Diabetes

The incidence of gout was approximately 40% lower in diabetes patients who were prescribed sodium-glucose cotransporter 2 inhibitors (SGLT2) than it was in those who were prescribed glucagonlike peptide–1 receptor (GLP-1) agonists in a population-based new-user cohort study.

Hyperuricemia is a known cause of gout and common in type 2 diabetes patients. SGLT2 inhibitors may reduce the risk of gout by preventing the reabsorption of glucose and lowering serum uric acid levels; however, the impact on gout risk remains uncertain, wrote Michael Fralick, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

In a study published in the Annals of Internal Medicine, the researchers compared SGLT2 inhibitors and GLP-1 agonists in patients with type 2 diabetes to assess protection against gout.

The study population included adults with type 2 diabetes mellitus who had a new prescription for an SGTL2 inhibitor or GLP-1 agonist. The average age of the patients was 54 years; approximately half were women. Baseline characteristics were similar between the groups.

Overall, the researchers found a relative risk reduction of approximately 40% and an absolute risk reduction of approximately three fewer cases per 1,000 person-years in patients who received SGLT2 inhibitors, compared with those who received GLP-1 agonists. The incidence rate for gout in the SGLT2 and GLP-1 groups were 4.9 per 1,000 person-years and 7.8 per 1,000 person-years, respectively.

The study findings were limited by the investigators’ inability to measure potential confounding variables such as body mass index, alcohol use, and high purine diet; incomplete lab data on creatinine and hemoglobin A; and a low baseline risk for gout in the study population, the researchers noted. However, the results persisted across sensitivity analysis and, if replicated, suggest that “SGLT2 inhibitors might be an effective class of medication for the prevention of gout for patients with diabetes or metabolic disorders,” they wrote.

The study was supported in part by Brigham and Women’s Hospital; lead author Dr. Fralick disclosed funding from the Eliot Phillipson Clinician-Scientist Training Program at the University of Toronto and the Canadian Institutes of Health Research.

SOURCE: Fralick M et al. Ann Intern Med. 2020 Jan 14. doi: 10.7326/M19-2610.

The incidence of gout was approximately 40% lower in diabetes patients who were prescribed sodium-glucose cotransporter 2 inhibitors (SGLT2) than it was in those who were prescribed glucagonlike peptide–1 receptor (GLP-1) agonists in a population-based new-user cohort study.

Hyperuricemia is a known cause of gout and common in type 2 diabetes patients. SGLT2 inhibitors may reduce the risk of gout by preventing the reabsorption of glucose and lowering serum uric acid levels; however, the impact on gout risk remains uncertain, wrote Michael Fralick, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

In a study published in the Annals of Internal Medicine, the researchers compared SGLT2 inhibitors and GLP-1 agonists in patients with type 2 diabetes to assess protection against gout.

The study population included adults with type 2 diabetes mellitus who had a new prescription for an SGTL2 inhibitor or GLP-1 agonist. The average age of the patients was 54 years; approximately half were women. Baseline characteristics were similar between the groups.

Overall, the researchers found a relative risk reduction of approximately 40% and an absolute risk reduction of approximately three fewer cases per 1,000 person-years in patients who received SGLT2 inhibitors, compared with those who received GLP-1 agonists. The incidence rate for gout in the SGLT2 and GLP-1 groups were 4.9 per 1,000 person-years and 7.8 per 1,000 person-years, respectively.

The study findings were limited by the investigators’ inability to measure potential confounding variables such as body mass index, alcohol use, and high purine diet; incomplete lab data on creatinine and hemoglobin A; and a low baseline risk for gout in the study population, the researchers noted. However, the results persisted across sensitivity analysis and, if replicated, suggest that “SGLT2 inhibitors might be an effective class of medication for the prevention of gout for patients with diabetes or metabolic disorders,” they wrote.

The study was supported in part by Brigham and Women’s Hospital; lead author Dr. Fralick disclosed funding from the Eliot Phillipson Clinician-Scientist Training Program at the University of Toronto and the Canadian Institutes of Health Research.

SOURCE: Fralick M et al. Ann Intern Med. 2020 Jan 14. doi: 10.7326/M19-2610.

The incidence of gout was approximately 40% lower in diabetes patients who were prescribed sodium-glucose cotransporter 2 inhibitors (SGLT2) than it was in those who were prescribed glucagonlike peptide–1 receptor (GLP-1) agonists in a population-based new-user cohort study.

Hyperuricemia is a known cause of gout and common in type 2 diabetes patients. SGLT2 inhibitors may reduce the risk of gout by preventing the reabsorption of glucose and lowering serum uric acid levels; however, the impact on gout risk remains uncertain, wrote Michael Fralick, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

In a study published in the Annals of Internal Medicine, the researchers compared SGLT2 inhibitors and GLP-1 agonists in patients with type 2 diabetes to assess protection against gout.

The study population included adults with type 2 diabetes mellitus who had a new prescription for an SGTL2 inhibitor or GLP-1 agonist. The average age of the patients was 54 years; approximately half were women. Baseline characteristics were similar between the groups.

Overall, the researchers found a relative risk reduction of approximately 40% and an absolute risk reduction of approximately three fewer cases per 1,000 person-years in patients who received SGLT2 inhibitors, compared with those who received GLP-1 agonists. The incidence rate for gout in the SGLT2 and GLP-1 groups were 4.9 per 1,000 person-years and 7.8 per 1,000 person-years, respectively.

The study findings were limited by the investigators’ inability to measure potential confounding variables such as body mass index, alcohol use, and high purine diet; incomplete lab data on creatinine and hemoglobin A; and a low baseline risk for gout in the study population, the researchers noted. However, the results persisted across sensitivity analysis and, if replicated, suggest that “SGLT2 inhibitors might be an effective class of medication for the prevention of gout for patients with diabetes or metabolic disorders,” they wrote.

The study was supported in part by Brigham and Women’s Hospital; lead author Dr. Fralick disclosed funding from the Eliot Phillipson Clinician-Scientist Training Program at the University of Toronto and the Canadian Institutes of Health Research.

SOURCE: Fralick M et al. Ann Intern Med. 2020 Jan 14. doi: 10.7326/M19-2610.

LOS ANGELES – When it comes to the optimal treatment of patients with heart failure with preserved ejection fraction and diabetes, cardiologists like Mark T. Kearney, MB ChB, MD, remain stumped.

Courtesy Dr. Mark T. Kearney

“Over the years, the diagnosis of heart failure with preserved ejection fraction has been notoriously difficult [to treat], controversial, and ultimately involves aggressive catheterization of the heart to assess diastolic dysfunction, complex echocardiography, and invasive tests,” Dr. Kearney said at the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease. “These patients have an ejection fraction of over 50% and classic signs and symptoms of heart failure. Studies of beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers have been unsuccessful in this group of patients. We’re at the beginning of a journey in understanding this disorder, and it’s important, because more and more patients present to us with signs and symptoms of heart failure with an ejection fraction greater than 50%.”

In a recent analysis of 1,797 patients with chronic heart failure, Dr. Kearney, British Heart Foundation Professor of Cardiovascular and Diabetes Research at the Leeds (England) Institute of Cardiovascular and Metabolic Medicine, and colleagues examined whether beta-blockers and ACE inhibitors were associated with differential effects on mortality in patients with and without diabetes (Diabetes Care. 2018;41:136-42). Mean follow-up was 4 years.

For the ACE inhibitor component of the trial, the researchers correlated the dose of ramipril to outcomes and found that each milligram increase of ramipril reduced the risk of death by about 3%. “In the nondiabetic patients who did not receive an ACE inhibitor, mortality was about 60% – worse than most cancers,” Dr. Kearney said. “In patients with diabetes, there was a similar pattern. If you didn’t get an ACE inhibitor, mortality was 70%. So, if you get patients on an optimal dose of an ACE inhibitor, you improve their mortality substantially, whether they have diabetes or not.”

The beta-blocker component of the trial yielded similar results. Each milligram of bisoprolol reduced the risk of death over a mean of 4 years by about 3% in patients without diabetes and 9% in those with diabetes. “Among patients who did not receive a beta-blocker, the mortality was about 70% at 5 years – really terrible,” he said. “Every milligram of bisoprolol was associated with a reduction in mortality of about 9%. So, if a patient gets on an optimal dose of a beta-blocker and they have diabetes, it’s associated with prolongation of life over a year.”

Dr. Kearney said that patients often do not want to take an increased dose of a beta-blocker because of concerns about side effects, such as tiredness. “They ask me what the side effects of an increased dose would be. My answer is: ‘It will make you live longer.’ Usually, they’ll respond by agreeing to have a little bit more of the beta-blocker. The message here is, if you have a patient with ejection fraction heart failure and diabetes, get them on the optimal dose of a beta-blocker, even at the expense of an ACE inhibitor.”

In 2016, the European Society of Cardiology introduced guidelines for physicians to make a diagnosis of heart failure with preserved ejection fraction. The guidelines mandate that a diagnosis requires signs and symptoms of heart failure, elevated levels of natriuretic peptide, and echocardiographic abnormalities of cardiac structure and/or function in the presence of a left ventricular ejection fraction of 50% or more (Eur J Heart Fail. 2016;18[8]:891-975).

“Signs and symptoms of heart failure, elevated BNP [brain natriuretic peptide], and echocardiography allow us to make a diagnosis of heart failure with preserved ejection fraction,” Dr. Kearney, who is also dean of the Leeds University School of Medicine. “But we don’t know the outcome of these patients, we don’t know how to treat them, and we don’t know the impact on hospitalizations.”

In a large, unpublished cohort study conducted at Leeds, Dr. Kearney and colleagues evaluated how many patients met criteria for heart failure with reduced ejection fraction or heart failure with preserved ejection fraction after undergoing a BNP measurement. Ultimately, 959 patients met criteria. After assessment, 23% had no heart failure, 44% had heart failure with preserved ejection fraction, and 33% had heart failure with reduced ejection fraction. They found that patients with preserved ejection fraction were older (mean age, 84 years); were more likely to be female; and had less ischemia, less diabetes, and more hypertension. In addition, patients with preserved ejection fraction had significantly better survival than patients with reduced ejection fraction over 5 years follow-up.

“What was really interesting were the findings related to hospitalization,” he said. “All 959 patients accounted for 20,517 days in the hospital over 5 years, which is the equivalent of 1 patient occupying a hospital bed for 56 years. This disorder [heart failure with preserved ejection fraction], despite having a lower mortality than heart failure with reduced ejection fraction, leads to a significant burden on health care systems.”

Among patients with preserved ejection fraction, 82% were hospitalized for a noncardiovascular cause, 6.9% because of heart failure, and 11% were caused by other cardiovascular causes. Most of the hospital admissions were because of chest infections, falls, and other frailty-linked causes. “This link between systemic frailty and heart failure with preserved ejection fraction warrants further investigation,” Dr. Kearney said. “This is a major burden on patient hospital care.”

When the researchers examined outcomes in patients with and without diabetes, those with diabetes were younger, more likely to be male, and have a higher body mass index. They found that, in the presence of diabetes, mortality was increased in heart failure with preserved and reduced ejection fraction. “So, even at the age of 81 or 82, diabetes changes the pathophysiology of mortality in what was previously believed to be a benign disease,” he said.

In a subset analysis of patients with and without diabetes who were not taking a beta-blocker, there did not seem to be increased sympathetic activation in the patients with diabetes and heart failure with preserved ejection fraction, nor a difference in heart rate between the nondiabetic patients and patients with diabetes. However, among patients with heart failure with reduced ejection fraction, those with diabetes had an increased heart rate.

“Is heart failure with preserved ejection fraction in diabetes benign? I think the answer is no,” Dr. Kearney said. “It increases hospitalization and is a major burden on health care systems. What should we do? We deal with comorbidity and fall risk. It’s good old-fashioned doctoring, really. We address frailty and respiratory tract infections, but the key thing here is that we need more research.”

