Miriam E. Tucker

TOPLINE:

Patients with type 1 diabetes who received transplanted islets along with a kidney transplant had significantly reduced mortality and transplant failure risks, compared with those who received kidney alone and continued to use insulin.

METHODOLOGY:

• Study population was all patients with type 1 diabetes in France who received a kidney transplant between 2000 and 2017.
• Among 2,393 patients, 327 were eligible for islet transplantation, including 47 who were actually transplanted with islets.
• The subjects were matched for factors including year of transplantation, recipient age, kidney function, and hemoglobin A1c.

TAKEAWAY:

• Those receiving islets along with the kidney transplant had a 53% lower risk of graft failure, compared with the kidney-alone group.
• Those receiving islet transplantation had a significantly higher estimated life expectancy during 10-year follow-up (9.61 vs. 8.85 years).
• At 1 year post islet transplant, there was an estimated 89.4% probability of graft survival and a 70.2% probability of achieving independence from insulin.

IN PRACTICE:

“Although islet transplantation has previously been shown to improve glycemic control, compared with conventional insulin therapy in recent clinical trials, little was known about its long-term impact on patient prognosis until now. ... These results are exciting and provide hope for people living with type 1 diabetes and kidney transplants.”

SOURCE:

Presented Sept. 17, 2023, at the European Society for Organ Transplantation (ESOT) Congress 2023 by Mehdi Maanaoui, MD, a nephrologist at the University of Lille (France).

LIMITATIONS:

Observational, potential for residual confounding.

DISCLOSURES:

Dr. Maanaoui reports no relevant financial relationships.

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

TOPLINE:

Patients with type 1 diabetes who received transplanted islets along with a kidney transplant had significantly reduced mortality and transplant failure risks, compared with those who received kidney alone and continued to use insulin.

METHODOLOGY:

• Study population was all patients with type 1 diabetes in France who received a kidney transplant between 2000 and 2017.
• Among 2,393 patients, 327 were eligible for islet transplantation, including 47 who were actually transplanted with islets.
• The subjects were matched for factors including year of transplantation, recipient age, kidney function, and hemoglobin A1c.

TAKEAWAY:

• Those receiving islets along with the kidney transplant had a 53% lower risk of graft failure, compared with the kidney-alone group.
• Those receiving islet transplantation had a significantly higher estimated life expectancy during 10-year follow-up (9.61 vs. 8.85 years).
• At 1 year post islet transplant, there was an estimated 89.4% probability of graft survival and a 70.2% probability of achieving independence from insulin.

IN PRACTICE:

“Although islet transplantation has previously been shown to improve glycemic control, compared with conventional insulin therapy in recent clinical trials, little was known about its long-term impact on patient prognosis until now. ... These results are exciting and provide hope for people living with type 1 diabetes and kidney transplants.”

SOURCE:

Presented Sept. 17, 2023, at the European Society for Organ Transplantation (ESOT) Congress 2023 by Mehdi Maanaoui, MD, a nephrologist at the University of Lille (France).

LIMITATIONS:

Observational, potential for residual confounding.

DISCLOSURES:

Dr. Maanaoui reports no relevant financial relationships.

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

TOPLINE:

Patients with type 1 diabetes who received transplanted islets along with a kidney transplant had significantly reduced mortality and transplant failure risks, compared with those who received kidney alone and continued to use insulin.

METHODOLOGY:

• Study population was all patients with type 1 diabetes in France who received a kidney transplant between 2000 and 2017.
• Among 2,393 patients, 327 were eligible for islet transplantation, including 47 who were actually transplanted with islets.
• The subjects were matched for factors including year of transplantation, recipient age, kidney function, and hemoglobin A1c.

TAKEAWAY:

• Those receiving islets along with the kidney transplant had a 53% lower risk of graft failure, compared with the kidney-alone group.
• Those receiving islet transplantation had a significantly higher estimated life expectancy during 10-year follow-up (9.61 vs. 8.85 years).
• At 1 year post islet transplant, there was an estimated 89.4% probability of graft survival and a 70.2% probability of achieving independence from insulin.

IN PRACTICE:

“Although islet transplantation has previously been shown to improve glycemic control, compared with conventional insulin therapy in recent clinical trials, little was known about its long-term impact on patient prognosis until now. ... These results are exciting and provide hope for people living with type 1 diabetes and kidney transplants.”

SOURCE:

Presented Sept. 17, 2023, at the European Society for Organ Transplantation (ESOT) Congress 2023 by Mehdi Maanaoui, MD, a nephrologist at the University of Lille (France).

LIMITATIONS:

Observational, potential for residual confounding.

DISCLOSURES:

Dr. Maanaoui reports no relevant financial relationships.

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

TOPLINE:

The COVID-19 booster vaccine typically causes transient, clinically insignificant elevations in glucose levels in people with type 1 diabetes, but some individuals may develop more pronounced hyperglycemia.

METHODOLOGY:

• In a single-center prospective cohort study of 21 adults with type 1 diabetes, patients were given a blinded Dexcom G6 Pro continuous glucose monitor (CGM) at the first research clinic visit.
• After 3-4 days, participants received a COVID-19 booster vaccine.
• They returned to the clinic 10 days after the initial visit (5-6 days after booster vaccination) to have the CGM removed and glycemia assessed.

TAKEAWAY:

• Compared with baseline, the mean daily glucose level was significantly increased at day 2 (162.9 mg/dL vs. 172.8 mg/dL; P = .04) and day 3 (173.1 mg/dL; P = .02) post vaccination.
• Glucose excursions at day 0 (173.2 mg/dL; P = .058) and day 1 (173.1 mg/dL; P = .078) didn’t quite reach statistical significance.
• One participant experienced increases in glucose of 36%, 69%, 35%, 26%, 22%, and 19% on days 0-5, respectively, compared with baseline.
• Glucose excursions of at least 25% above baseline occurred in four participants on day 0 and day 1 and in three participants on days 2 and 5.
• Insulin resistance, as measured by Total Daily Insulin Resistance (a metric that integrates daily mean glucose concentration with total daily insulin dose), was also significantly increased from baseline to day 2 post vaccination (7,171 mg/dL vs. 8,070 mg/dL units; P = .03).
• No other measures of glycemia differed significantly, compared with baseline.
• Outcomes didn’t differ significantly by sex, age, or vaccine manufacturer.

IN PRACTICE:

• “To our knowledge this is the first study investigating the effect of the COVID-19 booster vaccine on glycemia specifically in people with type 1 diabetes,” say the authors.
• “Clinicians, pharmacists, and other health care providers may need to counsel people with T1D to be more vigilant with glucose testing and insulin dosing for the first 5 days after vaccination. Most importantly, insulin, required to control glycemia, may need to be transiently increased.”
• “Further studies are warranted to investigate whether other vaccines have similar glycemic effects, and which individuals are at highest risk for profound glucose perturbations post vaccination.”

SOURCE:

The study was conducted by Mihail Zilbermint, MD, of the division of hospital medicine, Johns Hopkins Medicine, Bethesda, Md., and colleagues. It was published in Diabetes Research and Clinical Practice.

LIMITATIONS:

• The sample size was small.
• There were no measurements of inflammatory markers, dietary intake, physical activity, or survey patient symptomatology to adjust for variables that may have influenced glycemic control.
• In the study cohort, glycemia was moderately well controlled at baseline.

DISCLOSURES:

The study was supported by an investigator-initiated study grant from DexCom Inc. Dr. Zilbermint has consulted for EMD Serono.

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

TOPLINE:

The COVID-19 booster vaccine typically causes transient, clinically insignificant elevations in glucose levels in people with type 1 diabetes, but some individuals may develop more pronounced hyperglycemia.

METHODOLOGY:

• In a single-center prospective cohort study of 21 adults with type 1 diabetes, patients were given a blinded Dexcom G6 Pro continuous glucose monitor (CGM) at the first research clinic visit.
• After 3-4 days, participants received a COVID-19 booster vaccine.
• They returned to the clinic 10 days after the initial visit (5-6 days after booster vaccination) to have the CGM removed and glycemia assessed.

TAKEAWAY:

• Compared with baseline, the mean daily glucose level was significantly increased at day 2 (162.9 mg/dL vs. 172.8 mg/dL; P = .04) and day 3 (173.1 mg/dL; P = .02) post vaccination.
• Glucose excursions at day 0 (173.2 mg/dL; P = .058) and day 1 (173.1 mg/dL; P = .078) didn’t quite reach statistical significance.
• One participant experienced increases in glucose of 36%, 69%, 35%, 26%, 22%, and 19% on days 0-5, respectively, compared with baseline.
• Glucose excursions of at least 25% above baseline occurred in four participants on day 0 and day 1 and in three participants on days 2 and 5.
• Insulin resistance, as measured by Total Daily Insulin Resistance (a metric that integrates daily mean glucose concentration with total daily insulin dose), was also significantly increased from baseline to day 2 post vaccination (7,171 mg/dL vs. 8,070 mg/dL units; P = .03).
• No other measures of glycemia differed significantly, compared with baseline.
• Outcomes didn’t differ significantly by sex, age, or vaccine manufacturer.

IN PRACTICE:

• “To our knowledge this is the first study investigating the effect of the COVID-19 booster vaccine on glycemia specifically in people with type 1 diabetes,” say the authors.
• “Clinicians, pharmacists, and other health care providers may need to counsel people with T1D to be more vigilant with glucose testing and insulin dosing for the first 5 days after vaccination. Most importantly, insulin, required to control glycemia, may need to be transiently increased.”
• “Further studies are warranted to investigate whether other vaccines have similar glycemic effects, and which individuals are at highest risk for profound glucose perturbations post vaccination.”

SOURCE:

The study was conducted by Mihail Zilbermint, MD, of the division of hospital medicine, Johns Hopkins Medicine, Bethesda, Md., and colleagues. It was published in Diabetes Research and Clinical Practice.

LIMITATIONS:

• The sample size was small.
• There were no measurements of inflammatory markers, dietary intake, physical activity, or survey patient symptomatology to adjust for variables that may have influenced glycemic control.
• In the study cohort, glycemia was moderately well controlled at baseline.

DISCLOSURES:

The study was supported by an investigator-initiated study grant from DexCom Inc. Dr. Zilbermint has consulted for EMD Serono.

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

TOPLINE:

The COVID-19 booster vaccine typically causes transient, clinically insignificant elevations in glucose levels in people with type 1 diabetes, but some individuals may develop more pronounced hyperglycemia.

METHODOLOGY:

• In a single-center prospective cohort study of 21 adults with type 1 diabetes, patients were given a blinded Dexcom G6 Pro continuous glucose monitor (CGM) at the first research clinic visit.
• After 3-4 days, participants received a COVID-19 booster vaccine.
• They returned to the clinic 10 days after the initial visit (5-6 days after booster vaccination) to have the CGM removed and glycemia assessed.

TAKEAWAY:

• Compared with baseline, the mean daily glucose level was significantly increased at day 2 (162.9 mg/dL vs. 172.8 mg/dL; P = .04) and day 3 (173.1 mg/dL; P = .02) post vaccination.
• Glucose excursions at day 0 (173.2 mg/dL; P = .058) and day 1 (173.1 mg/dL; P = .078) didn’t quite reach statistical significance.
• One participant experienced increases in glucose of 36%, 69%, 35%, 26%, 22%, and 19% on days 0-5, respectively, compared with baseline.
• Glucose excursions of at least 25% above baseline occurred in four participants on day 0 and day 1 and in three participants on days 2 and 5.
• Insulin resistance, as measured by Total Daily Insulin Resistance (a metric that integrates daily mean glucose concentration with total daily insulin dose), was also significantly increased from baseline to day 2 post vaccination (7,171 mg/dL vs. 8,070 mg/dL units; P = .03).
• No other measures of glycemia differed significantly, compared with baseline.
• Outcomes didn’t differ significantly by sex, age, or vaccine manufacturer.

IN PRACTICE:

• “To our knowledge this is the first study investigating the effect of the COVID-19 booster vaccine on glycemia specifically in people with type 1 diabetes,” say the authors.
• “Clinicians, pharmacists, and other health care providers may need to counsel people with T1D to be more vigilant with glucose testing and insulin dosing for the first 5 days after vaccination. Most importantly, insulin, required to control glycemia, may need to be transiently increased.”
• “Further studies are warranted to investigate whether other vaccines have similar glycemic effects, and which individuals are at highest risk for profound glucose perturbations post vaccination.”

SOURCE:

The study was conducted by Mihail Zilbermint, MD, of the division of hospital medicine, Johns Hopkins Medicine, Bethesda, Md., and colleagues. It was published in Diabetes Research and Clinical Practice.

LIMITATIONS:

• The sample size was small.
• There were no measurements of inflammatory markers, dietary intake, physical activity, or survey patient symptomatology to adjust for variables that may have influenced glycemic control.
• In the study cohort, glycemia was moderately well controlled at baseline.

