Medical News, Michael A. Weber, MD, professor of medicine at State University of New York, said he thought the current article appears to overreach in questioning captopril’s safety in the COVID-19 setting.

“Captopril was the first ACE inhibitor available for clinical use. In early prescribing its dosage was not well understood and it might have been administered in excessive amounts,” Weber notes.

“There were some renal and other adverse effects reported that at first were attributed to the fact that captopril, unlike any other popular ACE inhibitors, contained a sulfhydryl (SH) group in its molecule,” he said. “It is not clear whether this feature could be responsible for the increased pulmonary side effects and potential danger to COVID-19 patients now reported with captopril in this new pharmacy article.”

But he adds: “The article contains no evidence that the effect of captopril or any other ACE inhibitor on the pulmonary ACE-2 enzyme has a deleterious effect on outcomes of COVID-19 disease. In any case, captopril — which should be prescribed in a twice-daily dose — is not frequently prescribed these days since newer ACE inhibitors are effective with just once-daily dosing.”

This article first appeared on Medscape.com.

Captopril appears to be associated with a higher rate of pulmonary adverse reactions in patients with diabetes than that of other ACE inhibitors or angiotensin receptor blockers (ARBs) and therefore may not be the best choice for patients with diabetes and COVID-19, a new study suggests.

The study was published online in the Journal of the American Pharmacists Association.

The authors, led by Emma G. Stafford, PharmD, University of Missouri-Kansas City School of Pharmacy, note that diabetes seems to confer a higher risk of adverse outcomes in COVID-19 infection and there is conflicting data on the contribution of ACE inhibitors and ARBs, commonly used medications in diabetes, on the mortality and morbidity of COVID-19.

“In light of the recent COVID-19 outbreak, more research is needed to understand the effects that diabetes (and its medications) may have on the respiratory system and how that could affect the management of diseases such as COVID-19,” they say.

“Although ACE inhibitors and ARBs are generally considered to have similar adverse event profiles, evaluation of postmarketing adverse events may shed light on minute differences that could have important clinical impacts,” they add.

For the current study, the researchers analyzed data from multiple publicly available data sources on adverse drug reactions in patients with diabetes taking ACE inhibitors or ARBs. The data included all adverse drug events (ADEs) reported nationally to the US Food and Drug Administration and internationally to the Medical Dictionary for Regulatory Activities (MedDRA).

Results showed that captopril, the first ACE inhibitor approved back in 1981, has a higher incidence of pulmonary ADEs in patients with diabetes as compared with other ACE-inhibitor drugs (P = .005) as well as a statistically significant difference in pulmonary events compared with ARBs (P = .012).

“These analyses suggest that pharmacists and clinicians will need to consider the specific medication’s adverse event profile, particularly captopril, on how it may affect infections and other acute disease states that alter pulmonary function, such as COVID-19,” the authors conclude.

They say that the high incidence of pulmonary adverse drug effects with captopril “highlights the fact that the drugs belonging in one class are not identical and that its pharmacokinetics and pharmacodynamics can affect the patients’ health especially during acute processes like COVID-19.”

“This is especially important as current observational studies of COVID-19 patients tend to group drugs within a class and are not analyzing the potential differences within each class,” they add.

They note that ACE inhibitors can be broadly classified into 3 structural classes: sulfhydryl-, dicarboxyl-, and phosphorous- containing molecules. Notably, captopril is the only currently available ACE inhibitor belonging to the sulfhydryl-containing class and may explain the higher incidence of adverse drug effects observed, they comment.

“Health care providers have been left with many questions when treating patients with COVID-19, including how ACE inhibitors or ARBs may affect their clinical course. Results from this study may be helpful when prescribing or continuing ACE inhibitors or ARBs for patients with diabetes and infections or illnesses that may affect pulmonary function, such as COVID-19,” they conclude.

Questioning safety in COVID-19 an “overreach”

Commenting for Medscape Medical News, Michael A. Weber, MD, professor of medicine at State University of New York, said he thought the current article appears to overreach in questioning captopril’s safety in the COVID-19 setting.

“Captopril was the first ACE inhibitor available for clinical use. In early prescribing its dosage was not well understood and it might have been administered in excessive amounts,” Weber notes.

“There were some renal and other adverse effects reported that at first were attributed to the fact that captopril, unlike any other popular ACE inhibitors, contained a sulfhydryl (SH) group in its molecule,” he said. “It is not clear whether this feature could be responsible for the increased pulmonary side effects and potential danger to COVID-19 patients now reported with captopril in this new pharmacy article.”

But he adds: “The article contains no evidence that the effect of captopril or any other ACE inhibitor on the pulmonary ACE-2 enzyme has a deleterious effect on outcomes of COVID-19 disease. In any case, captopril — which should be prescribed in a twice-daily dose — is not frequently prescribed these days since newer ACE inhibitors are effective with just once-daily dosing.”

This article first appeared on Medscape.com.

Captopril appears to be associated with a higher rate of pulmonary adverse reactions in patients with diabetes than that of other ACE inhibitors or angiotensin receptor blockers (ARBs) and therefore may not be the best choice for patients with diabetes and COVID-19, a new study suggests.

The study was published online in the Journal of the American Pharmacists Association.

The authors, led by Emma G. Stafford, PharmD, University of Missouri-Kansas City School of Pharmacy, note that diabetes seems to confer a higher risk of adverse outcomes in COVID-19 infection and there is conflicting data on the contribution of ACE inhibitors and ARBs, commonly used medications in diabetes, on the mortality and morbidity of COVID-19.

“In light of the recent COVID-19 outbreak, more research is needed to understand the effects that diabetes (and its medications) may have on the respiratory system and how that could affect the management of diseases such as COVID-19,” they say.

“Although ACE inhibitors and ARBs are generally considered to have similar adverse event profiles, evaluation of postmarketing adverse events may shed light on minute differences that could have important clinical impacts,” they add.