Dr. Kearney reported having no relevant financial disclosures.

[email protected]

LOS ANGELES – When it comes to the optimal treatment of patients with heart failure with preserved ejection fraction and diabetes, cardiologists like Mark T. Kearney, MB ChB, MD, remain stumped.

Courtesy Dr. Mark T. Kearney

“Over the years, the diagnosis of heart failure with preserved ejection fraction has been notoriously difficult [to treat], controversial, and ultimately involves aggressive catheterization of the heart to assess diastolic dysfunction, complex echocardiography, and invasive tests,” Dr. Kearney said at the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease. “These patients have an ejection fraction of over 50% and classic signs and symptoms of heart failure. Studies of beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers have been unsuccessful in this group of patients. We’re at the beginning of a journey in understanding this disorder, and it’s important, because more and more patients present to us with signs and symptoms of heart failure with an ejection fraction greater than 50%.”

In a recent analysis of 1,797 patients with chronic heart failure, Dr. Kearney, British Heart Foundation Professor of Cardiovascular and Diabetes Research at the Leeds (England) Institute of Cardiovascular and Metabolic Medicine, and colleagues examined whether beta-blockers and ACE inhibitors were associated with differential effects on mortality in patients with and without diabetes (Diabetes Care. 2018;41:136-42). Mean follow-up was 4 years.

For the ACE inhibitor component of the trial, the researchers correlated the dose of ramipril to outcomes and found that each milligram increase of ramipril reduced the risk of death by about 3%. “In the nondiabetic patients who did not receive an ACE inhibitor, mortality was about 60% – worse than most cancers,” Dr. Kearney said. “In patients with diabetes, there was a similar pattern. If you didn’t get an ACE inhibitor, mortality was 70%. So, if you get patients on an optimal dose of an ACE inhibitor, you improve their mortality substantially, whether they have diabetes or not.”

The beta-blocker component of the trial yielded similar results. Each milligram of bisoprolol reduced the risk of death over a mean of 4 years by about 3% in patients without diabetes and 9% in those with diabetes. “Among patients who did not receive a beta-blocker, the mortality was about 70% at 5 years – really terrible,” he said. “Every milligram of bisoprolol was associated with a reduction in mortality of about 9%. So, if a patient gets on an optimal dose of a beta-blocker and they have diabetes, it’s associated with prolongation of life over a year.”

Dr. Kearney said that patients often do not want to take an increased dose of a beta-blocker because of concerns about side effects, such as tiredness. “They ask me what the side effects of an increased dose would be. My answer is: ‘It will make you live longer.’ Usually, they’ll respond by agreeing to have a little bit more of the beta-blocker. The message here is, if you have a patient with ejection fraction heart failure and diabetes, get them on the optimal dose of a beta-blocker, even at the expense of an ACE inhibitor.”

In 2016, the European Society of Cardiology introduced guidelines for physicians to make a diagnosis of heart failure with preserved ejection fraction. The guidelines mandate that a diagnosis requires signs and symptoms of heart failure, elevated levels of natriuretic peptide, and echocardiographic abnormalities of cardiac structure and/or function in the presence of a left ventricular ejection fraction of 50% or more (Eur J Heart Fail. 2016;18[8]:891-975).

“Signs and symptoms of heart failure, elevated BNP [brain natriuretic peptide], and echocardiography allow us to make a diagnosis of heart failure with preserved ejection fraction,” Dr. Kearney, who is also dean of the Leeds University School of Medicine. “But we don’t know the outcome of these patients, we don’t know how to treat them, and we don’t know the impact on hospitalizations.”

In a large, unpublished cohort study conducted at Leeds, Dr. Kearney and colleagues evaluated how many patients met criteria for heart failure with reduced ejection fraction or heart failure with preserved ejection fraction after undergoing a BNP measurement. Ultimately, 959 patients met criteria. After assessment, 23% had no heart failure, 44% had heart failure with preserved ejection fraction, and 33% had heart failure with reduced ejection fraction. They found that patients with preserved ejection fraction were older (mean age, 84 years); were more likely to be female; and had less ischemia, less diabetes, and more hypertension. In addition, patients with preserved ejection fraction had significantly better survival than patients with reduced ejection fraction over 5 years follow-up.

“What was really interesting were the findings related to hospitalization,” he said. “All 959 patients accounted for 20,517 days in the hospital over 5 years, which is the equivalent of 1 patient occupying a hospital bed for 56 years. This disorder [heart failure with preserved ejection fraction], despite having a lower mortality than heart failure with reduced ejection fraction, leads to a significant burden on health care systems.”

Among patients with preserved ejection fraction, 82% were hospitalized for a noncardiovascular cause, 6.9% because of heart failure, and 11% were caused by other cardiovascular causes. Most of the hospital admissions were because of chest infections, falls, and other frailty-linked causes. “This link between systemic frailty and heart failure with preserved ejection fraction warrants further investigation,” Dr. Kearney said. “This is a major burden on patient hospital care.”

When the researchers examined outcomes in patients with and without diabetes, those with diabetes were younger, more likely to be male, and have a higher body mass index. They found that, in the presence of diabetes, mortality was increased in heart failure with preserved and reduced ejection fraction. “So, even at the age of 81 or 82, diabetes changes the pathophysiology of mortality in what was previously believed to be a benign disease,” he said.

In a subset analysis of patients with and without diabetes who were not taking a beta-blocker, there did not seem to be increased sympathetic activation in the patients with diabetes and heart failure with preserved ejection fraction, nor a difference in heart rate between the nondiabetic patients and patients with diabetes. However, among patients with heart failure with reduced ejection fraction, those with diabetes had an increased heart rate.

“Is heart failure with preserved ejection fraction in diabetes benign? I think the answer is no,” Dr. Kearney said. “It increases hospitalization and is a major burden on health care systems. What should we do? We deal with comorbidity and fall risk. It’s good old-fashioned doctoring, really. We address frailty and respiratory tract infections, but the key thing here is that we need more research.”

Dr. Kearney reported having no relevant financial disclosures.

[email protected]

LOS ANGELES – When it comes to the optimal treatment of patients with heart failure with preserved ejection fraction and diabetes, cardiologists like Mark T. Kearney, MB ChB, MD, remain stumped.

Courtesy Dr. Mark T. Kearney

“Over the years, the diagnosis of heart failure with preserved ejection fraction has been notoriously difficult [to treat], controversial, and ultimately involves aggressive catheterization of the heart to assess diastolic dysfunction, complex echocardiography, and invasive tests,” Dr. Kearney said at the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease. “These patients have an ejection fraction of over 50% and classic signs and symptoms of heart failure. Studies of beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers have been unsuccessful in this group of patients. We’re at the beginning of a journey in understanding this disorder, and it’s important, because more and more patients present to us with signs and symptoms of heart failure with an ejection fraction greater than 50%.”

In a recent analysis of 1,797 patients with chronic heart failure, Dr. Kearney, British Heart Foundation Professor of Cardiovascular and Diabetes Research at the Leeds (England) Institute of Cardiovascular and Metabolic Medicine, and colleagues examined whether beta-blockers and ACE inhibitors were associated with differential effects on mortality in patients with and without diabetes (Diabetes Care. 2018;41:136-42). Mean follow-up was 4 years.

For the ACE inhibitor component of the trial, the researchers correlated the dose of ramipril to outcomes and found that each milligram increase of ramipril reduced the risk of death by about 3%. “In the nondiabetic patients who did not receive an ACE inhibitor, mortality was about 60% – worse than most cancers,” Dr. Kearney said. “In patients with diabetes, there was a similar pattern. If you didn’t get an ACE inhibitor, mortality was 70%. So, if you get patients on an optimal dose of an ACE inhibitor, you improve their mortality substantially, whether they have diabetes or not.”

The beta-blocker component of the trial yielded similar results. Each milligram of bisoprolol reduced the risk of death over a mean of 4 years by about 3% in patients without diabetes and 9% in those with diabetes. “Among patients who did not receive a beta-blocker, the mortality was about 70% at 5 years – really terrible,” he said. “Every milligram of bisoprolol was associated with a reduction in mortality of about 9%. So, if a patient gets on an optimal dose of a beta-blocker and they have diabetes, it’s associated with prolongation of life over a year.”

Dr. Kearney said that patients often do not want to take an increased dose of a beta-blocker because of concerns about side effects, such as tiredness. “They ask me what the side effects of an increased dose would be. My answer is: ‘It will make you live longer.’ Usually, they’ll respond by agreeing to have a little bit more of the beta-blocker. The message here is, if you have a patient with ejection fraction heart failure and diabetes, get them on the optimal dose of a beta-blocker, even at the expense of an ACE inhibitor.”

In 2016, the European Society of Cardiology introduced guidelines for physicians to make a diagnosis of heart failure with preserved ejection fraction. The guidelines mandate that a diagnosis requires signs and symptoms of heart failure, elevated levels of natriuretic peptide, and echocardiographic abnormalities of cardiac structure and/or function in the presence of a left ventricular ejection fraction of 50% or more (Eur J Heart Fail. 2016;18[8]:891-975).

“Signs and symptoms of heart failure, elevated BNP [brain natriuretic peptide], and echocardiography allow us to make a diagnosis of heart failure with preserved ejection fraction,” Dr. Kearney, who is also dean of the Leeds University School of Medicine. “But we don’t know the outcome of these patients, we don’t know how to treat them, and we don’t know the impact on hospitalizations.”

In a large, unpublished cohort study conducted at Leeds, Dr. Kearney and colleagues evaluated how many patients met criteria for heart failure with reduced ejection fraction or heart failure with preserved ejection fraction after undergoing a BNP measurement. Ultimately, 959 patients met criteria. After assessment, 23% had no heart failure, 44% had heart failure with preserved ejection fraction, and 33% had heart failure with reduced ejection fraction. They found that patients with preserved ejection fraction were older (mean age, 84 years); were more likely to be female; and had less ischemia, less diabetes, and more hypertension. In addition, patients with preserved ejection fraction had significantly better survival than patients with reduced ejection fraction over 5 years follow-up.

“What was really interesting were the findings related to hospitalization,” he said. “All 959 patients accounted for 20,517 days in the hospital over 5 years, which is the equivalent of 1 patient occupying a hospital bed for 56 years. This disorder [heart failure with preserved ejection fraction], despite having a lower mortality than heart failure with reduced ejection fraction, leads to a significant burden on health care systems.”

Among patients with preserved ejection fraction, 82% were hospitalized for a noncardiovascular cause, 6.9% because of heart failure, and 11% were caused by other cardiovascular causes. Most of the hospital admissions were because of chest infections, falls, and other frailty-linked causes. “This link between systemic frailty and heart failure with preserved ejection fraction warrants further investigation,” Dr. Kearney said. “This is a major burden on patient hospital care.”

When the researchers examined outcomes in patients with and without diabetes, those with diabetes were younger, more likely to be male, and have a higher body mass index. They found that, in the presence of diabetes, mortality was increased in heart failure with preserved and reduced ejection fraction. “So, even at the age of 81 or 82, diabetes changes the pathophysiology of mortality in what was previously believed to be a benign disease,” he said.

In a subset analysis of patients with and without diabetes who were not taking a beta-blocker, there did not seem to be increased sympathetic activation in the patients with diabetes and heart failure with preserved ejection fraction, nor a difference in heart rate between the nondiabetic patients and patients with diabetes. However, among patients with heart failure with reduced ejection fraction, those with diabetes had an increased heart rate.

“Is heart failure with preserved ejection fraction in diabetes benign? I think the answer is no,” Dr. Kearney said. “It increases hospitalization and is a major burden on health care systems. What should we do? We deal with comorbidity and fall risk. It’s good old-fashioned doctoring, really. We address frailty and respiratory tract infections, but the key thing here is that we need more research.”

Dr. Kearney reported having no relevant financial disclosures.