DISCLOSURES:

The study was supported by an investigator-initiated study grant from DexCom Inc. Dr. Zilbermint has consulted for EMD Serono.

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

People with type 1 diabetes have not experienced the same improved survival after a heart attack over the past 15 years that has occurred in people with type 2 diabetes and those without diabetes, new research shows.

Between 2006 and 2020, the annual incidences of overall mortality and major adverse cardiovascular events after a first-time myocardial infarction dropped significantly for people with type 2 diabetes and those without diabetes (controls).

However, the same trend was not seen for people with type 1 diabetes.

“There is an urgent need for further studies understanding cardiovascular disease in people with type 1 diabetes. Clinicians have to be aware of the absence of the declined mortality trend in people with type 1 diabetes having a first-time myocardial infarction,” lead author Thomas Nyström, MD, professor of medicine at the Karolinska Institute, Stockholm, said in an interview.

The findings are scheduled to be presented Oct. 5, 2023, at the annual meeting of the European Association for the Study of Diabetes.

Discussing potential reasons for the findings, the authors say that the standard care after a heart attack has improved with more availability of, for example, percutaneous coronary intervention and better overall medical treatment. However, this standard of care should have improved in all three groups.

“Although glycemic control and diabetes duration were much different between diabetes groups, in that those with type 1 had been exposed for a longer period of glycemia, the current study cannot tell whether glucose control is behind the association between mortality trends observed. Whether this is the case must be investigated with further studies,” Nyström said.
 

Data from Swedish health care registry

Among people with a first-time MI recorded in national Swedish health care registries between 2006 and 2020, there were 2,527 individuals with type 1 diabetes, 48,321 with type 2 diabetes, and 243,170 controls with neither form of diabetes.

Those with type 1 diabetes were younger than those with type 2 diabetes and controls (62 years vs. 75 and 73 years, respectively). The type 1 diabetes group also had a higher proportion of females (43.6% vs. 38.1% of both the type 2 diabetes and control groups).

The proportions of people with the most severe type of heart attack, ST-elevation MI (STEMI), versus non-STEMI were 29% versus 71% in the type 1 diabetes group, 30% versus 70% in the type 2 diabetes group, and 39% versus 61% in the control group, respectively.

After adjustment for covariates including age, sex, comorbidities, socioeconomic factors, and medication, there was a significant decreased annual incidence trend for all-cause death among the controls (–1.9%) and persons with type 2 diabetes (–1.3%), but there was no such decrease among those with type 1 diabetes.

For cardiovascular deaths, the annual incidence declines were –2.0% and –1.6% in the control group and the type 2 diabetes group, respectively, versus a nonsignificant –0.5% decline in the type 1 diabetes group. Similarly, for major adverse cardiovascular events, those decreases were –2.0% for controls and –1.6% for those with type 2 diabetes, but –0.6% for those with type 1 diabetes – again, a nonsignificant value.

“During the last 15 years, the risk of death and major cardiovascular events in people without diabetes and with type 2 diabetes after having a first-time heart attack has decreased significantly. In contrast, this decreasing trend was absent in people with type 1 diabetes. Our study highlights the urgent need for understanding the cardiovascular risk in people with type 1 diabetes,” the authors conclude.

Dr. Nyström has received honoraria from AstraZeneca, Merck Sharp & Dohme, Novo Nordisk, Eli Lilly , Boehringer Ingelheim, Abbott, and Amgen. The authors acknowledge the ALF agreement between Stockholm County Council and Karolinska Institutet.

A version of this article appeared on Medscape.com.

People with type 1 diabetes have not experienced the same improved survival after a heart attack over the past 15 years that has occurred in people with type 2 diabetes and those without diabetes, new research shows.

Between 2006 and 2020, the annual incidences of overall mortality and major adverse cardiovascular events after a first-time myocardial infarction dropped significantly for people with type 2 diabetes and those without diabetes (controls).

However, the same trend was not seen for people with type 1 diabetes.

“There is an urgent need for further studies understanding cardiovascular disease in people with type 1 diabetes. Clinicians have to be aware of the absence of the declined mortality trend in people with type 1 diabetes having a first-time myocardial infarction,” lead author Thomas Nyström, MD, professor of medicine at the Karolinska Institute, Stockholm, said in an interview.

The findings are scheduled to be presented Oct. 5, 2023, at the annual meeting of the European Association for the Study of Diabetes.

Discussing potential reasons for the findings, the authors say that the standard care after a heart attack has improved with more availability of, for example, percutaneous coronary intervention and better overall medical treatment. However, this standard of care should have improved in all three groups.

“Although glycemic control and diabetes duration were much different between diabetes groups, in that those with type 1 had been exposed for a longer period of glycemia, the current study cannot tell whether glucose control is behind the association between mortality trends observed. Whether this is the case must be investigated with further studies,” Nyström said.
 

Data from Swedish health care registry

Among people with a first-time MI recorded in national Swedish health care registries between 2006 and 2020, there were 2,527 individuals with type 1 diabetes, 48,321 with type 2 diabetes, and 243,170 controls with neither form of diabetes.

Those with type 1 diabetes were younger than those with type 2 diabetes and controls (62 years vs. 75 and 73 years, respectively). The type 1 diabetes group also had a higher proportion of females (43.6% vs. 38.1% of both the type 2 diabetes and control groups).

The proportions of people with the most severe type of heart attack, ST-elevation MI (STEMI), versus non-STEMI were 29% versus 71% in the type 1 diabetes group, 30% versus 70% in the type 2 diabetes group, and 39% versus 61% in the control group, respectively.

After adjustment for covariates including age, sex, comorbidities, socioeconomic factors, and medication, there was a significant decreased annual incidence trend for all-cause death among the controls (–1.9%) and persons with type 2 diabetes (–1.3%), but there was no such decrease among those with type 1 diabetes.

For cardiovascular deaths, the annual incidence declines were –2.0% and –1.6% in the control group and the type 2 diabetes group, respectively, versus a nonsignificant –0.5% decline in the type 1 diabetes group. Similarly, for major adverse cardiovascular events, those decreases were –2.0% for controls and –1.6% for those with type 2 diabetes, but –0.6% for those with type 1 diabetes – again, a nonsignificant value.

“During the last 15 years, the risk of death and major cardiovascular events in people without diabetes and with type 2 diabetes after having a first-time heart attack has decreased significantly. In contrast, this decreasing trend was absent in people with type 1 diabetes. Our study highlights the urgent need for understanding the cardiovascular risk in people with type 1 diabetes,” the authors conclude.

Dr. Nyström has received honoraria from AstraZeneca, Merck Sharp & Dohme, Novo Nordisk, Eli Lilly , Boehringer Ingelheim, Abbott, and Amgen. The authors acknowledge the ALF agreement between Stockholm County Council and Karolinska Institutet.

A version of this article appeared on Medscape.com.

People with type 1 diabetes have not experienced the same improved survival after a heart attack over the past 15 years that has occurred in people with type 2 diabetes and those without diabetes, new research shows.

Between 2006 and 2020, the annual incidences of overall mortality and major adverse cardiovascular events after a first-time myocardial infarction dropped significantly for people with type 2 diabetes and those without diabetes (controls).

However, the same trend was not seen for people with type 1 diabetes.

“There is an urgent need for further studies understanding cardiovascular disease in people with type 1 diabetes. Clinicians have to be aware of the absence of the declined mortality trend in people with type 1 diabetes having a first-time myocardial infarction,” lead author Thomas Nyström, MD, professor of medicine at the Karolinska Institute, Stockholm, said in an interview.

The findings are scheduled to be presented Oct. 5, 2023, at the annual meeting of the European Association for the Study of Diabetes.

Discussing potential reasons for the findings, the authors say that the standard care after a heart attack has improved with more availability of, for example, percutaneous coronary intervention and better overall medical treatment. However, this standard of care should have improved in all three groups.

“Although glycemic control and diabetes duration were much different between diabetes groups, in that those with type 1 had been exposed for a longer period of glycemia, the current study cannot tell whether glucose control is behind the association between mortality trends observed. Whether this is the case must be investigated with further studies,” Nyström said.
 

Data from Swedish health care registry

Among people with a first-time MI recorded in national Swedish health care registries between 2006 and 2020, there were 2,527 individuals with type 1 diabetes, 48,321 with type 2 diabetes, and 243,170 controls with neither form of diabetes.

Those with type 1 diabetes were younger than those with type 2 diabetes and controls (62 years vs. 75 and 73 years, respectively). The type 1 diabetes group also had a higher proportion of females (43.6% vs. 38.1% of both the type 2 diabetes and control groups).

The proportions of people with the most severe type of heart attack, ST-elevation MI (STEMI), versus non-STEMI were 29% versus 71% in the type 1 diabetes group, 30% versus 70% in the type 2 diabetes group, and 39% versus 61% in the control group, respectively.

After adjustment for covariates including age, sex, comorbidities, socioeconomic factors, and medication, there was a significant decreased annual incidence trend for all-cause death among the controls (–1.9%) and persons with type 2 diabetes (–1.3%), but there was no such decrease among those with type 1 diabetes.

For cardiovascular deaths, the annual incidence declines were –2.0% and –1.6% in the control group and the type 2 diabetes group, respectively, versus a nonsignificant –0.5% decline in the type 1 diabetes group. Similarly, for major adverse cardiovascular events, those decreases were –2.0% for controls and –1.6% for those with type 2 diabetes, but –0.6% for those with type 1 diabetes – again, a nonsignificant value.

“During the last 15 years, the risk of death and major cardiovascular events in people without diabetes and with type 2 diabetes after having a first-time heart attack has decreased significantly. In contrast, this decreasing trend was absent in people with type 1 diabetes. Our study highlights the urgent need for understanding the cardiovascular risk in people with type 1 diabetes,” the authors conclude.

Dr. Nyström has received honoraria from AstraZeneca, Merck Sharp & Dohme, Novo Nordisk, Eli Lilly , Boehringer Ingelheim, Abbott, and Amgen. The authors acknowledge the ALF agreement between Stockholm County Council and Karolinska Institutet.

A version of this article appeared on Medscape.com.

TOPLINE:

In an online survey of 605 people with diabetes who use insulin and continuous glucose monitors (CGMs), a majority expressed satisfaction with many aspects of the devices’ performance. However, significant proportions also reported concerns about accuracy under certain circumstances and about skin problems.

METHODOLOGY:

Researchers did an online survey of 504 people with type 1 diabetes from the T1D Exchange and 101 with type 2 diabetes from the Dynata database.

TAKEAWAY:

• The Dexcom G6 device was used by 60.7% of all current CGM users, including 69% of those with type 1 diabetes vs. 12% with type 2 diabetes.
• People with type 2 diabetes were more likely to use older Dexcom versions (G4/G5) (32%) or Abbott’s FreeStyle Libre systems (35%).
• Overall, 90% agreed that most sensors were accurate, but just 79% and 78%, respectively, were satisfied with sensor performance on the first and last day of wear.
• Moreover, 42% suspected variations in accuracy from sensor to sensor, and 32% continue to perform finger-stick monitoring more than six times a week.
• Individuals with type 2 diabetes were more likely than those with type 1 diabetes to be concerned about poor sensor performance affecting confidence in making diabetes management decisions (52% vs. 19%).
• Over half reported skin reactions and/or pain with the sensors (53.7% and 55.4%, respectively).
• Concerns about medications affecting sensor accuracy were more common among those with type 2 vs. type 1 diabetes (65% vs. 29%).
• Among overall concerns about substances or situations affecting sensor accuracy, the top choice (47%) was dehydration (despite a lack of supportive published literature), followed by pain medications (43%), cold/flu medications (32%), and coffee (24%).
• Inaccurate/false alarms negatively affected daily life for 36% of participants and diabetes management for 34%.

IN PRACTICE:

“CGM is a game-changing technology and has evolved in the past decade to overcome many technical and usability obstacles. Our survey suggests that there remain areas for further improvement ... Mistrust in CGM performance was more common than expected.”

SOURCE:

The study was done by Elizabeth Holt, of LifeScan, and colleagues. It was published in Clinical Diabetes.

LIMITATIONS:

• The databases used to recruit study participants may not be representative of the entire respective patient populations.
• Exercise wasn’t given as an option for affecting CGM accuracy, which might partly explain the dehydration finding.

DISCLOSURES:

Funding for this study and preparation of the manuscript were provided by LifeScan Inc. Two authors are LifeScan employees, and two others currently work for the T1D Exchange.

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

TOPLINE:

In an online survey of 605 people with diabetes who use insulin and continuous glucose monitors (CGMs), a majority expressed satisfaction with many aspects of the devices’ performance. However, significant proportions also reported concerns about accuracy under certain circumstances and about skin problems.