For the current study, the researchers analyzed data from multiple publicly available data sources on adverse drug reactions in patients with diabetes taking ACE inhibitors or ARBs. The data included all adverse drug events (ADEs) reported nationally to the US Food and Drug Administration and internationally to the Medical Dictionary for Regulatory Activities (MedDRA).

Results showed that captopril, the first ACE inhibitor approved back in 1981, has a higher incidence of pulmonary ADEs in patients with diabetes as compared with other ACE-inhibitor drugs (P = .005) as well as a statistically significant difference in pulmonary events compared with ARBs (P = .012).

“These analyses suggest that pharmacists and clinicians will need to consider the specific medication’s adverse event profile, particularly captopril, on how it may affect infections and other acute disease states that alter pulmonary function, such as COVID-19,” the authors conclude.

They say that the high incidence of pulmonary adverse drug effects with captopril “highlights the fact that the drugs belonging in one class are not identical and that its pharmacokinetics and pharmacodynamics can affect the patients’ health especially during acute processes like COVID-19.”

“This is especially important as current observational studies of COVID-19 patients tend to group drugs within a class and are not analyzing the potential differences within each class,” they add.

They note that ACE inhibitors can be broadly classified into 3 structural classes: sulfhydryl-, dicarboxyl-, and phosphorous- containing molecules. Notably, captopril is the only currently available ACE inhibitor belonging to the sulfhydryl-containing class and may explain the higher incidence of adverse drug effects observed, they comment.

“Health care providers have been left with many questions when treating patients with COVID-19, including how ACE inhibitors or ARBs may affect their clinical course. Results from this study may be helpful when prescribing or continuing ACE inhibitors or ARBs for patients with diabetes and infections or illnesses that may affect pulmonary function, such as COVID-19,” they conclude.

Questioning safety in COVID-19 an “overreach”

Commenting for Medscape Medical News, Michael A. Weber, MD, professor of medicine at State University of New York, said he thought the current article appears to overreach in questioning captopril’s safety in the COVID-19 setting.

“Captopril was the first ACE inhibitor available for clinical use. In early prescribing its dosage was not well understood and it might have been administered in excessive amounts,” Weber notes.

“There were some renal and other adverse effects reported that at first were attributed to the fact that captopril, unlike any other popular ACE inhibitors, contained a sulfhydryl (SH) group in its molecule,” he said. “It is not clear whether this feature could be responsible for the increased pulmonary side effects and potential danger to COVID-19 patients now reported with captopril in this new pharmacy article.”

But he adds: “The article contains no evidence that the effect of captopril or any other ACE inhibitor on the pulmonary ACE-2 enzyme has a deleterious effect on outcomes of COVID-19 disease. In any case, captopril — which should be prescribed in a twice-daily dose — is not frequently prescribed these days since newer ACE inhibitors are effective with just once-daily dosing.”

This article first appeared on Medscape.com.

Previously, I introduced the topic of self-care for patients with diabetes to prevent complications. Now let’s explore how to help reduce risk for cardiovascular conditions in these patients, starting with blood pressure control.

CASE CONTINUED

Mr. W’s vitals include a heart rate of 82; BP, 150/86 mm Hg; and O2 saturation, 98%. He is afebrile. You consider how to best manage glucose control and reduce the risk for cardiovascular conditions.

Reducing the Risk for Cardiovascular Conditions

The ADA recommends at least annual systematic assessment of cardiovascular risk factors, including weight, hypertension, dyslipidemia, chronic kidney disease (CKD), and presence of albuminuria.² Managing these conditions to the standards supported by currently available evidence should reduce the risk for ASCVD in patients such as Mr. W. Two newer medication classes—glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors—offer potential benefit in reducing cardiovascular risk.^15,16 Consider these medications for patients with diabetes or known ASCVD or for those who are at high risk for ASCVD and/or CKD.^2,7

Furthermore, the ADA recommends using a risk calculator, such as the ASCVD Risk Estimator Plus created by the American College of Cardiology/American Heart Association (see http://tools.acc.org/ASCVD-Risk-Estimator-Plus), to stratify the 10-year risk for a first ASCVD event.2 This calculator can produce results that can help guide an individualized risk-reduction treatment plan for each patient. Also, consider low-dose aspirin for primary prevention in those at high risk for ASCVD (10-year risk > 10%) and for secondary prevention of ASCVD in those who have already had a cardiovascular event.^2,7

Setting and Meeting BP Goals

Hypertension is common in patients with diabetes, with a recent study suggesting that ≥ 67% of these patients have elevated BP.¹⁷ Significant evidence demonstrates that BP control reduces morbidity and mortality in diabetes.¹⁸ Although the importance of BP control in this setting is widely known, recent studies have demonstrated that only 30% to 42% of affected patients meet their BP goals.^19,20

How to make a BP goal. Guideline recommendations for setting specific BP goals have varied slightly over the past several years and are influenced by known comorbidities such as ASCVD and CKD. Patients should be part of the decision-making process to individualize goals based on their circumstances and safety. A BP goal of < 130/80 mm Hg is generally acceptable for patients who are known to have ASCVD or who are at high risk (≥ 15% risk) for ASCVD in the next 10 years.⁷ A goal of < 140/90 mm Hg is considered appropriate in those with a lower risk for ASCVD.^7,8,21,22

Medications. Selecting an appropriate antihypertensive medication relies on multiple factors. Evidence supports the use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for diabetes, and both the AACE and ADA recommend these medications as an initial treatment option.^2,7 They help reduce the progression of kidney disease in patients with albuminuria and may improve cardiovascular outcomes.^23-27 When additional agents are needed to meet BP goals, the ADA recommends thiazide-like diuretics (chlorthalidone and indapamide) or calcium channel blockers (dihydropyridine).² Although some hyperglycemic adverse effects have been observed with use of thiazide-like diuretics, these might be outweighed by the benefit of BP control.²⁴