[email protected]

LAS VEGAS – U.S. patients with diabetes who underwent bariatric surgery during 2015-2017 had a 49% higher rate of deep surgical-site infections and a 31% higher rate of 30-day ICU admissions, compared with patients without diabetes, in an analysis of more than 550,000 patients who underwent this surgery.

Mitchel L. Zoler/MDedge News

The analysis also showed that among patients with diabetes undergoing bariatric surgery, those with insulin-dependent diabetes had significantly higher rates of these and other complications, compared with patients with diabetes but no insulin dependence, Andrew A. Wheeler, MD, said at a meeting presented by The Obesity Society and the American Society for Metabolic and Bariatric Surgery.

The specific factors driving these observations remain unknown, but may relate at least in part to the efficacy of glycemic control in patients during the months and weeks before surgery, said Dr. Wheeler, chief of metabolic and bariatric surgery at the University of Missouri in Columbia.

“Perioperative blood glucose control reflected in hemoglobin A_1c may help us understand if certain patients with diabetes are at increased risk of surgical complications,” Dr. Wheeler said during his talk. “We need to see whether preoperative hemoglobin A_1c tracks with the rate of complications,” he added in an interview. “Some surgeons will defer surgery until the level goes down, but right now, everyone uses a different level.”

The study by Dr. Wheeler and associates used data collected from essentially all the bariatric surgeries done at the roughly 840 U.S. centers accredited to do the surgery during 2015-2017 – a total of 555,239 patients – in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program run by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. The cohort included 413,239 patients without diabetes and 136,010 with diabetes, with the remainder having an unknown status. Nearly all patients underwent either sleeve gastrectomy or gastric bypass, with significantly more patients, 74%, having sleeve gastrectomy in the group without diabetes, and 62% of those with diabetes undergoing sleeve gastrectomy.

Patients with diabetes uniformly had significantly higher rates of complications as measured by several parameters, and among those with diabetes, the complication rates were highest in those with insulin dependence. The researchers ran a multivariate analysis that controlled for many demographic and clinical variables, and found that despite these corrections, patients with diabetes, and especially those with insulin dependence, had higher relative rates of many complications that were statistically significant. In addition to the increased rates of deep surgical-site infections and 30-day ICU admissions, patients with diabetes had a 54% relatively increased rate of wound disruption, and a 29% increased relative rate of superficial surgical-site infections, compared with those without diabetes. And among patients with diabetes, those with insulin dependence had a 40% increased rate of surgical-site infections, a 74% increase in progressive renal failure, and a 39% increased rate of hospital readmission relative to patients with diabetes that was not insulin dependent, Dr. Wheeler reported.

The absolute complication rates were, in general, low. For example, the total rate of superficial plus deep surgical-site infections was less than 1% both in patients with diabetes and those without, although the rate rose above 1% in patients with insulin-dependent diabetes. The most common complication reported by Dr. Wheeler was 30-day hospital readmission, which was 4.0% in patients without diabetes, 4.8% in those with diabetes, and 6.4% in patients with insulin-dependent diabetes. The data also showed that gastric bypass led to more complications than did sleeve gastrectomy, but complications with both types of surgeries increased in patients with diabetes, compared with those without diabetes.

Dr. Wheeler had no disclosures.

[email protected]

SOURCE: Wheeler AA et al. Obesity Week 2019, Abstract A133.

LAS VEGAS – U.S. patients with diabetes who underwent bariatric surgery during 2015-2017 had a 49% higher rate of deep surgical-site infections and a 31% higher rate of 30-day ICU admissions, compared with patients without diabetes, in an analysis of more than 550,000 patients who underwent this surgery.

Mitchel L. Zoler/MDedge News

The analysis also showed that among patients with diabetes undergoing bariatric surgery, those with insulin-dependent diabetes had significantly higher rates of these and other complications, compared with patients with diabetes but no insulin dependence, Andrew A. Wheeler, MD, said at a meeting presented by The Obesity Society and the American Society for Metabolic and Bariatric Surgery.

The specific factors driving these observations remain unknown, but may relate at least in part to the efficacy of glycemic control in patients during the months and weeks before surgery, said Dr. Wheeler, chief of metabolic and bariatric surgery at the University of Missouri in Columbia.

“Perioperative blood glucose control reflected in hemoglobin A_1c may help us understand if certain patients with diabetes are at increased risk of surgical complications,” Dr. Wheeler said during his talk. “We need to see whether preoperative hemoglobin A_1c tracks with the rate of complications,” he added in an interview. “Some surgeons will defer surgery until the level goes down, but right now, everyone uses a different level.”

The study by Dr. Wheeler and associates used data collected from essentially all the bariatric surgeries done at the roughly 840 U.S. centers accredited to do the surgery during 2015-2017 – a total of 555,239 patients – in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program run by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. The cohort included 413,239 patients without diabetes and 136,010 with diabetes, with the remainder having an unknown status. Nearly all patients underwent either sleeve gastrectomy or gastric bypass, with significantly more patients, 74%, having sleeve gastrectomy in the group without diabetes, and 62% of those with diabetes undergoing sleeve gastrectomy.

Patients with diabetes uniformly had significantly higher rates of complications as measured by several parameters, and among those with diabetes, the complication rates were highest in those with insulin dependence. The researchers ran a multivariate analysis that controlled for many demographic and clinical variables, and found that despite these corrections, patients with diabetes, and especially those with insulin dependence, had higher relative rates of many complications that were statistically significant. In addition to the increased rates of deep surgical-site infections and 30-day ICU admissions, patients with diabetes had a 54% relatively increased rate of wound disruption, and a 29% increased relative rate of superficial surgical-site infections, compared with those without diabetes. And among patients with diabetes, those with insulin dependence had a 40% increased rate of surgical-site infections, a 74% increase in progressive renal failure, and a 39% increased rate of hospital readmission relative to patients with diabetes that was not insulin dependent, Dr. Wheeler reported.

The absolute complication rates were, in general, low. For example, the total rate of superficial plus deep surgical-site infections was less than 1% both in patients with diabetes and those without, although the rate rose above 1% in patients with insulin-dependent diabetes. The most common complication reported by Dr. Wheeler was 30-day hospital readmission, which was 4.0% in patients without diabetes, 4.8% in those with diabetes, and 6.4% in patients with insulin-dependent diabetes. The data also showed that gastric bypass led to more complications than did sleeve gastrectomy, but complications with both types of surgeries increased in patients with diabetes, compared with those without diabetes.

Dr. Wheeler had no disclosures.

[email protected]

SOURCE: Wheeler AA et al. Obesity Week 2019, Abstract A133.

LAS VEGAS – U.S. patients with diabetes who underwent bariatric surgery during 2015-2017 had a 49% higher rate of deep surgical-site infections and a 31% higher rate of 30-day ICU admissions, compared with patients without diabetes, in an analysis of more than 550,000 patients who underwent this surgery.

Mitchel L. Zoler/MDedge News

The analysis also showed that among patients with diabetes undergoing bariatric surgery, those with insulin-dependent diabetes had significantly higher rates of these and other complications, compared with patients with diabetes but no insulin dependence, Andrew A. Wheeler, MD, said at a meeting presented by The Obesity Society and the American Society for Metabolic and Bariatric Surgery.

The specific factors driving these observations remain unknown, but may relate at least in part to the efficacy of glycemic control in patients during the months and weeks before surgery, said Dr. Wheeler, chief of metabolic and bariatric surgery at the University of Missouri in Columbia.

“Perioperative blood glucose control reflected in hemoglobin A_1c may help us understand if certain patients with diabetes are at increased risk of surgical complications,” Dr. Wheeler said during his talk. “We need to see whether preoperative hemoglobin A_1c tracks with the rate of complications,” he added in an interview. “Some surgeons will defer surgery until the level goes down, but right now, everyone uses a different level.”

The study by Dr. Wheeler and associates used data collected from essentially all the bariatric surgeries done at the roughly 840 U.S. centers accredited to do the surgery during 2015-2017 – a total of 555,239 patients – in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program run by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. The cohort included 413,239 patients without diabetes and 136,010 with diabetes, with the remainder having an unknown status. Nearly all patients underwent either sleeve gastrectomy or gastric bypass, with significantly more patients, 74%, having sleeve gastrectomy in the group without diabetes, and 62% of those with diabetes undergoing sleeve gastrectomy.

Patients with diabetes uniformly had significantly higher rates of complications as measured by several parameters, and among those with diabetes, the complication rates were highest in those with insulin dependence. The researchers ran a multivariate analysis that controlled for many demographic and clinical variables, and found that despite these corrections, patients with diabetes, and especially those with insulin dependence, had higher relative rates of many complications that were statistically significant. In addition to the increased rates of deep surgical-site infections and 30-day ICU admissions, patients with diabetes had a 54% relatively increased rate of wound disruption, and a 29% increased relative rate of superficial surgical-site infections, compared with those without diabetes. And among patients with diabetes, those with insulin dependence had a 40% increased rate of surgical-site infections, a 74% increase in progressive renal failure, and a 39% increased rate of hospital readmission relative to patients with diabetes that was not insulin dependent, Dr. Wheeler reported.

The absolute complication rates were, in general, low. For example, the total rate of superficial plus deep surgical-site infections was less than 1% both in patients with diabetes and those without, although the rate rose above 1% in patients with insulin-dependent diabetes. The most common complication reported by Dr. Wheeler was 30-day hospital readmission, which was 4.0% in patients without diabetes, 4.8% in those with diabetes, and 6.4% in patients with insulin-dependent diabetes. The data also showed that gastric bypass led to more complications than did sleeve gastrectomy, but complications with both types of surgeries increased in patients with diabetes, compared with those without diabetes.

Dr. Wheeler had no disclosures.

[email protected]

SOURCE: Wheeler AA et al. Obesity Week 2019, Abstract A133.

LOS ANGELES – Carbohydrate restriction is a viable patient choice for type 2 diabetes reversal, according to Sarah Hallberg, DO.

Doug Brunk/MDedge Medical News

“Nutritional ketosis supports diabetes reversal by reducing insulin resistance while providing an alternative fuel to glucose with favorable signaling properties,” she said at the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease.

Low-carbohydrate nutritional patterns including ketosis have extensive clinical trial evidence for improvement of type 2 diabetes, including preliminary results from a 5-year study of 465 patients enrolled in the Indiana Type 2 Diabetes Reversal Trial that Dr. Hallberg is overseeing in her role as medical director and founder of the medically supervised weight-loss program at Indiana University Health Arnett, Lafayette.

“The ketogenic diet is not a fad diet, it’s what we used to treat people with before the advent of insulin,” said Dr. Hallberg, who has been recommending and counseling patients with type 2 diabetes to follow a ketogenic diet for nearly 10 years. “Of course, insulin has been wonderful. It’s saved so many people with type 1 diabetes. But we also misused it in type 2 diabetes. Instead of counseling people the way we used to about the food that they’re taking in to control their blood sugar, we’ve just been putting [them] on medication, including insulin.”

The American Diabetes Association and other organizations have updated their guidelines to include low-carbohydrate eating patterns for type 2 diabetes treatment, she continued. Veterans Affairs/Department of Defense recommend carbohydrate levels as low as 14%.

Dr. Hallberg, who is also medical director for Virta Health, defined a very-low-carbohydrate or ketogenic diet as less than 50 g of carbohydrates per day, or fewer than 10% of calories consumed. A low-carbohydrate diet is 51-130 g of carbohydrates per day, or 25% or fewer calories consumed, whereas anything above 25% calories consumed is a not a low-carbohydrate diet. A well-formulated ketogenic diet, she continued, consists of 5%-10% carbohydrates (or less than 50 g), 15%-20% protein, and 70%-80% fat. The carbohydrates include 5-10 g per day of protein-based food, 10-15 g of vegetables, 5-10 g of nuts/seeds, 5-10 g of fruits, and 5-10 g of miscellaneous nutrients. “When we’re talking about a total carbohydrate intake per day of under 50 g, you can get a lot of vegetables and nuts in,” she said. “I like to tell my patients they’re not eating GPS: no grains, no potatoes, and no sugar.”