METHODOLOGY:

Researchers did an online survey of 504 people with type 1 diabetes from the T1D Exchange and 101 with type 2 diabetes from the Dynata database.

TAKEAWAY:

• The Dexcom G6 device was used by 60.7% of all current CGM users, including 69% of those with type 1 diabetes vs. 12% with type 2 diabetes.
• People with type 2 diabetes were more likely to use older Dexcom versions (G4/G5) (32%) or Abbott’s FreeStyle Libre systems (35%).
• Overall, 90% agreed that most sensors were accurate, but just 79% and 78%, respectively, were satisfied with sensor performance on the first and last day of wear.
• Moreover, 42% suspected variations in accuracy from sensor to sensor, and 32% continue to perform finger-stick monitoring more than six times a week.
• Individuals with type 2 diabetes were more likely than those with type 1 diabetes to be concerned about poor sensor performance affecting confidence in making diabetes management decisions (52% vs. 19%).
• Over half reported skin reactions and/or pain with the sensors (53.7% and 55.4%, respectively).
• Concerns about medications affecting sensor accuracy were more common among those with type 2 vs. type 1 diabetes (65% vs. 29%).
• Among overall concerns about substances or situations affecting sensor accuracy, the top choice (47%) was dehydration (despite a lack of supportive published literature), followed by pain medications (43%), cold/flu medications (32%), and coffee (24%).
• Inaccurate/false alarms negatively affected daily life for 36% of participants and diabetes management for 34%.

IN PRACTICE:

“CGM is a game-changing technology and has evolved in the past decade to overcome many technical and usability obstacles. Our survey suggests that there remain areas for further improvement ... Mistrust in CGM performance was more common than expected.”

SOURCE:

The study was done by Elizabeth Holt, of LifeScan, and colleagues. It was published in Clinical Diabetes.

LIMITATIONS:

• The databases used to recruit study participants may not be representative of the entire respective patient populations.
• Exercise wasn’t given as an option for affecting CGM accuracy, which might partly explain the dehydration finding.

DISCLOSURES:

Funding for this study and preparation of the manuscript were provided by LifeScan Inc. Two authors are LifeScan employees, and two others currently work for the T1D Exchange.

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

TOPLINE:

In an online survey of 605 people with diabetes who use insulin and continuous glucose monitors (CGMs), a majority expressed satisfaction with many aspects of the devices’ performance. However, significant proportions also reported concerns about accuracy under certain circumstances and about skin problems.

METHODOLOGY:

Researchers did an online survey of 504 people with type 1 diabetes from the T1D Exchange and 101 with type 2 diabetes from the Dynata database.

TAKEAWAY:

• The Dexcom G6 device was used by 60.7% of all current CGM users, including 69% of those with type 1 diabetes vs. 12% with type 2 diabetes.
• People with type 2 diabetes were more likely to use older Dexcom versions (G4/G5) (32%) or Abbott’s FreeStyle Libre systems (35%).
• Overall, 90% agreed that most sensors were accurate, but just 79% and 78%, respectively, were satisfied with sensor performance on the first and last day of wear.
• Moreover, 42% suspected variations in accuracy from sensor to sensor, and 32% continue to perform finger-stick monitoring more than six times a week.
• Individuals with type 2 diabetes were more likely than those with type 1 diabetes to be concerned about poor sensor performance affecting confidence in making diabetes management decisions (52% vs. 19%).
• Over half reported skin reactions and/or pain with the sensors (53.7% and 55.4%, respectively).
• Concerns about medications affecting sensor accuracy were more common among those with type 2 vs. type 1 diabetes (65% vs. 29%).
• Among overall concerns about substances or situations affecting sensor accuracy, the top choice (47%) was dehydration (despite a lack of supportive published literature), followed by pain medications (43%), cold/flu medications (32%), and coffee (24%).
• Inaccurate/false alarms negatively affected daily life for 36% of participants and diabetes management for 34%.

IN PRACTICE:

“CGM is a game-changing technology and has evolved in the past decade to overcome many technical and usability obstacles. Our survey suggests that there remain areas for further improvement ... Mistrust in CGM performance was more common than expected.”

SOURCE:

The study was done by Elizabeth Holt, of LifeScan, and colleagues. It was published in Clinical Diabetes.

LIMITATIONS:

• The databases used to recruit study participants may not be representative of the entire respective patient populations.
• Exercise wasn’t given as an option for affecting CGM accuracy, which might partly explain the dehydration finding.

DISCLOSURES:

Funding for this study and preparation of the manuscript were provided by LifeScan Inc. Two authors are LifeScan employees, and two others currently work for the T1D Exchange.

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

Ketogenic diets may improve reproductive hormone levels in women with polycystic ovary syndrome (PCOS), new research suggests.

In the first-ever systematic review and meta-analysis of clinical trials on the association, ketogenic diets followed for 45 days to 24 weeks showed improvements in the luteinizing hormone (LH)/follicle-stimulating hormone (FSH) ratio, serum free testosterone, and serum sex hormone binding globulin (SHBG).  

Previous evidence supporting ketogenic diets in PCOS has been “relatively patchy,” and although there have been reviews on the topic, this is the first meta-analysis, write Karniza Khalid, MD, of the National Institutes of Health, Ministry of Health Malaysia, and colleagues. 

Study co-author Syed A.A. Rizvi, MD, PhD, told this news organization: “Our paper supports the positive effects of short-term ketogenic diets on hormonal imbalances commonly associated with PCOS, a complex disease state associated with a multitude of presenting symptoms among individuals. Based on the presentation and individual patient circumstances, besides pharmacologic treatment, lifestyle changes and a ketogenic diet can lead to even faster improvements.”

However, Dr. Rizvi, a professor at the College of Biomedical Sciences, Larkin University, Miami, cautioned: “I would highly recommend a keto diet to women suffering from PCOS, but we all know every person has a different situation. Some may not want to change their diet, some may not be able to afford it, and for some it is just too much work. ... This is why any lifestyle change has to be discussed and planned carefully between patients and their health care providers.”

The findings were published online in the Journal of the Endocrine Society.
 

The literature search yielded seven qualifying studies of ketogenic diets, generally defined as a daily carbohydrate intake below 50 g while allowing variable amounts of fat and protein. A total of 170 participants were enrolled in the studies from Italy, China, and the United States.

Pooled data showed a significant association between ketogenic diet and reduced LH/FSH ratio (P < .001) and free testosterone (P < .001). There was also a significant increase in circulating SHBG (P = .002).

On the other hand, serum progesterone levels did not change significantly (P = .353).

Weight loss, a secondary outcome, was significantly greater with the ketogenic diet (P < .001).

“Since low-carbohydrate diets have shown to be effective in addressing obesity and type 2 diabetes, it makes sense that they would also be helpful to the patients with PCOS, and in fact, it has been the case,” Dr. Rizvi noted.

The exact mechanisms for the hormonal effects aren’t clear, but one theory is that the reduction in hyperinsulinemia from the ketogenic diet decreases stimulation of ovarian androgen production and increases SHBG levels. Another is that the physiologic ketosis induced by low carbohydrate intake reduces both circulating insulin and insulin-like growth factor-1, thereby suppressing the stimulus on the production of both ovarian and adrenal androgens.

The analysis didn’t include pregnancy rates. However, Dr. Rizvi noted, “there have been published studies showing that [patients with] PCOS on keto diets have significantly improved pregnancy rates, also including via [in vitro fertilization].”

The study received no outside funding. The authors have reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Ketogenic diets may improve reproductive hormone levels in women with polycystic ovary syndrome (PCOS), new research suggests.

In the first-ever systematic review and meta-analysis of clinical trials on the association, ketogenic diets followed for 45 days to 24 weeks showed improvements in the luteinizing hormone (LH)/follicle-stimulating hormone (FSH) ratio, serum free testosterone, and serum sex hormone binding globulin (SHBG).  

Previous evidence supporting ketogenic diets in PCOS has been “relatively patchy,” and although there have been reviews on the topic, this is the first meta-analysis, write Karniza Khalid, MD, of the National Institutes of Health, Ministry of Health Malaysia, and colleagues. 

Study co-author Syed A.A. Rizvi, MD, PhD, told this news organization: “Our paper supports the positive effects of short-term ketogenic diets on hormonal imbalances commonly associated with PCOS, a complex disease state associated with a multitude of presenting symptoms among individuals. Based on the presentation and individual patient circumstances, besides pharmacologic treatment, lifestyle changes and a ketogenic diet can lead to even faster improvements.”

However, Dr. Rizvi, a professor at the College of Biomedical Sciences, Larkin University, Miami, cautioned: “I would highly recommend a keto diet to women suffering from PCOS, but we all know every person has a different situation. Some may not want to change their diet, some may not be able to afford it, and for some it is just too much work. ... This is why any lifestyle change has to be discussed and planned carefully between patients and their health care providers.”

The findings were published online in the Journal of the Endocrine Society.
 

The literature search yielded seven qualifying studies of ketogenic diets, generally defined as a daily carbohydrate intake below 50 g while allowing variable amounts of fat and protein. A total of 170 participants were enrolled in the studies from Italy, China, and the United States.

Pooled data showed a significant association between ketogenic diet and reduced LH/FSH ratio (P < .001) and free testosterone (P < .001). There was also a significant increase in circulating SHBG (P = .002).

On the other hand, serum progesterone levels did not change significantly (P = .353).

Weight loss, a secondary outcome, was significantly greater with the ketogenic diet (P < .001).

“Since low-carbohydrate diets have shown to be effective in addressing obesity and type 2 diabetes, it makes sense that they would also be helpful to the patients with PCOS, and in fact, it has been the case,” Dr. Rizvi noted.

The exact mechanisms for the hormonal effects aren’t clear, but one theory is that the reduction in hyperinsulinemia from the ketogenic diet decreases stimulation of ovarian androgen production and increases SHBG levels. Another is that the physiologic ketosis induced by low carbohydrate intake reduces both circulating insulin and insulin-like growth factor-1, thereby suppressing the stimulus on the production of both ovarian and adrenal androgens.

The analysis didn’t include pregnancy rates. However, Dr. Rizvi noted, “there have been published studies showing that [patients with] PCOS on keto diets have significantly improved pregnancy rates, also including via [in vitro fertilization].”

The study received no outside funding. The authors have reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Ketogenic diets may improve reproductive hormone levels in women with polycystic ovary syndrome (PCOS), new research suggests.

In the first-ever systematic review and meta-analysis of clinical trials on the association, ketogenic diets followed for 45 days to 24 weeks showed improvements in the luteinizing hormone (LH)/follicle-stimulating hormone (FSH) ratio, serum free testosterone, and serum sex hormone binding globulin (SHBG).  

Previous evidence supporting ketogenic diets in PCOS has been “relatively patchy,” and although there have been reviews on the topic, this is the first meta-analysis, write Karniza Khalid, MD, of the National Institutes of Health, Ministry of Health Malaysia, and colleagues. 

Study co-author Syed A.A. Rizvi, MD, PhD, told this news organization: “Our paper supports the positive effects of short-term ketogenic diets on hormonal imbalances commonly associated with PCOS, a complex disease state associated with a multitude of presenting symptoms among individuals. Based on the presentation and individual patient circumstances, besides pharmacologic treatment, lifestyle changes and a ketogenic diet can lead to even faster improvements.”

However, Dr. Rizvi, a professor at the College of Biomedical Sciences, Larkin University, Miami, cautioned: “I would highly recommend a keto diet to women suffering from PCOS, but we all know every person has a different situation. Some may not want to change their diet, some may not be able to afford it, and for some it is just too much work. ... This is why any lifestyle change has to be discussed and planned carefully between patients and their health care providers.”

The findings were published online in the Journal of the Endocrine Society.
 

The literature search yielded seven qualifying studies of ketogenic diets, generally defined as a daily carbohydrate intake below 50 g while allowing variable amounts of fat and protein. A total of 170 participants were enrolled in the studies from Italy, China, and the United States.

Pooled data showed a significant association between ketogenic diet and reduced LH/FSH ratio (P < .001) and free testosterone (P < .001). There was also a significant increase in circulating SHBG (P = .002).

On the other hand, serum progesterone levels did not change significantly (P = .353).

Weight loss, a secondary outcome, was significantly greater with the ketogenic diet (P < .001).

“Since low-carbohydrate diets have shown to be effective in addressing obesity and type 2 diabetes, it makes sense that they would also be helpful to the patients with PCOS, and in fact, it has been the case,” Dr. Rizvi noted.

The exact mechanisms for the hormonal effects aren’t clear, but one theory is that the reduction in hyperinsulinemia from the ketogenic diet decreases stimulation of ovarian androgen production and increases SHBG levels. Another is that the physiologic ketosis induced by low carbohydrate intake reduces both circulating insulin and insulin-like growth factor-1, thereby suppressing the stimulus on the production of both ovarian and adrenal androgens.