Continue to: Monitor the patient's BP

Monitor the patient’s BP at every visit, and advise the patient to regularly measure his or her BP at home with a BP cuff. Patients who may need assistance with at-home monitoring can be directed to an online guide on how to accurately measure their BP (see www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home). For those who report consistently above-goal measurements at home, advise them to check their BP cuff, because an ill-fitting cuff is a well-known cause of inaccurate measurement. Patients also should be assessed for medication nonadherence, white coat hypertension, and secondary hypertension.^7,8 If a patient’s BP is truly above goal, a step-up in therapy may be appropriate because without adequate BP control, the benefit in mortality and morbidity may not be fully realized.²⁸

In Part 3, we’ll check in with Mr. W and discuss which patients require assessment for dyslipidemia. We’ll also explore the treatments, such as statin therapy, for this condition.

Previously, I introduced the topic of self-care for patients with diabetes to prevent complications. Now let’s explore how to help reduce risk for cardiovascular conditions in these patients, starting with blood pressure control.

CASE CONTINUED

Mr. W’s vitals include a heart rate of 82; BP, 150/86 mm Hg; and O2 saturation, 98%. He is afebrile. You consider how to best manage glucose control and reduce the risk for cardiovascular conditions.

Reducing the Risk for Cardiovascular Conditions

The ADA recommends at least annual systematic assessment of cardiovascular risk factors, including weight, hypertension, dyslipidemia, chronic kidney disease (CKD), and presence of albuminuria.² Managing these conditions to the standards supported by currently available evidence should reduce the risk for ASCVD in patients such as Mr. W. Two newer medication classes—glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors—offer potential benefit in reducing cardiovascular risk.^15,16 Consider these medications for patients with diabetes or known ASCVD or for those who are at high risk for ASCVD and/or CKD.^2,7

Furthermore, the ADA recommends using a risk calculator, such as the ASCVD Risk Estimator Plus created by the American College of Cardiology/American Heart Association (see http://tools.acc.org/ASCVD-Risk-Estimator-Plus), to stratify the 10-year risk for a first ASCVD event.2 This calculator can produce results that can help guide an individualized risk-reduction treatment plan for each patient. Also, consider low-dose aspirin for primary prevention in those at high risk for ASCVD (10-year risk > 10%) and for secondary prevention of ASCVD in those who have already had a cardiovascular event.^2,7

Setting and Meeting BP Goals

Hypertension is common in patients with diabetes, with a recent study suggesting that ≥ 67% of these patients have elevated BP.¹⁷ Significant evidence demonstrates that BP control reduces morbidity and mortality in diabetes.¹⁸ Although the importance of BP control in this setting is widely known, recent studies have demonstrated that only 30% to 42% of affected patients meet their BP goals.^19,20

How to make a BP goal. Guideline recommendations for setting specific BP goals have varied slightly over the past several years and are influenced by known comorbidities such as ASCVD and CKD. Patients should be part of the decision-making process to individualize goals based on their circumstances and safety. A BP goal of < 130/80 mm Hg is generally acceptable for patients who are known to have ASCVD or who are at high risk (≥ 15% risk) for ASCVD in the next 10 years.⁷ A goal of < 140/90 mm Hg is considered appropriate in those with a lower risk for ASCVD.^7,8,21,22

Medications. Selecting an appropriate antihypertensive medication relies on multiple factors. Evidence supports the use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for diabetes, and both the AACE and ADA recommend these medications as an initial treatment option.^2,7 They help reduce the progression of kidney disease in patients with albuminuria and may improve cardiovascular outcomes.^23-27 When additional agents are needed to meet BP goals, the ADA recommends thiazide-like diuretics (chlorthalidone and indapamide) or calcium channel blockers (dihydropyridine).² Although some hyperglycemic adverse effects have been observed with use of thiazide-like diuretics, these might be outweighed by the benefit of BP control.²⁴

Continue to: Monitor the patient's BP

Monitor the patient’s BP at every visit, and advise the patient to regularly measure his or her BP at home with a BP cuff. Patients who may need assistance with at-home monitoring can be directed to an online guide on how to accurately measure their BP (see www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home). For those who report consistently above-goal measurements at home, advise them to check their BP cuff, because an ill-fitting cuff is a well-known cause of inaccurate measurement. Patients also should be assessed for medication nonadherence, white coat hypertension, and secondary hypertension.^7,8 If a patient’s BP is truly above goal, a step-up in therapy may be appropriate because without adequate BP control, the benefit in mortality and morbidity may not be fully realized.²⁸

In Part 3, we’ll check in with Mr. W and discuss which patients require assessment for dyslipidemia. We’ll also explore the treatments, such as statin therapy, for this condition.

Previously, I introduced the topic of self-care for patients with diabetes to prevent complications. Now let’s explore how to help reduce risk for cardiovascular conditions in these patients, starting with blood pressure control.

CASE CONTINUED

Mr. W’s vitals include a heart rate of 82; BP, 150/86 mm Hg; and O2 saturation, 98%. He is afebrile. You consider how to best manage glucose control and reduce the risk for cardiovascular conditions.