Recently, Dr. Hallberg and colleagues published a review in which they sought to evaluate the appropriateness of sources cited in the ADA’s guidelines on eating patterns for the management of type 2 diabetes, identify additional relevant sources, and evaluate the evidence (Diabetes Obes Metab. 2019;21[8]:1769-79). “We looked at how much evidence there is for the low-carb diet, the Mediterranean diet, the DASH [Dietary Approaches to Stop Hypertension] diet, and a plant-based diet,” she said. “We found a wide variation in the evidence for each eating pattern, but the low-carb eating pattern for diabetes has so much more evidence than any of the other eating patterns.”

In an earlier study, researchers followed 10 inpatients with diabetes in a metabolic ward for 3 weeks. Their mean age was 51 years, and their mean body mass index was 40.3 kg/m². The patients were fed a standard diet for 7 days, then a low-carbohydrate diet (21 g per day) for 14 days (Ann Intern Med 2005; 142[6]:403-11). After 2 weeks of the low-carbohydrate diet, their mean fasting blood glucose dropped from 7.5 to 6.3 mmol/L, and their mean hemoglobin A_1c (HbA_1c) fell from 7.3% to 6.8%. “The levels came down very fast,” said Dr. Hallberg, who was not involved with the study. “This is an important part of the intervention, because when you get a patient who’s tried everything, who’s injecting hundreds of units of insulin every day, you can make a huge difference in the first couple of weeks. It is not unusual for us to pull patients off of 200-plus units of insulin. This is as motivating as all get out. It also affects their pocketbook right away. This is one of the reasons our patients are able to sustain a ketogenic diet along with support: early motivation and satisfaction.”

In a longer-term trial, researchers evaluated the impact of a ketogenic diet in 64 obese patients with diabetes over the course of 56 weeks (Moll Cell Biochem. 2007;302[1-2]:249-56). The body weight, body mass index, and levels of blood glucose, total cholesterol, LDL cholesterol, triglycerides, and urea showed a significant decrease from week 1 to week 56 (P less than .0001), while the level of HDL cholesterol increased significantly (P less than .0001).

A separate trial conducted in Israel evaluated the effects of a low-carbohydrate diet, compared with a Mediterranean or low-fat diet in 322 moderately obese patients over the course of 2 years (N Engl J Med. 2008;359:229-41). The rate of adherence to a study diet was 85% at 2 years. The mean weight change was greatest for those on the low-carbohydrate diet, followed by the Mediterranean and low-fat diets. Fasting glucose was best for those on the Mediterranean diet at the end of 2 years, whereas change in HbA_1c was best among those on the low-carbohydrate diet.

Another study randomized patients to a low-carbohydrate ketogenic diet (less than 20 g per day with no calorie restriction) or to a low–glycemic index diet (55% carbohydrate restriction of 500 kcal from baseline) over the course of 24 weeks (Nutr Metab [Lond]. 2008 Dec 19. doi:10.1186/1743-7075-5-36). Between baseline and week 24, the mean HbA_1c fell from 8.8% to 7.3% in the very-low-carbohydrate diet group, and from 8.3% to 7.8% in the low–glycemic diet group, for a between-group comparison P value of .03. In addition, 95% of patients in the low-carbohydrate diet group were able to reduce or eliminate the number of medications they were taking, compared with 62% of patients in the low–glycemic diet group (P less than .01).

Dr. Hallberg and colleagues are currently in year 4 of the 5-year Indiana Type 2 Diabetes Reversal Study, a prospective, nonrandomized, controlled trial of carbohydrate restriction in 465 patients, making it the largest and longest study of its kind. Of the 465 patients, 387 are in the continuous-care arm, which consists of a diet from Virta Health based on principles of nutritional ketosis, and 87 patients in a usual care arm who are followed for 2 years. The trial includes patients who have been prescribed insulin and who have been diagnosed with diabetes for an average of 8 years.

At the meeting, Dr. Hallberg presented preliminary results based on 2 years of data collection. The retention rate was 83% at 1 year and 74% at 2 years. In the treatment arm, the researchers observed that the level of beta hydroxybutyrate, or evidence of ketogenesis, was the same at 2 years as it had been at 1 year. “So, people were still following the diet, as well as being engaged,” she said.

At the end of 2 years, the mean HbA_1c reduction was 0.9, the mean reduction for the Homeostatic Model Assessment of Insulin Resistance was 32%, and 55% of completers experienced reversal of their diabetes. Overall, 91% of insulin users reduced or eliminated their use of insulin, and the average weight loss was 10% of baseline weight. “Medication reduction was across the board,” she added. “This is huge from a cost-savings and a patient-satisfaction standpoint. We were improving A_1c levels in patients who have had diabetes for an average of over 8 years while we were getting [them] off medication, including insulin. Low carb is now the standard of care.”

Even patients who did not experience a reversal of their diabetes were conferred a benefit. They had an average reduction of 1.2 in HbA_1c level, to 7%; their average weight loss was 9.8%; 45% of patients eliminated their diabetes prescriptions; 81% reduced or eliminated their use of insulin; there was an average reduction of 27% in triglyceride levels; and they had a 17% reduction in their 10-year risk score for atherosclerotic cardiovascular disease.

In the overall cohort, the 10-year Atherosclerotic Cardiovascular Disease risk score improved by 12%; almost all markers for cardiovascular disease improved at 1 year. “We were giving these patients appropriate support, which I think is key,” Dr. Hallberg said. “No matter what you do, you have to have a high-touch intervention, and supply that through technology. We do better than medication adherence. Putting patients on a carbohydrate-restricted diet with the appropriate support works for sustainability.”

Dr. Hallberg disclosed that she is an employee of Virta Health and that she is an adviser for Simply Good Foods.

LOS ANGELES – Carbohydrate restriction is a viable patient choice for type 2 diabetes reversal, according to Sarah Hallberg, DO.

Doug Brunk/MDedge Medical News

“Nutritional ketosis supports diabetes reversal by reducing insulin resistance while providing an alternative fuel to glucose with favorable signaling properties,” she said at the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease.

Low-carbohydrate nutritional patterns including ketosis have extensive clinical trial evidence for improvement of type 2 diabetes, including preliminary results from a 5-year study of 465 patients enrolled in the Indiana Type 2 Diabetes Reversal Trial that Dr. Hallberg is overseeing in her role as medical director and founder of the medically supervised weight-loss program at Indiana University Health Arnett, Lafayette.

“The ketogenic diet is not a fad diet, it’s what we used to treat people with before the advent of insulin,” said Dr. Hallberg, who has been recommending and counseling patients with type 2 diabetes to follow a ketogenic diet for nearly 10 years. “Of course, insulin has been wonderful. It’s saved so many people with type 1 diabetes. But we also misused it in type 2 diabetes. Instead of counseling people the way we used to about the food that they’re taking in to control their blood sugar, we’ve just been putting [them] on medication, including insulin.”

The American Diabetes Association and other organizations have updated their guidelines to include low-carbohydrate eating patterns for type 2 diabetes treatment, she continued. Veterans Affairs/Department of Defense recommend carbohydrate levels as low as 14%.

Dr. Hallberg, who is also medical director for Virta Health, defined a very-low-carbohydrate or ketogenic diet as less than 50 g of carbohydrates per day, or fewer than 10% of calories consumed. A low-carbohydrate diet is 51-130 g of carbohydrates per day, or 25% or fewer calories consumed, whereas anything above 25% calories consumed is a not a low-carbohydrate diet. A well-formulated ketogenic diet, she continued, consists of 5%-10% carbohydrates (or less than 50 g), 15%-20% protein, and 70%-80% fat. The carbohydrates include 5-10 g per day of protein-based food, 10-15 g of vegetables, 5-10 g of nuts/seeds, 5-10 g of fruits, and 5-10 g of miscellaneous nutrients. “When we’re talking about a total carbohydrate intake per day of under 50 g, you can get a lot of vegetables and nuts in,” she said. “I like to tell my patients they’re not eating GPS: no grains, no potatoes, and no sugar.”

Recently, Dr. Hallberg and colleagues published a review in which they sought to evaluate the appropriateness of sources cited in the ADA’s guidelines on eating patterns for the management of type 2 diabetes, identify additional relevant sources, and evaluate the evidence (Diabetes Obes Metab. 2019;21[8]:1769-79). “We looked at how much evidence there is for the low-carb diet, the Mediterranean diet, the DASH [Dietary Approaches to Stop Hypertension] diet, and a plant-based diet,” she said. “We found a wide variation in the evidence for each eating pattern, but the low-carb eating pattern for diabetes has so much more evidence than any of the other eating patterns.”

In an earlier study, researchers followed 10 inpatients with diabetes in a metabolic ward for 3 weeks. Their mean age was 51 years, and their mean body mass index was 40.3 kg/m². The patients were fed a standard diet for 7 days, then a low-carbohydrate diet (21 g per day) for 14 days (Ann Intern Med 2005; 142[6]:403-11). After 2 weeks of the low-carbohydrate diet, their mean fasting blood glucose dropped from 7.5 to 6.3 mmol/L, and their mean hemoglobin A_1c (HbA_1c) fell from 7.3% to 6.8%. “The levels came down very fast,” said Dr. Hallberg, who was not involved with the study. “This is an important part of the intervention, because when you get a patient who’s tried everything, who’s injecting hundreds of units of insulin every day, you can make a huge difference in the first couple of weeks. It is not unusual for us to pull patients off of 200-plus units of insulin. This is as motivating as all get out. It also affects their pocketbook right away. This is one of the reasons our patients are able to sustain a ketogenic diet along with support: early motivation and satisfaction.”

In a longer-term trial, researchers evaluated the impact of a ketogenic diet in 64 obese patients with diabetes over the course of 56 weeks (Moll Cell Biochem. 2007;302[1-2]:249-56). The body weight, body mass index, and levels of blood glucose, total cholesterol, LDL cholesterol, triglycerides, and urea showed a significant decrease from week 1 to week 56 (P less than .0001), while the level of HDL cholesterol increased significantly (P less than .0001).

A separate trial conducted in Israel evaluated the effects of a low-carbohydrate diet, compared with a Mediterranean or low-fat diet in 322 moderately obese patients over the course of 2 years (N Engl J Med. 2008;359:229-41). The rate of adherence to a study diet was 85% at 2 years. The mean weight change was greatest for those on the low-carbohydrate diet, followed by the Mediterranean and low-fat diets. Fasting glucose was best for those on the Mediterranean diet at the end of 2 years, whereas change in HbA_1c was best among those on the low-carbohydrate diet.

Another study randomized patients to a low-carbohydrate ketogenic diet (less than 20 g per day with no calorie restriction) or to a low–glycemic index diet (55% carbohydrate restriction of 500 kcal from baseline) over the course of 24 weeks (Nutr Metab [Lond]. 2008 Dec 19. doi:10.1186/1743-7075-5-36). Between baseline and week 24, the mean HbA_1c fell from 8.8% to 7.3% in the very-low-carbohydrate diet group, and from 8.3% to 7.8% in the low–glycemic diet group, for a between-group comparison P value of .03. In addition, 95% of patients in the low-carbohydrate diet group were able to reduce or eliminate the number of medications they were taking, compared with 62% of patients in the low–glycemic diet group (P less than .01).

Dr. Hallberg and colleagues are currently in year 4 of the 5-year Indiana Type 2 Diabetes Reversal Study, a prospective, nonrandomized, controlled trial of carbohydrate restriction in 465 patients, making it the largest and longest study of its kind. Of the 465 patients, 387 are in the continuous-care arm, which consists of a diet from Virta Health based on principles of nutritional ketosis, and 87 patients in a usual care arm who are followed for 2 years. The trial includes patients who have been prescribed insulin and who have been diagnosed with diabetes for an average of 8 years.