The analysis didn’t include pregnancy rates. However, Dr. Rizvi noted, “there have been published studies showing that [patients with] PCOS on keto diets have significantly improved pregnancy rates, also including via [in vitro fertilization].”

The study received no outside funding. The authors have reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

In contrast to an overall decline in cardiovascular mortality, obesity-related cardiovascular deaths have risen substantially in the past 2 decades, most prominently among Black women. “We observed a threefold increase in obesity-related cardiovascular age-adjusted mortality rates between 1999 and 2020,” wrote the authors.

METHODOLOGY:

Data from the U.S. population-level Multiple Cause of Death database were analyzed, including 281,135 deaths in 1999-2020 for which obesity was listed as a contributing factor.

TAKEAWAY:

• Overall, the crude rate of all cardiovascular deaths dropped by 17.6% across all races.
• However, age-adjusted obesity-related cardiovascular mortality tripled from 2.2/100,000 to 6.6/100,000 from 1999 to 2020, consistent across all racial groups.
• Blacks had the highest age-adjusted obesity-related cardiovascular mortality (rising from 4.2/100,000 in 1999 to 11.6/100,000 in 2000).
• Ischemic heart disease was the most common cardiovascular cause of death across all races, and hypertensive disease was second.
• Age-adjusted obesity-related cardiovascular mortality was higher among Blacks (6.7/100,000) than any other racial group, followed by American Indians or Alaskan Natives (3.8/100,000), and lowest among Asian or Pacific Islanders (0.9/100,000).
• The risk of obesity-related cardiovascular disease death rose most rapidly among American Indians and Alaskan Natives.
• Among Blacks, age-adjusted mortality was slightly higher among women than men (6.7/100,000 vs. 6.6/100,000), whereas the reverse was true for all other races (0.6-3.0/100,000 vs. 1.2-6.0/100,000).
• Blacks living in urban settings experienced higher rates of age-adjusted cardiovascular mortality than those living in rural areas (6.8/100,000 vs. 5.9/100,000), whereas the opposite was true for all other racial groups (0.9-3.5/100,000 vs. 2.2-5.4/100,000).

IN PRACTICE:

“There is need for dedicated health strategies aimed at individual communities to better understand and tackle the social determinants of obesity and to design interventions that may alleviate the population burden of both obesity and cardiovascular disease,” the authors wrote.

SOURCE:

The study, by Zahra Raisi-Estabragh, MD, PhD, Queen Mary University, London, and colleagues, was published online Sept. 6 in the Journal of the American Heart Association.

LIMITATIONS:

• Database limited to U.S. residents.
• Possible miscoding or diagnostic errors.
• Potential for residual confounding.
• No data on underlying drivers of observed trends.

DISCLOSURES:

Dr. Raisi-Estabragh has reported receiving funding from the Integrated Academic Training program of the National Institute for Health Research and a Clinical Research Training Fellowship from the British Heart Foundation. Another author has reported receiving research support from the National Heart, Lung, and Blood Institute.

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

TOPLINE:

In contrast to an overall decline in cardiovascular mortality, obesity-related cardiovascular deaths have risen substantially in the past 2 decades, most prominently among Black women. “We observed a threefold increase in obesity-related cardiovascular age-adjusted mortality rates between 1999 and 2020,” wrote the authors.

METHODOLOGY:

Data from the U.S. population-level Multiple Cause of Death database were analyzed, including 281,135 deaths in 1999-2020 for which obesity was listed as a contributing factor.

TAKEAWAY:

• Overall, the crude rate of all cardiovascular deaths dropped by 17.6% across all races.
• However, age-adjusted obesity-related cardiovascular mortality tripled from 2.2/100,000 to 6.6/100,000 from 1999 to 2020, consistent across all racial groups.
• Blacks had the highest age-adjusted obesity-related cardiovascular mortality (rising from 4.2/100,000 in 1999 to 11.6/100,000 in 2000).
• Ischemic heart disease was the most common cardiovascular cause of death across all races, and hypertensive disease was second.
• Age-adjusted obesity-related cardiovascular mortality was higher among Blacks (6.7/100,000) than any other racial group, followed by American Indians or Alaskan Natives (3.8/100,000), and lowest among Asian or Pacific Islanders (0.9/100,000).
• The risk of obesity-related cardiovascular disease death rose most rapidly among American Indians and Alaskan Natives.
• Among Blacks, age-adjusted mortality was slightly higher among women than men (6.7/100,000 vs. 6.6/100,000), whereas the reverse was true for all other races (0.6-3.0/100,000 vs. 1.2-6.0/100,000).
• Blacks living in urban settings experienced higher rates of age-adjusted cardiovascular mortality than those living in rural areas (6.8/100,000 vs. 5.9/100,000), whereas the opposite was true for all other racial groups (0.9-3.5/100,000 vs. 2.2-5.4/100,000).

IN PRACTICE:

“There is need for dedicated health strategies aimed at individual communities to better understand and tackle the social determinants of obesity and to design interventions that may alleviate the population burden of both obesity and cardiovascular disease,” the authors wrote.

SOURCE:

The study, by Zahra Raisi-Estabragh, MD, PhD, Queen Mary University, London, and colleagues, was published online Sept. 6 in the Journal of the American Heart Association.

LIMITATIONS:

• Database limited to U.S. residents.
• Possible miscoding or diagnostic errors.
• Potential for residual confounding.
• No data on underlying drivers of observed trends.

DISCLOSURES:

Dr. Raisi-Estabragh has reported receiving funding from the Integrated Academic Training program of the National Institute for Health Research and a Clinical Research Training Fellowship from the British Heart Foundation. Another author has reported receiving research support from the National Heart, Lung, and Blood Institute.

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

TOPLINE:

In contrast to an overall decline in cardiovascular mortality, obesity-related cardiovascular deaths have risen substantially in the past 2 decades, most prominently among Black women. “We observed a threefold increase in obesity-related cardiovascular age-adjusted mortality rates between 1999 and 2020,” wrote the authors.

METHODOLOGY:

Data from the U.S. population-level Multiple Cause of Death database were analyzed, including 281,135 deaths in 1999-2020 for which obesity was listed as a contributing factor.

TAKEAWAY:

• Overall, the crude rate of all cardiovascular deaths dropped by 17.6% across all races.
• However, age-adjusted obesity-related cardiovascular mortality tripled from 2.2/100,000 to 6.6/100,000 from 1999 to 2020, consistent across all racial groups.
• Blacks had the highest age-adjusted obesity-related cardiovascular mortality (rising from 4.2/100,000 in 1999 to 11.6/100,000 in 2000).
• Ischemic heart disease was the most common cardiovascular cause of death across all races, and hypertensive disease was second.
• Age-adjusted obesity-related cardiovascular mortality was higher among Blacks (6.7/100,000) than any other racial group, followed by American Indians or Alaskan Natives (3.8/100,000), and lowest among Asian or Pacific Islanders (0.9/100,000).
• The risk of obesity-related cardiovascular disease death rose most rapidly among American Indians and Alaskan Natives.
• Among Blacks, age-adjusted mortality was slightly higher among women than men (6.7/100,000 vs. 6.6/100,000), whereas the reverse was true for all other races (0.6-3.0/100,000 vs. 1.2-6.0/100,000).
• Blacks living in urban settings experienced higher rates of age-adjusted cardiovascular mortality than those living in rural areas (6.8/100,000 vs. 5.9/100,000), whereas the opposite was true for all other racial groups (0.9-3.5/100,000 vs. 2.2-5.4/100,000).

IN PRACTICE:

“There is need for dedicated health strategies aimed at individual communities to better understand and tackle the social determinants of obesity and to design interventions that may alleviate the population burden of both obesity and cardiovascular disease,” the authors wrote.

SOURCE:

The study, by Zahra Raisi-Estabragh, MD, PhD, Queen Mary University, London, and colleagues, was published online Sept. 6 in the Journal of the American Heart Association.

LIMITATIONS:

• Database limited to U.S. residents.
• Possible miscoding or diagnostic errors.
• Potential for residual confounding.
• No data on underlying drivers of observed trends.

DISCLOSURES:

Dr. Raisi-Estabragh has reported receiving funding from the Integrated Academic Training program of the National Institute for Health Research and a Clinical Research Training Fellowship from the British Heart Foundation. Another author has reported receiving research support from the National Heart, Lung, and Blood Institute.

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

Low-dose aspirin reduces the risk for type 2 diabetes among older adults and slows the increase in fasting glucose levels over time, new research finds.

The data come from a secondary analysis of ASPREE, a double-blind, placebo-controlled trial of healthy adults aged 65 years or older, showing that 100 mg of aspirin taken daily for about 5 years did not provide a cardiovascular benefit but did significantly raise the risk for bleeding.

This new analysis shows that individuals taking aspirin had a 15% lower risk for developing type 2 diabetes and that the medication slowed the rate of increase in fasting plasma glucose, compared with placebo, during follow-up.

However, lead author Sophia Zoungas, MBBS, PhD, head of the School of Public Health and Preventive Medicine, Monash University, Melbourne, said: “Major prescribing guidelines now recommend older adults take daily aspirin only when there is a medical reason to do so, such as after a heart attack. ... Although these new findings are of interest, they do not change the clinical advice about aspirin use in older people at this time.”

Nonetheless, she said in an interview, “at this time, our findings are exploratory but ignite the debate of the important role that anti-inflammatory approaches may play in preventing diabetes. Further work is currently underway to understand which subpopulations may be better targeted and to understand the balance of risk versus benefit.”

The results are scheduled to be presented at the upcoming meeting of the European Association for the Study of Diabetes, taking place Oct. 2-6 in Hamburg, Germany.
 

New findings not robust enough to change current practice

Asked to comment, Debabrata Mukherjee, MD, said: “Given the post hoc secondary nature of the analysis, the findings should be considered hypothesis generating and not definitive… At this time, based on prospective randomized studies, the risks of aspirin outweigh the benefits for aspirin in older adults.”

Among those studies was an ASPREE substudy showing failure of low-dose aspirin to reduce fracture risk while increasing the risk for serious falls, and two other trials, ARRIVE and ASCEND, also showing that harms of aspirin outweigh the benefits in people with cardiovascular risk but not diabetes, and in those with diabetes, respectively, said Dr. Mukherjee, professor and chair of the department of internal medicine at Texas Tech University Health Sciences Center at El Paso.

And, Mukherjee noted, in 2019 the American College of Cardiology updated its practice guidelines to say that low-dose aspirin should not be administered on a routine basis for the primary prevention of atherosclerotic cardiovascular disease in adults over age 70. In 2021, the American Diabetes Association seconded that recommendation.

Asked whether these newest findings might change current practice for any higher-risk subgroup, such as people with prediabetes, Dr. Mukherjee replied: “Unless there is a prospective randomized trial that validates these findings in those with prediabetes, the findings should not change practice. There are also no data [showing] that another antiplatelet agent would be indicated or would be beneficial. Instead, I would recommend lifestyle changes including regular exercise and a healthy diet to minimize risk of diabetes.”

The 16,209 ASPREE participants were community dwelling and did not have diabetes, cardiovascular disease, or dementia at baseline. They were randomized in a 1:1 ratio to receive 100 mg/d of enteric-coated aspirin or placebo. Over a median follow-up of 4.7 years, the proportions developing type 2 diabetes were 5.7% with aspirin versus 6.6% with placebo (hazard ratio, 0.85; P = .01).

The annual rate of increase in fasting plasma glucose over the follow-up period was slowed by 0.006 mmol/L with aspirin, compared with placebo, also a significant difference (P = .004).

According to Dr. Zoungas, “the potential for anti-inflammatory agents like aspirin to prevent type 2 diabetes or improve glucose levels needs further study.”

The ASPREE trial was supported by the U.S. National Institutes of Health, the National Health and Medical Research Council of Australia, Monash University, and the Victorian Cancer Agency. Dr. Zoungas and Dr. Mukherjee have no disclosures.

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

Low-dose aspirin reduces the risk for type 2 diabetes among older adults and slows the increase in fasting glucose levels over time, new research finds.

The data come from a secondary analysis of ASPREE, a double-blind, placebo-controlled trial of healthy adults aged 65 years or older, showing that 100 mg of aspirin taken daily for about 5 years did not provide a cardiovascular benefit but did significantly raise the risk for bleeding.

This new analysis shows that individuals taking aspirin had a 15% lower risk for developing type 2 diabetes and that the medication slowed the rate of increase in fasting plasma glucose, compared with placebo, during follow-up.

However, lead author Sophia Zoungas, MBBS, PhD, head of the School of Public Health and Preventive Medicine, Monash University, Melbourne, said: “Major prescribing guidelines now recommend older adults take daily aspirin only when there is a medical reason to do so, such as after a heart attack. ... Although these new findings are of interest, they do not change the clinical advice about aspirin use in older people at this time.”