Reducing the Risk for Cardiovascular Conditions

The ADA recommends at least annual systematic assessment of cardiovascular risk factors, including weight, hypertension, dyslipidemia, chronic kidney disease (CKD), and presence of albuminuria.² Managing these conditions to the standards supported by currently available evidence should reduce the risk for ASCVD in patients such as Mr. W. Two newer medication classes—glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors—offer potential benefit in reducing cardiovascular risk.^15,16 Consider these medications for patients with diabetes or known ASCVD or for those who are at high risk for ASCVD and/or CKD.^2,7

Furthermore, the ADA recommends using a risk calculator, such as the ASCVD Risk Estimator Plus created by the American College of Cardiology/American Heart Association (see http://tools.acc.org/ASCVD-Risk-Estimator-Plus), to stratify the 10-year risk for a first ASCVD event.2 This calculator can produce results that can help guide an individualized risk-reduction treatment plan for each patient. Also, consider low-dose aspirin for primary prevention in those at high risk for ASCVD (10-year risk > 10%) and for secondary prevention of ASCVD in those who have already had a cardiovascular event.^2,7

Setting and Meeting BP Goals

Hypertension is common in patients with diabetes, with a recent study suggesting that ≥ 67% of these patients have elevated BP.¹⁷ Significant evidence demonstrates that BP control reduces morbidity and mortality in diabetes.¹⁸ Although the importance of BP control in this setting is widely known, recent studies have demonstrated that only 30% to 42% of affected patients meet their BP goals.^19,20

How to make a BP goal. Guideline recommendations for setting specific BP goals have varied slightly over the past several years and are influenced by known comorbidities such as ASCVD and CKD. Patients should be part of the decision-making process to individualize goals based on their circumstances and safety. A BP goal of < 130/80 mm Hg is generally acceptable for patients who are known to have ASCVD or who are at high risk (≥ 15% risk) for ASCVD in the next 10 years.⁷ A goal of < 140/90 mm Hg is considered appropriate in those with a lower risk for ASCVD.^7,8,21,22

Medications. Selecting an appropriate antihypertensive medication relies on multiple factors. Evidence supports the use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for diabetes, and both the AACE and ADA recommend these medications as an initial treatment option.^2,7 They help reduce the progression of kidney disease in patients with albuminuria and may improve cardiovascular outcomes.^23-27 When additional agents are needed to meet BP goals, the ADA recommends thiazide-like diuretics (chlorthalidone and indapamide) or calcium channel blockers (dihydropyridine).² Although some hyperglycemic adverse effects have been observed with use of thiazide-like diuretics, these might be outweighed by the benefit of BP control.²⁴

Continue to: Monitor the patient's BP

Monitor the patient’s BP at every visit, and advise the patient to regularly measure his or her BP at home with a BP cuff. Patients who may need assistance with at-home monitoring can be directed to an online guide on how to accurately measure their BP (see www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home). For those who report consistently above-goal measurements at home, advise them to check their BP cuff, because an ill-fitting cuff is a well-known cause of inaccurate measurement. Patients also should be assessed for medication nonadherence, white coat hypertension, and secondary hypertension.^7,8 If a patient’s BP is truly above goal, a step-up in therapy may be appropriate because without adequate BP control, the benefit in mortality and morbidity may not be fully realized.²⁸

In Part 3, we’ll check in with Mr. W and discuss which patients require assessment for dyslipidemia. We’ll also explore the treatments, such as statin therapy, for this condition.

Teens and young adults with diabetes have cognitive deficits that vary by diabetes type and could negatively impact their medical literacy and self-care, an investigator reported at the virtual annual scientific sessions of the American Diabetes Association.

Individuals with youth-onset type 1 or 2 diabetes all performed below average on tests that measure flexible thinking and problem solving, according to the investigator, who reported an analysis including 1,380 individuals enrolled in the SEARCH for Diabetes in Youth study.

That finding suggests that diabetes diagnosed before age 20 contributes to poor fluid cognitive function, which consists of skills that facilitate goal-directed behaviors, according to investigator Allison Shapiro, MPH, PhD, of the University of Colorado at Denver, Aurora.

However, individuals with type 2 diabetes (T2D) performed even worse than those with type 1 diabetes (T1D) on the fluid cognitive function tests, even after adjustment for demographic factors and other confounders, Dr. Shapiro said in her presentation.

Further analysis revealed that individuals with T2D performed significantly worse on measures of crystallized cognition, a domain that includes skills such as vocabulary and language. That suggests the poor fluid cognitive abilities in youths with diabetes may in fact be a result of poor crystallized cognitive development, according to the investigator.

“Among adolescents and young adults with youth-onset type 2 diabetes specifically, intervention should focus on developing both fluid cognitive skills and crystallized cognitive skills,” Dr. Shapiro said.

Deficits in fluid cognitive function (such as reasoning or processing speed) can negatively affect diabetes self-care, thereby potentially increasing the risk of diabetes-related complications, while deficits in crystallized cognitive function (such as vocabulary and understanding of language) could impact medical literacy further compounding the self-care issues.

The study is believed to be one of the first to compare cognitive function deficits in youths with type 1 or 2 diabetes. Although studies in adults clearly show a detrimental relationship between diabetes and cognitive function, according to Dr. Shapiro, the bulk of the research in youths has focused on T1D.

“While limited work has been done in youth-onset type 2 diabetes, cognitive deficits are consistently observed, compared to youth without diabetes,” she said.

Results of this study emphasize the importance of dietary changes and other lifestyle interventions in young patients with diabetes, according to David Della-Morte, MD, PhD, associate professor of neurology at the University of Miami.

“Even the youngest patients may develop cognitive dysfunction,” Dr. Della-Morte said in an interview. “That means that lifestyle is very important, especially in obese patients that are prone to develop type 2 diabetes.”

The analysis by Dr. Shapiro and coinvestigators included 1,095 youths and young adults with T1D and 285 with T2D who had undergone a cognition assessment as part of a study visit. They were aged an average of 22 years, and had an average diabetes duration of 11 years.

The overall fluid cognition score was significantly lower in those individuals with T2D, compared with those with T1D, investigators found. Compared with the national average score of 100, the T2D group scored 84.7, or a full standard deviation below that average, said Dr. Shapiro, while those with T1D scored 95.5 (P < .001).

Participants with T2D also scored significantly lower in individual measures of fluid cognition, including processing speed, inhibitory control and attention, working memory, and episodic memory, she reported. At first glance, that suggested youth-onset T2D has a specific effect on fluid cognition; however, the story remains incomplete without looking at crystallized cognition markers such as vocabulary and language.

