Type 2 Diabetes ICYMI

Calculating the estimated glucose disposal rate (eGDR) as a proxy for the level of insulin resistance may be useful way to determine if someone with type 2 diabetes (T2D) is at risk for having a first stroke, Swedish researchers have found.

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In a large population-based study, the lower the eGDR score went, the higher the risk for having a first stroke became.

The eGDR score was also predictive of the chance of dying from any or a cardiovascular cause, Alexander Zabala, MD, reported at the annual meeting of the European Association for the Study of Diabetes (Abstract OP 01-4).

The link between insulin resistance and an increased risk for stroke has been known for some time, and not just in people with T2D. However, the current way of determining insulin resistance is not suitable for widespread practice.

“The goal standard technique for measuring insulin resistance is the euglycemic clamp method,” said Dr. Zabala, an internal medical resident at Södersjukhuset hospital and researcher at the Karolinska Institutet in Stockholm.

“For that reason, [the eGDR], a method based on readily available clinical factors – waist circumference, hypertension, and glycosylated hemoglobin was developed,” he explained. Body mass index can also be used in place of waist circumference, he qualified.

The eGDR has already been proven to be very precise in people with type 1 diabetes, said Dr. Zabala, and could be an “excellent tool to measure insulin resistance in a large patient population.”
 

Investigating the link between eGDR and first stroke risk

The aim of the study he presented was to see if changes in the eGDR were associated with changes in the risk of someone with T2D experiencing a first stroke, or dying from a cardiovascular or other cause.

An observational cohort was formed by first considering data on all adult patients with T2D who were logged in the Swedish National Diabetes Registry (NDR) during 2004-2016. Then anyone with a history of stroke, or with any missing data on the clinical variables needed to calculate the eGDR, were excluded.

This resulted in an overall population of 104,697 individuals, aged a mean of 63 years, who had developed T2D at around the age of 59 years. About 44% of the study population were women. The mean eGDR for the whole population was 5.6 mg/kg per min.

The study subjects were grouped according to four eGDR levels: 24,706 were in the lowest quartile of eGDR (less than 4 mg/kg per min), signifying the highest level of insulin resistance, and 18,762 were in the upper quartile of eGDR (greater than 8 mg/kg per min), signifying the lowest level of insulin resistance. The middle two groups had an eGDR between 4 and 6 mg/kg per min (40,187), and 6 and 8 mg/kg/min (21,042).

Data from the NDR were then combined with the Swedish Cause of Death register, the Swedish In-patient Care Diagnoses registry, and the Longitudinal Database for Health Insurance and Labour Market Studies (LISA) to determine the rates of stroke, ischemic stroke, hemorrhagic stroke, all-cause mortality, and cardiovascular mortality.
 

Increasing insulin resistance ups risk for stroke, death

After a median follow-up of 5.6 years, 4% (4,201) of the study population had had a stroke.

“We clearly see an increased occurrence of first-time stroke in the group with the lowest eGDR, indicating worst insulin resistance, in comparison with the group with the highest eGDR, indicating less insulin resistance,” Dr. Zabala reported.

After adjustment for potential confounding factors, including age at baseline, gender, diabetes duration, among other variables, the risk for stroke was lowest in those with a high eGDR value and highest for those with a low eGDR value.

Using individuals with the lowest eGDR (less than 4 mg/kg per min) and thus greatest risk of stroke as the reference, adjusted hazard ratios (aHR) for first-time stroke were: 0.60, 0.68, and 0.77 for those with an eGDR of greater than 8, 6-8, and 4-6 mg/kg per min, respectively.

The corresponding values for risk of ischemic stroke were 0.55, 0.68, and 0.75. Regarding hemorrhagic stroke, there was no statistically significant correlation between eGDR levels and stroke occurrence. This was due to the small number of cases recorded.

As for all-cause and cardiovascular mortality, a similar pattern was seen, with higher rates of death linked to increasing insulin resistance. Adjusted hazard ratios according to increasing insulin resistance (decreasing eGDR scores) for all-cause death were 0.68, 0.75, and 0.82 and for cardiovascular mortality were 0.65, 0.75, and 0.82.

A sensitivity analysis, using BMI instead of waist circumference to calculate the eGDR, showed a similar pattern, and “interestingly, a correlation between eGDR levels and risk of hemorrhagic stroke.” Dr. Zabala said.
 

Limitations and take-homes

Of course, this is an observational cohort study, so no conclusions on causality can be made and there are no data on the use of anti-diabetic treatments specifically. But there are strengths such as covering almost all adults with T2D in Sweden and a relatively long-follow-up time.

The findings suggest that “eGDR, which may reflect insulin resistance may be a useful risk marker for stroke and death in people with type 2 diabetes,” said Dr. Zabala.

“You had a very large cohort, and that certainly makes your results very valid,” observed Peter Novodvorsky, MUDr. (Hons), PhD, MRCP, a consultant diabetologist in Trenčín, Slovakia.

Dr. Novodvorsky, who chaired the session, picked up on the lack of information about how many people were taking newer diabetes drugs, such as the glucagon-like peptide 1 receptor antagonists and sodium glucose-lowering transport 2 inhibitors.

“As we all know, these might have protective effects which are not necessarily related to the glucose lowering or insulin resistance-lowering” effects, so could have influenced the results. In terms of how practical the eGDR is for clinical practice, Dr. Zabala observed in a press release: “eGDR could be used to help T2D patients better understand and manage their risk of stroke and death. 

“It could also be of importance in research. In this era of personalized medicine, better stratification of type 2 diabetes patients will help optimize clinical trials and further vital research into treatment, diagnosis, care and prevention.”

The research was a collaboration between the Karolinska Institutet, Gothenburg University and the Swedish National Diabetes Registry. Dr. Zabala and coauthors reported having no conflicts of interest.

Calculating the estimated glucose disposal rate (eGDR) as a proxy for the level of insulin resistance may be useful way to determine if someone with type 2 diabetes (T2D) is at risk for having a first stroke, Swedish researchers have found.

purestock/Thinkstock

In a large population-based study, the lower the eGDR score went, the higher the risk for having a first stroke became.

The eGDR score was also predictive of the chance of dying from any or a cardiovascular cause, Alexander Zabala, MD, reported at the annual meeting of the European Association for the Study of Diabetes (Abstract OP 01-4).

The link between insulin resistance and an increased risk for stroke has been known for some time, and not just in people with T2D. However, the current way of determining insulin resistance is not suitable for widespread practice.

“The goal standard technique for measuring insulin resistance is the euglycemic clamp method,” said Dr. Zabala, an internal medical resident at Södersjukhuset hospital and researcher at the Karolinska Institutet in Stockholm.

“For that reason, [the eGDR], a method based on readily available clinical factors – waist circumference, hypertension, and glycosylated hemoglobin was developed,” he explained. Body mass index can also be used in place of waist circumference, he qualified.

The eGDR has already been proven to be very precise in people with type 1 diabetes, said Dr. Zabala, and could be an “excellent tool to measure insulin resistance in a large patient population.”
 

Investigating the link between eGDR and first stroke risk

The aim of the study he presented was to see if changes in the eGDR were associated with changes in the risk of someone with T2D experiencing a first stroke, or dying from a cardiovascular or other cause.

An observational cohort was formed by first considering data on all adult patients with T2D who were logged in the Swedish National Diabetes Registry (NDR) during 2004-2016. Then anyone with a history of stroke, or with any missing data on the clinical variables needed to calculate the eGDR, were excluded.

This resulted in an overall population of 104,697 individuals, aged a mean of 63 years, who had developed T2D at around the age of 59 years. About 44% of the study population were women. The mean eGDR for the whole population was 5.6 mg/kg per min.

The study subjects were grouped according to four eGDR levels: 24,706 were in the lowest quartile of eGDR (less than 4 mg/kg per min), signifying the highest level of insulin resistance, and 18,762 were in the upper quartile of eGDR (greater than 8 mg/kg per min), signifying the lowest level of insulin resistance. The middle two groups had an eGDR between 4 and 6 mg/kg per min (40,187), and 6 and 8 mg/kg/min (21,042).

Data from the NDR were then combined with the Swedish Cause of Death register, the Swedish In-patient Care Diagnoses registry, and the Longitudinal Database for Health Insurance and Labour Market Studies (LISA) to determine the rates of stroke, ischemic stroke, hemorrhagic stroke, all-cause mortality, and cardiovascular mortality.
 

Increasing insulin resistance ups risk for stroke, death

After a median follow-up of 5.6 years, 4% (4,201) of the study population had had a stroke.

“We clearly see an increased occurrence of first-time stroke in the group with the lowest eGDR, indicating worst insulin resistance, in comparison with the group with the highest eGDR, indicating less insulin resistance,” Dr. Zabala reported.

After adjustment for potential confounding factors, including age at baseline, gender, diabetes duration, among other variables, the risk for stroke was lowest in those with a high eGDR value and highest for those with a low eGDR value.

Using individuals with the lowest eGDR (less than 4 mg/kg per min) and thus greatest risk of stroke as the reference, adjusted hazard ratios (aHR) for first-time stroke were: 0.60, 0.68, and 0.77 for those with an eGDR of greater than 8, 6-8, and 4-6 mg/kg per min, respectively.

The corresponding values for risk of ischemic stroke were 0.55, 0.68, and 0.75. Regarding hemorrhagic stroke, there was no statistically significant correlation between eGDR levels and stroke occurrence. This was due to the small number of cases recorded.

As for all-cause and cardiovascular mortality, a similar pattern was seen, with higher rates of death linked to increasing insulin resistance. Adjusted hazard ratios according to increasing insulin resistance (decreasing eGDR scores) for all-cause death were 0.68, 0.75, and 0.82 and for cardiovascular mortality were 0.65, 0.75, and 0.82.

A sensitivity analysis, using BMI instead of waist circumference to calculate the eGDR, showed a similar pattern, and “interestingly, a correlation between eGDR levels and risk of hemorrhagic stroke.” Dr. Zabala said.
 

Limitations and take-homes

Of course, this is an observational cohort study, so no conclusions on causality can be made and there are no data on the use of anti-diabetic treatments specifically. But there are strengths such as covering almost all adults with T2D in Sweden and a relatively long-follow-up time.

The findings suggest that “eGDR, which may reflect insulin resistance may be a useful risk marker for stroke and death in people with type 2 diabetes,” said Dr. Zabala.

“You had a very large cohort, and that certainly makes your results very valid,” observed Peter Novodvorsky, MUDr. (Hons), PhD, MRCP, a consultant diabetologist in Trenčín, Slovakia.

Dr. Novodvorsky, who chaired the session, picked up on the lack of information about how many people were taking newer diabetes drugs, such as the glucagon-like peptide 1 receptor antagonists and sodium glucose-lowering transport 2 inhibitors.

“As we all know, these might have protective effects which are not necessarily related to the glucose lowering or insulin resistance-lowering” effects, so could have influenced the results. In terms of how practical the eGDR is for clinical practice, Dr. Zabala observed in a press release: “eGDR could be used to help T2D patients better understand and manage their risk of stroke and death. 

“It could also be of importance in research. In this era of personalized medicine, better stratification of type 2 diabetes patients will help optimize clinical trials and further vital research into treatment, diagnosis, care and prevention.”

The research was a collaboration between the Karolinska Institutet, Gothenburg University and the Swedish National Diabetes Registry. Dr. Zabala and coauthors reported having no conflicts of interest.

Calculating the estimated glucose disposal rate (eGDR) as a proxy for the level of insulin resistance may be useful way to determine if someone with type 2 diabetes (T2D) is at risk for having a first stroke, Swedish researchers have found.

purestock/Thinkstock

In a large population-based study, the lower the eGDR score went, the higher the risk for having a first stroke became.

The eGDR score was also predictive of the chance of dying from any or a cardiovascular cause, Alexander Zabala, MD, reported at the annual meeting of the European Association for the Study of Diabetes (Abstract OP 01-4).

The link between insulin resistance and an increased risk for stroke has been known for some time, and not just in people with T2D. However, the current way of determining insulin resistance is not suitable for widespread practice.

“The goal standard technique for measuring insulin resistance is the euglycemic clamp method,” said Dr. Zabala, an internal medical resident at Södersjukhuset hospital and researcher at the Karolinska Institutet in Stockholm.

“For that reason, [the eGDR], a method based on readily available clinical factors – waist circumference, hypertension, and glycosylated hemoglobin was developed,” he explained. Body mass index can also be used in place of waist circumference, he qualified.

The eGDR has already been proven to be very precise in people with type 1 diabetes, said Dr. Zabala, and could be an “excellent tool to measure insulin resistance in a large patient population.”
 

Investigating the link between eGDR and first stroke risk

The aim of the study he presented was to see if changes in the eGDR were associated with changes in the risk of someone with T2D experiencing a first stroke, or dying from a cardiovascular or other cause.

An observational cohort was formed by first considering data on all adult patients with T2D who were logged in the Swedish National Diabetes Registry (NDR) during 2004-2016. Then anyone with a history of stroke, or with any missing data on the clinical variables needed to calculate the eGDR, were excluded.

This resulted in an overall population of 104,697 individuals, aged a mean of 63 years, who had developed T2D at around the age of 59 years. About 44% of the study population were women. The mean eGDR for the whole population was 5.6 mg/kg per min.

The study subjects were grouped according to four eGDR levels: 24,706 were in the lowest quartile of eGDR (less than 4 mg/kg per min), signifying the highest level of insulin resistance, and 18,762 were in the upper quartile of eGDR (greater than 8 mg/kg per min), signifying the lowest level of insulin resistance. The middle two groups had an eGDR between 4 and 6 mg/kg per min (40,187), and 6 and 8 mg/kg/min (21,042).

Data from the NDR were then combined with the Swedish Cause of Death register, the Swedish In-patient Care Diagnoses registry, and the Longitudinal Database for Health Insurance and Labour Market Studies (LISA) to determine the rates of stroke, ischemic stroke, hemorrhagic stroke, all-cause mortality, and cardiovascular mortality.
 

Increasing insulin resistance ups risk for stroke, death

After a median follow-up of 5.6 years, 4% (4,201) of the study population had had a stroke.

“We clearly see an increased occurrence of first-time stroke in the group with the lowest eGDR, indicating worst insulin resistance, in comparison with the group with the highest eGDR, indicating less insulin resistance,” Dr. Zabala reported.

After adjustment for potential confounding factors, including age at baseline, gender, diabetes duration, among other variables, the risk for stroke was lowest in those with a high eGDR value and highest for those with a low eGDR value.

Using individuals with the lowest eGDR (less than 4 mg/kg per min) and thus greatest risk of stroke as the reference, adjusted hazard ratios (aHR) for first-time stroke were: 0.60, 0.68, and 0.77 for those with an eGDR of greater than 8, 6-8, and 4-6 mg/kg per min, respectively.

The corresponding values for risk of ischemic stroke were 0.55, 0.68, and 0.75. Regarding hemorrhagic stroke, there was no statistically significant correlation between eGDR levels and stroke occurrence. This was due to the small number of cases recorded.

As for all-cause and cardiovascular mortality, a similar pattern was seen, with higher rates of death linked to increasing insulin resistance. Adjusted hazard ratios according to increasing insulin resistance (decreasing eGDR scores) for all-cause death were 0.68, 0.75, and 0.82 and for cardiovascular mortality were 0.65, 0.75, and 0.82.

A sensitivity analysis, using BMI instead of waist circumference to calculate the eGDR, showed a similar pattern, and “interestingly, a correlation between eGDR levels and risk of hemorrhagic stroke.” Dr. Zabala said.
 

Limitations and take-homes

Of course, this is an observational cohort study, so no conclusions on causality can be made and there are no data on the use of anti-diabetic treatments specifically. But there are strengths such as covering almost all adults with T2D in Sweden and a relatively long-follow-up time.

The findings suggest that “eGDR, which may reflect insulin resistance may be a useful risk marker for stroke and death in people with type 2 diabetes,” said Dr. Zabala.

“You had a very large cohort, and that certainly makes your results very valid,” observed Peter Novodvorsky, MUDr. (Hons), PhD, MRCP, a consultant diabetologist in Trenčín, Slovakia.

Dr. Novodvorsky, who chaired the session, picked up on the lack of information about how many people were taking newer diabetes drugs, such as the glucagon-like peptide 1 receptor antagonists and sodium glucose-lowering transport 2 inhibitors.

“As we all know, these might have protective effects which are not necessarily related to the glucose lowering or insulin resistance-lowering” effects, so could have influenced the results. In terms of how practical the eGDR is for clinical practice, Dr. Zabala observed in a press release: “eGDR could be used to help T2D patients better understand and manage their risk of stroke and death. 

“It could also be of importance in research. In this era of personalized medicine, better stratification of type 2 diabetes patients will help optimize clinical trials and further vital research into treatment, diagnosis, care and prevention.”

The research was a collaboration between the Karolinska Institutet, Gothenburg University and the Swedish National Diabetes Registry. Dr. Zabala and coauthors reported having no conflicts of interest.

Despite the extensive recent focus on its cost, insulin use in the United States remains dominated by insulin glargine and other analogs, as well as pen devices for delivery, new research shows.

The findings come from a nationally representative audit of outpatient care with input from nearly 5,000 physicians who prescribed insulin to patients with type 2 diabetes in 2016-2020.

The dramatic rise in the price of insulin in the United States has been extensively discussed in recent years, particularly with the newer analogs as compared with older human insulins.

Few studies indicate analog insulins better than human insulins

“Our findings suggest that even with increased public scrutiny for insulin products ... [the market is] dominated by the use of insulin analogs and insulin pen delivery devices, with persistent uptake of newer products as they are approved,” lead author Rita R. Kalyani, MD, told this news organization.