Nonetheless, she said in an interview, “at this time, our findings are exploratory but ignite the debate of the important role that anti-inflammatory approaches may play in preventing diabetes. Further work is currently underway to understand which subpopulations may be better targeted and to understand the balance of risk versus benefit.”

The results are scheduled to be presented at the upcoming meeting of the European Association for the Study of Diabetes, taking place Oct. 2-6 in Hamburg, Germany.
 

New findings not robust enough to change current practice

Asked to comment, Debabrata Mukherjee, MD, said: “Given the post hoc secondary nature of the analysis, the findings should be considered hypothesis generating and not definitive… At this time, based on prospective randomized studies, the risks of aspirin outweigh the benefits for aspirin in older adults.”

Among those studies was an ASPREE substudy showing failure of low-dose aspirin to reduce fracture risk while increasing the risk for serious falls, and two other trials, ARRIVE and ASCEND, also showing that harms of aspirin outweigh the benefits in people with cardiovascular risk but not diabetes, and in those with diabetes, respectively, said Dr. Mukherjee, professor and chair of the department of internal medicine at Texas Tech University Health Sciences Center at El Paso.

And, Mukherjee noted, in 2019 the American College of Cardiology updated its practice guidelines to say that low-dose aspirin should not be administered on a routine basis for the primary prevention of atherosclerotic cardiovascular disease in adults over age 70. In 2021, the American Diabetes Association seconded that recommendation.

Asked whether these newest findings might change current practice for any higher-risk subgroup, such as people with prediabetes, Dr. Mukherjee replied: “Unless there is a prospective randomized trial that validates these findings in those with prediabetes, the findings should not change practice. There are also no data [showing] that another antiplatelet agent would be indicated or would be beneficial. Instead, I would recommend lifestyle changes including regular exercise and a healthy diet to minimize risk of diabetes.”

The 16,209 ASPREE participants were community dwelling and did not have diabetes, cardiovascular disease, or dementia at baseline. They were randomized in a 1:1 ratio to receive 100 mg/d of enteric-coated aspirin or placebo. Over a median follow-up of 4.7 years, the proportions developing type 2 diabetes were 5.7% with aspirin versus 6.6% with placebo (hazard ratio, 0.85; P = .01).

The annual rate of increase in fasting plasma glucose over the follow-up period was slowed by 0.006 mmol/L with aspirin, compared with placebo, also a significant difference (P = .004).

According to Dr. Zoungas, “the potential for anti-inflammatory agents like aspirin to prevent type 2 diabetes or improve glucose levels needs further study.”

The ASPREE trial was supported by the U.S. National Institutes of Health, the National Health and Medical Research Council of Australia, Monash University, and the Victorian Cancer Agency. Dr. Zoungas and Dr. Mukherjee have no disclosures.

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

Low-dose aspirin reduces the risk for type 2 diabetes among older adults and slows the increase in fasting glucose levels over time, new research finds.

The data come from a secondary analysis of ASPREE, a double-blind, placebo-controlled trial of healthy adults aged 65 years or older, showing that 100 mg of aspirin taken daily for about 5 years did not provide a cardiovascular benefit but did significantly raise the risk for bleeding.

This new analysis shows that individuals taking aspirin had a 15% lower risk for developing type 2 diabetes and that the medication slowed the rate of increase in fasting plasma glucose, compared with placebo, during follow-up.

However, lead author Sophia Zoungas, MBBS, PhD, head of the School of Public Health and Preventive Medicine, Monash University, Melbourne, said: “Major prescribing guidelines now recommend older adults take daily aspirin only when there is a medical reason to do so, such as after a heart attack. ... Although these new findings are of interest, they do not change the clinical advice about aspirin use in older people at this time.”

Nonetheless, she said in an interview, “at this time, our findings are exploratory but ignite the debate of the important role that anti-inflammatory approaches may play in preventing diabetes. Further work is currently underway to understand which subpopulations may be better targeted and to understand the balance of risk versus benefit.”

The results are scheduled to be presented at the upcoming meeting of the European Association for the Study of Diabetes, taking place Oct. 2-6 in Hamburg, Germany.
 

New findings not robust enough to change current practice

Asked to comment, Debabrata Mukherjee, MD, said: “Given the post hoc secondary nature of the analysis, the findings should be considered hypothesis generating and not definitive… At this time, based on prospective randomized studies, the risks of aspirin outweigh the benefits for aspirin in older adults.”

Among those studies was an ASPREE substudy showing failure of low-dose aspirin to reduce fracture risk while increasing the risk for serious falls, and two other trials, ARRIVE and ASCEND, also showing that harms of aspirin outweigh the benefits in people with cardiovascular risk but not diabetes, and in those with diabetes, respectively, said Dr. Mukherjee, professor and chair of the department of internal medicine at Texas Tech University Health Sciences Center at El Paso.

And, Mukherjee noted, in 2019 the American College of Cardiology updated its practice guidelines to say that low-dose aspirin should not be administered on a routine basis for the primary prevention of atherosclerotic cardiovascular disease in adults over age 70. In 2021, the American Diabetes Association seconded that recommendation.

Asked whether these newest findings might change current practice for any higher-risk subgroup, such as people with prediabetes, Dr. Mukherjee replied: “Unless there is a prospective randomized trial that validates these findings in those with prediabetes, the findings should not change practice. There are also no data [showing] that another antiplatelet agent would be indicated or would be beneficial. Instead, I would recommend lifestyle changes including regular exercise and a healthy diet to minimize risk of diabetes.”

The 16,209 ASPREE participants were community dwelling and did not have diabetes, cardiovascular disease, or dementia at baseline. They were randomized in a 1:1 ratio to receive 100 mg/d of enteric-coated aspirin or placebo. Over a median follow-up of 4.7 years, the proportions developing type 2 diabetes were 5.7% with aspirin versus 6.6% with placebo (hazard ratio, 0.85; P = .01).

The annual rate of increase in fasting plasma glucose over the follow-up period was slowed by 0.006 mmol/L with aspirin, compared with placebo, also a significant difference (P = .004).

According to Dr. Zoungas, “the potential for anti-inflammatory agents like aspirin to prevent type 2 diabetes or improve glucose levels needs further study.”

The ASPREE trial was supported by the U.S. National Institutes of Health, the National Health and Medical Research Council of Australia, Monash University, and the Victorian Cancer Agency. Dr. Zoungas and Dr. Mukherjee have no disclosures.

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

It’s an ongoing debate in the diabetes world: Is it ideal to consume a very-low-carbohydrate diet, or is it better to go with moderate amounts of healthful carbs?

At the annual scientific sessions of the American Diabetes Association, Carol F. Kirkpatrick, PhD, RDN, spoke first, arguing in favor of diets consisting of moderate, high-quality carbohydrates.

Dina Hafez Griauzde, MD, countered that very-low-carbohydrate diets are more beneficial for people with diabetes, primarily type 2 diabetes.

Both speakers based their arguments on published evidence but agreed in the end that discussion with patients about individual dietary preferences should play a major role in the ultimate decision.
 

Moderate-carbohydrate eating is best

Dr. Kirkpatrick began by explaining that definitions of “low carb” vary in the literature, which makes comparisons between studies difficult. On the basis of a 2019 review that she coauthored, “moderate” carbohydrate consumption was defined as a diet in which 26%-44% of total daily calories are from carbohydrates. “Low” carbohydrate consumption was defined as a diet in which 10%-25% of calories were from carbohydrates. Consuming less than 10% was defined as a very-low-carbohydrate diet (i.e., a ketogenic diet).

Across studies, she noted, the literature shows that within the first 6 months weight loss is typically greater with carbohydrate-restricted diets than with higher-carbohydrate diets, but that by 1 year and beyond weight loss is similar.

“That can be partly due to the difficulty in people maintaining that very severe dietary restriction, although ... we can all acknowledge that it’s difficult for patients to adhere to any dietary pattern, so for sure by 12 months, the difference in the weight loss is gone between the two,” said Dr. Kirkpatrick, of Midwest Biomedical Research, Pocatello, Idaho.

In a recent meta-analysis of 35 trials that examined the dose-dependent effects of carbohydrate restriction for patients with type 2 diabetes, there was a significant decrease in weight as carbohydrates were reduced. But by 12 months (17 trials), the greatest weight reduction was seen at 35% carbohydrate intake.

“It may just be that people were able to adhere to that moderate intake better,” she explained.

Regarding lipids, in her 2019 review and in several meta-analyses since, the effects on low-density lipoprotein cholesterol (LDL-C) varied. For some patients, adhering to a low-carb diet led to reductions in LDL-C, especially if the participants also lost weight, whereas in other patients, a low-carb diet led to an increase in LDL-C.

Either way, a high intake of saturated fatty acids is key to an increase in LDL-C, Dr. Kirkpatrick noted. “So, it’s important that, if a patient chooses to follow a very low carbohydrate diet or any kind of dietary pattern that restricts carbohydrate, that they replace the carbohydrate with unsaturated fat and not saturated fatty acid foods to avoid that increase in LDL-C.”

Generally, the evidence also shows that carbohydrate restriction typically leads to lower triglyceride levels and higher high-density lipoprotein (HDL) cholesterol levels. However, the same meta-analysis showed that the greatest reduction in LDL-C occurred at about 40% carbohydrate consumption.

Another recent meta-analysis showed that LDL-C rose significantly by an average 12.4 mg/dL with very-low-carb (3%-30%) diets, but only slightly, by 0.4 mg/dL, with moderate carb (40%-45%) intake.

Consuming very-low-carb diets did lead to greater reductions in triglycerides, compared with consuming moderate carb diets (23.9 mg/dL vs. 8.9 mg/dL).

“However, in terms of cardiovascular health, we are not entirely sure what that means. ... We have to look at the overall results in the presence of both triglyceride lowering as well as LDL cholesterol,” Dr. Kirkpatrick noted.

Carbohydrate restriction did consistently lead to lower hemoglobin A1c levels by an average of 0.4, 0.6, and 1.0 percentage points at 6 months for diets of 40%, 30%, and 15% carbohydrate, respectively. However, by 12 months, the effect had waned to 0.15, 0.2, and 0.4 A1c percentage points.

“Again, carbohydrate restriction, especially severe, is difficult for people to adhere to, and moderate carbohydrate intake would allow our patients to consume an appropriate amount of carbohydrate and still achieve improved glycemic control,” Dr. Kirkpatrick said.

Two large randomized controlled trials – PREDIMED and CORDIOPREV – examined the effects of the Mediterranean diet on cardiovascular disease prevention. Both showed a decrease in cardiovascular events with the Mediterranean diet, which involves consuming moderate amounts of carbohydrates.

“The Mediterranean dietary pattern has the strongest evidence for benefit, and it’s moderate in carbohydrates,” she concluded.
 

Very-low-carbohydrate eating is best

Dr. Griauzde was a last-minute replacement speaker for William S. Yancy Jr, MD, of Duke University, Durham, N.C., and presented his slides. She argued that consuming a very low carb diet improves glycemia and that it does not increase but possibly lowers cardiovascular risk.

She began by noting that prior to the discovery of insulin very-low-carb diets had been consumed for over a century to prolong life for people with type 1 diabetes.

“We have long recognized the deleterious role of carbohydrate in type 1 diabetes management, and we have increasingly recognized that role in the management of type 2 diabetes,” said Dr. Griauzde of the University of Michigan in Ann Arbor.

In a small study that compared maintaining a very-low-carb diet for 2 weeks with maintaining a high-carb diet for 2 weeks, total glucose areas under the curve were substantially lower (P < .05) during the low-carb phase, while A1c levels dropped from 7.3% to 6.8% (P = .006).

“We don’t see those outcomes with meds,” Dr. Griauzde noted, adding, “A diet very low in carbohydrates is one of the most potent tools we have to help our patients achieve glycemic control.”

Dr. Griauzde said that the carbohydrate-insulin model provides an explanation for why dietary carbohydrates are particularly obesogenic and metabolically harmful. That model contrasts with the energy balance model, which suggests that all calories are equal.

The rationale of the carbohydrate-insulin model is that dietary carbohydrate – either sugar or starch – raises serum glucose and insulin levels. A carbohydrate-restricted diet therefore reduces the dietary contribution to serum glucose, which then results in lower insulin levels. Insulin is a potent stimulator of lipogenesis (fat storage), and it is a potent inhibitor of lipolysis (the burning of fat). By lowering insulin levels, stored body fat is burned, serum ketone levels increase, and body weight is lowered.

This model suggests that, when insulin levels are chronically high because of excess carbohydrate consumption, circulating fuels are lowered, which leads to an increase in hunger and to overeating. This was demonstrated in a study that compared different levels of isocaloric glycemic index diets in 12 teenage boys with overweight or obesity. The higher-carbohydrate meals led to higher glucose and insulin levels and more food consumption.