At the meeting, Dr. Hallberg presented preliminary results based on 2 years of data collection. The retention rate was 83% at 1 year and 74% at 2 years. In the treatment arm, the researchers observed that the level of beta hydroxybutyrate, or evidence of ketogenesis, was the same at 2 years as it had been at 1 year. “So, people were still following the diet, as well as being engaged,” she said.

At the end of 2 years, the mean HbA_1c reduction was 0.9, the mean reduction for the Homeostatic Model Assessment of Insulin Resistance was 32%, and 55% of completers experienced reversal of their diabetes. Overall, 91% of insulin users reduced or eliminated their use of insulin, and the average weight loss was 10% of baseline weight. “Medication reduction was across the board,” she added. “This is huge from a cost-savings and a patient-satisfaction standpoint. We were improving A_1c levels in patients who have had diabetes for an average of over 8 years while we were getting [them] off medication, including insulin. Low carb is now the standard of care.”

Even patients who did not experience a reversal of their diabetes were conferred a benefit. They had an average reduction of 1.2 in HbA_1c level, to 7%; their average weight loss was 9.8%; 45% of patients eliminated their diabetes prescriptions; 81% reduced or eliminated their use of insulin; there was an average reduction of 27% in triglyceride levels; and they had a 17% reduction in their 10-year risk score for atherosclerotic cardiovascular disease.

In the overall cohort, the 10-year Atherosclerotic Cardiovascular Disease risk score improved by 12%; almost all markers for cardiovascular disease improved at 1 year. “We were giving these patients appropriate support, which I think is key,” Dr. Hallberg said. “No matter what you do, you have to have a high-touch intervention, and supply that through technology. We do better than medication adherence. Putting patients on a carbohydrate-restricted diet with the appropriate support works for sustainability.”

Dr. Hallberg disclosed that she is an employee of Virta Health and that she is an adviser for Simply Good Foods.

LOS ANGELES – Carbohydrate restriction is a viable patient choice for type 2 diabetes reversal, according to Sarah Hallberg, DO.

Doug Brunk/MDedge Medical News

“Nutritional ketosis supports diabetes reversal by reducing insulin resistance while providing an alternative fuel to glucose with favorable signaling properties,” she said at the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease.

Low-carbohydrate nutritional patterns including ketosis have extensive clinical trial evidence for improvement of type 2 diabetes, including preliminary results from a 5-year study of 465 patients enrolled in the Indiana Type 2 Diabetes Reversal Trial that Dr. Hallberg is overseeing in her role as medical director and founder of the medically supervised weight-loss program at Indiana University Health Arnett, Lafayette.

“The ketogenic diet is not a fad diet, it’s what we used to treat people with before the advent of insulin,” said Dr. Hallberg, who has been recommending and counseling patients with type 2 diabetes to follow a ketogenic diet for nearly 10 years. “Of course, insulin has been wonderful. It’s saved so many people with type 1 diabetes. But we also misused it in type 2 diabetes. Instead of counseling people the way we used to about the food that they’re taking in to control their blood sugar, we’ve just been putting [them] on medication, including insulin.”

The American Diabetes Association and other organizations have updated their guidelines to include low-carbohydrate eating patterns for type 2 diabetes treatment, she continued. Veterans Affairs/Department of Defense recommend carbohydrate levels as low as 14%.

Dr. Hallberg, who is also medical director for Virta Health, defined a very-low-carbohydrate or ketogenic diet as less than 50 g of carbohydrates per day, or fewer than 10% of calories consumed. A low-carbohydrate diet is 51-130 g of carbohydrates per day, or 25% or fewer calories consumed, whereas anything above 25% calories consumed is a not a low-carbohydrate diet. A well-formulated ketogenic diet, she continued, consists of 5%-10% carbohydrates (or less than 50 g), 15%-20% protein, and 70%-80% fat. The carbohydrates include 5-10 g per day of protein-based food, 10-15 g of vegetables, 5-10 g of nuts/seeds, 5-10 g of fruits, and 5-10 g of miscellaneous nutrients. “When we’re talking about a total carbohydrate intake per day of under 50 g, you can get a lot of vegetables and nuts in,” she said. “I like to tell my patients they’re not eating GPS: no grains, no potatoes, and no sugar.”

Recently, Dr. Hallberg and colleagues published a review in which they sought to evaluate the appropriateness of sources cited in the ADA’s guidelines on eating patterns for the management of type 2 diabetes, identify additional relevant sources, and evaluate the evidence (Diabetes Obes Metab. 2019;21[8]:1769-79). “We looked at how much evidence there is for the low-carb diet, the Mediterranean diet, the DASH [Dietary Approaches to Stop Hypertension] diet, and a plant-based diet,” she said. “We found a wide variation in the evidence for each eating pattern, but the low-carb eating pattern for diabetes has so much more evidence than any of the other eating patterns.”

In an earlier study, researchers followed 10 inpatients with diabetes in a metabolic ward for 3 weeks. Their mean age was 51 years, and their mean body mass index was 40.3 kg/m². The patients were fed a standard diet for 7 days, then a low-carbohydrate diet (21 g per day) for 14 days (Ann Intern Med 2005; 142[6]:403-11). After 2 weeks of the low-carbohydrate diet, their mean fasting blood glucose dropped from 7.5 to 6.3 mmol/L, and their mean hemoglobin A_1c (HbA_1c) fell from 7.3% to 6.8%. “The levels came down very fast,” said Dr. Hallberg, who was not involved with the study. “This is an important part of the intervention, because when you get a patient who’s tried everything, who’s injecting hundreds of units of insulin every day, you can make a huge difference in the first couple of weeks. It is not unusual for us to pull patients off of 200-plus units of insulin. This is as motivating as all get out. It also affects their pocketbook right away. This is one of the reasons our patients are able to sustain a ketogenic diet along with support: early motivation and satisfaction.”

In a longer-term trial, researchers evaluated the impact of a ketogenic diet in 64 obese patients with diabetes over the course of 56 weeks (Moll Cell Biochem. 2007;302[1-2]:249-56). The body weight, body mass index, and levels of blood glucose, total cholesterol, LDL cholesterol, triglycerides, and urea showed a significant decrease from week 1 to week 56 (P less than .0001), while the level of HDL cholesterol increased significantly (P less than .0001).

A separate trial conducted in Israel evaluated the effects of a low-carbohydrate diet, compared with a Mediterranean or low-fat diet in 322 moderately obese patients over the course of 2 years (N Engl J Med. 2008;359:229-41). The rate of adherence to a study diet was 85% at 2 years. The mean weight change was greatest for those on the low-carbohydrate diet, followed by the Mediterranean and low-fat diets. Fasting glucose was best for those on the Mediterranean diet at the end of 2 years, whereas change in HbA_1c was best among those on the low-carbohydrate diet.

Another study randomized patients to a low-carbohydrate ketogenic diet (less than 20 g per day with no calorie restriction) or to a low–glycemic index diet (55% carbohydrate restriction of 500 kcal from baseline) over the course of 24 weeks (Nutr Metab [Lond]. 2008 Dec 19. doi:10.1186/1743-7075-5-36). Between baseline and week 24, the mean HbA_1c fell from 8.8% to 7.3% in the very-low-carbohydrate diet group, and from 8.3% to 7.8% in the low–glycemic diet group, for a between-group comparison P value of .03. In addition, 95% of patients in the low-carbohydrate diet group were able to reduce or eliminate the number of medications they were taking, compared with 62% of patients in the low–glycemic diet group (P less than .01).

Dr. Hallberg and colleagues are currently in year 4 of the 5-year Indiana Type 2 Diabetes Reversal Study, a prospective, nonrandomized, controlled trial of carbohydrate restriction in 465 patients, making it the largest and longest study of its kind. Of the 465 patients, 387 are in the continuous-care arm, which consists of a diet from Virta Health based on principles of nutritional ketosis, and 87 patients in a usual care arm who are followed for 2 years. The trial includes patients who have been prescribed insulin and who have been diagnosed with diabetes for an average of 8 years.

At the meeting, Dr. Hallberg presented preliminary results based on 2 years of data collection. The retention rate was 83% at 1 year and 74% at 2 years. In the treatment arm, the researchers observed that the level of beta hydroxybutyrate, or evidence of ketogenesis, was the same at 2 years as it had been at 1 year. “So, people were still following the diet, as well as being engaged,” she said.

At the end of 2 years, the mean HbA_1c reduction was 0.9, the mean reduction for the Homeostatic Model Assessment of Insulin Resistance was 32%, and 55% of completers experienced reversal of their diabetes. Overall, 91% of insulin users reduced or eliminated their use of insulin, and the average weight loss was 10% of baseline weight. “Medication reduction was across the board,” she added. “This is huge from a cost-savings and a patient-satisfaction standpoint. We were improving A_1c levels in patients who have had diabetes for an average of over 8 years while we were getting [them] off medication, including insulin. Low carb is now the standard of care.”

Even patients who did not experience a reversal of their diabetes were conferred a benefit. They had an average reduction of 1.2 in HbA_1c level, to 7%; their average weight loss was 9.8%; 45% of patients eliminated their diabetes prescriptions; 81% reduced or eliminated their use of insulin; there was an average reduction of 27% in triglyceride levels; and they had a 17% reduction in their 10-year risk score for atherosclerotic cardiovascular disease.

In the overall cohort, the 10-year Atherosclerotic Cardiovascular Disease risk score improved by 12%; almost all markers for cardiovascular disease improved at 1 year. “We were giving these patients appropriate support, which I think is key,” Dr. Hallberg said. “No matter what you do, you have to have a high-touch intervention, and supply that through technology. We do better than medication adherence. Putting patients on a carbohydrate-restricted diet with the appropriate support works for sustainability.”

Dr. Hallberg disclosed that she is an employee of Virta Health and that she is an adviser for Simply Good Foods.

LAS VEGAS – Researchers have devised a risk calculator for patients with obesity and type 2 diabetes that can estimate their 10-year risk for death and cardiovascular disease events if their clinical status continues relatively unchanged, or if they opt to undergo bariatric surgery.

Mitchel L. Zoler/MDedge News

The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.

The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.

“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.

The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m² or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), body mass index (about 44 kg/m²), and the prevalence of various comorbidities at baseline.

Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).

The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age; baseline body mass index, heart failure, and need for insulin; and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.

The risk score may help patients better understand the potential role that metabolic surgery can have in reducing their future event risk, thereby helping them better appreciate the benefit they stand to gain from undergoing surgery, Dr. Aminian said.

The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.

The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.

[email protected]

SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.

LAS VEGAS – Researchers have devised a risk calculator for patients with obesity and type 2 diabetes that can estimate their 10-year risk for death and cardiovascular disease events if their clinical status continues relatively unchanged, or if they opt to undergo bariatric surgery.

Mitchel L. Zoler/MDedge News

The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.

The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.

“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.

The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m² or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), body mass index (about 44 kg/m²), and the prevalence of various comorbidities at baseline.

Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).

The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age; baseline body mass index, heart failure, and need for insulin; and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.

The risk score may help patients better understand the potential role that metabolic surgery can have in reducing their future event risk, thereby helping them better appreciate the benefit they stand to gain from undergoing surgery, Dr. Aminian said.

The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.

The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.

[email protected]

SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.

LAS VEGAS – Researchers have devised a risk calculator for patients with obesity and type 2 diabetes that can estimate their 10-year risk for death and cardiovascular disease events if their clinical status continues relatively unchanged, or if they opt to undergo bariatric surgery.

Mitchel L. Zoler/MDedge News

The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.

The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.

“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.

The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m² or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), body mass index (about 44 kg/m²), and the prevalence of various comorbidities at baseline.

Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).

The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age; baseline body mass index, heart failure, and need for insulin; and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.

The risk score may help patients better understand the potential role that metabolic surgery can have in reducing their future event risk, thereby helping them better appreciate the benefit they stand to gain from undergoing surgery, Dr. Aminian said.