“Though newer insulins offer potentially greater flexibility with reduced hypoglycemia for many patients, they are also much more costly, with minimal to no head-to-head studies suggesting significant differences in glucose-lowering efficacy when compared to human insulins,” she stressed.

“We found it surprising that, despite the much-publicized concerns regarding insulin costs, analog insulins continue to represent more than 80% of insulin visits in the U.S.” added Dr. Kalyani, of the Division of Endocrinology, Diabetes & Metabolism at Johns Hopkins University School of Medicine, Baltimore.

However, as expected, the study also revealed a gradual increased uptake in the use of biosimilar insulins as more have been introduced to the market.

Dr. Kalyani advised, “Clinicians should be aware of their individual prescribing patterns for insulin and consider the affordability of insulin for patients as part of shared decision-making during clinic visits, particularly given the greater financial strain that many patients have faced during the ongoing COVID-19 pandemic and the rising societal costs for diabetes care.”

The research was published online October 12 in JAMA Network Open by Dr. Kalyani and colleagues.

Analogs prevailed, while biosimilar use rose

The data come from the Health National Disease and Therapeutic Index, a quarterly sampling of approximately 4,800 physicians that provides nationally representative diagnostic and prescribing information on patients treated by office-based physicians in the United States.

Overall, there were 27,860,691 insulin treatment visits for type 2 diabetes in 2016-2020. Of those, long-acting analog insulins (glargine [Lantus], detemir [Levemir], and degludec [Tresiba]) accounted for 67.3% of treatment visits in 2016 and 74.8% of treatment visits in 2020.

Rapid-acting insulin analogs (lispro [Humalog], aspart [Novolog], faster aspart [Fiasp], and glulisine [Apidra]) accounted for about 21.2% of visits in 2016 and about 16.5% in 2020.

On the other hand, intermediate- and short-acting human insulins (NPH and regular) accounted for just 3.7% of visits in 2016 and 2.6% in 2020.

Grouped together, the long- and short-acting analogs accounted for 92.7% of visits in 2016 and 86.3% in 2020, while the human insulins represented just 7.3% of visits in 2016 and 5.5% in 2020.

The biosimilar analog insulins (glargine and lispro) first appeared in the database in 2017, accounting for 2.6% of visits that year and 8.2% by 2020.

Overall, the number of visits for insulin treatment declined by 18% between 2016 and 2020, from 6.0 million to 4.9 million. That drop may be due to multiple factors, Dr. Kalyani said.

“Recently updated clinical practice guidelines from professional societies such as the American Diabetes Association recommend the use of glucagon-like peptide-1 (GLP-1) receptor agonists prior to insulin when injectable medications are being considered [for type 2 diabetes],” she noted.

“In addition, during the pandemic, patients may not have been seeing their health care providers for routine diabetes care as often as before ... These and other factors may have contributed to the decrease in insulin visits that we observed.”

By specific insulins, glargine has topped the list all along, accounting for about half of all treatment visits, at 52.6% in 2020. Degludec came in second, at 17.4%, and lispro third, at 9.5%.

Use of pen devices also increased

The proportion of treatment visits for insulin vials/syringes declined from 63.9% in 2016 to 41.1% in 2020, while visits for insulin pens rose from 36.1% to 58.7%.

“Many pens are more costly compared to vials of the same insulin product. Interestingly, some studies have found that use of insulin pens may promote greater patient adherence to insulin and, as a result, more broadly decrease health care costs associated with diabetes. However, we did not specifically investigate the cost of insulin in our study,” Dr. Kalyani noted.

The proportion of visits for “newer” insulins, defined as those approved in 2010 or later, rose from 18.1% in 2016 to 40.9% in 2020, while the concurrent drop for insulins approved prior to 2010 was from 81.9% to 59.1%.

“The findings of our study provide insight into potential drivers of insulin costs in the U.S. and may inform health policy,” the researchers conclude.

Funded in part by the National Heart, Lung, and Blood Institute. Dr. Kalyani currently serves on the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration.

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

Despite the extensive recent focus on its cost, insulin use in the United States remains dominated by insulin glargine and other analogs, as well as pen devices for delivery, new research shows.

The findings come from a nationally representative audit of outpatient care with input from nearly 5,000 physicians who prescribed insulin to patients with type 2 diabetes in 2016-2020.

The dramatic rise in the price of insulin in the United States has been extensively discussed in recent years, particularly with the newer analogs as compared with older human insulins.

Few studies indicate analog insulins better than human insulins

“Our findings suggest that even with increased public scrutiny for insulin products ... [the market is] dominated by the use of insulin analogs and insulin pen delivery devices, with persistent uptake of newer products as they are approved,” lead author Rita R. Kalyani, MD, told this news organization.

“Though newer insulins offer potentially greater flexibility with reduced hypoglycemia for many patients, they are also much more costly, with minimal to no head-to-head studies suggesting significant differences in glucose-lowering efficacy when compared to human insulins,” she stressed.

“We found it surprising that, despite the much-publicized concerns regarding insulin costs, analog insulins continue to represent more than 80% of insulin visits in the U.S.” added Dr. Kalyani, of the Division of Endocrinology, Diabetes & Metabolism at Johns Hopkins University School of Medicine, Baltimore.

However, as expected, the study also revealed a gradual increased uptake in the use of biosimilar insulins as more have been introduced to the market.

Dr. Kalyani advised, “Clinicians should be aware of their individual prescribing patterns for insulin and consider the affordability of insulin for patients as part of shared decision-making during clinic visits, particularly given the greater financial strain that many patients have faced during the ongoing COVID-19 pandemic and the rising societal costs for diabetes care.”

The research was published online October 12 in JAMA Network Open by Dr. Kalyani and colleagues.

Analogs prevailed, while biosimilar use rose

The data come from the Health National Disease and Therapeutic Index, a quarterly sampling of approximately 4,800 physicians that provides nationally representative diagnostic and prescribing information on patients treated by office-based physicians in the United States.

Overall, there were 27,860,691 insulin treatment visits for type 2 diabetes in 2016-2020. Of those, long-acting analog insulins (glargine [Lantus], detemir [Levemir], and degludec [Tresiba]) accounted for 67.3% of treatment visits in 2016 and 74.8% of treatment visits in 2020.

Rapid-acting insulin analogs (lispro [Humalog], aspart [Novolog], faster aspart [Fiasp], and glulisine [Apidra]) accounted for about 21.2% of visits in 2016 and about 16.5% in 2020.

On the other hand, intermediate- and short-acting human insulins (NPH and regular) accounted for just 3.7% of visits in 2016 and 2.6% in 2020.

Grouped together, the long- and short-acting analogs accounted for 92.7% of visits in 2016 and 86.3% in 2020, while the human insulins represented just 7.3% of visits in 2016 and 5.5% in 2020.

The biosimilar analog insulins (glargine and lispro) first appeared in the database in 2017, accounting for 2.6% of visits that year and 8.2% by 2020.

Overall, the number of visits for insulin treatment declined by 18% between 2016 and 2020, from 6.0 million to 4.9 million. That drop may be due to multiple factors, Dr. Kalyani said.

“Recently updated clinical practice guidelines from professional societies such as the American Diabetes Association recommend the use of glucagon-like peptide-1 (GLP-1) receptor agonists prior to insulin when injectable medications are being considered [for type 2 diabetes],” she noted.

“In addition, during the pandemic, patients may not have been seeing their health care providers for routine diabetes care as often as before ... These and other factors may have contributed to the decrease in insulin visits that we observed.”

By specific insulins, glargine has topped the list all along, accounting for about half of all treatment visits, at 52.6% in 2020. Degludec came in second, at 17.4%, and lispro third, at 9.5%.

Use of pen devices also increased

The proportion of treatment visits for insulin vials/syringes declined from 63.9% in 2016 to 41.1% in 2020, while visits for insulin pens rose from 36.1% to 58.7%.

“Many pens are more costly compared to vials of the same insulin product. Interestingly, some studies have found that use of insulin pens may promote greater patient adherence to insulin and, as a result, more broadly decrease health care costs associated with diabetes. However, we did not specifically investigate the cost of insulin in our study,” Dr. Kalyani noted.

The proportion of visits for “newer” insulins, defined as those approved in 2010 or later, rose from 18.1% in 2016 to 40.9% in 2020, while the concurrent drop for insulins approved prior to 2010 was from 81.9% to 59.1%.

“The findings of our study provide insight into potential drivers of insulin costs in the U.S. and may inform health policy,” the researchers conclude.

Funded in part by the National Heart, Lung, and Blood Institute. Dr. Kalyani currently serves on the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration.

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

Despite the extensive recent focus on its cost, insulin use in the United States remains dominated by insulin glargine and other analogs, as well as pen devices for delivery, new research shows.

The findings come from a nationally representative audit of outpatient care with input from nearly 5,000 physicians who prescribed insulin to patients with type 2 diabetes in 2016-2020.

The dramatic rise in the price of insulin in the United States has been extensively discussed in recent years, particularly with the newer analogs as compared with older human insulins.

Few studies indicate analog insulins better than human insulins

“Our findings suggest that even with increased public scrutiny for insulin products ... [the market is] dominated by the use of insulin analogs and insulin pen delivery devices, with persistent uptake of newer products as they are approved,” lead author Rita R. Kalyani, MD, told this news organization.

“Though newer insulins offer potentially greater flexibility with reduced hypoglycemia for many patients, they are also much more costly, with minimal to no head-to-head studies suggesting significant differences in glucose-lowering efficacy when compared to human insulins,” she stressed.

“We found it surprising that, despite the much-publicized concerns regarding insulin costs, analog insulins continue to represent more than 80% of insulin visits in the U.S.” added Dr. Kalyani, of the Division of Endocrinology, Diabetes & Metabolism at Johns Hopkins University School of Medicine, Baltimore.

However, as expected, the study also revealed a gradual increased uptake in the use of biosimilar insulins as more have been introduced to the market.

Dr. Kalyani advised, “Clinicians should be aware of their individual prescribing patterns for insulin and consider the affordability of insulin for patients as part of shared decision-making during clinic visits, particularly given the greater financial strain that many patients have faced during the ongoing COVID-19 pandemic and the rising societal costs for diabetes care.”

The research was published online October 12 in JAMA Network Open by Dr. Kalyani and colleagues.

Analogs prevailed, while biosimilar use rose

The data come from the Health National Disease and Therapeutic Index, a quarterly sampling of approximately 4,800 physicians that provides nationally representative diagnostic and prescribing information on patients treated by office-based physicians in the United States.

Overall, there were 27,860,691 insulin treatment visits for type 2 diabetes in 2016-2020. Of those, long-acting analog insulins (glargine [Lantus], detemir [Levemir], and degludec [Tresiba]) accounted for 67.3% of treatment visits in 2016 and 74.8% of treatment visits in 2020.

Rapid-acting insulin analogs (lispro [Humalog], aspart [Novolog], faster aspart [Fiasp], and glulisine [Apidra]) accounted for about 21.2% of visits in 2016 and about 16.5% in 2020.

On the other hand, intermediate- and short-acting human insulins (NPH and regular) accounted for just 3.7% of visits in 2016 and 2.6% in 2020.

Grouped together, the long- and short-acting analogs accounted for 92.7% of visits in 2016 and 86.3% in 2020, while the human insulins represented just 7.3% of visits in 2016 and 5.5% in 2020.

The biosimilar analog insulins (glargine and lispro) first appeared in the database in 2017, accounting for 2.6% of visits that year and 8.2% by 2020.

Overall, the number of visits for insulin treatment declined by 18% between 2016 and 2020, from 6.0 million to 4.9 million. That drop may be due to multiple factors, Dr. Kalyani said.

“Recently updated clinical practice guidelines from professional societies such as the American Diabetes Association recommend the use of glucagon-like peptide-1 (GLP-1) receptor agonists prior to insulin when injectable medications are being considered [for type 2 diabetes],” she noted.

“In addition, during the pandemic, patients may not have been seeing their health care providers for routine diabetes care as often as before ... These and other factors may have contributed to the decrease in insulin visits that we observed.”

By specific insulins, glargine has topped the list all along, accounting for about half of all treatment visits, at 52.6% in 2020. Degludec came in second, at 17.4%, and lispro third, at 9.5%.

Use of pen devices also increased

The proportion of treatment visits for insulin vials/syringes declined from 63.9% in 2016 to 41.1% in 2020, while visits for insulin pens rose from 36.1% to 58.7%.

“Many pens are more costly compared to vials of the same insulin product. Interestingly, some studies have found that use of insulin pens may promote greater patient adherence to insulin and, as a result, more broadly decrease health care costs associated with diabetes. However, we did not specifically investigate the cost of insulin in our study,” Dr. Kalyani noted.

The proportion of visits for “newer” insulins, defined as those approved in 2010 or later, rose from 18.1% in 2016 to 40.9% in 2020, while the concurrent drop for insulins approved prior to 2010 was from 81.9% to 59.1%.

“The findings of our study provide insight into potential drivers of insulin costs in the U.S. and may inform health policy,” the researchers conclude.

Funded in part by the National Heart, Lung, and Blood Institute. Dr. Kalyani currently serves on the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration.

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

It’s hard for people to completely escape a history of obesity, even when they later achieve a healthy weight.

American adults who once had obesity but later achieved and maintained a healthy body mass index (BMI) normalized some, but not all, of the excess clinical risk associated with obesity in a review of data collected from about 20,000 people during a series of eight NHANES surveys.

Maia P. Smith, MD, reported the findings at the virtual European Association for the Study of Diabetes (EASD) 2021 Annual Meeting.

“For some conditions, such as hypertension and dyslipidemia, the recovery [following a sharp drop in BMI] appears to be total, while for other conditions, like diabetes, the recovery is probabilistic. Some recover, but some don’t,” explained Dr. Smith in an interview.

“Weight loss reverses all, or essentially all, of the damage done by obesity in some people, but does not cause full reversal of the harm and does not fully resolve [type 2] diabetes in many others,” added Dr. Smith, an epidemiologist in the Department of Public Health and Preventive Medicine at St. George’s University, Grenada.

“The fact that ... analyses comparing formerly obese people to normal weight populations demonstrated improvement in population mean levels of hypertension and dyslipidemia is remarkable,” commented Rebecca T. Emeny, PhD, an epidemiologist at the Dartmouth Institute of Health Policy and Clinical Practice in Lebanon, New Hampshire, who was not involved with Dr. Smith’s study.

“The observation that the individuals who were able to maintain normal weight after past obesity were still at greater risk for diabetes compared with the normal weight group speaks to the recent discussion of obesity as a metabolic disorder rather than a problem of calories in and calories out,” said Dr. Emeny in an interview.

She cited a recent article that proposed a carbohydrate-insulin model for obesity in place of an energy-balance model. This, however, is still somewhat contentious.

Dr. Emeny also cautioned that “the results of this study compare populations. The design and analysis do not allow for interpretation of individual risk resulting from changes in weight.”
 

Those who formerly had obesity can reverse hypertension, dyslipidemia

The study by Dr. Smith and associates used data collected in the National Health and Nutrition Examination Survey (NHANES), which is performed every 2 years by the U.S. Centers for Disease Control and Prevention.

They used data from eight consecutive surveys starting in 1999-2000 and continuing through 2013-2014, yielding data from nearly 40,000 adults who were at least 20 years old.

In addition to the 326 people who formerly had obesity at some time previously during their life (BMI ≥30 kg/m²) but now had a healthy BMI, and 6,235 who were consistently at a healthy BMI, they also included 13,710 people who currently had obesity. They dropped the remaining survey participants who did not fit into one of these three categories.

The participants who formerly had obesity averaged 54 years old, compared with a mean age of 48 years among those with current obesity and 41 years among those who currently had a healthy BMI (who had never had obesity). The results showed no differences by sex, but those who formerly had obesity had a much higher smoking prevalence.

The people who reported a healthy BMI (18.5-24.9 kg/m²) after previously having obesity had current prevalence rates of hypertension and dyslipidemia that were, respectively, 8% and 13% higher than the prevalence rates among adults who consistently maintained a healthy BMI – differences that were not significant.

In contrast, people who had current BMIs that indicated obesity had prevalence rates of hypertension and dyslipidemia that were each a significant threefold higher than those with a healthy BMI.

The 326 respondents who formerly had obesity but now were at a healthy BMI had a threefold higher prevalence of diabetes than did the 6,235 who consistently had maintained a healthy BMI. This was substantially less than the over sevenfold higher prevalence of diabetes among those who currently had obesity compared with those who always had a healthy BMI.

All these analyses were adjusted for the potential confounders of age, sex, smoking history, and ethnicity.
 

‘Quitting’ obesity better than current obesity

The finding that reaching a healthy BMI after a period of obesity could reverse some but not all risks associated with obesity is reminiscent of the effects of smoking, noted Dr. Smith.

“Never is better than ever, but quitting,” or dropping weight to reach a healthy BMI, “is better than current,” she concluded.

But Dr. Emeny said this interpretation, “while motivating and catchy, places emphasis on individual responsibility and choice rather than on social circumstances.”

Social effects “must be considered when evaluating population-level disparities in obesity-related cardiometabolic risk,” cautioned Dr. Emeny.

“’Quitting’ obesity is much more complicated than individual choice or ability.”

Dr. Smith also conceded that her analyses did not correct for the possible confounding effects that changes in diet or physical activity may have had on the observations.

“Neither diet nor physical activity has a well-known summary measure that we could have included as an adjuster,” she explained.