In a systematic review of 13 trials of restricted-carbohydrate diets (< 45% carbohydrates) for adults with diabetes, the degree of improvement in A1c level correlated with the degree of carbohydrate restriction over 2-26 weeks (P = .013).

And in a network meta-analysis of 56 trials that compared nine diets among a total of 4,937 participants with type 2 diabetes, one conclusion was that “for reducing A1c, the low-carbohydrate diet was ranked as the best dietary approach (SUCRA: 84%), followed by the Mediterranean diet (80%), and Paleolithic diet (76%), compared with a control diet.”

Regarding the criticism that very-low-carbohydrate diets are high in saturated fat and therefore raise the risk of cardiovascular disease, Dr. Griauzde pointed to another meta-analysis of 21 prospective studies with more than 300,000 participants with 5-25 years of follow-up. In that analysis, the intake of saturated fat was not associated with an increased risk of cardiovascular disease or stroke.

Furthermore, a 12-week randomized controlled trial that involved 40 adults with overweight also suggested that a very-low-carb diet may be superior to a low-fat diet in improving aspects of the metabolic syndrome, including body mass index, lipid levels, and insulin sensitivity. Small LDL particles, which are more atherogenic than larger LDL particles, also decreased despite a threefold increase in saturated fat intake.
 

Rebuttals: Overall diet, patient preference matter

During the rebuttals, Dr. Kirkpatrick pointed out that large LDL particles are also atherogenic. In addition, she noted that the studies that showed that saturated fat isn’t associated with cardiovascular disease didn’t consider the macronutrients that replaced the saturated fat.

“It really is about increasing consumption of foods that we know are associated with cardiovascular benefit, including plant-based foods that are high quality and not refined carbohydrates ... and healthy protein sources. ... Hopefully we can step away from just looking at macronutrients and look at the total amount of food that people are choosing to eat.”

Importantly, Dr. Kirkpatrick said, patients need to be asked about their current dietary patterns and preferences. “Interventions should be patient centered and sensitive to cultural differences. Personalized lifestyle interventions increase the likelihood of success.”

Dr. Griauzde pointed out that newer antiobesity drugs can be added to any diet to decrease appetite and enhance adherence.

Dr. Griauzde also observed, “We can label a very-low-carbohydrate diet ‘extreme,’ but maybe, from the patient’s perspective, it’s extreme to take 200 units of insulin a day. If you can give them the opportunity to discontinue use of the insulin by following a very-low-carbohydrate dietary pattern, that is the opportunity that our patients deserve to have.”

But overall, she agreed with Dr. Kirkpatrick about individualizing any dietary approach: “We will never know from any of the trials that have been done or that will be done in the future what diet is best for an individual patient. ... Our job is to help our patients find the dietary approach that works best for them.”

Dr. Kirkpatrick is a clinical scientist with Midwest Biomedical Research, which has received funding from various food and pharmaceutical companies. She has not received any direct funding. Dr. Yancy is a consultant for The Simply Good Foods Co. Dr. Griauzde has disclosed no relevant financial relationships.

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

It’s an ongoing debate in the diabetes world: Is it ideal to consume a very-low-carbohydrate diet, or is it better to go with moderate amounts of healthful carbs?

At the annual scientific sessions of the American Diabetes Association, Carol F. Kirkpatrick, PhD, RDN, spoke first, arguing in favor of diets consisting of moderate, high-quality carbohydrates.

Dina Hafez Griauzde, MD, countered that very-low-carbohydrate diets are more beneficial for people with diabetes, primarily type 2 diabetes.

Both speakers based their arguments on published evidence but agreed in the end that discussion with patients about individual dietary preferences should play a major role in the ultimate decision.
 

Moderate-carbohydrate eating is best

Dr. Kirkpatrick began by explaining that definitions of “low carb” vary in the literature, which makes comparisons between studies difficult. On the basis of a 2019 review that she coauthored, “moderate” carbohydrate consumption was defined as a diet in which 26%-44% of total daily calories are from carbohydrates. “Low” carbohydrate consumption was defined as a diet in which 10%-25% of calories were from carbohydrates. Consuming less than 10% was defined as a very-low-carbohydrate diet (i.e., a ketogenic diet).

Across studies, she noted, the literature shows that within the first 6 months weight loss is typically greater with carbohydrate-restricted diets than with higher-carbohydrate diets, but that by 1 year and beyond weight loss is similar.

“That can be partly due to the difficulty in people maintaining that very severe dietary restriction, although ... we can all acknowledge that it’s difficult for patients to adhere to any dietary pattern, so for sure by 12 months, the difference in the weight loss is gone between the two,” said Dr. Kirkpatrick, of Midwest Biomedical Research, Pocatello, Idaho.

In a recent meta-analysis of 35 trials that examined the dose-dependent effects of carbohydrate restriction for patients with type 2 diabetes, there was a significant decrease in weight as carbohydrates were reduced. But by 12 months (17 trials), the greatest weight reduction was seen at 35% carbohydrate intake.

“It may just be that people were able to adhere to that moderate intake better,” she explained.

Regarding lipids, in her 2019 review and in several meta-analyses since, the effects on low-density lipoprotein cholesterol (LDL-C) varied. For some patients, adhering to a low-carb diet led to reductions in LDL-C, especially if the participants also lost weight, whereas in other patients, a low-carb diet led to an increase in LDL-C.

Either way, a high intake of saturated fatty acids is key to an increase in LDL-C, Dr. Kirkpatrick noted. “So, it’s important that, if a patient chooses to follow a very low carbohydrate diet or any kind of dietary pattern that restricts carbohydrate, that they replace the carbohydrate with unsaturated fat and not saturated fatty acid foods to avoid that increase in LDL-C.”

Generally, the evidence also shows that carbohydrate restriction typically leads to lower triglyceride levels and higher high-density lipoprotein (HDL) cholesterol levels. However, the same meta-analysis showed that the greatest reduction in LDL-C occurred at about 40% carbohydrate consumption.

Another recent meta-analysis showed that LDL-C rose significantly by an average 12.4 mg/dL with very-low-carb (3%-30%) diets, but only slightly, by 0.4 mg/dL, with moderate carb (40%-45%) intake.

Consuming very-low-carb diets did lead to greater reductions in triglycerides, compared with consuming moderate carb diets (23.9 mg/dL vs. 8.9 mg/dL).

“However, in terms of cardiovascular health, we are not entirely sure what that means. ... We have to look at the overall results in the presence of both triglyceride lowering as well as LDL cholesterol,” Dr. Kirkpatrick noted.

Carbohydrate restriction did consistently lead to lower hemoglobin A1c levels by an average of 0.4, 0.6, and 1.0 percentage points at 6 months for diets of 40%, 30%, and 15% carbohydrate, respectively. However, by 12 months, the effect had waned to 0.15, 0.2, and 0.4 A1c percentage points.

“Again, carbohydrate restriction, especially severe, is difficult for people to adhere to, and moderate carbohydrate intake would allow our patients to consume an appropriate amount of carbohydrate and still achieve improved glycemic control,” Dr. Kirkpatrick said.

Two large randomized controlled trials – PREDIMED and CORDIOPREV – examined the effects of the Mediterranean diet on cardiovascular disease prevention. Both showed a decrease in cardiovascular events with the Mediterranean diet, which involves consuming moderate amounts of carbohydrates.

“The Mediterranean dietary pattern has the strongest evidence for benefit, and it’s moderate in carbohydrates,” she concluded.
 

Very-low-carbohydrate eating is best

Dr. Griauzde was a last-minute replacement speaker for William S. Yancy Jr, MD, of Duke University, Durham, N.C., and presented his slides. She argued that consuming a very low carb diet improves glycemia and that it does not increase but possibly lowers cardiovascular risk.

She began by noting that prior to the discovery of insulin very-low-carb diets had been consumed for over a century to prolong life for people with type 1 diabetes.

“We have long recognized the deleterious role of carbohydrate in type 1 diabetes management, and we have increasingly recognized that role in the management of type 2 diabetes,” said Dr. Griauzde of the University of Michigan in Ann Arbor.

In a small study that compared maintaining a very-low-carb diet for 2 weeks with maintaining a high-carb diet for 2 weeks, total glucose areas under the curve were substantially lower (P < .05) during the low-carb phase, while A1c levels dropped from 7.3% to 6.8% (P = .006).

“We don’t see those outcomes with meds,” Dr. Griauzde noted, adding, “A diet very low in carbohydrates is one of the most potent tools we have to help our patients achieve glycemic control.”

Dr. Griauzde said that the carbohydrate-insulin model provides an explanation for why dietary carbohydrates are particularly obesogenic and metabolically harmful. That model contrasts with the energy balance model, which suggests that all calories are equal.

The rationale of the carbohydrate-insulin model is that dietary carbohydrate – either sugar or starch – raises serum glucose and insulin levels. A carbohydrate-restricted diet therefore reduces the dietary contribution to serum glucose, which then results in lower insulin levels. Insulin is a potent stimulator of lipogenesis (fat storage), and it is a potent inhibitor of lipolysis (the burning of fat). By lowering insulin levels, stored body fat is burned, serum ketone levels increase, and body weight is lowered.

This model suggests that, when insulin levels are chronically high because of excess carbohydrate consumption, circulating fuels are lowered, which leads to an increase in hunger and to overeating. This was demonstrated in a study that compared different levels of isocaloric glycemic index diets in 12 teenage boys with overweight or obesity. The higher-carbohydrate meals led to higher glucose and insulin levels and more food consumption.

In a systematic review of 13 trials of restricted-carbohydrate diets (< 45% carbohydrates) for adults with diabetes, the degree of improvement in A1c level correlated with the degree of carbohydrate restriction over 2-26 weeks (P = .013).

And in a network meta-analysis of 56 trials that compared nine diets among a total of 4,937 participants with type 2 diabetes, one conclusion was that “for reducing A1c, the low-carbohydrate diet was ranked as the best dietary approach (SUCRA: 84%), followed by the Mediterranean diet (80%), and Paleolithic diet (76%), compared with a control diet.”

Regarding the criticism that very-low-carbohydrate diets are high in saturated fat and therefore raise the risk of cardiovascular disease, Dr. Griauzde pointed to another meta-analysis of 21 prospective studies with more than 300,000 participants with 5-25 years of follow-up. In that analysis, the intake of saturated fat was not associated with an increased risk of cardiovascular disease or stroke.

Furthermore, a 12-week randomized controlled trial that involved 40 adults with overweight also suggested that a very-low-carb diet may be superior to a low-fat diet in improving aspects of the metabolic syndrome, including body mass index, lipid levels, and insulin sensitivity. Small LDL particles, which are more atherogenic than larger LDL particles, also decreased despite a threefold increase in saturated fat intake.
 

Rebuttals: Overall diet, patient preference matter

During the rebuttals, Dr. Kirkpatrick pointed out that large LDL particles are also atherogenic. In addition, she noted that the studies that showed that saturated fat isn’t associated with cardiovascular disease didn’t consider the macronutrients that replaced the saturated fat.

“It really is about increasing consumption of foods that we know are associated with cardiovascular benefit, including plant-based foods that are high quality and not refined carbohydrates ... and healthy protein sources. ... Hopefully we can step away from just looking at macronutrients and look at the total amount of food that people are choosing to eat.”

Importantly, Dr. Kirkpatrick said, patients need to be asked about their current dietary patterns and preferences. “Interventions should be patient centered and sensitive to cultural differences. Personalized lifestyle interventions increase the likelihood of success.”

Dr. Griauzde pointed out that newer antiobesity drugs can be added to any diet to decrease appetite and enhance adherence.

Dr. Griauzde also observed, “We can label a very-low-carbohydrate diet ‘extreme,’ but maybe, from the patient’s perspective, it’s extreme to take 200 units of insulin a day. If you can give them the opportunity to discontinue use of the insulin by following a very-low-carbohydrate dietary pattern, that is the opportunity that our patients deserve to have.”

But overall, she agreed with Dr. Kirkpatrick about individualizing any dietary approach: “We will never know from any of the trials that have been done or that will be done in the future what diet is best for an individual patient. ... Our job is to help our patients find the dietary approach that works best for them.”

Dr. Kirkpatrick is a clinical scientist with Midwest Biomedical Research, which has received funding from various food and pharmaceutical companies. She has not received any direct funding. Dr. Yancy is a consultant for The Simply Good Foods Co. Dr. Griauzde has disclosed no relevant financial relationships.

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

It’s an ongoing debate in the diabetes world: Is it ideal to consume a very-low-carbohydrate diet, or is it better to go with moderate amounts of healthful carbs?

At the annual scientific sessions of the American Diabetes Association, Carol F. Kirkpatrick, PhD, RDN, spoke first, arguing in favor of diets consisting of moderate, high-quality carbohydrates.

Dina Hafez Griauzde, MD, countered that very-low-carbohydrate diets are more beneficial for people with diabetes, primarily type 2 diabetes.