The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.

The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.

[email protected]

SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.

The Food and Drug Administration has approved a 100 U/mL fast-acting insulin aspart injection (Fiasp) as a new mealtime insulin option for children with type 1 diabetes, making it the first fast-acting mealtime insulin injection that does not come with a premeal dosing recommendation, according to a release.

Olivier Le Moal/Getty Images

The injection is now available in various dosing options for both adult and pediatric patients with diabetes. Fast-acting mealtime insulin was approved in September 2017 for adults with type 1 or 2 disease, and in October 2019, it was approved for use in insulin pumps for adults.

The most recent approval was based on findings from the onset 7 trial, a 26-week, phase 3b, partially double-blind, treat-to-target trial that included 777 patients aged 1-18 years and demonstrated noninferiority to ordinary, non–fast-acting insulin aspart (Diabetes Care. 2019 Jul;42[7]:1255-62).

Removal of the premeal dosing requirement could help better manage mealtime insulin needs in children, according to the release from Novo Nordisk.

Use of the mealtime insulin injection comes with concerns of serious side effects, such as hypoglycemia, hypokalemia, serious allergic reactions, and heart failure. Common side effects can include skin problems (such as rash, itching, and swelling), injection-site reactions, and weight gain.

The Food and Drug Administration has approved a 100 U/mL fast-acting insulin aspart injection (Fiasp) as a new mealtime insulin option for children with type 1 diabetes, making it the first fast-acting mealtime insulin injection that does not come with a premeal dosing recommendation, according to a release.

Olivier Le Moal/Getty Images

The injection is now available in various dosing options for both adult and pediatric patients with diabetes. Fast-acting mealtime insulin was approved in September 2017 for adults with type 1 or 2 disease, and in October 2019, it was approved for use in insulin pumps for adults.

The most recent approval was based on findings from the onset 7 trial, a 26-week, phase 3b, partially double-blind, treat-to-target trial that included 777 patients aged 1-18 years and demonstrated noninferiority to ordinary, non–fast-acting insulin aspart (Diabetes Care. 2019 Jul;42[7]:1255-62).

Removal of the premeal dosing requirement could help better manage mealtime insulin needs in children, according to the release from Novo Nordisk.

Use of the mealtime insulin injection comes with concerns of serious side effects, such as hypoglycemia, hypokalemia, serious allergic reactions, and heart failure. Common side effects can include skin problems (such as rash, itching, and swelling), injection-site reactions, and weight gain.

The Food and Drug Administration has approved a 100 U/mL fast-acting insulin aspart injection (Fiasp) as a new mealtime insulin option for children with type 1 diabetes, making it the first fast-acting mealtime insulin injection that does not come with a premeal dosing recommendation, according to a release.

Olivier Le Moal/Getty Images

The injection is now available in various dosing options for both adult and pediatric patients with diabetes. Fast-acting mealtime insulin was approved in September 2017 for adults with type 1 or 2 disease, and in October 2019, it was approved for use in insulin pumps for adults.

The most recent approval was based on findings from the onset 7 trial, a 26-week, phase 3b, partially double-blind, treat-to-target trial that included 777 patients aged 1-18 years and demonstrated noninferiority to ordinary, non–fast-acting insulin aspart (Diabetes Care. 2019 Jul;42[7]:1255-62).

Removal of the premeal dosing requirement could help better manage mealtime insulin needs in children, according to the release from Novo Nordisk.

Use of the mealtime insulin injection comes with concerns of serious side effects, such as hypoglycemia, hypokalemia, serious allergic reactions, and heart failure. Common side effects can include skin problems (such as rash, itching, and swelling), injection-site reactions, and weight gain.

The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.

Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.

The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.

“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.

Find the full press release on the AstraZeneca website.

[email protected]

The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.

Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.

The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.

“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.

Find the full press release on the AstraZeneca website.

[email protected]

The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.

Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.

The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.

“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.

Find the full press release on the AstraZeneca website.

[email protected]

BUSAN, SOUTH KOREA – Sodium-glucose transporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes seem to be as safe and effective in people aged 65 years and older as they are in younger individuals, new research suggests.

Findings from a real-world observational study of 50 older adults with type 2 diabetes were recently presented at the International Diabetes Federation congress by Carlos Trescoli-Serrano, MD, of Hospital Universitario de la Ribera, Valencia, Spain.

“The results are quite similar to those of younger people. … In a selected population they are safe. It doesn’t matter if patients are older or younger. You have to review the patients for complications,” Dr. Trescoli-Serrano said in an interview.

Asked to comment, session moderator Samuel Dagogo-Jack, MD, said: “We need more and more studies in older people for reassurance. The elderly have impaired kidneys, and these drugs depend on kidney filtration. It’s good to have data on elderly patients in the real world.”
 

Most had comorbidities

The 50 adults were a mean age of 67 years, and the oldest was 81 years. They had a mean diabetes duration of 12.5 years, and 40% were women. They had all been taking SGLT2 inhibitors for more than 3 years (mean 43.9 months) during 2015-2019.

At baseline, most (75%) were also taking metformin, 45% also took sulfonylureas, 37% dipeptidyl peptidase-4 (DPP-4) inhibitors, and 36% insulin.

Most (81%) also had hypertension, half (51%) had hypercholesterolemia, a third (33%) had obesity, and 32% had a previous cardiovascular event.

With SGLT2-inhibitor treatment, the average hemoglobin A_1c level dropped from 8.5% to 7.3% (P less than .01), body weight was reduced from 91.0 kg to 84.7 kg (P less than .01), systolic blood pressure from 134.5 mm Hg to 130.4 mm Hg (P = .02), and diastolic blood pressure from 76.2 mm Hg to 73.3 mm Hg (P = .04).

This effect on blood pressure “should be considered” because it means that “antihypertensive treatment might need to be reviewed,” Dr. Trescoli-Serrano commented.

There were no significant changes in estimated glomerular filtration rate (eGFR), microalbuminuria, lipid profile, hematocrit, or heart rate, although there were positive trends in both renal function and lipid profiles.

No patient had a fall, volume depletion symptoms, or diabetic ketoacidosis. However, 38% of patients were treated for urinary-genital infections, and 8% had to stop taking the SGLT2 inhibitor because of such infections.

That percentage seemed unusually high and was “an outlier, not the general experience,” commented Dr. Dagogo-Jack, chief of the Division of Endocrinology, Diabetes and Metabolism at the University of Tennessee Health Science Center, Memphis. He noted that infections with SGLT2 inhibitors are more often genital fungal than urinary tract infections, but the latter are more common in people with diabetes overall, and the study wasn’t randomized, so this might explain the finding.

New nonfatal cardiovascular events occurred in 22% of the patients, mainly cerebrovascular disease during the treatment period. Of those, 66% had had a previous cardiovascular event prior to starting on SGLT2 inhibitors.

Severe hypoglycemia was recorded in one patient, who was also taking insulin. Overall 10% died, mainly because of neoplastic causes.

“Long-term treatment with SGLT2 inhibitors are safe and effective when added to not-well-controlled elderly type 2 diabetes patients in a real-world experience,” Dr. Trescoli-Serrano concluded.

Dr. Dagogo-Jack is a consultant for Merck, Janssen, and Sanofi and owns stock in Dance Pharma and Jana Care.



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

BUSAN, SOUTH KOREA – Sodium-glucose transporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes seem to be as safe and effective in people aged 65 years and older as they are in younger individuals, new research suggests.

Findings from a real-world observational study of 50 older adults with type 2 diabetes were recently presented at the International Diabetes Federation congress by Carlos Trescoli-Serrano, MD, of Hospital Universitario de la Ribera, Valencia, Spain.

“The results are quite similar to those of younger people. … In a selected population they are safe. It doesn’t matter if patients are older or younger. You have to review the patients for complications,” Dr. Trescoli-Serrano said in an interview.

Asked to comment, session moderator Samuel Dagogo-Jack, MD, said: “We need more and more studies in older people for reassurance. The elderly have impaired kidneys, and these drugs depend on kidney filtration. It’s good to have data on elderly patients in the real world.”
 

Most had comorbidities

The 50 adults were a mean age of 67 years, and the oldest was 81 years. They had a mean diabetes duration of 12.5 years, and 40% were women. They had all been taking SGLT2 inhibitors for more than 3 years (mean 43.9 months) during 2015-2019.

At baseline, most (75%) were also taking metformin, 45% also took sulfonylureas, 37% dipeptidyl peptidase-4 (DPP-4) inhibitors, and 36% insulin.

Most (81%) also had hypertension, half (51%) had hypercholesterolemia, a third (33%) had obesity, and 32% had a previous cardiovascular event.

With SGLT2-inhibitor treatment, the average hemoglobin A_1c level dropped from 8.5% to 7.3% (P less than .01), body weight was reduced from 91.0 kg to 84.7 kg (P less than .01), systolic blood pressure from 134.5 mm Hg to 130.4 mm Hg (P = .02), and diastolic blood pressure from 76.2 mm Hg to 73.3 mm Hg (P = .04).

This effect on blood pressure “should be considered” because it means that “antihypertensive treatment might need to be reviewed,” Dr. Trescoli-Serrano commented.

There were no significant changes in estimated glomerular filtration rate (eGFR), microalbuminuria, lipid profile, hematocrit, or heart rate, although there were positive trends in both renal function and lipid profiles.

No patient had a fall, volume depletion symptoms, or diabetic ketoacidosis. However, 38% of patients were treated for urinary-genital infections, and 8% had to stop taking the SGLT2 inhibitor because of such infections.

That percentage seemed unusually high and was “an outlier, not the general experience,” commented Dr. Dagogo-Jack, chief of the Division of Endocrinology, Diabetes and Metabolism at the University of Tennessee Health Science Center, Memphis. He noted that infections with SGLT2 inhibitors are more often genital fungal than urinary tract infections, but the latter are more common in people with diabetes overall, and the study wasn’t randomized, so this might explain the finding.

New nonfatal cardiovascular events occurred in 22% of the patients, mainly cerebrovascular disease during the treatment period. Of those, 66% had had a previous cardiovascular event prior to starting on SGLT2 inhibitors.

Severe hypoglycemia was recorded in one patient, who was also taking insulin. Overall 10% died, mainly because of neoplastic causes.

“Long-term treatment with SGLT2 inhibitors are safe and effective when added to not-well-controlled elderly type 2 diabetes patients in a real-world experience,” Dr. Trescoli-Serrano concluded.

Dr. Dagogo-Jack is a consultant for Merck, Janssen, and Sanofi and owns stock in Dance Pharma and Jana Care.



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

BUSAN, SOUTH KOREA – Sodium-glucose transporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes seem to be as safe and effective in people aged 65 years and older as they are in younger individuals, new research suggests.

Findings from a real-world observational study of 50 older adults with type 2 diabetes were recently presented at the International Diabetes Federation congress by Carlos Trescoli-Serrano, MD, of Hospital Universitario de la Ribera, Valencia, Spain.

“The results are quite similar to those of younger people. … In a selected population they are safe. It doesn’t matter if patients are older or younger. You have to review the patients for complications,” Dr. Trescoli-Serrano said in an interview.

Asked to comment, session moderator Samuel Dagogo-Jack, MD, said: “We need more and more studies in older people for reassurance. The elderly have impaired kidneys, and these drugs depend on kidney filtration. It’s good to have data on elderly patients in the real world.”
 

Most had comorbidities

The 50 adults were a mean age of 67 years, and the oldest was 81 years. They had a mean diabetes duration of 12.5 years, and 40% were women. They had all been taking SGLT2 inhibitors for more than 3 years (mean 43.9 months) during 2015-2019.

At baseline, most (75%) were also taking metformin, 45% also took sulfonylureas, 37% dipeptidyl peptidase-4 (DPP-4) inhibitors, and 36% insulin.