Toward that end, a picture vocabulary test conducted as part of the cognitive assessment showed a significant difference between those with T2D, who on average scored 91.5, and those with T1D, who scored 103.6 (P < .001). Accounting for those picture vocabulary scores attenuated the differences between groups in fluid cognitive scores, suggesting that differences in crystallized cognitive function underly the observed differences in fluid cognitive function between groups, Dr. Shapiro said.

Skills such as vocabulary and language are thought to be stable and not influenced by neurologic changes brought on by disease processes such as youth-onset diabetes, but rather, influenced by factors such as childcare and education, according to Dr. Shapiro.

“Crystallized cognition therefore provides a window into an individual’s cognitive functioning, independent of their disease or premorbid to the onset of their disease,” she said.

Dr. Shapiro said she had no conflicts of interest to disclose.

SOURCE: Shapiro A et al. ADA 2020, Abstract 279-OR.

Teens and young adults with diabetes have cognitive deficits that vary by diabetes type and could negatively impact their medical literacy and self-care, an investigator reported at the virtual annual scientific sessions of the American Diabetes Association.

Individuals with youth-onset type 1 or 2 diabetes all performed below average on tests that measure flexible thinking and problem solving, according to the investigator, who reported an analysis including 1,380 individuals enrolled in the SEARCH for Diabetes in Youth study.

That finding suggests that diabetes diagnosed before age 20 contributes to poor fluid cognitive function, which consists of skills that facilitate goal-directed behaviors, according to investigator Allison Shapiro, MPH, PhD, of the University of Colorado at Denver, Aurora.

However, individuals with type 2 diabetes (T2D) performed even worse than those with type 1 diabetes (T1D) on the fluid cognitive function tests, even after adjustment for demographic factors and other confounders, Dr. Shapiro said in her presentation.

Further analysis revealed that individuals with T2D performed significantly worse on measures of crystallized cognition, a domain that includes skills such as vocabulary and language. That suggests the poor fluid cognitive abilities in youths with diabetes may in fact be a result of poor crystallized cognitive development, according to the investigator.

“Among adolescents and young adults with youth-onset type 2 diabetes specifically, intervention should focus on developing both fluid cognitive skills and crystallized cognitive skills,” Dr. Shapiro said.

Deficits in fluid cognitive function (such as reasoning or processing speed) can negatively affect diabetes self-care, thereby potentially increasing the risk of diabetes-related complications, while deficits in crystallized cognitive function (such as vocabulary and understanding of language) could impact medical literacy further compounding the self-care issues.

The study is believed to be one of the first to compare cognitive function deficits in youths with type 1 or 2 diabetes. Although studies in adults clearly show a detrimental relationship between diabetes and cognitive function, according to Dr. Shapiro, the bulk of the research in youths has focused on T1D.

“While limited work has been done in youth-onset type 2 diabetes, cognitive deficits are consistently observed, compared to youth without diabetes,” she said.

Results of this study emphasize the importance of dietary changes and other lifestyle interventions in young patients with diabetes, according to David Della-Morte, MD, PhD, associate professor of neurology at the University of Miami.

“Even the youngest patients may develop cognitive dysfunction,” Dr. Della-Morte said in an interview. “That means that lifestyle is very important, especially in obese patients that are prone to develop type 2 diabetes.”

The analysis by Dr. Shapiro and coinvestigators included 1,095 youths and young adults with T1D and 285 with T2D who had undergone a cognition assessment as part of a study visit. They were aged an average of 22 years, and had an average diabetes duration of 11 years.

The overall fluid cognition score was significantly lower in those individuals with T2D, compared with those with T1D, investigators found. Compared with the national average score of 100, the T2D group scored 84.7, or a full standard deviation below that average, said Dr. Shapiro, while those with T1D scored 95.5 (P < .001).

Participants with T2D also scored significantly lower in individual measures of fluid cognition, including processing speed, inhibitory control and attention, working memory, and episodic memory, she reported. At first glance, that suggested youth-onset T2D has a specific effect on fluid cognition; however, the story remains incomplete without looking at crystallized cognition markers such as vocabulary and language.

Toward that end, a picture vocabulary test conducted as part of the cognitive assessment showed a significant difference between those with T2D, who on average scored 91.5, and those with T1D, who scored 103.6 (P < .001). Accounting for those picture vocabulary scores attenuated the differences between groups in fluid cognitive scores, suggesting that differences in crystallized cognitive function underly the observed differences in fluid cognitive function between groups, Dr. Shapiro said.

Skills such as vocabulary and language are thought to be stable and not influenced by neurologic changes brought on by disease processes such as youth-onset diabetes, but rather, influenced by factors such as childcare and education, according to Dr. Shapiro.

“Crystallized cognition therefore provides a window into an individual’s cognitive functioning, independent of their disease or premorbid to the onset of their disease,” she said.

Dr. Shapiro said she had no conflicts of interest to disclose.

SOURCE: Shapiro A et al. ADA 2020, Abstract 279-OR.

Teens and young adults with diabetes have cognitive deficits that vary by diabetes type and could negatively impact their medical literacy and self-care, an investigator reported at the virtual annual scientific sessions of the American Diabetes Association.

Individuals with youth-onset type 1 or 2 diabetes all performed below average on tests that measure flexible thinking and problem solving, according to the investigator, who reported an analysis including 1,380 individuals enrolled in the SEARCH for Diabetes in Youth study.

That finding suggests that diabetes diagnosed before age 20 contributes to poor fluid cognitive function, which consists of skills that facilitate goal-directed behaviors, according to investigator Allison Shapiro, MPH, PhD, of the University of Colorado at Denver, Aurora.

However, individuals with type 2 diabetes (T2D) performed even worse than those with type 1 diabetes (T1D) on the fluid cognitive function tests, even after adjustment for demographic factors and other confounders, Dr. Shapiro said in her presentation.