Both speakers based their arguments on published evidence but agreed in the end that discussion with patients about individual dietary preferences should play a major role in the ultimate decision.
 

Moderate-carbohydrate eating is best

Dr. Kirkpatrick began by explaining that definitions of “low carb” vary in the literature, which makes comparisons between studies difficult. On the basis of a 2019 review that she coauthored, “moderate” carbohydrate consumption was defined as a diet in which 26%-44% of total daily calories are from carbohydrates. “Low” carbohydrate consumption was defined as a diet in which 10%-25% of calories were from carbohydrates. Consuming less than 10% was defined as a very-low-carbohydrate diet (i.e., a ketogenic diet).

Across studies, she noted, the literature shows that within the first 6 months weight loss is typically greater with carbohydrate-restricted diets than with higher-carbohydrate diets, but that by 1 year and beyond weight loss is similar.

“That can be partly due to the difficulty in people maintaining that very severe dietary restriction, although ... we can all acknowledge that it’s difficult for patients to adhere to any dietary pattern, so for sure by 12 months, the difference in the weight loss is gone between the two,” said Dr. Kirkpatrick, of Midwest Biomedical Research, Pocatello, Idaho.

In a recent meta-analysis of 35 trials that examined the dose-dependent effects of carbohydrate restriction for patients with type 2 diabetes, there was a significant decrease in weight as carbohydrates were reduced. But by 12 months (17 trials), the greatest weight reduction was seen at 35% carbohydrate intake.

“It may just be that people were able to adhere to that moderate intake better,” she explained.

Regarding lipids, in her 2019 review and in several meta-analyses since, the effects on low-density lipoprotein cholesterol (LDL-C) varied. For some patients, adhering to a low-carb diet led to reductions in LDL-C, especially if the participants also lost weight, whereas in other patients, a low-carb diet led to an increase in LDL-C.

Either way, a high intake of saturated fatty acids is key to an increase in LDL-C, Dr. Kirkpatrick noted. “So, it’s important that, if a patient chooses to follow a very low carbohydrate diet or any kind of dietary pattern that restricts carbohydrate, that they replace the carbohydrate with unsaturated fat and not saturated fatty acid foods to avoid that increase in LDL-C.”

Generally, the evidence also shows that carbohydrate restriction typically leads to lower triglyceride levels and higher high-density lipoprotein (HDL) cholesterol levels. However, the same meta-analysis showed that the greatest reduction in LDL-C occurred at about 40% carbohydrate consumption.

Another recent meta-analysis showed that LDL-C rose significantly by an average 12.4 mg/dL with very-low-carb (3%-30%) diets, but only slightly, by 0.4 mg/dL, with moderate carb (40%-45%) intake.

Consuming very-low-carb diets did lead to greater reductions in triglycerides, compared with consuming moderate carb diets (23.9 mg/dL vs. 8.9 mg/dL).

“However, in terms of cardiovascular health, we are not entirely sure what that means. ... We have to look at the overall results in the presence of both triglyceride lowering as well as LDL cholesterol,” Dr. Kirkpatrick noted.

Carbohydrate restriction did consistently lead to lower hemoglobin A1c levels by an average of 0.4, 0.6, and 1.0 percentage points at 6 months for diets of 40%, 30%, and 15% carbohydrate, respectively. However, by 12 months, the effect had waned to 0.15, 0.2, and 0.4 A1c percentage points.

“Again, carbohydrate restriction, especially severe, is difficult for people to adhere to, and moderate carbohydrate intake would allow our patients to consume an appropriate amount of carbohydrate and still achieve improved glycemic control,” Dr. Kirkpatrick said.

Two large randomized controlled trials – PREDIMED and CORDIOPREV – examined the effects of the Mediterranean diet on cardiovascular disease prevention. Both showed a decrease in cardiovascular events with the Mediterranean diet, which involves consuming moderate amounts of carbohydrates.

“The Mediterranean dietary pattern has the strongest evidence for benefit, and it’s moderate in carbohydrates,” she concluded.
 

Very-low-carbohydrate eating is best

Dr. Griauzde was a last-minute replacement speaker for William S. Yancy Jr, MD, of Duke University, Durham, N.C., and presented his slides. She argued that consuming a very low carb diet improves glycemia and that it does not increase but possibly lowers cardiovascular risk.

She began by noting that prior to the discovery of insulin very-low-carb diets had been consumed for over a century to prolong life for people with type 1 diabetes.

“We have long recognized the deleterious role of carbohydrate in type 1 diabetes management, and we have increasingly recognized that role in the management of type 2 diabetes,” said Dr. Griauzde of the University of Michigan in Ann Arbor.

In a small study that compared maintaining a very-low-carb diet for 2 weeks with maintaining a high-carb diet for 2 weeks, total glucose areas under the curve were substantially lower (P < .05) during the low-carb phase, while A1c levels dropped from 7.3% to 6.8% (P = .006).

“We don’t see those outcomes with meds,” Dr. Griauzde noted, adding, “A diet very low in carbohydrates is one of the most potent tools we have to help our patients achieve glycemic control.”

Dr. Griauzde said that the carbohydrate-insulin model provides an explanation for why dietary carbohydrates are particularly obesogenic and metabolically harmful. That model contrasts with the energy balance model, which suggests that all calories are equal.

The rationale of the carbohydrate-insulin model is that dietary carbohydrate – either sugar or starch – raises serum glucose and insulin levels. A carbohydrate-restricted diet therefore reduces the dietary contribution to serum glucose, which then results in lower insulin levels. Insulin is a potent stimulator of lipogenesis (fat storage), and it is a potent inhibitor of lipolysis (the burning of fat). By lowering insulin levels, stored body fat is burned, serum ketone levels increase, and body weight is lowered.

This model suggests that, when insulin levels are chronically high because of excess carbohydrate consumption, circulating fuels are lowered, which leads to an increase in hunger and to overeating. This was demonstrated in a study that compared different levels of isocaloric glycemic index diets in 12 teenage boys with overweight or obesity. The higher-carbohydrate meals led to higher glucose and insulin levels and more food consumption.

In a systematic review of 13 trials of restricted-carbohydrate diets (< 45% carbohydrates) for adults with diabetes, the degree of improvement in A1c level correlated with the degree of carbohydrate restriction over 2-26 weeks (P = .013).

And in a network meta-analysis of 56 trials that compared nine diets among a total of 4,937 participants with type 2 diabetes, one conclusion was that “for reducing A1c, the low-carbohydrate diet was ranked as the best dietary approach (SUCRA: 84%), followed by the Mediterranean diet (80%), and Paleolithic diet (76%), compared with a control diet.”

Regarding the criticism that very-low-carbohydrate diets are high in saturated fat and therefore raise the risk of cardiovascular disease, Dr. Griauzde pointed to another meta-analysis of 21 prospective studies with more than 300,000 participants with 5-25 years of follow-up. In that analysis, the intake of saturated fat was not associated with an increased risk of cardiovascular disease or stroke.

Furthermore, a 12-week randomized controlled trial that involved 40 adults with overweight also suggested that a very-low-carb diet may be superior to a low-fat diet in improving aspects of the metabolic syndrome, including body mass index, lipid levels, and insulin sensitivity. Small LDL particles, which are more atherogenic than larger LDL particles, also decreased despite a threefold increase in saturated fat intake.
 

Rebuttals: Overall diet, patient preference matter

During the rebuttals, Dr. Kirkpatrick pointed out that large LDL particles are also atherogenic. In addition, she noted that the studies that showed that saturated fat isn’t associated with cardiovascular disease didn’t consider the macronutrients that replaced the saturated fat.

“It really is about increasing consumption of foods that we know are associated with cardiovascular benefit, including plant-based foods that are high quality and not refined carbohydrates ... and healthy protein sources. ... Hopefully we can step away from just looking at macronutrients and look at the total amount of food that people are choosing to eat.”

Importantly, Dr. Kirkpatrick said, patients need to be asked about their current dietary patterns and preferences. “Interventions should be patient centered and sensitive to cultural differences. Personalized lifestyle interventions increase the likelihood of success.”

Dr. Griauzde pointed out that newer antiobesity drugs can be added to any diet to decrease appetite and enhance adherence.

Dr. Griauzde also observed, “We can label a very-low-carbohydrate diet ‘extreme,’ but maybe, from the patient’s perspective, it’s extreme to take 200 units of insulin a day. If you can give them the opportunity to discontinue use of the insulin by following a very-low-carbohydrate dietary pattern, that is the opportunity that our patients deserve to have.”

But overall, she agreed with Dr. Kirkpatrick about individualizing any dietary approach: “We will never know from any of the trials that have been done or that will be done in the future what diet is best for an individual patient. ... Our job is to help our patients find the dietary approach that works best for them.”

Dr. Kirkpatrick is a clinical scientist with Midwest Biomedical Research, which has received funding from various food and pharmaceutical companies. She has not received any direct funding. Dr. Yancy is a consultant for The Simply Good Foods Co. Dr. Griauzde has disclosed no relevant financial relationships.

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

The glucose-lowering drug class sodium-glucose cotransporter 2 (SGLT2) inhibitors appear to reduce the risk for recurrent gout flares in people with gout and type 2 diabetes, and to lessen excess mortality in those individuals, compared with those who initiated other types of glucose-lowering medications, new data suggest.

Among nearly 6,000 adults with both type 2 diabetes and gout from a U.K. primary care database, initiation of SGLT2 inhibitor treatment was associated with 19% fewer recurrent gout flares and 29% lower mortality.

Moreover, unlike other urate-lowering therapies, there were no apparent transient increases in the risk of gout flares after initiating therapy, Jie Wei, PhD, of Health Management Center, Xiangya Hospital, Central South University, Changsha, China, and colleagues reported in JAMA Network Open.

These results are important because current management of gout is suboptimal. Many patients either don’t receive adequate urate-lowering therapies such as allopurinol or stop taking them, Dr. Wei and colleagues said.

In addition to lowering glucose, SGLT2 inhibitors also reduce the risk for major adverse cardiovascular events and all-cause mortality in people regardless of their diabetes status. Previous studies have also found that SGLT2 inhibitors reduce the risk for developing gout and of gout flares.

Asked to comment, gout specialist John D. FitzGerald, MD, PhD, clinical chief of rheumatology at the University of California, Los Angeles, said in an interview: “I think it’s a well-done paper, with a large dataset. I think it just reinforces the findings from the other papers. Mostly anything that lowers uric acid levels is going to lower recurrent gout attacks, so it all makes sense.”

However, while Dr. FitzGerald thinks the drug class is a good option for people with diabetes or cardiorenal indications for them who also have gout, he doesn’t envision it as first-line for most other patients with gout. “The current treatments are very effective. Allopurinol brings down uric acid levels by 5-7 points. There are patients who fail allopurinol, but those are less than 5%.”

The most common reason patients stop taking allopurinol is the frequent initial gout flare. But that’s preventable, Dr. FitzGerald said, either by titrating up slowly, or by adding colchicine along with it. “By going slowly, you can avoid that flare risk. I think that’s what’s going on with the SGLT2 inhibitor. It’s not a dramatic urate-lowering drug, but it is clinically meaningful. I think that’s what this paper is showing.”

But, he noted, “I think there are so many reasons to start the SGLT2 inhibitors that if somebody also has gout, all the better. And, if somebody is on the margin with diabetes and gout control and can’t go with allopurinol, it would be great to add for both conditions.”

Less gout recurrence, lower mortality

The retrospective study was conducted from Jan. 1, 2013, to March 31, 2022. Among 5,931 patients with both type 2 diabetes and gout, 1,548 (26.1%) initiated an SGLT2 inhibitor (dapagliflozin, empagliflozin, or canagliflozin), while 4,383 (73.9%) initiated treatment with other active comparators, mostly (92.6%) dipeptidyl peptidase–4 inhibitors.

Gout flares were identified in the charts for a total of 86% of the participants. The weighted incidence rates for the first recurrent flare were 32.4 versus 41.2 per 1,000 person-years in the SGLT2 inhibitor versus comparator groups, with a weighted absolute rate difference of –8.8/1,000 and weighted hazard ratio of 0.81, a significant difference.

All-cause mortality was 18.8 versus 24.9 per 1,000 person-years, respectively, giving an HR of 0.71 at 5-year follow-up.

Dr. FitzGerald, who chaired the American College of Rheumatology’s 2020 gout guidelines, said he anticipates that the SGLT2 inhibitors will be mentioned in the next update to the ACR’s now “living” guidelines, although he was not speaking on the organization’s behalf.

“We talk about losartan in the current [ACR guidelines], about its specific uric acid–lowering effect. Drugs can make uric acid worse or better. For example, thiazides make it higher. I think the SGLT2 [inhibitors] are important, but I don’t think they’re huge. The study is great, and I think the drugs are great, but I don’t think they will change the way gout is managed.”