Most (81%) also had hypertension, half (51%) had hypercholesterolemia, a third (33%) had obesity, and 32% had a previous cardiovascular event.

With SGLT2-inhibitor treatment, the average hemoglobin A_1c level dropped from 8.5% to 7.3% (P less than .01), body weight was reduced from 91.0 kg to 84.7 kg (P less than .01), systolic blood pressure from 134.5 mm Hg to 130.4 mm Hg (P = .02), and diastolic blood pressure from 76.2 mm Hg to 73.3 mm Hg (P = .04).

This effect on blood pressure “should be considered” because it means that “antihypertensive treatment might need to be reviewed,” Dr. Trescoli-Serrano commented.

There were no significant changes in estimated glomerular filtration rate (eGFR), microalbuminuria, lipid profile, hematocrit, or heart rate, although there were positive trends in both renal function and lipid profiles.

No patient had a fall, volume depletion symptoms, or diabetic ketoacidosis. However, 38% of patients were treated for urinary-genital infections, and 8% had to stop taking the SGLT2 inhibitor because of such infections.

That percentage seemed unusually high and was “an outlier, not the general experience,” commented Dr. Dagogo-Jack, chief of the Division of Endocrinology, Diabetes and Metabolism at the University of Tennessee Health Science Center, Memphis. He noted that infections with SGLT2 inhibitors are more often genital fungal than urinary tract infections, but the latter are more common in people with diabetes overall, and the study wasn’t randomized, so this might explain the finding.

New nonfatal cardiovascular events occurred in 22% of the patients, mainly cerebrovascular disease during the treatment period. Of those, 66% had had a previous cardiovascular event prior to starting on SGLT2 inhibitors.

Severe hypoglycemia was recorded in one patient, who was also taking insulin. Overall 10% died, mainly because of neoplastic causes.

“Long-term treatment with SGLT2 inhibitors are safe and effective when added to not-well-controlled elderly type 2 diabetes patients in a real-world experience,” Dr. Trescoli-Serrano concluded.

Dr. Dagogo-Jack is a consultant for Merck, Janssen, and Sanofi and owns stock in Dance Pharma and Jana Care.



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

BUSAN, SOUTH KOREA – With much misinformation online about diabetes, it is important to know which websites and other online portals offer trustworthy information for clinicians and patients with type 1 and type 2, says endocrinologist Irl B. Hirsch, MD, professor of medicine and diabetes treatment and teaching chair at the University of Washington, Seattle.

Speaking at the recent International Diabetes Federation Congress, Dr. Hirsch offered the international audience a list of sites he considers reliable and helpful, but with the caveat that “this is by no means a complete list, but these are some of my favorites.”

Session moderator David M. Maahs, MD, PhD, chief of pediatric endocrinology at Stanford (Calif.) University, said in an interview that it is now pointless to try to tell patients not to look things up online. “Everyone is going to go on the Internet, so point people in the right direction for reliable information,” he advised.

For general diabetes information, Dr. Hirsch said society websites are a good place for clinicians and patients to start. Among the best of these, he said, are:

• American Diabetes Association (ADA).
• Diabetes Australia.
• Diabetes UK.
• European Association for the Study of Diabetes (EASD).
• International Diabetes Federation (IDF).
• JDRF (type 1 diabetes).

Sites for type 1 diabetes

He pointed out in his talk that he was able to find many more reliable sites for type 1 diabetes than for type 2 diabetes. Among his top picks was the Children with Diabetes (CWD) website, which he said was “an outstanding site for type 1 diabetes for children, parents, grandparents, and also adults with type 1 diabetes.” Its content includes up-to-date information about all aspects of type 1 diabetes research, frequent polls of common questions, and discussion forums.

“It’s not just the United States. People from all over the world are looking at this site,” Dr. Hirsch noted.

For 2 decades, the CWD has sponsored the Friends for Life conference, which takes place in Orlando every July. The event is now attended by around 3,000 children and young adults with type 1 diabetes and their family members, he noted.

Dr. Maahs seconded Dr. Hirsch’s CWD recommendation. “They’ve continued to have a wonderful website, a great source of information. The conference is great. They’ll put you in touch with people in your area.”

Another good type 1 diabetes site for patients and families is that of the JDRF (formerly the Juvenile Diabetes Research Foundation), which provides “an outstanding review of type 1 diabetes research and social action,” Dr. Hirsch commented. In addition to the main site, there are also regional JDRF sites in Australia, the United Kingdom, and Canada.

Beyond Type 1 is part of a network that also includes Beyond Type 2 and Spanish-language sites for both Beyond Type 1 and Beyond Type 2. The sites feature news, stories, self-help, and resources.

The International Society for Pediatric and Adolescent Diabetes (ISPAD) has a site for clinicians and families with type 1 diabetes, according to Dr. Hirsch. It provides information about events, resources, and guidelines. A recent article, for example, addresses fasting during Ramadan or young people with diabetes.

Dr. Maahs, who is secretary general of ISPAD and edited the organization’s 2018 Clinical Practice Consensus Guidelines, noted that all of the clinical guidelines and patient education materials are free on the site, as are conference presentations from the past 3 years. A lot of the material is also available in different languages, he noted.

He also pointed out that ISPAD’s recommendations for pediatric diabetes are mostly in line with that of the ADA, but they include far more information – 25 chapters versus just one ADA chapter. Also, in 2018, ISPAD lowered its A_1c target for children from 7.5% to 7.0%, which aligns with Scandinavian but not U.S. recommendations.

In addition to the type 1 diabetes sites that Dr. Hirsch listed, Dr. Maahs added the T1D Exchange online community site Glu, which he said was a good patient advocacy site.
 

Sites for type 2 diabetes

Dr. Hirsch recommended several sites for patients with type 2 diabetes, including:

• The Johns Hopkins Patient Guide to Diabetes, one of his favorite type 2 diabetes sites because of its “artistry, the graphics – you get it from just looking at the pictures. There’s a tech corner, videos, and patient stories. There’s just a lot here for patients.”
• Diabetes Sisters, specifically for women with diabetes.
• Diabetes Strong, which focuses on exercise.
• Wildly Fluctuating, with topics “from humor to serious stuff to miscellaneous musings on the diabetes news of the week by a type 2 diabetes patient/expert.”

Sites for clinicians

For clinicians, Dr. Hirsch said the following sites provide free and up-to-date information on the management of type 2 diabetes (some also include type 1 diabetes):

• ADA/EASD Standards of Care.
• Diabetes Canada 2018 Guidelines.
• American Association of Clinical Endocrinologists Type 2 Diabetes Management Algorithm.
• UK National Institute for Health and Care Excellence, which Dr. Hirsch called “extensive evidence-based guidelines. They really dig into the evidence as much, if not more, than most of the national standards of care around the world.”
• Clinical Diabetes, an ADA journal that provides “outstanding articles geared for nonspecialists free to clinicians online 6 months after publication.” It includes some primary data articles, but it is mostly review, he noted.

Regional sites

Dr. Hirsch included information about regional sites as well:

• Dr. Mohan’s Diabetes Specialties Centre, “a very good site for those living in India.”
• HealthDirect in Australia.
• Diabetes UK.

Dr. Hirsch is a consultant for Abbott Diabetes Care, Roche, and Bigfoot; conducts research for Medtronic; and is an editor on diabetes for UpToDate. Dr. Maahs has received research support from the National Institutes of Health, JDRF, National Science Foundation, and Leona M. and Harry B. Helmsley Charitable Trust and has consulted for Abbott, Helmsley, Sanofi, Novo Nordisk, Eli Lilly, and Insulet.
 

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

BUSAN, SOUTH KOREA – With much misinformation online about diabetes, it is important to know which websites and other online portals offer trustworthy information for clinicians and patients with type 1 and type 2, says endocrinologist Irl B. Hirsch, MD, professor of medicine and diabetes treatment and teaching chair at the University of Washington, Seattle.

Speaking at the recent International Diabetes Federation Congress, Dr. Hirsch offered the international audience a list of sites he considers reliable and helpful, but with the caveat that “this is by no means a complete list, but these are some of my favorites.”

Session moderator David M. Maahs, MD, PhD, chief of pediatric endocrinology at Stanford (Calif.) University, said in an interview that it is now pointless to try to tell patients not to look things up online. “Everyone is going to go on the Internet, so point people in the right direction for reliable information,” he advised.

For general diabetes information, Dr. Hirsch said society websites are a good place for clinicians and patients to start. Among the best of these, he said, are:

• American Diabetes Association (ADA).
• Diabetes Australia.
• Diabetes UK.
• European Association for the Study of Diabetes (EASD).
• International Diabetes Federation (IDF).
• JDRF (type 1 diabetes).

Sites for type 1 diabetes

He pointed out in his talk that he was able to find many more reliable sites for type 1 diabetes than for type 2 diabetes. Among his top picks was the Children with Diabetes (CWD) website, which he said was “an outstanding site for type 1 diabetes for children, parents, grandparents, and also adults with type 1 diabetes.” Its content includes up-to-date information about all aspects of type 1 diabetes research, frequent polls of common questions, and discussion forums.

“It’s not just the United States. People from all over the world are looking at this site,” Dr. Hirsch noted.

For 2 decades, the CWD has sponsored the Friends for Life conference, which takes place in Orlando every July. The event is now attended by around 3,000 children and young adults with type 1 diabetes and their family members, he noted.

Dr. Maahs seconded Dr. Hirsch’s CWD recommendation. “They’ve continued to have a wonderful website, a great source of information. The conference is great. They’ll put you in touch with people in your area.”

Another good type 1 diabetes site for patients and families is that of the JDRF (formerly the Juvenile Diabetes Research Foundation), which provides “an outstanding review of type 1 diabetes research and social action,” Dr. Hirsch commented. In addition to the main site, there are also regional JDRF sites in Australia, the United Kingdom, and Canada.

Beyond Type 1 is part of a network that also includes Beyond Type 2 and Spanish-language sites for both Beyond Type 1 and Beyond Type 2. The sites feature news, stories, self-help, and resources.

The International Society for Pediatric and Adolescent Diabetes (ISPAD) has a site for clinicians and families with type 1 diabetes, according to Dr. Hirsch. It provides information about events, resources, and guidelines. A recent article, for example, addresses fasting during Ramadan or young people with diabetes.

Dr. Maahs, who is secretary general of ISPAD and edited the organization’s 2018 Clinical Practice Consensus Guidelines, noted that all of the clinical guidelines and patient education materials are free on the site, as are conference presentations from the past 3 years. A lot of the material is also available in different languages, he noted.

He also pointed out that ISPAD’s recommendations for pediatric diabetes are mostly in line with that of the ADA, but they include far more information – 25 chapters versus just one ADA chapter. Also, in 2018, ISPAD lowered its A_1c target for children from 7.5% to 7.0%, which aligns with Scandinavian but not U.S. recommendations.

In addition to the type 1 diabetes sites that Dr. Hirsch listed, Dr. Maahs added the T1D Exchange online community site Glu, which he said was a good patient advocacy site.
 

Sites for type 2 diabetes

Dr. Hirsch recommended several sites for patients with type 2 diabetes, including:

• The Johns Hopkins Patient Guide to Diabetes, one of his favorite type 2 diabetes sites because of its “artistry, the graphics – you get it from just looking at the pictures. There’s a tech corner, videos, and patient stories. There’s just a lot here for patients.”
• Diabetes Sisters, specifically for women with diabetes.
• Diabetes Strong, which focuses on exercise.
• Wildly Fluctuating, with topics “from humor to serious stuff to miscellaneous musings on the diabetes news of the week by a type 2 diabetes patient/expert.”