Dr. Smith and Dr. Emeny have reported no relevant financial relationships.

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

It’s hard for people to completely escape a history of obesity, even when they later achieve a healthy weight.

American adults who once had obesity but later achieved and maintained a healthy body mass index (BMI) normalized some, but not all, of the excess clinical risk associated with obesity in a review of data collected from about 20,000 people during a series of eight NHANES surveys.

Maia P. Smith, MD, reported the findings at the virtual European Association for the Study of Diabetes (EASD) 2021 Annual Meeting.

“For some conditions, such as hypertension and dyslipidemia, the recovery [following a sharp drop in BMI] appears to be total, while for other conditions, like diabetes, the recovery is probabilistic. Some recover, but some don’t,” explained Dr. Smith in an interview.

“Weight loss reverses all, or essentially all, of the damage done by obesity in some people, but does not cause full reversal of the harm and does not fully resolve [type 2] diabetes in many others,” added Dr. Smith, an epidemiologist in the Department of Public Health and Preventive Medicine at St. George’s University, Grenada.

“The fact that ... analyses comparing formerly obese people to normal weight populations demonstrated improvement in population mean levels of hypertension and dyslipidemia is remarkable,” commented Rebecca T. Emeny, PhD, an epidemiologist at the Dartmouth Institute of Health Policy and Clinical Practice in Lebanon, New Hampshire, who was not involved with Dr. Smith’s study.

“The observation that the individuals who were able to maintain normal weight after past obesity were still at greater risk for diabetes compared with the normal weight group speaks to the recent discussion of obesity as a metabolic disorder rather than a problem of calories in and calories out,” said Dr. Emeny in an interview.

She cited a recent article that proposed a carbohydrate-insulin model for obesity in place of an energy-balance model. This, however, is still somewhat contentious.

Dr. Emeny also cautioned that “the results of this study compare populations. The design and analysis do not allow for interpretation of individual risk resulting from changes in weight.”
 

Those who formerly had obesity can reverse hypertension, dyslipidemia

The study by Dr. Smith and associates used data collected in the National Health and Nutrition Examination Survey (NHANES), which is performed every 2 years by the U.S. Centers for Disease Control and Prevention.

They used data from eight consecutive surveys starting in 1999-2000 and continuing through 2013-2014, yielding data from nearly 40,000 adults who were at least 20 years old.

In addition to the 326 people who formerly had obesity at some time previously during their life (BMI ≥30 kg/m²) but now had a healthy BMI, and 6,235 who were consistently at a healthy BMI, they also included 13,710 people who currently had obesity. They dropped the remaining survey participants who did not fit into one of these three categories.

The participants who formerly had obesity averaged 54 years old, compared with a mean age of 48 years among those with current obesity and 41 years among those who currently had a healthy BMI (who had never had obesity). The results showed no differences by sex, but those who formerly had obesity had a much higher smoking prevalence.

The people who reported a healthy BMI (18.5-24.9 kg/m²) after previously having obesity had current prevalence rates of hypertension and dyslipidemia that were, respectively, 8% and 13% higher than the prevalence rates among adults who consistently maintained a healthy BMI – differences that were not significant.

In contrast, people who had current BMIs that indicated obesity had prevalence rates of hypertension and dyslipidemia that were each a significant threefold higher than those with a healthy BMI.

The 326 respondents who formerly had obesity but now were at a healthy BMI had a threefold higher prevalence of diabetes than did the 6,235 who consistently had maintained a healthy BMI. This was substantially less than the over sevenfold higher prevalence of diabetes among those who currently had obesity compared with those who always had a healthy BMI.

All these analyses were adjusted for the potential confounders of age, sex, smoking history, and ethnicity.
 

‘Quitting’ obesity better than current obesity

The finding that reaching a healthy BMI after a period of obesity could reverse some but not all risks associated with obesity is reminiscent of the effects of smoking, noted Dr. Smith.

“Never is better than ever, but quitting,” or dropping weight to reach a healthy BMI, “is better than current,” she concluded.

But Dr. Emeny said this interpretation, “while motivating and catchy, places emphasis on individual responsibility and choice rather than on social circumstances.”

Social effects “must be considered when evaluating population-level disparities in obesity-related cardiometabolic risk,” cautioned Dr. Emeny.

“’Quitting’ obesity is much more complicated than individual choice or ability.”

Dr. Smith also conceded that her analyses did not correct for the possible confounding effects that changes in diet or physical activity may have had on the observations.

“Neither diet nor physical activity has a well-known summary measure that we could have included as an adjuster,” she explained.

Dr. Smith and Dr. Emeny have reported no relevant financial relationships.

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

It’s hard for people to completely escape a history of obesity, even when they later achieve a healthy weight.

American adults who once had obesity but later achieved and maintained a healthy body mass index (BMI) normalized some, but not all, of the excess clinical risk associated with obesity in a review of data collected from about 20,000 people during a series of eight NHANES surveys.

Maia P. Smith, MD, reported the findings at the virtual European Association for the Study of Diabetes (EASD) 2021 Annual Meeting.

“For some conditions, such as hypertension and dyslipidemia, the recovery [following a sharp drop in BMI] appears to be total, while for other conditions, like diabetes, the recovery is probabilistic. Some recover, but some don’t,” explained Dr. Smith in an interview.

“Weight loss reverses all, or essentially all, of the damage done by obesity in some people, but does not cause full reversal of the harm and does not fully resolve [type 2] diabetes in many others,” added Dr. Smith, an epidemiologist in the Department of Public Health and Preventive Medicine at St. George’s University, Grenada.

“The fact that ... analyses comparing formerly obese people to normal weight populations demonstrated improvement in population mean levels of hypertension and dyslipidemia is remarkable,” commented Rebecca T. Emeny, PhD, an epidemiologist at the Dartmouth Institute of Health Policy and Clinical Practice in Lebanon, New Hampshire, who was not involved with Dr. Smith’s study.

“The observation that the individuals who were able to maintain normal weight after past obesity were still at greater risk for diabetes compared with the normal weight group speaks to the recent discussion of obesity as a metabolic disorder rather than a problem of calories in and calories out,” said Dr. Emeny in an interview.

She cited a recent article that proposed a carbohydrate-insulin model for obesity in place of an energy-balance model. This, however, is still somewhat contentious.

Dr. Emeny also cautioned that “the results of this study compare populations. The design and analysis do not allow for interpretation of individual risk resulting from changes in weight.”
 

Those who formerly had obesity can reverse hypertension, dyslipidemia

The study by Dr. Smith and associates used data collected in the National Health and Nutrition Examination Survey (NHANES), which is performed every 2 years by the U.S. Centers for Disease Control and Prevention.

They used data from eight consecutive surveys starting in 1999-2000 and continuing through 2013-2014, yielding data from nearly 40,000 adults who were at least 20 years old.

In addition to the 326 people who formerly had obesity at some time previously during their life (BMI ≥30 kg/m²) but now had a healthy BMI, and 6,235 who were consistently at a healthy BMI, they also included 13,710 people who currently had obesity. They dropped the remaining survey participants who did not fit into one of these three categories.

The participants who formerly had obesity averaged 54 years old, compared with a mean age of 48 years among those with current obesity and 41 years among those who currently had a healthy BMI (who had never had obesity). The results showed no differences by sex, but those who formerly had obesity had a much higher smoking prevalence.

The people who reported a healthy BMI (18.5-24.9 kg/m²) after previously having obesity had current prevalence rates of hypertension and dyslipidemia that were, respectively, 8% and 13% higher than the prevalence rates among adults who consistently maintained a healthy BMI – differences that were not significant.

In contrast, people who had current BMIs that indicated obesity had prevalence rates of hypertension and dyslipidemia that were each a significant threefold higher than those with a healthy BMI.

The 326 respondents who formerly had obesity but now were at a healthy BMI had a threefold higher prevalence of diabetes than did the 6,235 who consistently had maintained a healthy BMI. This was substantially less than the over sevenfold higher prevalence of diabetes among those who currently had obesity compared with those who always had a healthy BMI.

All these analyses were adjusted for the potential confounders of age, sex, smoking history, and ethnicity.
 

‘Quitting’ obesity better than current obesity

The finding that reaching a healthy BMI after a period of obesity could reverse some but not all risks associated with obesity is reminiscent of the effects of smoking, noted Dr. Smith.

“Never is better than ever, but quitting,” or dropping weight to reach a healthy BMI, “is better than current,” she concluded.

But Dr. Emeny said this interpretation, “while motivating and catchy, places emphasis on individual responsibility and choice rather than on social circumstances.”

Social effects “must be considered when evaluating population-level disparities in obesity-related cardiometabolic risk,” cautioned Dr. Emeny.

“’Quitting’ obesity is much more complicated than individual choice or ability.”

Dr. Smith also conceded that her analyses did not correct for the possible confounding effects that changes in diet or physical activity may have had on the observations.

“Neither diet nor physical activity has a well-known summary measure that we could have included as an adjuster,” she explained.

Dr. Smith and Dr. Emeny have reported no relevant financial relationships.

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

Five years out, sleeve gastrectomy had a lower risk of mortality, complications, and reinterventions than gastric bypass, but there was a higher risk of surgical revision, including conversion to another bariatric surgery, gastrectomy, or anastomotic revision, according to a new analysis.

herjua/Thinkstock

Sleeve gastrectomy has gained rapid popularity, and now represents 60% of all bariatric procedures. It has demonstrated good efficacy and short-term safety, it is easier to perform than laparoscopic Roux-en-Y gastric bypass, and it is a safe option for high-risk patients, authors led by Ryan Howard, MD, of University of Michigan, Ann Arbor, wrote in JAMA Surgery.

Still, there are few comparative data on the long-term efficacy of the two procedures. Randomized, controlled trials have conducted long-term follow-up, but their small size has made it difficult to detect differences in rare outcomes. Observational studies are limited by the potential for bias. A novel approach to limiting bias is instrumental variables analysis, which controls for possible confounding using a factor that impacts treatment choice, but not patient outcome, to control for possible confounders. Studies using this approach confirmed the superior safety profile of sleeve gastrectomy in the short term.

The current study’s authors, used that method to examined 5-year outcomes in a Medicare population, in which obesity and its complications are especially frequent. Partly because of that lack of data, the Medical Evidence Development and Coverage Committee has called for more data in older patients and in patients with disabilities.

The researchers analyzed data from 95,405 Medicare claims between 2012 and 2018, using state-level variation in sleeve gastrectomy as the instrumental variable.

At 5 years, sleeve gastrectomy was associated with a lower cumulative frequency of mortality (4.27%; 95% confidence interval, 4.25%-4.30% vs. 5.67%; 95% CI, 5.63%-5.69%]), complications (22.10%; 95% CI, 22.06%-22.13% vs. 29.03%; 95% CI, 28.99%-29.08%), and reintervention (25.23%; 95% CI, 25.19%-25.27% vs. 33.57%; 95% CI, 33.52%-33.63%). At 5 years, surgical revision was more common in the sleeve gastrectomy group (2.91%; 95% CI, 2.90%-2.93% vs. 1.46%; 95% CI, 1.45%-1.47%).

The sleeve gastrectomy group had lower odds of all-cause hospitalization at 1 year (adjusted hazard ratio, 0.83; 95% CI, 0.80-0.86) and 3 years (aHR, 0.94; 95% CI, 0.90-0.98), as well as emergency department use at 1 year (aHR, 0.87; 95% CI, 0.84-0.90) and 3 years (aHR, 0.93; 95% CI, 0.90-0.97). There was no significant difference between the two groups at 5 years with respect to either outcome.

The effort to understand long-term outcomes of these two procedures has been challenging because follow-up is often incomplete, and because reporting isn’t always standardized, according Anita P. Courcoulas, MD, MPH, and Bestoun Ahmed, MD, in an accompanying editorial in JAMA Surgery. They noted that the differences in mortality is a new finding and the difference in surgical revisions confirmed something often seen in clinical practice. “Overall, these novel methods, which creatively balance unmeasured factors, have succeeded in providing important incremental findings about the long-term comparative safety outcomes between bariatric procedures that will be helpful in clinical practice,” the editorial authors wrote.

The complications discussed in the study are also difficult to interpret, according to Ali Aminian, MD, who is a professor of surgery and director of Bariatric and Metabolic Institute at Cleveland Clinic. They may be related to the surgery, or they may be complications that accrue as patients age. “So that doesn’t mean those were surgical complications, but [the findings are] in line with the other literature that [gastric sleeve] may be safer than gastric bypass, but in a different cohort of patients,” said Dr. Aminian, who was asked to comment.

“I thought it validated that which many of us in clinical practice see on a day to day basis,” said Shanu Kothari, MD, chair of surgery at Prisma Health, and the current president of American Society for Bariatric and Metabolic Surgery. He pointed out that the study was limited by its reliance on administrative claims, which makes it impossible to know the reduction in weight and obesity-related comorbid conditions following the procedures, as well as factors driving individual decisions: A surgeon might offer sleeve to a patient at higher risk of complications, but a gastric bypass to someone with more comorbidities. “What we don’t know is how to interpret this 35,000-foot view of Medicare data to that conversation with the patient sitting right in front of you,” said Dr. Kothari.

The authors similarly cited the “lack of clinical granularity in administrative claims data” among study limitations, as well as how the use of instrumental variables may leave the findings less applicable to patients more strongly indicated for one procedure over the other.

“Longer-term randomized clinical trials and observational studies are warranted to confirm these findings,” the study authors concluded. “Understanding the risk profile of various bariatric operations may further help patients and surgeons make the most appropriate decisions regarding plans of care.”

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Some study authors and editorialists reported funding from various groups and institutions, such as the National Institutes of Health and the VA Ann Arbor Health System. Dr. Kothari and Dr. Aminian have no relevant financial disclosures.

Five years out, sleeve gastrectomy had a lower risk of mortality, complications, and reinterventions than gastric bypass, but there was a higher risk of surgical revision, including conversion to another bariatric surgery, gastrectomy, or anastomotic revision, according to a new analysis.

herjua/Thinkstock

Sleeve gastrectomy has gained rapid popularity, and now represents 60% of all bariatric procedures. It has demonstrated good efficacy and short-term safety, it is easier to perform than laparoscopic Roux-en-Y gastric bypass, and it is a safe option for high-risk patients, authors led by Ryan Howard, MD, of University of Michigan, Ann Arbor, wrote in JAMA Surgery.

Still, there are few comparative data on the long-term efficacy of the two procedures. Randomized, controlled trials have conducted long-term follow-up, but their small size has made it difficult to detect differences in rare outcomes. Observational studies are limited by the potential for bias. A novel approach to limiting bias is instrumental variables analysis, which controls for possible confounding using a factor that impacts treatment choice, but not patient outcome, to control for possible confounders. Studies using this approach confirmed the superior safety profile of sleeve gastrectomy in the short term.

The current study’s authors, used that method to examined 5-year outcomes in a Medicare population, in which obesity and its complications are especially frequent. Partly because of that lack of data, the Medical Evidence Development and Coverage Committee has called for more data in older patients and in patients with disabilities.

The researchers analyzed data from 95,405 Medicare claims between 2012 and 2018, using state-level variation in sleeve gastrectomy as the instrumental variable.

At 5 years, sleeve gastrectomy was associated with a lower cumulative frequency of mortality (4.27%; 95% confidence interval, 4.25%-4.30% vs. 5.67%; 95% CI, 5.63%-5.69%]), complications (22.10%; 95% CI, 22.06%-22.13% vs. 29.03%; 95% CI, 28.99%-29.08%), and reintervention (25.23%; 95% CI, 25.19%-25.27% vs. 33.57%; 95% CI, 33.52%-33.63%). At 5 years, surgical revision was more common in the sleeve gastrectomy group (2.91%; 95% CI, 2.90%-2.93% vs. 1.46%; 95% CI, 1.45%-1.47%).

The sleeve gastrectomy group had lower odds of all-cause hospitalization at 1 year (adjusted hazard ratio, 0.83; 95% CI, 0.80-0.86) and 3 years (aHR, 0.94; 95% CI, 0.90-0.98), as well as emergency department use at 1 year (aHR, 0.87; 95% CI, 0.84-0.90) and 3 years (aHR, 0.93; 95% CI, 0.90-0.97). There was no significant difference between the two groups at 5 years with respect to either outcome.

The effort to understand long-term outcomes of these two procedures has been challenging because follow-up is often incomplete, and because reporting isn’t always standardized, according Anita P. Courcoulas, MD, MPH, and Bestoun Ahmed, MD, in an accompanying editorial in JAMA Surgery. They noted that the differences in mortality is a new finding and the difference in surgical revisions confirmed something often seen in clinical practice. “Overall, these novel methods, which creatively balance unmeasured factors, have succeeded in providing important incremental findings about the long-term comparative safety outcomes between bariatric procedures that will be helpful in clinical practice,” the editorial authors wrote.

The complications discussed in the study are also difficult to interpret, according to Ali Aminian, MD, who is a professor of surgery and director of Bariatric and Metabolic Institute at Cleveland Clinic. They may be related to the surgery, or they may be complications that accrue as patients age. “So that doesn’t mean those were surgical complications, but [the findings are] in line with the other literature that [gastric sleeve] may be safer than gastric bypass, but in a different cohort of patients,” said Dr. Aminian, who was asked to comment.