Further analysis revealed that individuals with T2D performed significantly worse on measures of crystallized cognition, a domain that includes skills such as vocabulary and language. That suggests the poor fluid cognitive abilities in youths with diabetes may in fact be a result of poor crystallized cognitive development, according to the investigator.

“Among adolescents and young adults with youth-onset type 2 diabetes specifically, intervention should focus on developing both fluid cognitive skills and crystallized cognitive skills,” Dr. Shapiro said.

Deficits in fluid cognitive function (such as reasoning or processing speed) can negatively affect diabetes self-care, thereby potentially increasing the risk of diabetes-related complications, while deficits in crystallized cognitive function (such as vocabulary and understanding of language) could impact medical literacy further compounding the self-care issues.

The study is believed to be one of the first to compare cognitive function deficits in youths with type 1 or 2 diabetes. Although studies in adults clearly show a detrimental relationship between diabetes and cognitive function, according to Dr. Shapiro, the bulk of the research in youths has focused on T1D.

“While limited work has been done in youth-onset type 2 diabetes, cognitive deficits are consistently observed, compared to youth without diabetes,” she said.

Results of this study emphasize the importance of dietary changes and other lifestyle interventions in young patients with diabetes, according to David Della-Morte, MD, PhD, associate professor of neurology at the University of Miami.

“Even the youngest patients may develop cognitive dysfunction,” Dr. Della-Morte said in an interview. “That means that lifestyle is very important, especially in obese patients that are prone to develop type 2 diabetes.”

The analysis by Dr. Shapiro and coinvestigators included 1,095 youths and young adults with T1D and 285 with T2D who had undergone a cognition assessment as part of a study visit. They were aged an average of 22 years, and had an average diabetes duration of 11 years.

The overall fluid cognition score was significantly lower in those individuals with T2D, compared with those with T1D, investigators found. Compared with the national average score of 100, the T2D group scored 84.7, or a full standard deviation below that average, said Dr. Shapiro, while those with T1D scored 95.5 (P < .001).

Participants with T2D also scored significantly lower in individual measures of fluid cognition, including processing speed, inhibitory control and attention, working memory, and episodic memory, she reported. At first glance, that suggested youth-onset T2D has a specific effect on fluid cognition; however, the story remains incomplete without looking at crystallized cognition markers such as vocabulary and language.

Toward that end, a picture vocabulary test conducted as part of the cognitive assessment showed a significant difference between those with T2D, who on average scored 91.5, and those with T1D, who scored 103.6 (P < .001). Accounting for those picture vocabulary scores attenuated the differences between groups in fluid cognitive scores, suggesting that differences in crystallized cognitive function underly the observed differences in fluid cognitive function between groups, Dr. Shapiro said.

Skills such as vocabulary and language are thought to be stable and not influenced by neurologic changes brought on by disease processes such as youth-onset diabetes, but rather, influenced by factors such as childcare and education, according to Dr. Shapiro.

“Crystallized cognition therefore provides a window into an individual’s cognitive functioning, independent of their disease or premorbid to the onset of their disease,” she said.

Dr. Shapiro said she had no conflicts of interest to disclose.

SOURCE: Shapiro A et al. ADA 2020, Abstract 279-OR.

Diabetes mellitus is prevalent in our society; 1 in 10 Americans has the condition and > 1 in 3 has prediabetes.¹ Due to the widespread comorbidities and complications of this disease, the American Diabetes Association (ADA) recommends that diabetes management focus on evaluation and treatment of complications.² Diabetes-related complications can be life-altering and challenging for patients because their quality of life suffers.

For providers, there are several evidence-based screening tools and preventive practices (in and beyond glycemic control) that reduce diabetes complications such as congestive heart failure, kidney failure, lower extremity amputation, and stroke.³ We as providers can treat patients by implementing appropriate goal-directed therapy.^4-6

In this 5-part series, I will explore the evidence and recommendations for a multimodal approach in a patient with type 2 diabetes. Here—in Part 1—I explore the self-care behaviors our patients can adopt to improve their symptoms of diabetes.

Case Report

Mr. W is an overweight 64-year-old man with hypertension, hyperlipidemia, and type 2 diabetes mellitus. He visits the clinic for his yearly physical exam. He is concerned because his father, who had diabetes, developed renal failure and had multiple amputations near the end of his life. He is worried that he might face the same outcomes and asks you what he can do to avoid his father’s fate.

Advising Your Patient on Self-care

The cornerstone of diabetes management is appropriate self-care. Both the ADA and the American Association of Clinical Endocrinologists (AACE) recommend that treatment plans should encourage the patient to adopt healthy lifestyle behaviors, including a healthy diet, regular exercise, weight control, and avoidance of tobacco.^2,7,8 These interventions have positive effects on blood pressure, glucose control, and lipid levels. They can also reduce the risk for diabetic complications, including atherosclerotic cardiovascular disease (ASCVD), which is the foremost cause of death among patients with diabetes. During a patient visit, clinicians can suggest the following self-care interventions for improving long-term outcomes.