Sites for clinicians

For clinicians, Dr. Hirsch said the following sites provide free and up-to-date information on the management of type 2 diabetes (some also include type 1 diabetes):

• ADA/EASD Standards of Care.
• Diabetes Canada 2018 Guidelines.
• American Association of Clinical Endocrinologists Type 2 Diabetes Management Algorithm.
• UK National Institute for Health and Care Excellence, which Dr. Hirsch called “extensive evidence-based guidelines. They really dig into the evidence as much, if not more, than most of the national standards of care around the world.”
• Clinical Diabetes, an ADA journal that provides “outstanding articles geared for nonspecialists free to clinicians online 6 months after publication.” It includes some primary data articles, but it is mostly review, he noted.

Regional sites

Dr. Hirsch included information about regional sites as well:

• Dr. Mohan’s Diabetes Specialties Centre, “a very good site for those living in India.”
• HealthDirect in Australia.
• Diabetes UK.

Dr. Hirsch is a consultant for Abbott Diabetes Care, Roche, and Bigfoot; conducts research for Medtronic; and is an editor on diabetes for UpToDate. Dr. Maahs has received research support from the National Institutes of Health, JDRF, National Science Foundation, and Leona M. and Harry B. Helmsley Charitable Trust and has consulted for Abbott, Helmsley, Sanofi, Novo Nordisk, Eli Lilly, and Insulet.
 

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

BUSAN, SOUTH KOREA – With much misinformation online about diabetes, it is important to know which websites and other online portals offer trustworthy information for clinicians and patients with type 1 and type 2, says endocrinologist Irl B. Hirsch, MD, professor of medicine and diabetes treatment and teaching chair at the University of Washington, Seattle.

Speaking at the recent International Diabetes Federation Congress, Dr. Hirsch offered the international audience a list of sites he considers reliable and helpful, but with the caveat that “this is by no means a complete list, but these are some of my favorites.”

Session moderator David M. Maahs, MD, PhD, chief of pediatric endocrinology at Stanford (Calif.) University, said in an interview that it is now pointless to try to tell patients not to look things up online. “Everyone is going to go on the Internet, so point people in the right direction for reliable information,” he advised.

For general diabetes information, Dr. Hirsch said society websites are a good place for clinicians and patients to start. Among the best of these, he said, are:

• American Diabetes Association (ADA).
• Diabetes Australia.
• Diabetes UK.
• European Association for the Study of Diabetes (EASD).
• International Diabetes Federation (IDF).
• JDRF (type 1 diabetes).

Sites for type 1 diabetes

He pointed out in his talk that he was able to find many more reliable sites for type 1 diabetes than for type 2 diabetes. Among his top picks was the Children with Diabetes (CWD) website, which he said was “an outstanding site for type 1 diabetes for children, parents, grandparents, and also adults with type 1 diabetes.” Its content includes up-to-date information about all aspects of type 1 diabetes research, frequent polls of common questions, and discussion forums.

“It’s not just the United States. People from all over the world are looking at this site,” Dr. Hirsch noted.

For 2 decades, the CWD has sponsored the Friends for Life conference, which takes place in Orlando every July. The event is now attended by around 3,000 children and young adults with type 1 diabetes and their family members, he noted.

Dr. Maahs seconded Dr. Hirsch’s CWD recommendation. “They’ve continued to have a wonderful website, a great source of information. The conference is great. They’ll put you in touch with people in your area.”

Another good type 1 diabetes site for patients and families is that of the JDRF (formerly the Juvenile Diabetes Research Foundation), which provides “an outstanding review of type 1 diabetes research and social action,” Dr. Hirsch commented. In addition to the main site, there are also regional JDRF sites in Australia, the United Kingdom, and Canada.

Beyond Type 1 is part of a network that also includes Beyond Type 2 and Spanish-language sites for both Beyond Type 1 and Beyond Type 2. The sites feature news, stories, self-help, and resources.

The International Society for Pediatric and Adolescent Diabetes (ISPAD) has a site for clinicians and families with type 1 diabetes, according to Dr. Hirsch. It provides information about events, resources, and guidelines. A recent article, for example, addresses fasting during Ramadan or young people with diabetes.

Dr. Maahs, who is secretary general of ISPAD and edited the organization’s 2018 Clinical Practice Consensus Guidelines, noted that all of the clinical guidelines and patient education materials are free on the site, as are conference presentations from the past 3 years. A lot of the material is also available in different languages, he noted.

He also pointed out that ISPAD’s recommendations for pediatric diabetes are mostly in line with that of the ADA, but they include far more information – 25 chapters versus just one ADA chapter. Also, in 2018, ISPAD lowered its A_1c target for children from 7.5% to 7.0%, which aligns with Scandinavian but not U.S. recommendations.

In addition to the type 1 diabetes sites that Dr. Hirsch listed, Dr. Maahs added the T1D Exchange online community site Glu, which he said was a good patient advocacy site.
 

Sites for type 2 diabetes

Dr. Hirsch recommended several sites for patients with type 2 diabetes, including:

• The Johns Hopkins Patient Guide to Diabetes, one of his favorite type 2 diabetes sites because of its “artistry, the graphics – you get it from just looking at the pictures. There’s a tech corner, videos, and patient stories. There’s just a lot here for patients.”
• Diabetes Sisters, specifically for women with diabetes.
• Diabetes Strong, which focuses on exercise.
• Wildly Fluctuating, with topics “from humor to serious stuff to miscellaneous musings on the diabetes news of the week by a type 2 diabetes patient/expert.”

Sites for clinicians

For clinicians, Dr. Hirsch said the following sites provide free and up-to-date information on the management of type 2 diabetes (some also include type 1 diabetes):

• ADA/EASD Standards of Care.
• Diabetes Canada 2018 Guidelines.
• American Association of Clinical Endocrinologists Type 2 Diabetes Management Algorithm.
• UK National Institute for Health and Care Excellence, which Dr. Hirsch called “extensive evidence-based guidelines. They really dig into the evidence as much, if not more, than most of the national standards of care around the world.”
• Clinical Diabetes, an ADA journal that provides “outstanding articles geared for nonspecialists free to clinicians online 6 months after publication.” It includes some primary data articles, but it is mostly review, he noted.

Regional sites

Dr. Hirsch included information about regional sites as well:

• Dr. Mohan’s Diabetes Specialties Centre, “a very good site for those living in India.”
• HealthDirect in Australia.
• Diabetes UK.

Dr. Hirsch is a consultant for Abbott Diabetes Care, Roche, and Bigfoot; conducts research for Medtronic; and is an editor on diabetes for UpToDate. Dr. Maahs has received research support from the National Institutes of Health, JDRF, National Science Foundation, and Leona M. and Harry B. Helmsley Charitable Trust and has consulted for Abbott, Helmsley, Sanofi, Novo Nordisk, Eli Lilly, and Insulet.
 

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

WASHINGTON – Insulin is the preferred agent for type 2 diabetes in pregnant women, yet about a third of pregnancies still have an adverse outcome, according Kim Boggess, MD, who spoke at the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

“We are not where we need to be,” said Dr. Boggess, who is leading a trial that brings metformin, the first-line agent for type 2 diabetes outside of pregnancy, back into the picture for pregnant women – as an add-on to insulin.

It is an interesting twist, because pregnant women taking metformin for preexisting type 2 or gestational diabetes have been shown in some studies to require supplemental insulin, more than occasionally, to achieve target glycemic control.

This was the case in a small, randomized, controlled trial at Dr. Boggess’ institution, the University of North Carolina at Chapel Hill, in which 43% of pregnant women with type 2 diabetes who were assigned to metformin required supplemental insulin (Am J Perinatol. 2013;30[6]:483-90). The study also found, however, that women treated with metformin had significantly fewer episodes of hypoglycemia, compared with women using insulin (0% vs. 36%, respectively) and fewer reports of glucose values less than 60 mg/dL (7.1% vs. 50%).

“I don’t consider this [need for supplemental insulin] ‘metformin failure,’ because studies that use metformin as monotherapy and that [show some patients] ultimately requiring insulin support ... also show that these women need less insulin,” she said. “What’s the risk of insulin alone? Hypoglycemia. So using less insulin could be a good thing.”

Other research suggests there may be less maternal weight gain, less neonatal hypoglycemia, fewer neonatal complications, and improved maternal glycemic control in patients treated with metformin, alone or with add-on insulin, than with insulin alone. “We’re starting to get a sense in the literature that, at least in the [pregnant] population with type 2 diabetes, there may be a role for metformin,” said Dr. Boggess, professor and program director for maternal-fetal medicine at the university.

* This article was updated 1/2/2020.

WASHINGTON – Insulin is the preferred agent for type 2 diabetes in pregnant women, yet about a third of pregnancies still have an adverse outcome, according Kim Boggess, MD, who spoke at the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

“We are not where we need to be,” said Dr. Boggess, who is leading a trial that brings metformin, the first-line agent for type 2 diabetes outside of pregnancy, back into the picture for pregnant women – as an add-on to insulin.

It is an interesting twist, because pregnant women taking metformin for preexisting type 2 or gestational diabetes have been shown in some studies to require supplemental insulin, more than occasionally, to achieve target glycemic control.

This was the case in a small, randomized, controlled trial at Dr. Boggess’ institution, the University of North Carolina at Chapel Hill, in which 43% of pregnant women with type 2 diabetes who were assigned to metformin required supplemental insulin (Am J Perinatol. 2013;30[6]:483-90). The study also found, however, that women treated with metformin had significantly fewer episodes of hypoglycemia, compared with women using insulin (0% vs. 36%, respectively) and fewer reports of glucose values less than 60 mg/dL (7.1% vs. 50%).

“I don’t consider this [need for supplemental insulin] ‘metformin failure,’ because studies that use metformin as monotherapy and that [show some patients] ultimately requiring insulin support ... also show that these women need less insulin,” she said. “What’s the risk of insulin alone? Hypoglycemia. So using less insulin could be a good thing.”

Other research suggests there may be less maternal weight gain, less neonatal hypoglycemia, fewer neonatal complications, and improved maternal glycemic control in patients treated with metformin, alone or with add-on insulin, than with insulin alone. “We’re starting to get a sense in the literature that, at least in the [pregnant] population with type 2 diabetes, there may be a role for metformin,” said Dr. Boggess, professor and program director for maternal-fetal medicine at the university.

* This article was updated 1/2/2020.

WASHINGTON – Insulin is the preferred agent for type 2 diabetes in pregnant women, yet about a third of pregnancies still have an adverse outcome, according Kim Boggess, MD, who spoke at the biennial meeting of the Diabetes in Pregnancy Study Group of North America.

“We are not where we need to be,” said Dr. Boggess, who is leading a trial that brings metformin, the first-line agent for type 2 diabetes outside of pregnancy, back into the picture for pregnant women – as an add-on to insulin.

It is an interesting twist, because pregnant women taking metformin for preexisting type 2 or gestational diabetes have been shown in some studies to require supplemental insulin, more than occasionally, to achieve target glycemic control.

This was the case in a small, randomized, controlled trial at Dr. Boggess’ institution, the University of North Carolina at Chapel Hill, in which 43% of pregnant women with type 2 diabetes who were assigned to metformin required supplemental insulin (Am J Perinatol. 2013;30[6]:483-90). The study also found, however, that women treated with metformin had significantly fewer episodes of hypoglycemia, compared with women using insulin (0% vs. 36%, respectively) and fewer reports of glucose values less than 60 mg/dL (7.1% vs. 50%).

“I don’t consider this [need for supplemental insulin] ‘metformin failure,’ because studies that use metformin as monotherapy and that [show some patients] ultimately requiring insulin support ... also show that these women need less insulin,” she said. “What’s the risk of insulin alone? Hypoglycemia. So using less insulin could be a good thing.”

Other research suggests there may be less maternal weight gain, less neonatal hypoglycemia, fewer neonatal complications, and improved maternal glycemic control in patients treated with metformin, alone or with add-on insulin, than with insulin alone. “We’re starting to get a sense in the literature that, at least in the [pregnant] population with type 2 diabetes, there may be a role for metformin,” said Dr. Boggess, professor and program director for maternal-fetal medicine at the university.

* This article was updated 1/2/2020.