“I thought it validated that which many of us in clinical practice see on a day to day basis,” said Shanu Kothari, MD, chair of surgery at Prisma Health, and the current president of American Society for Bariatric and Metabolic Surgery. He pointed out that the study was limited by its reliance on administrative claims, which makes it impossible to know the reduction in weight and obesity-related comorbid conditions following the procedures, as well as factors driving individual decisions: A surgeon might offer sleeve to a patient at higher risk of complications, but a gastric bypass to someone with more comorbidities. “What we don’t know is how to interpret this 35,000-foot view of Medicare data to that conversation with the patient sitting right in front of you,” said Dr. Kothari.

The authors similarly cited the “lack of clinical granularity in administrative claims data” among study limitations, as well as how the use of instrumental variables may leave the findings less applicable to patients more strongly indicated for one procedure over the other.

“Longer-term randomized clinical trials and observational studies are warranted to confirm these findings,” the study authors concluded. “Understanding the risk profile of various bariatric operations may further help patients and surgeons make the most appropriate decisions regarding plans of care.”

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Some study authors and editorialists reported funding from various groups and institutions, such as the National Institutes of Health and the VA Ann Arbor Health System. Dr. Kothari and Dr. Aminian have no relevant financial disclosures.

Five years out, sleeve gastrectomy had a lower risk of mortality, complications, and reinterventions than gastric bypass, but there was a higher risk of surgical revision, including conversion to another bariatric surgery, gastrectomy, or anastomotic revision, according to a new analysis.

herjua/Thinkstock

Sleeve gastrectomy has gained rapid popularity, and now represents 60% of all bariatric procedures. It has demonstrated good efficacy and short-term safety, it is easier to perform than laparoscopic Roux-en-Y gastric bypass, and it is a safe option for high-risk patients, authors led by Ryan Howard, MD, of University of Michigan, Ann Arbor, wrote in JAMA Surgery.

Still, there are few comparative data on the long-term efficacy of the two procedures. Randomized, controlled trials have conducted long-term follow-up, but their small size has made it difficult to detect differences in rare outcomes. Observational studies are limited by the potential for bias. A novel approach to limiting bias is instrumental variables analysis, which controls for possible confounding using a factor that impacts treatment choice, but not patient outcome, to control for possible confounders. Studies using this approach confirmed the superior safety profile of sleeve gastrectomy in the short term.

The current study’s authors, used that method to examined 5-year outcomes in a Medicare population, in which obesity and its complications are especially frequent. Partly because of that lack of data, the Medical Evidence Development and Coverage Committee has called for more data in older patients and in patients with disabilities.

The researchers analyzed data from 95,405 Medicare claims between 2012 and 2018, using state-level variation in sleeve gastrectomy as the instrumental variable.

At 5 years, sleeve gastrectomy was associated with a lower cumulative frequency of mortality (4.27%; 95% confidence interval, 4.25%-4.30% vs. 5.67%; 95% CI, 5.63%-5.69%]), complications (22.10%; 95% CI, 22.06%-22.13% vs. 29.03%; 95% CI, 28.99%-29.08%), and reintervention (25.23%; 95% CI, 25.19%-25.27% vs. 33.57%; 95% CI, 33.52%-33.63%). At 5 years, surgical revision was more common in the sleeve gastrectomy group (2.91%; 95% CI, 2.90%-2.93% vs. 1.46%; 95% CI, 1.45%-1.47%).

The sleeve gastrectomy group had lower odds of all-cause hospitalization at 1 year (adjusted hazard ratio, 0.83; 95% CI, 0.80-0.86) and 3 years (aHR, 0.94; 95% CI, 0.90-0.98), as well as emergency department use at 1 year (aHR, 0.87; 95% CI, 0.84-0.90) and 3 years (aHR, 0.93; 95% CI, 0.90-0.97). There was no significant difference between the two groups at 5 years with respect to either outcome.

The effort to understand long-term outcomes of these two procedures has been challenging because follow-up is often incomplete, and because reporting isn’t always standardized, according Anita P. Courcoulas, MD, MPH, and Bestoun Ahmed, MD, in an accompanying editorial in JAMA Surgery. They noted that the differences in mortality is a new finding and the difference in surgical revisions confirmed something often seen in clinical practice. “Overall, these novel methods, which creatively balance unmeasured factors, have succeeded in providing important incremental findings about the long-term comparative safety outcomes between bariatric procedures that will be helpful in clinical practice,” the editorial authors wrote.

The complications discussed in the study are also difficult to interpret, according to Ali Aminian, MD, who is a professor of surgery and director of Bariatric and Metabolic Institute at Cleveland Clinic. They may be related to the surgery, or they may be complications that accrue as patients age. “So that doesn’t mean those were surgical complications, but [the findings are] in line with the other literature that [gastric sleeve] may be safer than gastric bypass, but in a different cohort of patients,” said Dr. Aminian, who was asked to comment.

“I thought it validated that which many of us in clinical practice see on a day to day basis,” said Shanu Kothari, MD, chair of surgery at Prisma Health, and the current president of American Society for Bariatric and Metabolic Surgery. He pointed out that the study was limited by its reliance on administrative claims, which makes it impossible to know the reduction in weight and obesity-related comorbid conditions following the procedures, as well as factors driving individual decisions: A surgeon might offer sleeve to a patient at higher risk of complications, but a gastric bypass to someone with more comorbidities. “What we don’t know is how to interpret this 35,000-foot view of Medicare data to that conversation with the patient sitting right in front of you,” said Dr. Kothari.

The authors similarly cited the “lack of clinical granularity in administrative claims data” among study limitations, as well as how the use of instrumental variables may leave the findings less applicable to patients more strongly indicated for one procedure over the other.

“Longer-term randomized clinical trials and observational studies are warranted to confirm these findings,” the study authors concluded. “Understanding the risk profile of various bariatric operations may further help patients and surgeons make the most appropriate decisions regarding plans of care.”

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Some study authors and editorialists reported funding from various groups and institutions, such as the National Institutes of Health and the VA Ann Arbor Health System. Dr. Kothari and Dr. Aminian have no relevant financial disclosures.

American children gained a lot of weight in the last year, setting a dangerous trajectory towards metabolic disease that requires urgent policy change, according to a new report from the Robert Wood Johnson Foundation.

“Our nation’s safety net is fragile, outdated, and out of reach for millions of eligible kids and caregivers,” said Jamie Bussel, senior program officer at the RWJF, and senior author of the report. She added that the pandemic further fractured an already broken system that disproportionately overlooks “children of color and those who live farthest from economic opportunity”.
 

It’s time to think ‘bigger and better’

Ms. Bussel said, during a press conference, that congress responded to the pandemic with “an array of policy solutions,” but it’s now time to think ‘bigger and better.’

“There have been huge flexibilities deployed across the safety net program and these have been really important reliefs, but the fact is many of them are temporary emergency relief measures,” she explained.

For the past 3 years, the RWJF’s annual State of Childhood Obesity report has drawn national and state obesity data from large surveys including the National Survey of Children’s Health, the Youth Risk Behavior Surveillance System, the WIC Participant and Program Characteristics Survey, and the National Health and Nutrition Examination Survey.

Similar to in past years, this year’s data show that rates of obesity and overweight have remained relatively steady and have been highest among minority and low-income populations. For example, data from the 2019-2020 National Survey of Children’s Health, along with an analysis conducted by the Health Resources and Services Administration’s Maternal and Child Health Bureau, show that one in six – or 16.2% – of youth aged 10-17 years have obesity.

While non-Hispanic Asian children had the lowest obesity rate (8.1%), followed by non-Hispanic White children (12.1%), rates were significantly higher for Hispanic (21.4%), non-Hispanic Black (23.8%), and non-Hispanic American Indian/Alaska Native (28.7%) children, according to the report.

“Additional years of data are needed to assess whether obesity rates changed after the onset of the pandemic,” explained Ms. Bussel.
 

Digging deeper

Other studies included in this year’s report were specifically designed to measure the impact of the pandemic, and show a distinct rise in overweight and obesity, especially in younger children. For example, a retrospective cohort study using data from Kaiser Permanente Southern California showed the rate of overweight and obesity in children aged 5-11 years rose to 45.7% between March 2020 and January 2021, up from 36.2% before the pandemic.

Another of these studies, which was based on national electronic health records of more than 430,000 children, showed the obesity rate crept from 19.3% to 22.4% between August 2019 and August 2020.

“The lid we had been trying desperately to put on the obesity epidemic has come off again,” said Sandra G Hassink, MD, MSc, who is medical director of the American Academy of Pediatrics Institute for Healthy Childhood Weight.

“In the absence of COVID we had been seeing slow upticks in the numbers – and in some groups we’d been thinking maybe we were headed toward stabilization – but these numbers blow that out of the water ... COVID has escalated the rates,” she said in an interview.

“Unfortunately, these two crises – the COVID pandemic, the childhood obesity epidemic – in so many ways have exacerbated one another,” said Ms. Bussel. “It’s not a huge surprise that we’re seeing an increase in childhood obesity rates given the complete and utter disruption of every single system that circumscribes our lives.”
 

The systems that feed obesity

Addressing childhood obesity requires targeting far beyond healthy eating and physical activity, Ms. Bussel said.

“As important is whether that child has a safe place to call home. Does mom or dad or their care provider have a stable income? Is there reliable transportation? Is their access to health insurance? Is there access to high-quality health care? ... All of those factors influence the child and the family’s opportunities to live well, be healthy, and be at a healthy weight,” she noted.

The report includes a list of five main policy recommendations.

• Making free, universal school meal programs permanent.
• Extending eligibility for WIC, the Special Supplemental Nutrition Program for Women, Infants, and Children, to postpartum mothers and to children through age 6.
• Extending and expanding other programs, such as the Child Tax Credit.
• Closing the Medicaid coverage gap.
• Developing a consistent approach to collecting obesity data organized by race, ethnicity, and income level.

“Collectively, over at least the course of the last generation or two, our policy approach to obesity prevention has not been sufficient. But that doesn’t mean all of our policy approaches have been failures,” Ms. Bussel said during an interview. “Policy change does not always need to be dramatic to have a real impact on families.”

Fighting complacency

For Dr. Hassink, one of the barriers to change is society’s level of acceptance. She said an identifiable explanation for pandemic weight gain doesn’t mean society should simply shrug it off.

“If we regarded childhood obesity as the population level catastrophe that it is for chronic disease maybe people would be activated around these policy changes,” she said.

“We’re accepting a disease process that wreaks havoc on people,” noted Dr. Hassink, who was not involved in the new report. “I think it’s hard for people to realize the magnitude of the disease burden that we’re seeing. If you’re in a weight management clinic or any pediatrician’s office you would see it – you would see kids coming in with liver disease, 9-year-olds on [continuous positive airway pressure] for sleep apnea, kids needing their hips pinned because they had a hip fracture because of obesity.

“So, those of us that see the disease burden see what’s behind those numbers. The sadness of what we’re talking about is we know a lot about what could push the dial and help reduce this epidemic and we’re not doing what we already know,” added Dr. Hassink.

Ms. Bussel and Dr. Hassink reported no conflicts.

American children gained a lot of weight in the last year, setting a dangerous trajectory towards metabolic disease that requires urgent policy change, according to a new report from the Robert Wood Johnson Foundation.

“Our nation’s safety net is fragile, outdated, and out of reach for millions of eligible kids and caregivers,” said Jamie Bussel, senior program officer at the RWJF, and senior author of the report. She added that the pandemic further fractured an already broken system that disproportionately overlooks “children of color and those who live farthest from economic opportunity”.
 

It’s time to think ‘bigger and better’

Ms. Bussel said, during a press conference, that congress responded to the pandemic with “an array of policy solutions,” but it’s now time to think ‘bigger and better.’

“There have been huge flexibilities deployed across the safety net program and these have been really important reliefs, but the fact is many of them are temporary emergency relief measures,” she explained.

For the past 3 years, the RWJF’s annual State of Childhood Obesity report has drawn national and state obesity data from large surveys including the National Survey of Children’s Health, the Youth Risk Behavior Surveillance System, the WIC Participant and Program Characteristics Survey, and the National Health and Nutrition Examination Survey.

Similar to in past years, this year’s data show that rates of obesity and overweight have remained relatively steady and have been highest among minority and low-income populations. For example, data from the 2019-2020 National Survey of Children’s Health, along with an analysis conducted by the Health Resources and Services Administration’s Maternal and Child Health Bureau, show that one in six – or 16.2% – of youth aged 10-17 years have obesity.

While non-Hispanic Asian children had the lowest obesity rate (8.1%), followed by non-Hispanic White children (12.1%), rates were significantly higher for Hispanic (21.4%), non-Hispanic Black (23.8%), and non-Hispanic American Indian/Alaska Native (28.7%) children, according to the report.

“Additional years of data are needed to assess whether obesity rates changed after the onset of the pandemic,” explained Ms. Bussel.
 

Digging deeper

Other studies included in this year’s report were specifically designed to measure the impact of the pandemic, and show a distinct rise in overweight and obesity, especially in younger children. For example, a retrospective cohort study using data from Kaiser Permanente Southern California showed the rate of overweight and obesity in children aged 5-11 years rose to 45.7% between March 2020 and January 2021, up from 36.2% before the pandemic.

Another of these studies, which was based on national electronic health records of more than 430,000 children, showed the obesity rate crept from 19.3% to 22.4% between August 2019 and August 2020.

“The lid we had been trying desperately to put on the obesity epidemic has come off again,” said Sandra G Hassink, MD, MSc, who is medical director of the American Academy of Pediatrics Institute for Healthy Childhood Weight.

“In the absence of COVID we had been seeing slow upticks in the numbers – and in some groups we’d been thinking maybe we were headed toward stabilization – but these numbers blow that out of the water ... COVID has escalated the rates,” she said in an interview.

“Unfortunately, these two crises – the COVID pandemic, the childhood obesity epidemic – in so many ways have exacerbated one another,” said Ms. Bussel. “It’s not a huge surprise that we’re seeing an increase in childhood obesity rates given the complete and utter disruption of every single system that circumscribes our lives.”
 

The systems that feed obesity

Addressing childhood obesity requires targeting far beyond healthy eating and physical activity, Ms. Bussel said.

“As important is whether that child has a safe place to call home. Does mom or dad or their care provider have a stable income? Is there reliable transportation? Is their access to health insurance? Is there access to high-quality health care? ... All of those factors influence the child and the family’s opportunities to live well, be healthy, and be at a healthy weight,” she noted.

The report includes a list of five main policy recommendations.

• Making free, universal school meal programs permanent.
• Extending eligibility for WIC, the Special Supplemental Nutrition Program for Women, Infants, and Children, to postpartum mothers and to children through age 6.
• Extending and expanding other programs, such as the Child Tax Credit.
• Closing the Medicaid coverage gap.
• Developing a consistent approach to collecting obesity data organized by race, ethnicity, and income level.

“Collectively, over at least the course of the last generation or two, our policy approach to obesity prevention has not been sufficient. But that doesn’t mean all of our policy approaches have been failures,” Ms. Bussel said during an interview. “Policy change does not always need to be dramatic to have a real impact on families.”

Fighting complacency

For Dr. Hassink, one of the barriers to change is society’s level of acceptance. She said an identifiable explanation for pandemic weight gain doesn’t mean society should simply shrug it off.

“If we regarded childhood obesity as the population level catastrophe that it is for chronic disease maybe people would be activated around these policy changes,” she said.

“We’re accepting a disease process that wreaks havoc on people,” noted Dr. Hassink, who was not involved in the new report. “I think it’s hard for people to realize the magnitude of the disease burden that we’re seeing. If you’re in a weight management clinic or any pediatrician’s office you would see it – you would see kids coming in with liver disease, 9-year-olds on [continuous positive airway pressure] for sleep apnea, kids needing their hips pinned because they had a hip fracture because of obesity.

“So, those of us that see the disease burden see what’s behind those numbers. The sadness of what we’re talking about is we know a lot about what could push the dial and help reduce this epidemic and we’re not doing what we already know,” added Dr. Hassink.

Ms. Bussel and Dr. Hassink reported no conflicts.

American children gained a lot of weight in the last year, setting a dangerous trajectory towards metabolic disease that requires urgent policy change, according to a new report from the Robert Wood Johnson Foundation.

“Our nation’s safety net is fragile, outdated, and out of reach for millions of eligible kids and caregivers,” said Jamie Bussel, senior program officer at the RWJF, and senior author of the report. She added that the pandemic further fractured an already broken system that disproportionately overlooks “children of color and those who live farthest from economic opportunity”.
 

It’s time to think ‘bigger and better’

Ms. Bussel said, during a press conference, that congress responded to the pandemic with “an array of policy solutions,” but it’s now time to think ‘bigger and better.’

“There have been huge flexibilities deployed across the safety net program and these have been really important reliefs, but the fact is many of them are temporary emergency relief measures,” she explained.

For the past 3 years, the RWJF’s annual State of Childhood Obesity report has drawn national and state obesity data from large surveys including the National Survey of Children’s Health, the Youth Risk Behavior Surveillance System, the WIC Participant and Program Characteristics Survey, and the National Health and Nutrition Examination Survey.

Similar to in past years, this year’s data show that rates of obesity and overweight have remained relatively steady and have been highest among minority and low-income populations. For example, data from the 2019-2020 National Survey of Children’s Health, along with an analysis conducted by the Health Resources and Services Administration’s Maternal and Child Health Bureau, show that one in six – or 16.2% – of youth aged 10-17 years have obesity.

While non-Hispanic Asian children had the lowest obesity rate (8.1%), followed by non-Hispanic White children (12.1%), rates were significantly higher for Hispanic (21.4%), non-Hispanic Black (23.8%), and non-Hispanic American Indian/Alaska Native (28.7%) children, according to the report.