Education sessions. The ADA recommends that individuals with diabetes participate in diabetes self-management education and support (DSMES) sessions.² In these sessions, patients with diabetes are instructed on a variety of self-care behaviors, including lifestyle interventions, medication management, self-monitoring, and problem-solving.⁹ These programs—often paid for in part by health insurance—are taught by health care professionals such as registered dieticians, nutritionists, or certified diabetes educators.^9,10 Evidence suggests DSMES increases patients’ sense of self-efficacy and may improve blood sugar management.¹⁰ Clinicians can help guide their patients through the Association of Diabetes Care & Education Specialists’ online database to identify a DSMES program near them (see www.diabeteseducator.org/living-with-diabetes/find-an-education-program).¹¹

Diet. The AACE recommends a plant-based diet high in polyunsaturated and monounsaturated fatty acids and limited in trans fatty acids and saturated fats.⁷ Evidence strongly suggests that a Mediterranean diet with high vegetable intake and decreased saturated fats helps to reduce the risk for major cardiovascular events (myocardial infarction and stroke).¹²

Continue to: Exercise

Exercise. Both the ADA and AACE recommend that most adults with diabetes engage in at least 150 min/week of moderate-to-vigorous aerobic and strength-training exercises.^2,7 Clinicians should evaluate patients with sedentary lifestyles prior to them engaging in vigorous physical activity beyond simple walking.² The ADA also recommends that patients should avoid sitting for long periods of time by engaging in physical activity at least every 30 minutes.² For adults who may not be able to participate in moderate-to-vigorous exercise, recommend alternative flexibility and balance-training activities, such as yoga or tai chi, 2 to 3 times per week.²

Weight management—a combined effort of diet, exercise, and behavioral therapy—is pivotal in the management of type 2 diabetes due to the potential benefits in insulin resistance, blood pressure, hyperlipidemia, and other factors.² Weight loss may also improve glycemic control and reduce the need for glucose-lowering medications.² For patients who struggle with weight loss, consider prescribing FDA-approved weight-loss medications (phentermine, orlistat, lorcaserin, naltrexone/bupropion, liraglutide) or, in some cases, referring for bariatric surgery.^2,7

Sleep hygiene is an important element in any preventive treatment plan. This includes interventions as simple as going to bed at the same time every night, sleeping in a dark room, sleeping for at least 7 hours, and removing electronic devices from the bedroom.13 Patients should avoid alcohol, caffeine, and large meals before bedtime.¹³

Additionally, obstructive sleep apnea (OSA) is often underdiagnosed in patients with diabetes and contributes to insulin resistance, inflammation, and elevated blood pressure.^7,14 For early identification of OSA, order a sleep study when appropriate and refer patients to sleep specialists if needed. Patients who are recommended for treatment should be monitored for increasing compliance with care and to ensure benefit from treatment.

In Part 2, we’ll check in with Mr. W as I discuss the role of blood pressure monitoring and antihypertensive medications in reducing cardiovascular risks in patients with diabetes.

Diabetes mellitus is prevalent in our society; 1 in 10 Americans has the condition and > 1 in 3 has prediabetes.¹ Due to the widespread comorbidities and complications of this disease, the American Diabetes Association (ADA) recommends that diabetes management focus on evaluation and treatment of complications.² Diabetes-related complications can be life-altering and challenging for patients because their quality of life suffers.

For providers, there are several evidence-based screening tools and preventive practices (in and beyond glycemic control) that reduce diabetes complications such as congestive heart failure, kidney failure, lower extremity amputation, and stroke.³ We as providers can treat patients by implementing appropriate goal-directed therapy.^4-6

In this 5-part series, I will explore the evidence and recommendations for a multimodal approach in a patient with type 2 diabetes. Here—in Part 1—I explore the self-care behaviors our patients can adopt to improve their symptoms of diabetes.

Case Report

Mr. W is an overweight 64-year-old man with hypertension, hyperlipidemia, and type 2 diabetes mellitus. He visits the clinic for his yearly physical exam. He is concerned because his father, who had diabetes, developed renal failure and had multiple amputations near the end of his life. He is worried that he might face the same outcomes and asks you what he can do to avoid his father’s fate.

Advising Your Patient on Self-care

The cornerstone of diabetes management is appropriate self-care. Both the ADA and the American Association of Clinical Endocrinologists (AACE) recommend that treatment plans should encourage the patient to adopt healthy lifestyle behaviors, including a healthy diet, regular exercise, weight control, and avoidance of tobacco.^2,7,8 These interventions have positive effects on blood pressure, glucose control, and lipid levels. They can also reduce the risk for diabetic complications, including atherosclerotic cardiovascular disease (ASCVD), which is the foremost cause of death among patients with diabetes. During a patient visit, clinicians can suggest the following self-care interventions for improving long-term outcomes.

Education sessions. The ADA recommends that individuals with diabetes participate in diabetes self-management education and support (DSMES) sessions.² In these sessions, patients with diabetes are instructed on a variety of self-care behaviors, including lifestyle interventions, medication management, self-monitoring, and problem-solving.⁹ These programs—often paid for in part by health insurance—are taught by health care professionals such as registered dieticians, nutritionists, or certified diabetes educators.^9,10 Evidence suggests DSMES increases patients’ sense of self-efficacy and may improve blood sugar management.¹⁰ Clinicians can help guide their patients through the Association of Diabetes Care & Education Specialists’ online database to identify a DSMES program near them (see www.diabeteseducator.org/living-with-diabetes/find-an-education-program).¹¹

Diet. The AACE recommends a plant-based diet high in polyunsaturated and monounsaturated fatty acids and limited in trans fatty acids and saturated fats.⁷ Evidence strongly suggests that a Mediterranean diet with high vegetable intake and decreased saturated fats helps to reduce the risk for major cardiovascular events (myocardial infarction and stroke).¹²

Continue to: Exercise

Exercise. Both the ADA and AACE recommend that most adults with diabetes engage in at least 150 min/week of moderate-to-vigorous aerobic and strength-training exercises.^2,7 Clinicians should evaluate patients with sedentary lifestyles prior to them engaging in vigorous physical activity beyond simple walking.² The ADA also recommends that patients should avoid sitting for long periods of time by engaging in physical activity at least every 30 minutes.² For adults who may not be able to participate in moderate-to-vigorous exercise, recommend alternative flexibility and balance-training activities, such as yoga or tai chi, 2 to 3 times per week.²