This work was supported by grants from the National Key Research and Development Plan, the National Natural Science Foundation of China, the Project Program of National Clinical Research Center for Geriatric Disorders, and from the Natural Science Foundation of Hunan Province. Dr. Wei reported receiving grant funding from Xiangya Hospital Central South University Project Program of National Clinical Research Center for Geriatric Disorders and the Science and Technology Department of Hunan Province, the Natural Science Foundation of Hunan Province, during the conduct of the study. Dr. FitzGerald reported no relevant financial relationships.

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

The glucose-lowering drug class sodium-glucose cotransporter 2 (SGLT2) inhibitors appear to reduce the risk for recurrent gout flares in people with gout and type 2 diabetes, and to lessen excess mortality in those individuals, compared with those who initiated other types of glucose-lowering medications, new data suggest.

Among nearly 6,000 adults with both type 2 diabetes and gout from a U.K. primary care database, initiation of SGLT2 inhibitor treatment was associated with 19% fewer recurrent gout flares and 29% lower mortality.

Moreover, unlike other urate-lowering therapies, there were no apparent transient increases in the risk of gout flares after initiating therapy, Jie Wei, PhD, of Health Management Center, Xiangya Hospital, Central South University, Changsha, China, and colleagues reported in JAMA Network Open.

These results are important because current management of gout is suboptimal. Many patients either don’t receive adequate urate-lowering therapies such as allopurinol or stop taking them, Dr. Wei and colleagues said.

In addition to lowering glucose, SGLT2 inhibitors also reduce the risk for major adverse cardiovascular events and all-cause mortality in people regardless of their diabetes status. Previous studies have also found that SGLT2 inhibitors reduce the risk for developing gout and of gout flares.

Asked to comment, gout specialist John D. FitzGerald, MD, PhD, clinical chief of rheumatology at the University of California, Los Angeles, said in an interview: “I think it’s a well-done paper, with a large dataset. I think it just reinforces the findings from the other papers. Mostly anything that lowers uric acid levels is going to lower recurrent gout attacks, so it all makes sense.”

However, while Dr. FitzGerald thinks the drug class is a good option for people with diabetes or cardiorenal indications for them who also have gout, he doesn’t envision it as first-line for most other patients with gout. “The current treatments are very effective. Allopurinol brings down uric acid levels by 5-7 points. There are patients who fail allopurinol, but those are less than 5%.”

The most common reason patients stop taking allopurinol is the frequent initial gout flare. But that’s preventable, Dr. FitzGerald said, either by titrating up slowly, or by adding colchicine along with it. “By going slowly, you can avoid that flare risk. I think that’s what’s going on with the SGLT2 inhibitor. It’s not a dramatic urate-lowering drug, but it is clinically meaningful. I think that’s what this paper is showing.”

But, he noted, “I think there are so many reasons to start the SGLT2 inhibitors that if somebody also has gout, all the better. And, if somebody is on the margin with diabetes and gout control and can’t go with allopurinol, it would be great to add for both conditions.”

Less gout recurrence, lower mortality

The retrospective study was conducted from Jan. 1, 2013, to March 31, 2022. Among 5,931 patients with both type 2 diabetes and gout, 1,548 (26.1%) initiated an SGLT2 inhibitor (dapagliflozin, empagliflozin, or canagliflozin), while 4,383 (73.9%) initiated treatment with other active comparators, mostly (92.6%) dipeptidyl peptidase–4 inhibitors.

Gout flares were identified in the charts for a total of 86% of the participants. The weighted incidence rates for the first recurrent flare were 32.4 versus 41.2 per 1,000 person-years in the SGLT2 inhibitor versus comparator groups, with a weighted absolute rate difference of –8.8/1,000 and weighted hazard ratio of 0.81, a significant difference.

All-cause mortality was 18.8 versus 24.9 per 1,000 person-years, respectively, giving an HR of 0.71 at 5-year follow-up.

Dr. FitzGerald, who chaired the American College of Rheumatology’s 2020 gout guidelines, said he anticipates that the SGLT2 inhibitors will be mentioned in the next update to the ACR’s now “living” guidelines, although he was not speaking on the organization’s behalf.

“We talk about losartan in the current [ACR guidelines], about its specific uric acid–lowering effect. Drugs can make uric acid worse or better. For example, thiazides make it higher. I think the SGLT2 [inhibitors] are important, but I don’t think they’re huge. The study is great, and I think the drugs are great, but I don’t think they will change the way gout is managed.”

This work was supported by grants from the National Key Research and Development Plan, the National Natural Science Foundation of China, the Project Program of National Clinical Research Center for Geriatric Disorders, and from the Natural Science Foundation of Hunan Province. Dr. Wei reported receiving grant funding from Xiangya Hospital Central South University Project Program of National Clinical Research Center for Geriatric Disorders and the Science and Technology Department of Hunan Province, the Natural Science Foundation of Hunan Province, during the conduct of the study. Dr. FitzGerald reported no relevant financial relationships.

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

The glucose-lowering drug class sodium-glucose cotransporter 2 (SGLT2) inhibitors appear to reduce the risk for recurrent gout flares in people with gout and type 2 diabetes, and to lessen excess mortality in those individuals, compared with those who initiated other types of glucose-lowering medications, new data suggest.

Among nearly 6,000 adults with both type 2 diabetes and gout from a U.K. primary care database, initiation of SGLT2 inhibitor treatment was associated with 19% fewer recurrent gout flares and 29% lower mortality.

Moreover, unlike other urate-lowering therapies, there were no apparent transient increases in the risk of gout flares after initiating therapy, Jie Wei, PhD, of Health Management Center, Xiangya Hospital, Central South University, Changsha, China, and colleagues reported in JAMA Network Open.

These results are important because current management of gout is suboptimal. Many patients either don’t receive adequate urate-lowering therapies such as allopurinol or stop taking them, Dr. Wei and colleagues said.

In addition to lowering glucose, SGLT2 inhibitors also reduce the risk for major adverse cardiovascular events and all-cause mortality in people regardless of their diabetes status. Previous studies have also found that SGLT2 inhibitors reduce the risk for developing gout and of gout flares.

Asked to comment, gout specialist John D. FitzGerald, MD, PhD, clinical chief of rheumatology at the University of California, Los Angeles, said in an interview: “I think it’s a well-done paper, with a large dataset. I think it just reinforces the findings from the other papers. Mostly anything that lowers uric acid levels is going to lower recurrent gout attacks, so it all makes sense.”

However, while Dr. FitzGerald thinks the drug class is a good option for people with diabetes or cardiorenal indications for them who also have gout, he doesn’t envision it as first-line for most other patients with gout. “The current treatments are very effective. Allopurinol brings down uric acid levels by 5-7 points. There are patients who fail allopurinol, but those are less than 5%.”

The most common reason patients stop taking allopurinol is the frequent initial gout flare. But that’s preventable, Dr. FitzGerald said, either by titrating up slowly, or by adding colchicine along with it. “By going slowly, you can avoid that flare risk. I think that’s what’s going on with the SGLT2 inhibitor. It’s not a dramatic urate-lowering drug, but it is clinically meaningful. I think that’s what this paper is showing.”

But, he noted, “I think there are so many reasons to start the SGLT2 inhibitors that if somebody also has gout, all the better. And, if somebody is on the margin with diabetes and gout control and can’t go with allopurinol, it would be great to add for both conditions.”

Less gout recurrence, lower mortality

The retrospective study was conducted from Jan. 1, 2013, to March 31, 2022. Among 5,931 patients with both type 2 diabetes and gout, 1,548 (26.1%) initiated an SGLT2 inhibitor (dapagliflozin, empagliflozin, or canagliflozin), while 4,383 (73.9%) initiated treatment with other active comparators, mostly (92.6%) dipeptidyl peptidase–4 inhibitors.

Gout flares were identified in the charts for a total of 86% of the participants. The weighted incidence rates for the first recurrent flare were 32.4 versus 41.2 per 1,000 person-years in the SGLT2 inhibitor versus comparator groups, with a weighted absolute rate difference of –8.8/1,000 and weighted hazard ratio of 0.81, a significant difference.

All-cause mortality was 18.8 versus 24.9 per 1,000 person-years, respectively, giving an HR of 0.71 at 5-year follow-up.

Dr. FitzGerald, who chaired the American College of Rheumatology’s 2020 gout guidelines, said he anticipates that the SGLT2 inhibitors will be mentioned in the next update to the ACR’s now “living” guidelines, although he was not speaking on the organization’s behalf.

“We talk about losartan in the current [ACR guidelines], about its specific uric acid–lowering effect. Drugs can make uric acid worse or better. For example, thiazides make it higher. I think the SGLT2 [inhibitors] are important, but I don’t think they’re huge. The study is great, and I think the drugs are great, but I don’t think they will change the way gout is managed.”

This work was supported by grants from the National Key Research and Development Plan, the National Natural Science Foundation of China, the Project Program of National Clinical Research Center for Geriatric Disorders, and from the Natural Science Foundation of Hunan Province. Dr. Wei reported receiving grant funding from Xiangya Hospital Central South University Project Program of National Clinical Research Center for Geriatric Disorders and the Science and Technology Department of Hunan Province, the Natural Science Foundation of Hunan Province, during the conduct of the study. Dr. FitzGerald reported no relevant financial relationships.

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

The Food and Drug Administration has granted two new clearances to Welldoc’s BlueStar digital health platform to enable personalized insulin dosing recommendations for people with type 1 or type 2 diabetes.

The latest clearance, announced on Aug. 23, enables the app-based platform to provide bolus insulin dose recommendations that are based on glucose and trend data from a compatible continuous glucose monitoring (CGM) device. On Aug. 15, the FDA cleared the BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations.

Olivier Le Moal/Getty Images

“Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin,” according to a company statement.

“With this clearance, Welldoc is filling a significant gap for people who require complex insulin regimens. By connecting directly with CGM data and using both glucose values and trend arrows, the BlueStar solution will provide precise and in-the-moment insulin dosing guidance directly to individuals, helping them reach their glucose targets,” endocrinologist Grazia Aleppo, MD, of Northwestern University, Chicago, said in the statement.

The new features extend the platform’s existing digital diet and lifestyle coaching capabilities. Previous FDA clearances included expansions to use most types of available insulins, including bolus and premixed insulin titration for patients with type 2 diabetes, in September 2021 and for basal insulin adjustment in June 2020.

Dr. Aleppo was a principal investigator in Welldoc’s clinical validation study for BlueStar.

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

The Food and Drug Administration has granted two new clearances to Welldoc’s BlueStar digital health platform to enable personalized insulin dosing recommendations for people with type 1 or type 2 diabetes.

The latest clearance, announced on Aug. 23, enables the app-based platform to provide bolus insulin dose recommendations that are based on glucose and trend data from a compatible continuous glucose monitoring (CGM) device. On Aug. 15, the FDA cleared the BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations.

Olivier Le Moal/Getty Images

“Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin,” according to a company statement.

“With this clearance, Welldoc is filling a significant gap for people who require complex insulin regimens. By connecting directly with CGM data and using both glucose values and trend arrows, the BlueStar solution will provide precise and in-the-moment insulin dosing guidance directly to individuals, helping them reach their glucose targets,” endocrinologist Grazia Aleppo, MD, of Northwestern University, Chicago, said in the statement.

The new features extend the platform’s existing digital diet and lifestyle coaching capabilities. Previous FDA clearances included expansions to use most types of available insulins, including bolus and premixed insulin titration for patients with type 2 diabetes, in September 2021 and for basal insulin adjustment in June 2020.

Dr. Aleppo was a principal investigator in Welldoc’s clinical validation study for BlueStar.

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

The Food and Drug Administration has granted two new clearances to Welldoc’s BlueStar digital health platform to enable personalized insulin dosing recommendations for people with type 1 or type 2 diabetes.

The latest clearance, announced on Aug. 23, enables the app-based platform to provide bolus insulin dose recommendations that are based on glucose and trend data from a compatible continuous glucose monitoring (CGM) device. On Aug. 15, the FDA cleared the BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations.

Olivier Le Moal/Getty Images

“Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin,” according to a company statement.

“With this clearance, Welldoc is filling a significant gap for people who require complex insulin regimens. By connecting directly with CGM data and using both glucose values and trend arrows, the BlueStar solution will provide precise and in-the-moment insulin dosing guidance directly to individuals, helping them reach their glucose targets,” endocrinologist Grazia Aleppo, MD, of Northwestern University, Chicago, said in the statement.

The new features extend the platform’s existing digital diet and lifestyle coaching capabilities. Previous FDA clearances included expansions to use most types of available insulins, including bolus and premixed insulin titration for patients with type 2 diabetes, in September 2021 and for basal insulin adjustment in June 2020.

Dr. Aleppo was a principal investigator in Welldoc’s clinical validation study for BlueStar.

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