“Additional years of data are needed to assess whether obesity rates changed after the onset of the pandemic,” explained Ms. Bussel.
 

Digging deeper

Other studies included in this year’s report were specifically designed to measure the impact of the pandemic, and show a distinct rise in overweight and obesity, especially in younger children. For example, a retrospective cohort study using data from Kaiser Permanente Southern California showed the rate of overweight and obesity in children aged 5-11 years rose to 45.7% between March 2020 and January 2021, up from 36.2% before the pandemic.

Another of these studies, which was based on national electronic health records of more than 430,000 children, showed the obesity rate crept from 19.3% to 22.4% between August 2019 and August 2020.

“The lid we had been trying desperately to put on the obesity epidemic has come off again,” said Sandra G Hassink, MD, MSc, who is medical director of the American Academy of Pediatrics Institute for Healthy Childhood Weight.

“In the absence of COVID we had been seeing slow upticks in the numbers – and in some groups we’d been thinking maybe we were headed toward stabilization – but these numbers blow that out of the water ... COVID has escalated the rates,” she said in an interview.

“Unfortunately, these two crises – the COVID pandemic, the childhood obesity epidemic – in so many ways have exacerbated one another,” said Ms. Bussel. “It’s not a huge surprise that we’re seeing an increase in childhood obesity rates given the complete and utter disruption of every single system that circumscribes our lives.”
 

The systems that feed obesity

Addressing childhood obesity requires targeting far beyond healthy eating and physical activity, Ms. Bussel said.

“As important is whether that child has a safe place to call home. Does mom or dad or their care provider have a stable income? Is there reliable transportation? Is their access to health insurance? Is there access to high-quality health care? ... All of those factors influence the child and the family’s opportunities to live well, be healthy, and be at a healthy weight,” she noted.

The report includes a list of five main policy recommendations.

• Making free, universal school meal programs permanent.
• Extending eligibility for WIC, the Special Supplemental Nutrition Program for Women, Infants, and Children, to postpartum mothers and to children through age 6.
• Extending and expanding other programs, such as the Child Tax Credit.
• Closing the Medicaid coverage gap.
• Developing a consistent approach to collecting obesity data organized by race, ethnicity, and income level.

“Collectively, over at least the course of the last generation or two, our policy approach to obesity prevention has not been sufficient. But that doesn’t mean all of our policy approaches have been failures,” Ms. Bussel said during an interview. “Policy change does not always need to be dramatic to have a real impact on families.”

Fighting complacency

For Dr. Hassink, one of the barriers to change is society’s level of acceptance. She said an identifiable explanation for pandemic weight gain doesn’t mean society should simply shrug it off.

“If we regarded childhood obesity as the population level catastrophe that it is for chronic disease maybe people would be activated around these policy changes,” she said.

“We’re accepting a disease process that wreaks havoc on people,” noted Dr. Hassink, who was not involved in the new report. “I think it’s hard for people to realize the magnitude of the disease burden that we’re seeing. If you’re in a weight management clinic or any pediatrician’s office you would see it – you would see kids coming in with liver disease, 9-year-olds on [continuous positive airway pressure] for sleep apnea, kids needing their hips pinned because they had a hip fracture because of obesity.

“So, those of us that see the disease burden see what’s behind those numbers. The sadness of what we’re talking about is we know a lot about what could push the dial and help reduce this epidemic and we’re not doing what we already know,” added Dr. Hassink.

Ms. Bussel and Dr. Hassink reported no conflicts.

A newly published consensus statement on the management of type 1 diabetes in adults addresses the unique clinical needs of the population compared with those of children with type 1 diabetes or adults with type 2 diabetes.

“The focus on adults is kind of new and it is important. ... I do think it’s a bit of a forgotten population. Whenever we talk about diabetes in adults it’s assumed to be about type 2,” document coauthor M. Sue Kirkman, MD, said in an interview.

The document covers diagnosis of type 1 diabetes, goals and targets, schedule of care, self-management education and lifestyle, glucose monitoring, insulin therapy, hypoglycemia, psychosocial care, diabetic ketoacidosis (DKA), pancreas transplant/islet cell transplantation, adjunctive therapies, special populations (pregnant, older, hospitalized), and emergent and future perspectives.

Initially presented in draft form in June at the American Diabetes Association (ADA) 81st scientific sessions, the final version of the joint ADA/EASD statement was presented Oct. 1 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published in Diabetologia and Diabetes Care.

“We are aware of the many and rapid advances in the diagnosis and treatment of type 1 diabetes ... However, despite these advances, there is also a growing recognition of the psychosocial burden of living with type 1 diabetes,” writing group cochair Richard I.G. Holt, MB BChir, PhD, professor of diabetes and endocrinology at the University of Southampton, England, said when introducing the 90-minute EASD session.

“Although there is guidance for the management of type 1 diabetes, the aim of this report is to highlight the major areas that health care professionals should consider when managing adults with type 1 diabetes,” he added.

Noting that the joint EASD/ADA consensus report on type 2 diabetes has been “highly influential,” Dr. Holt said, “EASD and ADA recognized the need to develop a comparable consensus report specifically addressing type 1 diabetes.”

The overriding goals, Dr. Holt said, are to “support people with type 1 diabetes to live a long and healthy life” with four specific strategies: delivery of insulin to keep glucose levels as close to target as possible to prevent complications while minimizing hypoglycemia and preventing DKA; managing cardiovascular risk factors; minimizing psychosocial burden; and promoting psychological well-being.
 

Diagnostic algorithm

Another coauthor, J. Hans de Vries, MD, PhD, professor of internal medicine at the University of Amsterdam, explained the recommended approach to distinguishing type 1 diabetes from type 2 diabetes or monogenic diabetes in adults, which is often a clinical challenge.

This also was the topic prompting the most questions during the EASD session.

“Especially in adults, misdiagnosis of type of diabetes is common, occurring in up to 40% of patients diagnosed after the age of 30 years,” Dr. de Vries said.

Among the many reasons for the confusion are that C-peptide levels, a reflection of endogenous insulin secretion, can still be relatively high at the time of clinical onset of type 1 diabetes, but islet antibodies don’t have 100% positive predictive value.

Obesity and type 2 diabetes are increasingly seen at younger ages, and DKA can occur in type 2 diabetes (“ketosis-prone”). In addition, monogenic forms of diabetes can be disguised as type 1 diabetes.

“So, we thought there was a need for a diagnostic algorithm,” Dr. de Vries said, adding that the algorithm – displayed as a graphic in the statement – is only for adults in whom type 1 diabetes is suspected, not other types. Also, it’s based on data from White European populations.

The first step is to test islet autoantibodies. If positive, the diagnosis of type 1 diabetes can be made. If negative and the person is younger than 35 years and without signs of type 2 diabetes, testing C-peptide is advised. If that’s below 200 pmol/L, type 1 diabetes is the diagnosis. If above 200 pmol/L, genetic testing for monogenic diabetes is advised. If there are signs of type 2 diabetes and/or the person is over age 35, type 2 diabetes is the most likely diagnosis.

And if uncertainty remains, the recommendation is to try noninsulin therapy and retest C-peptide again in 3 years, as by that time it will be below 200 pmol/L in a person with type 1 diabetes.

Dr. Kirkman commented regarding the algorithm: “It’s very much from a European population perspective. In some ways that’s a limitation, especially in the U.S. where the population is diverse, but I do think it’s still useful to help guide people through how to think about somebody who presents as an adult where it’s not obviously type 2 or type 1 ... There is a lot of in-between stuff.”
 

Psychosocial support: Essential but often overlooked

Frank J. Snoek, PhD, professor of psychology at Amsterdam University Medical Centers, Vrije Universiteit, presented the section on behavioral and psychosocial care. He pointed out that diabetes-related emotional distress is reported by 20%-40% of adults with type 1 diabetes, and that the risk of such distress is especially high at the time of diagnosis and when complications develop.

About 15% of people with type 1 diabetes have depression, which is linked to elevated A1c levels, increased complication risk, and mortality. Anxiety also is very common and linked with diabetes-specific fears including hypoglycemia. Eating disorders are more prevalent among people with type 1 diabetes than in the general population and can further complicate diabetes management.

Recommendations include periodic evaluation of psychological health and social barriers to self-management and having clear referral pathways and access to psychological or psychiatric care for individuals in need. “All members of the diabetes care team have a responsibility when it comes to offering psychosocial support as part of ongoing diabetes care and education.”

Dr. Kirkman had identified this section as noteworthy: “I think the focus on psychosocial care and making that an ongoing part of diabetes care and assessment is important.”

More data needed on diets, many other areas

During the discussion, several attendees asked about low-carbohydrate diets, embraced by many individuals with type 1 diabetes.

The document states: “While low-carbohydrate and very low-carbohydrate eating patterns have become increasingly popular and reduce A1c levels in the short term, it is important to incorporate these in conjunction with healthy eating guidelines. Additional components of the meal, including high fat and/or high protein, may contribute to delayed hyperglycemia and the need for insulin dose adjustments. Since this is highly variable between individuals, postprandial glucose measurements for up to 3 hours or more may be needed to determine initial dose adjustments.”

Beyond that, Tomasz Klupa, MD, PhD, of the department of metabolic diseases, Jagiellonian University, Krakow, Poland, responded: “We don’t have much data on low-carb diets in type 1 diabetes. ... Compliance to those diets is pretty poor. We don’t have long-term follow-up and the studies are simply not conclusive. Initial results do show reductions in body weight and A1c, but with time the compliance goes down dramatically.”

“Certainly, when we think of low-carb diets, we have to meet our patients where they are,” said Amy Hess-Fischl, a nutritionist and certified diabetes care and education specialist at the University of Chicago. “We don’t have enough data to really say there’s positive long-term evidence. But we can find a happy medium to find some benefits in glycemic and weight control. ... It’s really that collaboration with that person to identify what’s going to work for them in a healthy way.”

The EASD session concluded with writing group cochair Anne L. Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles, summing up the many other knowledge gaps, including personalizing use of diabetes technology, the problems of health disparities and lack of access to care, and the feasibility of prevention and/or cure.  

She observed: “There is no one-size-fits-all approach to diabetes care, and the more we can individualize our approaches, the more successful we are likely to be. ... Hopefully this consensus statement has pushed the bar a bit higher, telling the powers that be that people with type 1 diabetes need and deserve the best.

“We have a very long way to go before all of our patients reach their goals and health equity is achieved. ... We need to provide each and every person the access to the care we describe in this consensus statement, so that all can prosper and thrive and look forward to a long and healthy life lived with type 1 diabetes.”  

Dr. Holt has financial relationships with Novo Nordisk, Abbott, Eli Lilly, Otsuka, and Roche. Dr. de Vries has financial relationships with Afon, Eli Lilly, Novo Nordisk, Adocia, and Zealand Pharma. Ms. Hess-Fischl has financial relationships with Abbott Diabetes Care and Xeris. Dr. Klupa has financial relationships with numerous drug and device companies. Dr. Snoek has financial relationships with Abbott, Eli Lilly, Sanofi, and Novo Nordisk. Dr. Peters has financial relationships with Abbott Diabetes Care, Dexcom, Eli Lilly, Insulet, Novo Nordisk, Medscape, and Zealand Pharmaceuticals. She holds stock options in Omada Health and Livongo and is a special government employee of the Food and Drug Administration.
 

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

A newly published consensus statement on the management of type 1 diabetes in adults addresses the unique clinical needs of the population compared with those of children with type 1 diabetes or adults with type 2 diabetes.

“The focus on adults is kind of new and it is important. ... I do think it’s a bit of a forgotten population. Whenever we talk about diabetes in adults it’s assumed to be about type 2,” document coauthor M. Sue Kirkman, MD, said in an interview.

The document covers diagnosis of type 1 diabetes, goals and targets, schedule of care, self-management education and lifestyle, glucose monitoring, insulin therapy, hypoglycemia, psychosocial care, diabetic ketoacidosis (DKA), pancreas transplant/islet cell transplantation, adjunctive therapies, special populations (pregnant, older, hospitalized), and emergent and future perspectives.

Initially presented in draft form in June at the American Diabetes Association (ADA) 81st scientific sessions, the final version of the joint ADA/EASD statement was presented Oct. 1 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published in Diabetologia and Diabetes Care.

“We are aware of the many and rapid advances in the diagnosis and treatment of type 1 diabetes ... However, despite these advances, there is also a growing recognition of the psychosocial burden of living with type 1 diabetes,” writing group cochair Richard I.G. Holt, MB BChir, PhD, professor of diabetes and endocrinology at the University of Southampton, England, said when introducing the 90-minute EASD session.

“Although there is guidance for the management of type 1 diabetes, the aim of this report is to highlight the major areas that health care professionals should consider when managing adults with type 1 diabetes,” he added.

Noting that the joint EASD/ADA consensus report on type 2 diabetes has been “highly influential,” Dr. Holt said, “EASD and ADA recognized the need to develop a comparable consensus report specifically addressing type 1 diabetes.”

The overriding goals, Dr. Holt said, are to “support people with type 1 diabetes to live a long and healthy life” with four specific strategies: delivery of insulin to keep glucose levels as close to target as possible to prevent complications while minimizing hypoglycemia and preventing DKA; managing cardiovascular risk factors; minimizing psychosocial burden; and promoting psychological well-being.
 

Diagnostic algorithm

Another coauthor, J. Hans de Vries, MD, PhD, professor of internal medicine at the University of Amsterdam, explained the recommended approach to distinguishing type 1 diabetes from type 2 diabetes or monogenic diabetes in adults, which is often a clinical challenge.

This also was the topic prompting the most questions during the EASD session.

“Especially in adults, misdiagnosis of type of diabetes is common, occurring in up to 40% of patients diagnosed after the age of 30 years,” Dr. de Vries said.

Among the many reasons for the confusion are that C-peptide levels, a reflection of endogenous insulin secretion, can still be relatively high at the time of clinical onset of type 1 diabetes, but islet antibodies don’t have 100% positive predictive value.

Obesity and type 2 diabetes are increasingly seen at younger ages, and DKA can occur in type 2 diabetes (“ketosis-prone”). In addition, monogenic forms of diabetes can be disguised as type 1 diabetes.

“So, we thought there was a need for a diagnostic algorithm,” Dr. de Vries said, adding that the algorithm – displayed as a graphic in the statement – is only for adults in whom type 1 diabetes is suspected, not other types. Also, it’s based on data from White European populations.

The first step is to test islet autoantibodies. If positive, the diagnosis of type 1 diabetes can be made. If negative and the person is younger than 35 years and without signs of type 2 diabetes, testing C-peptide is advised. If that’s below 200 pmol/L, type 1 diabetes is the diagnosis. If above 200 pmol/L, genetic testing for monogenic diabetes is advised. If there are signs of type 2 diabetes and/or the person is over age 35, type 2 diabetes is the most likely diagnosis.

And if uncertainty remains, the recommendation is to try noninsulin therapy and retest C-peptide again in 3 years, as by that time it will be below 200 pmol/L in a person with type 1 diabetes.

Dr. Kirkman commented regarding the algorithm: “It’s very much from a European population perspective. In some ways that’s a limitation, especially in the U.S. where the population is diverse, but I do think it’s still useful to help guide people through how to think about somebody who presents as an adult where it’s not obviously type 2 or type 1 ... There is a lot of in-between stuff.”
 

Psychosocial support: Essential but often overlooked

Frank J. Snoek, PhD, professor of psychology at Amsterdam University Medical Centers, Vrije Universiteit, presented the section on behavioral and psychosocial care. He pointed out that diabetes-related emotional distress is reported by 20%-40% of adults with type 1 diabetes, and that the risk of such distress is especially high at the time of diagnosis and when complications develop.

About 15% of people with type 1 diabetes have depression, which is linked to elevated A1c levels, increased complication risk, and mortality. Anxiety also is very common and linked with diabetes-specific fears including hypoglycemia. Eating disorders are more prevalent among people with type 1 diabetes than in the general population and can further complicate diabetes management.

Recommendations include periodic evaluation of psychological health and social barriers to self-management and having clear referral pathways and access to psychological or psychiatric care for individuals in need. “All members of the diabetes care team have a responsibility when it comes to offering psychosocial support as part of ongoing diabetes care and education.”

Dr. Kirkman had identified this section as noteworthy: “I think the focus on psychosocial care and making that an ongoing part of diabetes care and assessment is important.”

More data needed on diets, many other areas

During the discussion, several attendees asked about low-carbohydrate diets, embraced by many individuals with type 1 diabetes.

The document states: “While low-carbohydrate and very low-carbohydrate eating patterns have become increasingly popular and reduce A1c levels in the short term, it is important to incorporate these in conjunction with healthy eating guidelines. Additional components of the meal, including high fat and/or high protein, may contribute to delayed hyperglycemia and the need for insulin dose adjustments. Since this is highly variable between individuals, postprandial glucose measurements for up to 3 hours or more may be needed to determine initial dose adjustments.”

Beyond that, Tomasz Klupa, MD, PhD, of the department of metabolic diseases, Jagiellonian University, Krakow, Poland, responded: “We don’t have much data on low-carb diets in type 1 diabetes. ... Compliance to those diets is pretty poor. We don’t have long-term follow-up and the studies are simply not conclusive. Initial results do show reductions in body weight and A1c, but with time the compliance goes down dramatically.”

“Certainly, when we think of low-carb diets, we have to meet our patients where they are,” said Amy Hess-Fischl, a nutritionist and certified diabetes care and education specialist at the University of Chicago. “We don’t have enough data to really say there’s positive long-term evidence. But we can find a happy medium to find some benefits in glycemic and weight control. ... It’s really that collaboration with that person to identify what’s going to work for them in a healthy way.”