Weight management—a combined effort of diet, exercise, and behavioral therapy—is pivotal in the management of type 2 diabetes due to the potential benefits in insulin resistance, blood pressure, hyperlipidemia, and other factors.² Weight loss may also improve glycemic control and reduce the need for glucose-lowering medications.² For patients who struggle with weight loss, consider prescribing FDA-approved weight-loss medications (phentermine, orlistat, lorcaserin, naltrexone/bupropion, liraglutide) or, in some cases, referring for bariatric surgery.^2,7

Sleep hygiene is an important element in any preventive treatment plan. This includes interventions as simple as going to bed at the same time every night, sleeping in a dark room, sleeping for at least 7 hours, and removing electronic devices from the bedroom.13 Patients should avoid alcohol, caffeine, and large meals before bedtime.¹³

Additionally, obstructive sleep apnea (OSA) is often underdiagnosed in patients with diabetes and contributes to insulin resistance, inflammation, and elevated blood pressure.^7,14 For early identification of OSA, order a sleep study when appropriate and refer patients to sleep specialists if needed. Patients who are recommended for treatment should be monitored for increasing compliance with care and to ensure benefit from treatment.

In Part 2, we’ll check in with Mr. W as I discuss the role of blood pressure monitoring and antihypertensive medications in reducing cardiovascular risks in patients with diabetes.

Diabetes mellitus is prevalent in our society; 1 in 10 Americans has the condition and > 1 in 3 has prediabetes.¹ Due to the widespread comorbidities and complications of this disease, the American Diabetes Association (ADA) recommends that diabetes management focus on evaluation and treatment of complications.² Diabetes-related complications can be life-altering and challenging for patients because their quality of life suffers.

For providers, there are several evidence-based screening tools and preventive practices (in and beyond glycemic control) that reduce diabetes complications such as congestive heart failure, kidney failure, lower extremity amputation, and stroke.³ We as providers can treat patients by implementing appropriate goal-directed therapy.^4-6

In this 5-part series, I will explore the evidence and recommendations for a multimodal approach in a patient with type 2 diabetes. Here—in Part 1—I explore the self-care behaviors our patients can adopt to improve their symptoms of diabetes.

Case Report

Mr. W is an overweight 64-year-old man with hypertension, hyperlipidemia, and type 2 diabetes mellitus. He visits the clinic for his yearly physical exam. He is concerned because his father, who had diabetes, developed renal failure and had multiple amputations near the end of his life. He is worried that he might face the same outcomes and asks you what he can do to avoid his father’s fate.

Advising Your Patient on Self-care

The cornerstone of diabetes management is appropriate self-care. Both the ADA and the American Association of Clinical Endocrinologists (AACE) recommend that treatment plans should encourage the patient to adopt healthy lifestyle behaviors, including a healthy diet, regular exercise, weight control, and avoidance of tobacco.^2,7,8 These interventions have positive effects on blood pressure, glucose control, and lipid levels. They can also reduce the risk for diabetic complications, including atherosclerotic cardiovascular disease (ASCVD), which is the foremost cause of death among patients with diabetes. During a patient visit, clinicians can suggest the following self-care interventions for improving long-term outcomes.

Education sessions. The ADA recommends that individuals with diabetes participate in diabetes self-management education and support (DSMES) sessions.² In these sessions, patients with diabetes are instructed on a variety of self-care behaviors, including lifestyle interventions, medication management, self-monitoring, and problem-solving.⁹ These programs—often paid for in part by health insurance—are taught by health care professionals such as registered dieticians, nutritionists, or certified diabetes educators.^9,10 Evidence suggests DSMES increases patients’ sense of self-efficacy and may improve blood sugar management.¹⁰ Clinicians can help guide their patients through the Association of Diabetes Care & Education Specialists’ online database to identify a DSMES program near them (see www.diabeteseducator.org/living-with-diabetes/find-an-education-program).¹¹

Diet. The AACE recommends a plant-based diet high in polyunsaturated and monounsaturated fatty acids and limited in trans fatty acids and saturated fats.⁷ Evidence strongly suggests that a Mediterranean diet with high vegetable intake and decreased saturated fats helps to reduce the risk for major cardiovascular events (myocardial infarction and stroke).¹²

Continue to: Exercise

Exercise. Both the ADA and AACE recommend that most adults with diabetes engage in at least 150 min/week of moderate-to-vigorous aerobic and strength-training exercises.^2,7 Clinicians should evaluate patients with sedentary lifestyles prior to them engaging in vigorous physical activity beyond simple walking.² The ADA also recommends that patients should avoid sitting for long periods of time by engaging in physical activity at least every 30 minutes.² For adults who may not be able to participate in moderate-to-vigorous exercise, recommend alternative flexibility and balance-training activities, such as yoga or tai chi, 2 to 3 times per week.²

Weight management—a combined effort of diet, exercise, and behavioral therapy—is pivotal in the management of type 2 diabetes due to the potential benefits in insulin resistance, blood pressure, hyperlipidemia, and other factors.² Weight loss may also improve glycemic control and reduce the need for glucose-lowering medications.² For patients who struggle with weight loss, consider prescribing FDA-approved weight-loss medications (phentermine, orlistat, lorcaserin, naltrexone/bupropion, liraglutide) or, in some cases, referring for bariatric surgery.^2,7

Sleep hygiene is an important element in any preventive treatment plan. This includes interventions as simple as going to bed at the same time every night, sleeping in a dark room, sleeping for at least 7 hours, and removing electronic devices from the bedroom.13 Patients should avoid alcohol, caffeine, and large meals before bedtime.¹³

Additionally, obstructive sleep apnea (OSA) is often underdiagnosed in patients with diabetes and contributes to insulin resistance, inflammation, and elevated blood pressure.^7,14 For early identification of OSA, order a sleep study when appropriate and refer patients to sleep specialists if needed. Patients who are recommended for treatment should be monitored for increasing compliance with care and to ensure benefit from treatment.

In Part 2, we’ll check in with Mr. W as I discuss the role of blood pressure monitoring and antihypertensive medications in reducing cardiovascular risks in patients with diabetes.