The EASD session concluded with writing group cochair Anne L. Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles, summing up the many other knowledge gaps, including personalizing use of diabetes technology, the problems of health disparities and lack of access to care, and the feasibility of prevention and/or cure.  

She observed: “There is no one-size-fits-all approach to diabetes care, and the more we can individualize our approaches, the more successful we are likely to be. ... Hopefully this consensus statement has pushed the bar a bit higher, telling the powers that be that people with type 1 diabetes need and deserve the best.

“We have a very long way to go before all of our patients reach their goals and health equity is achieved. ... We need to provide each and every person the access to the care we describe in this consensus statement, so that all can prosper and thrive and look forward to a long and healthy life lived with type 1 diabetes.”  

Dr. Holt has financial relationships with Novo Nordisk, Abbott, Eli Lilly, Otsuka, and Roche. Dr. de Vries has financial relationships with Afon, Eli Lilly, Novo Nordisk, Adocia, and Zealand Pharma. Ms. Hess-Fischl has financial relationships with Abbott Diabetes Care and Xeris. Dr. Klupa has financial relationships with numerous drug and device companies. Dr. Snoek has financial relationships with Abbott, Eli Lilly, Sanofi, and Novo Nordisk. Dr. Peters has financial relationships with Abbott Diabetes Care, Dexcom, Eli Lilly, Insulet, Novo Nordisk, Medscape, and Zealand Pharmaceuticals. She holds stock options in Omada Health and Livongo and is a special government employee of the Food and Drug Administration.
 

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

A newly published consensus statement on the management of type 1 diabetes in adults addresses the unique clinical needs of the population compared with those of children with type 1 diabetes or adults with type 2 diabetes.

“The focus on adults is kind of new and it is important. ... I do think it’s a bit of a forgotten population. Whenever we talk about diabetes in adults it’s assumed to be about type 2,” document coauthor M. Sue Kirkman, MD, said in an interview.

The document covers diagnosis of type 1 diabetes, goals and targets, schedule of care, self-management education and lifestyle, glucose monitoring, insulin therapy, hypoglycemia, psychosocial care, diabetic ketoacidosis (DKA), pancreas transplant/islet cell transplantation, adjunctive therapies, special populations (pregnant, older, hospitalized), and emergent and future perspectives.

Initially presented in draft form in June at the American Diabetes Association (ADA) 81st scientific sessions, the final version of the joint ADA/EASD statement was presented Oct. 1 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published in Diabetologia and Diabetes Care.

“We are aware of the many and rapid advances in the diagnosis and treatment of type 1 diabetes ... However, despite these advances, there is also a growing recognition of the psychosocial burden of living with type 1 diabetes,” writing group cochair Richard I.G. Holt, MB BChir, PhD, professor of diabetes and endocrinology at the University of Southampton, England, said when introducing the 90-minute EASD session.

“Although there is guidance for the management of type 1 diabetes, the aim of this report is to highlight the major areas that health care professionals should consider when managing adults with type 1 diabetes,” he added.

Noting that the joint EASD/ADA consensus report on type 2 diabetes has been “highly influential,” Dr. Holt said, “EASD and ADA recognized the need to develop a comparable consensus report specifically addressing type 1 diabetes.”

The overriding goals, Dr. Holt said, are to “support people with type 1 diabetes to live a long and healthy life” with four specific strategies: delivery of insulin to keep glucose levels as close to target as possible to prevent complications while minimizing hypoglycemia and preventing DKA; managing cardiovascular risk factors; minimizing psychosocial burden; and promoting psychological well-being.
 

Diagnostic algorithm

Another coauthor, J. Hans de Vries, MD, PhD, professor of internal medicine at the University of Amsterdam, explained the recommended approach to distinguishing type 1 diabetes from type 2 diabetes or monogenic diabetes in adults, which is often a clinical challenge.

This also was the topic prompting the most questions during the EASD session.

“Especially in adults, misdiagnosis of type of diabetes is common, occurring in up to 40% of patients diagnosed after the age of 30 years,” Dr. de Vries said.

Among the many reasons for the confusion are that C-peptide levels, a reflection of endogenous insulin secretion, can still be relatively high at the time of clinical onset of type 1 diabetes, but islet antibodies don’t have 100% positive predictive value.

Obesity and type 2 diabetes are increasingly seen at younger ages, and DKA can occur in type 2 diabetes (“ketosis-prone”). In addition, monogenic forms of diabetes can be disguised as type 1 diabetes.

“So, we thought there was a need for a diagnostic algorithm,” Dr. de Vries said, adding that the algorithm – displayed as a graphic in the statement – is only for adults in whom type 1 diabetes is suspected, not other types. Also, it’s based on data from White European populations.

The first step is to test islet autoantibodies. If positive, the diagnosis of type 1 diabetes can be made. If negative and the person is younger than 35 years and without signs of type 2 diabetes, testing C-peptide is advised. If that’s below 200 pmol/L, type 1 diabetes is the diagnosis. If above 200 pmol/L, genetic testing for monogenic diabetes is advised. If there are signs of type 2 diabetes and/or the person is over age 35, type 2 diabetes is the most likely diagnosis.

And if uncertainty remains, the recommendation is to try noninsulin therapy and retest C-peptide again in 3 years, as by that time it will be below 200 pmol/L in a person with type 1 diabetes.

Dr. Kirkman commented regarding the algorithm: “It’s very much from a European population perspective. In some ways that’s a limitation, especially in the U.S. where the population is diverse, but I do think it’s still useful to help guide people through how to think about somebody who presents as an adult where it’s not obviously type 2 or type 1 ... There is a lot of in-between stuff.”
 

Psychosocial support: Essential but often overlooked

Frank J. Snoek, PhD, professor of psychology at Amsterdam University Medical Centers, Vrije Universiteit, presented the section on behavioral and psychosocial care. He pointed out that diabetes-related emotional distress is reported by 20%-40% of adults with type 1 diabetes, and that the risk of such distress is especially high at the time of diagnosis and when complications develop.

About 15% of people with type 1 diabetes have depression, which is linked to elevated A1c levels, increased complication risk, and mortality. Anxiety also is very common and linked with diabetes-specific fears including hypoglycemia. Eating disorders are more prevalent among people with type 1 diabetes than in the general population and can further complicate diabetes management.

Recommendations include periodic evaluation of psychological health and social barriers to self-management and having clear referral pathways and access to psychological or psychiatric care for individuals in need. “All members of the diabetes care team have a responsibility when it comes to offering psychosocial support as part of ongoing diabetes care and education.”

Dr. Kirkman had identified this section as noteworthy: “I think the focus on psychosocial care and making that an ongoing part of diabetes care and assessment is important.”

More data needed on diets, many other areas

During the discussion, several attendees asked about low-carbohydrate diets, embraced by many individuals with type 1 diabetes.

The document states: “While low-carbohydrate and very low-carbohydrate eating patterns have become increasingly popular and reduce A1c levels in the short term, it is important to incorporate these in conjunction with healthy eating guidelines. Additional components of the meal, including high fat and/or high protein, may contribute to delayed hyperglycemia and the need for insulin dose adjustments. Since this is highly variable between individuals, postprandial glucose measurements for up to 3 hours or more may be needed to determine initial dose adjustments.”

Beyond that, Tomasz Klupa, MD, PhD, of the department of metabolic diseases, Jagiellonian University, Krakow, Poland, responded: “We don’t have much data on low-carb diets in type 1 diabetes. ... Compliance to those diets is pretty poor. We don’t have long-term follow-up and the studies are simply not conclusive. Initial results do show reductions in body weight and A1c, but with time the compliance goes down dramatically.”

“Certainly, when we think of low-carb diets, we have to meet our patients where they are,” said Amy Hess-Fischl, a nutritionist and certified diabetes care and education specialist at the University of Chicago. “We don’t have enough data to really say there’s positive long-term evidence. But we can find a happy medium to find some benefits in glycemic and weight control. ... It’s really that collaboration with that person to identify what’s going to work for them in a healthy way.”

The EASD session concluded with writing group cochair Anne L. Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles, summing up the many other knowledge gaps, including personalizing use of diabetes technology, the problems of health disparities and lack of access to care, and the feasibility of prevention and/or cure.  

She observed: “There is no one-size-fits-all approach to diabetes care, and the more we can individualize our approaches, the more successful we are likely to be. ... Hopefully this consensus statement has pushed the bar a bit higher, telling the powers that be that people with type 1 diabetes need and deserve the best.

“We have a very long way to go before all of our patients reach their goals and health equity is achieved. ... We need to provide each and every person the access to the care we describe in this consensus statement, so that all can prosper and thrive and look forward to a long and healthy life lived with type 1 diabetes.”  

Dr. Holt has financial relationships with Novo Nordisk, Abbott, Eli Lilly, Otsuka, and Roche. Dr. de Vries has financial relationships with Afon, Eli Lilly, Novo Nordisk, Adocia, and Zealand Pharma. Ms. Hess-Fischl has financial relationships with Abbott Diabetes Care and Xeris. Dr. Klupa has financial relationships with numerous drug and device companies. Dr. Snoek has financial relationships with Abbott, Eli Lilly, Sanofi, and Novo Nordisk. Dr. Peters has financial relationships with Abbott Diabetes Care, Dexcom, Eli Lilly, Insulet, Novo Nordisk, Medscape, and Zealand Pharmaceuticals. She holds stock options in Omada Health and Livongo and is a special government employee of the Food and Drug Administration.
 

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

Men had a much higher rate of death following bariatric surgery performed in Austria during 2010-2018, compared with women in a retrospective analysis of nearly 20,000 patients based on health insurance records.

The reason may be that men undergoing bariatric surgery have “worse overall health at the time of surgery” than women, Hannes Beiglböck, MD, suggested at the annual meeting of the European Association for the Study of Diabetes.

The results also showed that “men tend to be older [at time of surgery] and that might have the biggest impact on outcomes after bariatric surgery,” said Dr. Beiglböck, a researcher in the division of endocrinology and metabolism at the Medical University of Vienna.

The findings confirm those of prior studies in various worldwide locations, he noted; that is, men undergoing bariatric surgery tend to be older than women and have more comorbidities and perioperative mortality. 

Dr. Beiglböck also highlighted earlier reports that indicate “profound” sex-specific differences in why patients undergo bariatric surgery, with men often driven by a medical condition and women motivated by appearance.

Hence, for men, it may be important to focus on preoperative counseling to try to get them to think about bariatric surgery earlier, “which may improve their postsurgical mortality rate,” he observed.
 

Nearly threefold higher mortality among men

Dr. Beiglböck and associates used medical claims data filed with the Austrian health system, which includes nearly all residents. In 2010-2018, 19,901 Austrian patients underwent bariatric surgery, and researchers tracked their outcomes for a median of 5.4 years, through April 2020.

During the 9-year period, 74% of patients who underwent bariatric surgery were women, again, a finding consistent with prior reports from other countries.

The 5,220 men were an average of 41.8 years old, with 65% undergoing gastric bypass and 30% gastric banding. The 14,681 women were an average of 40.1 years old, with 70% undergoing gastric bypass and 22% gastric banding.

During follow-up, 367 patients (1.8%) died. Among men, the overall mortality rate was 2.6-fold higher, compared with women (1.3% vs. 3.4%) and average mortality per year was 2.8-fold higher (0.64% vs. 0.24%).

The rate of death on the day of surgery among men also substantially exceeded that of women (0.29% vs. 0.05%), as did death within 30 days of surgery (0.48% vs. 0.08%). All of these between-sex differences were significant.

Baseline prevalence of four categories of comorbidities and how these differed by sex among patients who died during follow-up was also examined. Underlying cardiovascular disease was prevalent in 299 patients (81% of the deceased group), 200 (54%) had a psychiatric disorder, 138 (38%) had diabetes, and 132 (36%) had a malignancy.

The prevalence of cardiovascular disease and psychiatric disorders was roughly the same in men and women. Men had a significantly higher prevalence of diabetes, and a higher proportion of women had a malignancy.
 

Consistent with U.S. studies

A U.S. report in 2015 documented a higher prevalence of comorbidities and more severe illness among men undergoing bariatric surgery, compared with women, noted session chair Zhila Semnani-Azad, PhD, a researcher in the department of nutrition at Harvard School of Public Health in Boston.

“I think the [Austrian] data presented have relevance to the U.S. population,” Dr. Semnani-Azad said in an interview.

“The main limitation of these univariate analyses is they don’t account for potential confounding variables that could affect the association, such as lifestyle variables, age, and family history. There is always potential for other variables” to influence apparent sex-specific associations, she commented. Another limitation is the small total number of deaths analyzed, at 367.

“These results are a good starting point for future studies. More work is needed to better understand the impact of comorbidities and sex on postsurgical mortality,” Dr. Semnani-Azad concluded.

Dr. Beiglböck and Dr. Semnani-Azad have reported no relevant financial relationships.

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

Men had a much higher rate of death following bariatric surgery performed in Austria during 2010-2018, compared with women in a retrospective analysis of nearly 20,000 patients based on health insurance records.

The reason may be that men undergoing bariatric surgery have “worse overall health at the time of surgery” than women, Hannes Beiglböck, MD, suggested at the annual meeting of the European Association for the Study of Diabetes.

The results also showed that “men tend to be older [at time of surgery] and that might have the biggest impact on outcomes after bariatric surgery,” said Dr. Beiglböck, a researcher in the division of endocrinology and metabolism at the Medical University of Vienna.

The findings confirm those of prior studies in various worldwide locations, he noted; that is, men undergoing bariatric surgery tend to be older than women and have more comorbidities and perioperative mortality. 

Dr. Beiglböck also highlighted earlier reports that indicate “profound” sex-specific differences in why patients undergo bariatric surgery, with men often driven by a medical condition and women motivated by appearance.

Hence, for men, it may be important to focus on preoperative counseling to try to get them to think about bariatric surgery earlier, “which may improve their postsurgical mortality rate,” he observed.
 

Nearly threefold higher mortality among men

Dr. Beiglböck and associates used medical claims data filed with the Austrian health system, which includes nearly all residents. In 2010-2018, 19,901 Austrian patients underwent bariatric surgery, and researchers tracked their outcomes for a median of 5.4 years, through April 2020.

During the 9-year period, 74% of patients who underwent bariatric surgery were women, again, a finding consistent with prior reports from other countries.

The 5,220 men were an average of 41.8 years old, with 65% undergoing gastric bypass and 30% gastric banding. The 14,681 women were an average of 40.1 years old, with 70% undergoing gastric bypass and 22% gastric banding.

During follow-up, 367 patients (1.8%) died. Among men, the overall mortality rate was 2.6-fold higher, compared with women (1.3% vs. 3.4%) and average mortality per year was 2.8-fold higher (0.64% vs. 0.24%).

The rate of death on the day of surgery among men also substantially exceeded that of women (0.29% vs. 0.05%), as did death within 30 days of surgery (0.48% vs. 0.08%). All of these between-sex differences were significant.

Baseline prevalence of four categories of comorbidities and how these differed by sex among patients who died during follow-up was also examined. Underlying cardiovascular disease was prevalent in 299 patients (81% of the deceased group), 200 (54%) had a psychiatric disorder, 138 (38%) had diabetes, and 132 (36%) had a malignancy.

The prevalence of cardiovascular disease and psychiatric disorders was roughly the same in men and women. Men had a significantly higher prevalence of diabetes, and a higher proportion of women had a malignancy.
 

Consistent with U.S. studies

A U.S. report in 2015 documented a higher prevalence of comorbidities and more severe illness among men undergoing bariatric surgery, compared with women, noted session chair Zhila Semnani-Azad, PhD, a researcher in the department of nutrition at Harvard School of Public Health in Boston.

“I think the [Austrian] data presented have relevance to the U.S. population,” Dr. Semnani-Azad said in an interview.

“The main limitation of these univariate analyses is they don’t account for potential confounding variables that could affect the association, such as lifestyle variables, age, and family history. There is always potential for other variables” to influence apparent sex-specific associations, she commented. Another limitation is the small total number of deaths analyzed, at 367.

“These results are a good starting point for future studies. More work is needed to better understand the impact of comorbidities and sex on postsurgical mortality,” Dr. Semnani-Azad concluded.

Dr. Beiglböck and Dr. Semnani-Azad have reported no relevant financial relationships.

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

Men had a much higher rate of death following bariatric surgery performed in Austria during 2010-2018, compared with women in a retrospective analysis of nearly 20,000 patients based on health insurance records.

The reason may be that men undergoing bariatric surgery have “worse overall health at the time of surgery” than women, Hannes Beiglböck, MD, suggested at the annual meeting of the European Association for the Study of Diabetes.

The results also showed that “men tend to be older [at time of surgery] and that might have the biggest impact on outcomes after bariatric surgery,” said Dr. Beiglböck, a researcher in the division of endocrinology and metabolism at the Medical University of Vienna.

The findings confirm those of prior studies in various worldwide locations, he noted; that is, men undergoing bariatric surgery tend to be older than women and have more comorbidities and perioperative mortality. 

Dr. Beiglböck also highlighted earlier reports that indicate “profound” sex-specific differences in why patients undergo bariatric surgery, with men often driven by a medical condition and women motivated by appearance.

Hence, for men, it may be important to focus on preoperative counseling to try to get them to think about bariatric surgery earlier, “which may improve their postsurgical mortality rate,” he observed.
 

Nearly threefold higher mortality among men

Dr. Beiglböck and associates used medical claims data filed with the Austrian health system, which includes nearly all residents. In 2010-2018, 19,901 Austrian patients underwent bariatric surgery, and researchers tracked their outcomes for a median of 5.4 years, through April 2020.

During the 9-year period, 74% of patients who underwent bariatric surgery were women, again, a finding consistent with prior reports from other countries.

The 5,220 men were an average of 41.8 years old, with 65% undergoing gastric bypass and 30% gastric banding. The 14,681 women were an average of 40.1 years old, with 70% undergoing gastric bypass and 22% gastric banding.

During follow-up, 367 patients (1.8%) died. Among men, the overall mortality rate was 2.6-fold higher, compared with women (1.3% vs. 3.4%) and average mortality per year was 2.8-fold higher (0.64% vs. 0.24%).

The rate of death on the day of surgery among men also substantially exceeded that of women (0.29% vs. 0.05%), as did death within 30 days of surgery (0.48% vs. 0.08%). All of these between-sex differences were significant.

Baseline prevalence of four categories of comorbidities and how these differed by sex among patients who died during follow-up was also examined. Underlying cardiovascular disease was prevalent in 299 patients (81% of the deceased group), 200 (54%) had a psychiatric disorder, 138 (38%) had diabetes, and 132 (36%) had a malignancy.

The prevalence of cardiovascular disease and psychiatric disorders was roughly the same in men and women. Men had a significantly higher prevalence of diabetes, and a higher proportion of women had a malignancy.
 

Consistent with U.S. studies

A U.S. report in 2015 documented a higher prevalence of comorbidities and more severe illness among men undergoing bariatric surgery, compared with women, noted session chair Zhila Semnani-Azad, PhD, a researcher in the department of nutrition at Harvard School of Public Health in Boston.

“I think the [Austrian] data presented have relevance to the U.S. population,” Dr. Semnani-Azad said in an interview.

“The main limitation of these univariate analyses is they don’t account for potential confounding variables that could affect the association, such as lifestyle variables, age, and family history. There is always potential for other variables” to influence apparent sex-specific associations, she commented. Another limitation is the small total number of deaths analyzed, at 367.

“These results are a good starting point for future studies. More work is needed to better understand the impact of comorbidities and sex on postsurgical mortality,” Dr. Semnani-Azad concluded.

Dr. Beiglböck and Dr. Semnani-Azad have reported no relevant financial relationships.

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

Statin use is associated with increased likelihood of diabetes progression, according to a new matched cohort analysis of data from the Department of Veteran Affairs.

Patients with diabetes who were on statins were more likely to begin taking insulin, become hyperglycemic, and to develop acute glycemic complications, and they were also more likely to be prescribed medications from more glucose-lowering drug classes.

Although previous observational and randomized, controlled trials suggested a link between statin use and diabetes progression, they typically relied on measures like insulin resistance, hemoglobin A1c, or fasting blood glucose levels. The new work, however, outlines changes in glycemic control.

The differences between fasting glucose levels and A1c levels were generally smaller than the differences in insulin sensitivity. But A1c and fasting glucose may underestimate a potential effect of statins, since physicians may escalate antidiabetes therapy in response to changes.

Insulin sensitivity is also rarely measured in real-world settings. “This study translated findings reported on academic studies of increased insulin resistance associated with statin use in research papers into everyday language of patient care. That is, patients on statins may need to escalate their antidiabetes therapy and there may have higher occurrences of uncontrolled diabetes events,” lead author Ishak Mansi, MD, said in an interview.

The study was published online in JAMA Internal Medicine.

Dr. Mansi, who is staff internist at the VA North Texas Health System and a professor of medicine and data and population science at the University of Texas, both in Dallas, cautioned about overinterpretation of the findings. “This is an observational study; therefore, it can establish association, but not causation.”
 

No reason to turn down statins

Dr. Mansi noted that it’s important to distinguish between those being prescribed statins as a primary preventive measurement against cardiovascular disease, and those starting statins with preexisting cardiovascular disease for secondary prevention. Statins are a key therapeutic class for secondary prevention. “Their benefits are tremendous, and we should emphasize that no patient should stop taking their statins based on our study – rather, they should talk to their doctors,” said Dr. Mansi.

The study is one of few to look at statin use and diabetes progression in patients who already have diabetes, and the first with a propensity-matched design, according to Om Ganda, MD, who was asked for comment. The results should not deter physicians from prescribing and patients from accepting statins. “Statins should not be withheld in people with high risk of cardiovascular disease, even for primary prevention, as the risk of progression of glucose levels is relatively much smaller and manageable, rather than risking cardiovascular events by stopping or not initiating when indicated by current guidelines,” said Dr. Ganda, who is the medical director of the Lipid Clinic at the Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston.

It’s possible that statins could increase risk of diabetes progression through promoting insulin resistance, and they may also reduce beta-cell function, which could in turn reduce insulin secretion, according to Dr. Ganda.

The study group included 83,022 pairs of statin users and matched controls, of whom 95% were men; 68.2% were White; 22% were Black; 2.1% were Native American, Pacific Islander, or Alaska Native; and 0.8% were Asian. The mean age was 60 years.

Some 56% of statin users experienced diabetes progression, compared with 48% of control patients (odds ratio, 1.37; P < .001). Progression was defined as intensification of diabetes therapy through new use of insulin or increase in the number of medication classes, new onset chronic hyperglycemia, or acute complications from hyperglycemia.

The association was seen in the component measures, including an increased number of glucose-lowering medication classes (OR, 1.41; P < .001), the frequency of new insulin use (OR, 1.16; P < .001), persistent glycemia (OR, 1.13; P < .001), and a new diagnosis of ketoacidosis or uncontrolled diabetes (OR, 1.24; P < .001).

There was also a dose-response relationship between the intensity of LDL cholesterol–lowering medication and diabetes progression.
 

More research needed

The findings don’t necessarily have a strong clinical impact, but the researchers hope it pushes toward greater personalization of statin treatment. The benefits of statins have been well studied, but their potential harms have not received the same attention. Dr. Mansi hopes to learn more about which populations stand to gain the most for primary cardiovascular disease prevention, such as older versus younger populations, healthier or sicker patients, and those with well-controlled versus uncontrolled diabetes. “Answering these questions [would] impact hundreds of millions of patients and cannot be postponed,” said Dr. Mansi. He also called for dedicated funding for research into the adverse events of frequently used medications.

Dr. Mansi and Dr. Ganda have no relevant financial disclosures.

Statin use is associated with increased likelihood of diabetes progression, according to a new matched cohort analysis of data from the Department of Veteran Affairs.

Patients with diabetes who were on statins were more likely to begin taking insulin, become hyperglycemic, and to develop acute glycemic complications, and they were also more likely to be prescribed medications from more glucose-lowering drug classes.

Although previous observational and randomized, controlled trials suggested a link between statin use and diabetes progression, they typically relied on measures like insulin resistance, hemoglobin A1c, or fasting blood glucose levels. The new work, however, outlines changes in glycemic control.

The differences between fasting glucose levels and A1c levels were generally smaller than the differences in insulin sensitivity. But A1c and fasting glucose may underestimate a potential effect of statins, since physicians may escalate antidiabetes therapy in response to changes.

Insulin sensitivity is also rarely measured in real-world settings. “This study translated findings reported on academic studies of increased insulin resistance associated with statin use in research papers into everyday language of patient care. That is, patients on statins may need to escalate their antidiabetes therapy and there may have higher occurrences of uncontrolled diabetes events,” lead author Ishak Mansi, MD, said in an interview.

The study was published online in JAMA Internal Medicine.

Dr. Mansi, who is staff internist at the VA North Texas Health System and a professor of medicine and data and population science at the University of Texas, both in Dallas, cautioned about overinterpretation of the findings. “This is an observational study; therefore, it can establish association, but not causation.”
 

No reason to turn down statins

Dr. Mansi noted that it’s important to distinguish between those being prescribed statins as a primary preventive measurement against cardiovascular disease, and those starting statins with preexisting cardiovascular disease for secondary prevention. Statins are a key therapeutic class for secondary prevention. “Their benefits are tremendous, and we should emphasize that no patient should stop taking their statins based on our study – rather, they should talk to their doctors,” said Dr. Mansi.

The study is one of few to look at statin use and diabetes progression in patients who already have diabetes, and the first with a propensity-matched design, according to Om Ganda, MD, who was asked for comment. The results should not deter physicians from prescribing and patients from accepting statins. “Statins should not be withheld in people with high risk of cardiovascular disease, even for primary prevention, as the risk of progression of glucose levels is relatively much smaller and manageable, rather than risking cardiovascular events by stopping or not initiating when indicated by current guidelines,” said Dr. Ganda, who is the medical director of the Lipid Clinic at the Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston.

It’s possible that statins could increase risk of diabetes progression through promoting insulin resistance, and they may also reduce beta-cell function, which could in turn reduce insulin secretion, according to Dr. Ganda.

The study group included 83,022 pairs of statin users and matched controls, of whom 95% were men; 68.2% were White; 22% were Black; 2.1% were Native American, Pacific Islander, or Alaska Native; and 0.8% were Asian. The mean age was 60 years.

Some 56% of statin users experienced diabetes progression, compared with 48% of control patients (odds ratio, 1.37; P < .001). Progression was defined as intensification of diabetes therapy through new use of insulin or increase in the number of medication classes, new onset chronic hyperglycemia, or acute complications from hyperglycemia.

The association was seen in the component measures, including an increased number of glucose-lowering medication classes (OR, 1.41; P < .001), the frequency of new insulin use (OR, 1.16; P < .001), persistent glycemia (OR, 1.13; P < .001), and a new diagnosis of ketoacidosis or uncontrolled diabetes (OR, 1.24; P < .001).

There was also a dose-response relationship between the intensity of LDL cholesterol–lowering medication and diabetes progression.
 

More research needed

The findings don’t necessarily have a strong clinical impact, but the researchers hope it pushes toward greater personalization of statin treatment. The benefits of statins have been well studied, but their potential harms have not received the same attention. Dr. Mansi hopes to learn more about which populations stand to gain the most for primary cardiovascular disease prevention, such as older versus younger populations, healthier or sicker patients, and those with well-controlled versus uncontrolled diabetes. “Answering these questions [would] impact hundreds of millions of patients and cannot be postponed,” said Dr. Mansi. He also called for dedicated funding for research into the adverse events of frequently used medications.

Dr. Mansi and Dr. Ganda have no relevant financial disclosures.

Statin use is associated with increased likelihood of diabetes progression, according to a new matched cohort analysis of data from the Department of Veteran Affairs.

Patients with diabetes who were on statins were more likely to begin taking insulin, become hyperglycemic, and to develop acute glycemic complications, and they were also more likely to be prescribed medications from more glucose-lowering drug classes.

Although previous observational and randomized, controlled trials suggested a link between statin use and diabetes progression, they typically relied on measures like insulin resistance, hemoglobin A1c, or fasting blood glucose levels. The new work, however, outlines changes in glycemic control.

The differences between fasting glucose levels and A1c levels were generally smaller than the differences in insulin sensitivity. But A1c and fasting glucose may underestimate a potential effect of statins, since physicians may escalate antidiabetes therapy in response to changes.

Insulin sensitivity is also rarely measured in real-world settings. “This study translated findings reported on academic studies of increased insulin resistance associated with statin use in research papers into everyday language of patient care. That is, patients on statins may need to escalate their antidiabetes therapy and there may have higher occurrences of uncontrolled diabetes events,” lead author Ishak Mansi, MD, said in an interview.

The study was published online in JAMA Internal Medicine.

Dr. Mansi, who is staff internist at the VA North Texas Health System and a professor of medicine and data and population science at the University of Texas, both in Dallas, cautioned about overinterpretation of the findings. “This is an observational study; therefore, it can establish association, but not causation.”
 

No reason to turn down statins

Dr. Mansi noted that it’s important to distinguish between those being prescribed statins as a primary preventive measurement against cardiovascular disease, and those starting statins with preexisting cardiovascular disease for secondary prevention. Statins are a key therapeutic class for secondary prevention. “Their benefits are tremendous, and we should emphasize that no patient should stop taking their statins based on our study – rather, they should talk to their doctors,” said Dr. Mansi.

The study is one of few to look at statin use and diabetes progression in patients who already have diabetes, and the first with a propensity-matched design, according to Om Ganda, MD, who was asked for comment. The results should not deter physicians from prescribing and patients from accepting statins. “Statins should not be withheld in people with high risk of cardiovascular disease, even for primary prevention, as the risk of progression of glucose levels is relatively much smaller and manageable, rather than risking cardiovascular events by stopping or not initiating when indicated by current guidelines,” said Dr. Ganda, who is the medical director of the Lipid Clinic at the Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston.

It’s possible that statins could increase risk of diabetes progression through promoting insulin resistance, and they may also reduce beta-cell function, which could in turn reduce insulin secretion, according to Dr. Ganda.

The study group included 83,022 pairs of statin users and matched controls, of whom 95% were men; 68.2% were White; 22% were Black; 2.1% were Native American, Pacific Islander, or Alaska Native; and 0.8% were Asian. The mean age was 60 years.

Some 56% of statin users experienced diabetes progression, compared with 48% of control patients (odds ratio, 1.37; P < .001). Progression was defined as intensification of diabetes therapy through new use of insulin or increase in the number of medication classes, new onset chronic hyperglycemia, or acute complications from hyperglycemia.

The association was seen in the component measures, including an increased number of glucose-lowering medication classes (OR, 1.41; P < .001), the frequency of new insulin use (OR, 1.16; P < .001), persistent glycemia (OR, 1.13; P < .001), and a new diagnosis of ketoacidosis or uncontrolled diabetes (OR, 1.24; P < .001).

There was also a dose-response relationship between the intensity of LDL cholesterol–lowering medication and diabetes progression.
 

More research needed

The findings don’t necessarily have a strong clinical impact, but the researchers hope it pushes toward greater personalization of statin treatment. The benefits of statins have been well studied, but their potential harms have not received the same attention. Dr. Mansi hopes to learn more about which populations stand to gain the most for primary cardiovascular disease prevention, such as older versus younger populations, healthier or sicker patients, and those with well-controlled versus uncontrolled diabetes. “Answering these questions [would] impact hundreds of millions of patients and cannot be postponed,” said Dr. Mansi. He also called for dedicated funding for research into the adverse events of frequently used medications.

Dr. Mansi and Dr. Ganda have no relevant financial disclosures.

Medtronic has updated a previous recall of its MiniMed 600 series insulin pumps to include all with a potentially problematic clear retainer ring, not just those that appear damaged.

The U.S. Food and Drug Administration announced on Oct. 5 that Medtronic will now replace any MiniMed 600 series pump that has a clear retainer ring with an updated pump that includes a black retainer ring at no extra charge, regardless of warranty status.

In November 2019, Medtronic first advised patients to examine their pumps for potential damage to the ring, and to contact the company if it appeared to be loose, damaged, or missing. In February 2020, the FDA designated the recall as class 1, “the most serious type of recall,” for which use of the devices “may cause serious injuries or death.”

In this case, one potential risk is hyperglycemia. This can occur if the reservoir isn’t properly locked into place by the retainer ring, and insulin isn’t infused into the body. That, in turn, can lead to diabetic ketoacidosis. Another risk is hypoglycemia, which could result from over-delivery of insulin if the retainer ring breaks or detaches and the user inserts the reservoir back into the pump with the infusion set still connected to the body.

While serious injuries and deaths have been reported with the use of Minimed series 600 insulin pumps, “those adverse events may not have been directly related to the damaged clear retainer rings that are the basis for this recall,” according to the FDA notice. Nonetheless, lawsuits have reportedly been filed.

The new update is not a result of any new issues, Medtronic spokesperson Pamela Reese told this news organization. “Medtronic will proactively replace all MiniMed 600 series insulin pumps with the clear retainer ring design with an equivalent pump that has an updated black retainer ring design, which is designed to better withstand damage sustained by an accidental drop or bump on a hard surface.”

She added, “As we analyze the information that we continuously collect on the safety and performance of our insulin pumps, we recognize that patients who are still using the clear retainer ring could potentially encounter future problems. Therefore, we are currently accelerating our replacement as inventory allows over the coming months to eliminate any potential performance concerns and optimize patient safety and experience.”

The company has replaced nearly half of the clear retainer ring pumps that were in use since November 2019, she said.

The specific insulin pump products are the model 630G, distributed between September 2016 and February 2020; and the 670G, distributed between May 2015 and December 2020. The 630G is approved for people aged 16 years and older, and the 670G – which works with a continuous glucose monitor in a “hybrid closed-loop system – is available for people with type 1 diabetes as young as 7 years of age.

Medtronic has updated a previous recall of its MiniMed 600 series insulin pumps to include all with a potentially problematic clear retainer ring, not just those that appear damaged.

The U.S. Food and Drug Administration announced on Oct. 5 that Medtronic will now replace any MiniMed 600 series pump that has a clear retainer ring with an updated pump that includes a black retainer ring at no extra charge, regardless of warranty status.

In November 2019, Medtronic first advised patients to examine their pumps for potential damage to the ring, and to contact the company if it appeared to be loose, damaged, or missing. In February 2020, the FDA designated the recall as class 1, “the most serious type of recall,” for which use of the devices “may cause serious injuries or death.”

In this case, one potential risk is hyperglycemia. This can occur if the reservoir isn’t properly locked into place by the retainer ring, and insulin isn’t infused into the body. That, in turn, can lead to diabetic ketoacidosis. Another risk is hypoglycemia, which could result from over-delivery of insulin if the retainer ring breaks or detaches and the user inserts the reservoir back into the pump with the infusion set still connected to the body.

While serious injuries and deaths have been reported with the use of Minimed series 600 insulin pumps, “those adverse events may not have been directly related to the damaged clear retainer rings that are the basis for this recall,” according to the FDA notice. Nonetheless, lawsuits have reportedly been filed.

The new update is not a result of any new issues, Medtronic spokesperson Pamela Reese told this news organization. “Medtronic will proactively replace all MiniMed 600 series insulin pumps with the clear retainer ring design with an equivalent pump that has an updated black retainer ring design, which is designed to better withstand damage sustained by an accidental drop or bump on a hard surface.”

She added, “As we analyze the information that we continuously collect on the safety and performance of our insulin pumps, we recognize that patients who are still using the clear retainer ring could potentially encounter future problems. Therefore, we are currently accelerating our replacement as inventory allows over the coming months to eliminate any potential performance concerns and optimize patient safety and experience.”

The company has replaced nearly half of the clear retainer ring pumps that were in use since November 2019, she said.

The specific insulin pump products are the model 630G, distributed between September 2016 and February 2020; and the 670G, distributed between May 2015 and December 2020. The 630G is approved for people aged 16 years and older, and the 670G – which works with a continuous glucose monitor in a “hybrid closed-loop system – is available for people with type 1 diabetes as young as 7 years of age.

Medtronic has updated a previous recall of its MiniMed 600 series insulin pumps to include all with a potentially problematic clear retainer ring, not just those that appear damaged.

The U.S. Food and Drug Administration announced on Oct. 5 that Medtronic will now replace any MiniMed 600 series pump that has a clear retainer ring with an updated pump that includes a black retainer ring at no extra charge, regardless of warranty status.

In November 2019, Medtronic first advised patients to examine their pumps for potential damage to the ring, and to contact the company if it appeared to be loose, damaged, or missing. In February 2020, the FDA designated the recall as class 1, “the most serious type of recall,” for which use of the devices “may cause serious injuries or death.”

In this case, one potential risk is hyperglycemia. This can occur if the reservoir isn’t properly locked into place by the retainer ring, and insulin isn’t infused into the body. That, in turn, can lead to diabetic ketoacidosis. Another risk is hypoglycemia, which could result from over-delivery of insulin if the retainer ring breaks or detaches and the user inserts the reservoir back into the pump with the infusion set still connected to the body.

While serious injuries and deaths have been reported with the use of Minimed series 600 insulin pumps, “those adverse events may not have been directly related to the damaged clear retainer rings that are the basis for this recall,” according to the FDA notice. Nonetheless, lawsuits have reportedly been filed.

The new update is not a result of any new issues, Medtronic spokesperson Pamela Reese told this news organization. “Medtronic will proactively replace all MiniMed 600 series insulin pumps with the clear retainer ring design with an equivalent pump that has an updated black retainer ring design, which is designed to better withstand damage sustained by an accidental drop or bump on a hard surface.”

She added, “As we analyze the information that we continuously collect on the safety and performance of our insulin pumps, we recognize that patients who are still using the clear retainer ring could potentially encounter future problems. Therefore, we are currently accelerating our replacement as inventory allows over the coming months to eliminate any potential performance concerns and optimize patient safety and experience.”

The company has replaced nearly half of the clear retainer ring pumps that were in use since November 2019, she said.

The specific insulin pump products are the model 630G, distributed between September 2016 and February 2020; and the 670G, distributed between May 2015 and December 2020. The 630G is approved for people aged 16 years and older, and the 670G – which works with a continuous glucose monitor in a “hybrid closed-loop system – is available for people with type 1 diabetes as young as 7 years of age.

People with insulin-treated type 1 diabetes who had problems avoiding hypoglycemic episodes despite optimal care were helped significantly by a new psychoeducational program called HARPdoc, it was reported at the annual meeting of the European Association for the Study of Diabetes.

In a randomized controlled trial (RCT), both HARPdoc and the more established Blood Glucose Awareness Training (BGAT) were effective at reducing the number of severe hypoglycemia episodes seen, from five episodes at baseline to one at 1 year in both groups, and one and none at 2-years’ follow-up, respectively.

“HARPdoc is not superior to BGAT in its ability to restore hypoglycemia awareness and reduce severe hypoglycemia,” said Stephanie Amiel, MD, FRCP, the chief investigator for the trial. However, “it does reduce cognitive barriers to hypoglycemia avoidance, so it achieves what it set out to do.”

Dr. Amiel, professor of diabetes research at Kings College London, added that it was important to note that HARPdoc was better than BGAT at improving participants’ mental health, “producing a clinically important and sustainable reduction in diabetes distress, anxiety, and depression.”
 

What’s HARPdoc?

The Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia persisting despite optimised self-care (HARPdoc) was designed to specifically address why some people with type 1 diabetes find it difficult to avoid recurrent hypoglycemia.

“It’s a psychoeducational program with clinical knowledge about hypoglycemia and group learning, but also explicit topics on mindset and behavior change,” explained Nicole de Zoysa, DClinPsych, one of the clinical psychologists involved in the trial.

Over the course of the 6-week program, there are four group sessions (weeks 1-3, and week 6) and two individual sessions (weeks 4 and 5) ­that address important “cognitive barriers” or “thinking traps” to avoiding hypoglycemia that were identified during prior qualitative research.

HARPdoc is thus “an attempt to make sense of people’s reluctance or seeming reluctance to take action around hypoglycemia, Dr. de Zoysa said. The intervention draws on both cognitive behavioral theory “to work with the beliefs” and motivational interviewing “to work with the resistance.”
 

The HARPdoc RCT

Starting in 2017 and ending earlier this year, the HARPdoc RCT was a parallel group study conducted at three specialist diabetes centers in the United Kingdom and one in the United States.

A total of 99 adults with insulin-treated type 1 diabetes and impaired hypoglycemia awareness were enrolled – with 49 randomized to the HARPdoc arm and 50 to the BGAT arm. All had been offered technologies to help them potentially bring their hypoglycemia under better control, such as continuous glucose monitoring, insulin pumps, or closed loop systems, and received structured education on flexible insulin dosing.

The aim was to show superiority of the HARPdoc program over BGAT, in helping people avoid episodes of severe hypoglycemia, defined as episodes that needed other people’s intervention to help resolve.

BGAT is also a psychoeducation program that has been around since the 1980s but barely used in the United Kingdom, Dr. Amiel noted.

Baseline demographic characteristics were similar for the HARPdoc and BGAT arms: The mean age was 57 versus 52 years, there was a long (30+ years) duration of diabetes, over half of the participants were male, and almost all were White.
 

Primary endpoint not met, but still ‘impressive’

Although the primary endpoint of the trial was not met, the reductions in severe hypoglycemia seen are still “impressive,” said Ramzi Ajjan, MD, FRCP, of Leeds (England) University and Leeds Teaching Hospitals Trust.

“I was really blown away,” by the improvement in both study arms, said Dr. Ajjan, who was not involved in the trial. “These people have had proper clinical input,” he stressed, noting that both interventions worked, with no difference between them in terms of severe hypoglycemia.

Dr. Ajjan was not surprised by the better cognition scores measured using the A2A questionnaire seen with HARPdoc versus BGAT, as “this is what the intervention was designed to address.”

In terms of the mental health benefits seen, HARPdoc significantly reduced the level of diabetes distress as measured using the Problem Areas In Diabetes (PAID) questionnaire versus the BGAT intervention.

The PAID score was around 30 in both groups at baseline, this fell to about 26 at 1 year, and around 20 at 2 years in the HARPdoc group, which was significantly lower than the score seen in the BGAT group which rose slightly then fell back to baseline levels.

A similar pattern was seen in the levels of depression and anxiety, which were measured by the HADS-D and HADS-A instruments. So HARPdoc was more effective at improving psychological and mental health outcomes than BGAT, Dr. Ajjan observed.

The HARPdoc project is funded by the Juvenile Diabetes Research Foundation with additional support from the UK’s National Institute of Health Research. The HARPdoc RCT was jointly sponsored by King’s College London and King’s College Hospital NHS Foundation Trust. Dr. Amiel has served on advisory panels for Roche, Medtronic, and Novo Nordisk. Dr. de Zoysa did not state having any conflicts of interest. Dr. Ajjan disclosed that he has financial relationships with multiple pharmaceutical companies.

People with insulin-treated type 1 diabetes who had problems avoiding hypoglycemic episodes despite optimal care were helped significantly by a new psychoeducational program called HARPdoc, it was reported at the annual meeting of the European Association for the Study of Diabetes.

In a randomized controlled trial (RCT), both HARPdoc and the more established Blood Glucose Awareness Training (BGAT) were effective at reducing the number of severe hypoglycemia episodes seen, from five episodes at baseline to one at 1 year in both groups, and one and none at 2-years’ follow-up, respectively.

“HARPdoc is not superior to BGAT in its ability to restore hypoglycemia awareness and reduce severe hypoglycemia,” said Stephanie Amiel, MD, FRCP, the chief investigator for the trial. However, “it does reduce cognitive barriers to hypoglycemia avoidance, so it achieves what it set out to do.”

Dr. Amiel, professor of diabetes research at Kings College London, added that it was important to note that HARPdoc was better than BGAT at improving participants’ mental health, “producing a clinically important and sustainable reduction in diabetes distress, anxiety, and depression.”
 

What’s HARPdoc?

The Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia persisting despite optimised self-care (HARPdoc) was designed to specifically address why some people with type 1 diabetes find it difficult to avoid recurrent hypoglycemia.

“It’s a psychoeducational program with clinical knowledge about hypoglycemia and group learning, but also explicit topics on mindset and behavior change,” explained Nicole de Zoysa, DClinPsych, one of the clinical psychologists involved in the trial.

Over the course of the 6-week program, there are four group sessions (weeks 1-3, and week 6) and two individual sessions (weeks 4 and 5) ­that address important “cognitive barriers” or “thinking traps” to avoiding hypoglycemia that were identified during prior qualitative research.

HARPdoc is thus “an attempt to make sense of people’s reluctance or seeming reluctance to take action around hypoglycemia, Dr. de Zoysa said. The intervention draws on both cognitive behavioral theory “to work with the beliefs” and motivational interviewing “to work with the resistance.”
 

The HARPdoc RCT

Starting in 2017 and ending earlier this year, the HARPdoc RCT was a parallel group study conducted at three specialist diabetes centers in the United Kingdom and one in the United States.

A total of 99 adults with insulin-treated type 1 diabetes and impaired hypoglycemia awareness were enrolled – with 49 randomized to the HARPdoc arm and 50 to the BGAT arm. All had been offered technologies to help them potentially bring their hypoglycemia under better control, such as continuous glucose monitoring, insulin pumps, or closed loop systems, and received structured education on flexible insulin dosing.

The aim was to show superiority of the HARPdoc program over BGAT, in helping people avoid episodes of severe hypoglycemia, defined as episodes that needed other people’s intervention to help resolve.

BGAT is also a psychoeducation program that has been around since the 1980s but barely used in the United Kingdom, Dr. Amiel noted.

Baseline demographic characteristics were similar for the HARPdoc and BGAT arms: The mean age was 57 versus 52 years, there was a long (30+ years) duration of diabetes, over half of the participants were male, and almost all were White.
 

Primary endpoint not met, but still ‘impressive’

Although the primary endpoint of the trial was not met, the reductions in severe hypoglycemia seen are still “impressive,” said Ramzi Ajjan, MD, FRCP, of Leeds (England) University and Leeds Teaching Hospitals Trust.

“I was really blown away,” by the improvement in both study arms, said Dr. Ajjan, who was not involved in the trial. “These people have had proper clinical input,” he stressed, noting that both interventions worked, with no difference between them in terms of severe hypoglycemia.

Dr. Ajjan was not surprised by the better cognition scores measured using the A2A questionnaire seen with HARPdoc versus BGAT, as “this is what the intervention was designed to address.”

In terms of the mental health benefits seen, HARPdoc significantly reduced the level of diabetes distress as measured using the Problem Areas In Diabetes (PAID) questionnaire versus the BGAT intervention.

The PAID score was around 30 in both groups at baseline, this fell to about 26 at 1 year, and around 20 at 2 years in the HARPdoc group, which was significantly lower than the score seen in the BGAT group which rose slightly then fell back to baseline levels.

A similar pattern was seen in the levels of depression and anxiety, which were measured by the HADS-D and HADS-A instruments. So HARPdoc was more effective at improving psychological and mental health outcomes than BGAT, Dr. Ajjan observed.

The HARPdoc project is funded by the Juvenile Diabetes Research Foundation with additional support from the UK’s National Institute of Health Research. The HARPdoc RCT was jointly sponsored by King’s College London and King’s College Hospital NHS Foundation Trust. Dr. Amiel has served on advisory panels for Roche, Medtronic, and Novo Nordisk. Dr. de Zoysa did not state having any conflicts of interest. Dr. Ajjan disclosed that he has financial relationships with multiple pharmaceutical companies.

People with insulin-treated type 1 diabetes who had problems avoiding hypoglycemic episodes despite optimal care were helped significantly by a new psychoeducational program called HARPdoc, it was reported at the annual meeting of the European Association for the Study of Diabetes.

In a randomized controlled trial (RCT), both HARPdoc and the more established Blood Glucose Awareness Training (BGAT) were effective at reducing the number of severe hypoglycemia episodes seen, from five episodes at baseline to one at 1 year in both groups, and one and none at 2-years’ follow-up, respectively.

“HARPdoc is not superior to BGAT in its ability to restore hypoglycemia awareness and reduce severe hypoglycemia,” said Stephanie Amiel, MD, FRCP, the chief investigator for the trial. However, “it does reduce cognitive barriers to hypoglycemia avoidance, so it achieves what it set out to do.”

Dr. Amiel, professor of diabetes research at Kings College London, added that it was important to note that HARPdoc was better than BGAT at improving participants’ mental health, “producing a clinically important and sustainable reduction in diabetes distress, anxiety, and depression.”
 

What’s HARPdoc?

The Hypoglycaemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycaemia persisting despite optimised self-care (HARPdoc) was designed to specifically address why some people with type 1 diabetes find it difficult to avoid recurrent hypoglycemia.

“It’s a psychoeducational program with clinical knowledge about hypoglycemia and group learning, but also explicit topics on mindset and behavior change,” explained Nicole de Zoysa, DClinPsych, one of the clinical psychologists involved in the trial.

Over the course of the 6-week program, there are four group sessions (weeks 1-3, and week 6) and two individual sessions (weeks 4 and 5) ­that address important “cognitive barriers” or “thinking traps” to avoiding hypoglycemia that were identified during prior qualitative research.

HARPdoc is thus “an attempt to make sense of people’s reluctance or seeming reluctance to take action around hypoglycemia, Dr. de Zoysa said. The intervention draws on both cognitive behavioral theory “to work with the beliefs” and motivational interviewing “to work with the resistance.”
 

The HARPdoc RCT

Starting in 2017 and ending earlier this year, the HARPdoc RCT was a parallel group study conducted at three specialist diabetes centers in the United Kingdom and one in the United States.

A total of 99 adults with insulin-treated type 1 diabetes and impaired hypoglycemia awareness were enrolled – with 49 randomized to the HARPdoc arm and 50 to the BGAT arm. All had been offered technologies to help them potentially bring their hypoglycemia under better control, such as continuous glucose monitoring, insulin pumps, or closed loop systems, and received structured education on flexible insulin dosing.

The aim was to show superiority of the HARPdoc program over BGAT, in helping people avoid episodes of severe hypoglycemia, defined as episodes that needed other people’s intervention to help resolve.

BGAT is also a psychoeducation program that has been around since the 1980s but barely used in the United Kingdom, Dr. Amiel noted.

Baseline demographic characteristics were similar for the HARPdoc and BGAT arms: The mean age was 57 versus 52 years, there was a long (30+ years) duration of diabetes, over half of the participants were male, and almost all were White.
 

Primary endpoint not met, but still ‘impressive’

Although the primary endpoint of the trial was not met, the reductions in severe hypoglycemia seen are still “impressive,” said Ramzi Ajjan, MD, FRCP, of Leeds (England) University and Leeds Teaching Hospitals Trust.

“I was really blown away,” by the improvement in both study arms, said Dr. Ajjan, who was not involved in the trial. “These people have had proper clinical input,” he stressed, noting that both interventions worked, with no difference between them in terms of severe hypoglycemia.

Dr. Ajjan was not surprised by the better cognition scores measured using the A2A questionnaire seen with HARPdoc versus BGAT, as “this is what the intervention was designed to address.”

In terms of the mental health benefits seen, HARPdoc significantly reduced the level of diabetes distress as measured using the Problem Areas In Diabetes (PAID) questionnaire versus the BGAT intervention.

The PAID score was around 30 in both groups at baseline, this fell to about 26 at 1 year, and around 20 at 2 years in the HARPdoc group, which was significantly lower than the score seen in the BGAT group which rose slightly then fell back to baseline levels.

A similar pattern was seen in the levels of depression and anxiety, which were measured by the HADS-D and HADS-A instruments. So HARPdoc was more effective at improving psychological and mental health outcomes than BGAT, Dr. Ajjan observed.

The HARPdoc project is funded by the Juvenile Diabetes Research Foundation with additional support from the UK’s National Institute of Health Research. The HARPdoc RCT was jointly sponsored by King’s College London and King’s College Hospital NHS Foundation Trust. Dr. Amiel has served on advisory panels for Roche, Medtronic, and Novo Nordisk. Dr. de Zoysa did not state having any conflicts of interest. Dr. Ajjan disclosed that he has financial relationships with multiple pharmaceutical companies.