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New VA Initiative Battles Excesses of ‘Tight Glucose Control’ Trend

by U.S. Medicine

February 2, 2015

Effort Seeks to Reduce Hypoglycemia in Older Veterans

By Brenda L. Mooney

WASHINGTON – At the beginning of the 21st century, tight glucose control for patients with type 2 diabetes was all the rage.

Now, 15 years later, that one-size-fits-all approach has been rethought to such an extent that the VA now is launching an initiative to manage rampant hypoglycemia occurring in older veterans, largely brought on by overtreatment of high blood sugar. Instead, personalized healthcare goals and more patient self-management will be urged.

diabetes treatment

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That is a significant change from what appeared to be a breakthrough in preventing complications resulting from type 2 diabetes.

Published in 1998, the landmark United Kingdom Prospective Diabetes Study, involving nearly 4,000 patients with newly diagnosed type 2 diabetes, had suggested that long-term complications of type 2 diabetes could be prevented through intensive blood glucose management.1

While the possibility of pushing blood sugars too low was noted in passing, most of the hype focused on double-digit decreases in diabetes complications with use of sulphonylureas or insulin. The practice of tight glucose control was widely adopted at the VA, where more than a million patients are being treated for diabetes, and elsewhere.

That all began to turn around, however. In 2009, a VA study published in the New England Journal of Medicine, found that intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications, with the exception of progression of albuminuria. In that study, rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard-therapy group and 24.1% in the intensive-therapy group.2

Other studies linked hypoglycemia in the elderly with dementia and cardiovascular issues.

Fast forward to the present, and the VA is launching the national Hypoglycemic Safety Initiative (HSI) to encourage veterans with diabetes to seek support to lower the risk of hypoglycemia.

“The Hypoglycemic Safety Initiative is designed to enable veterans and their families, partners and caregivers to create a personal plan for blood sugar management based upon the veteran’s unique health goals,” said Carolyn Clancy, MD, interim Under Secretary for Health. “Our objective is to change how diabetes is managed in VA and the United States and to help patients improve their personal well-being, not just manage their numbers.”

Clancy added that hypoglycemia “has only recently been prioritized as a national public health issue, but federal agencies are taking a leadership role in addressing the problem. We are proud to note the collaboration of VA with the Department of Health and Human Services in aggressively addressing this problem.”

Intensive Treatment in Half of Patients

A year ago, a study conducted by VA’s New Jersey Health Care System reported that  patients with risk factors for serious hypoglycemia represent a large subset of veterans receiving agents to lower blood sugar. As late as 2009, when the data was collected, about one-half of the patients had evidence of intensive treatment.3

Rates of overtreatment were found to be 10.1% for HbA1c less than 6.0%, 25.2% for less than 6.5%, and 44.3% for less than 7.0%.

In the article published in JAMA Internal Medicine, study authors called for a patient safety indicator derived from administrative data to identify high-risk patients for whom reevaluation of glycemic management may be appropriate.

o'malley

Patrick G. O’Malley, MD, MPH

Commenting on that study last June in the Journal of the American Medical Association, Mary A. Andrews,MD of Walter Reed National Military Medical Center in Bethesda, MD, and Patrick G. O’Malley, MD, MPH, of the Uniformed Services University of the Health Sciences, also in Bethesda, warned of the dangers of intensive glycemic control in older patients.4

“The United Kingdom Prospective Diabetes Study (UKPDS) appeared to validate the targeting of lower hemoglobin A1c (HbA1c) levels in type 2 diabetes, as this randomized trial showed lower rates of microvascular complications of diabetes such as retinopathy and renal failure in patients under intensive glycemic control compared with conventional therapy,” Andrews and O’Malley wrote. “However, a growing body of evidence supports the idea that intensive glycemic control causes harm in certain subpopulations of diabetic patients who were underrepresented in trials like the UKPDS. Consider that patients in the UKPDS were newly diagnosed and relatively healthy, with a mean age of 53 years. Those older than 65 years were excluded.”

The commentators contrasted that study to the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, in which the upper age limit was 79 years and the mean age was 63 years. “This trial was stopped early because of higher all-cause mortality in the intensive therapy group,” they pointed out. “Clearly, for this patient demographic, intensive glycemic control is risky business. Indeed, what was previously considered good control for all is now considered overtreatment in elderly patients because it is associated with more harm than benefit.”

Andrews and O’Malley aren’t alone in suggesting that the rush to tighter glucose control for all patients with diabetes might have been ill-advised.

Therapies Cause Hypoglycemia

“Hypoglycemia is the most common acute complication of diabetes therapy and is associated with poor health outcomes,” according to Kasia Lipska, MD, of the Yale University School of Medicine, who was the lead author of a 2013 study finding that hypoglycemia can plague patients across all blood glucose levels in clinical practice. “While aggressive treatment of high blood sugar was once considered a hallmark of better care, recent clinical trials have raised concerns about the risks of tight control, particularly in the frail and elderly.”5

“It is important to note that it’s not the HbA1c that directly causes hypoglycemia, it’s the therapies we use to lower it,” Lipska said.

Recent studies continue to question whether strict glucose control has significant benefits. The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) study, for example, assessed the effects of routine blood-pressure lowering and strict glucose control in a broad cross-section of patients with Type 2 diabetes. Over a decade, patients were followed in ADVANCE-ON, a post-trial follow-up study. In results published a few months ago in the New England Journal of Medicine, no adverse or protective effect was seen, regardless of whether their blood sugar was tightly controlled, although strict blood pressure control did reduce cardiovascular and overall mortality during the trial.6

The undesirable side effects are better substantiated, however. In a 2013 JAMA Internal Medicine study, for example, VA researchers found that having a hypoglycemic event doubled the risk of dementia. At the same time, a dementia diagnosis more than doubled the risk of experiencing a hypoglycemic event (14.2% vs. 6.3%).7

Researchers from the San Francisco Veterans Affairs Medical Center and the University of California San Francisco tracked 783 older adults with diabetes mellitus (DM) for 12 years. All participants were participants in the prospective Health, Aging, and Body Composition Study that started in 1997, and all had baseline Modified Mini-Mental State Examination scores above 79. During the study period, 7.8% or 61 study participants, reported experiencing hypoglycemia, and nearly 19% (148) developed dementia.

“The association (between hypoglycemia and dementia) remained even after adjustment for age, sex, educational level, race/ethnicity, comorbidities and other covariates. These results provide evidence for a reciprocal association between hypoglycemia and dementia among older adults with DM,” the authors wrote.

At severely low levels, that study noted, neurons could be damaged.

In an interview with JAMA after his commentary on the recent VA study was published, O’Malley offered an opinion on how overtreatment of diabetes occurs, even when the potential dangers are known.

“In general, overtreatment is a multifactorial issue related to the culture of care,” he said. “In medicine, physicians always want to do something, to take something, such as a blood sugar value, from abnormal to normal. We rely on clinical evidence for these treatment goals, but sometimes, in the absence of good clinical evidence, we must instead rely on biologic plausibility, and extrapolate data from one population to another.”

Often, he pointed out, the extrapolation happens with the elderly, who are not included in many clinical trials.

“Another issue is the use of quality metrics, or A1c in the case of diabetes, with the notion of ‘lower is better’ driving this culture of aggressive care,” O’Malley added. “The VA system in particular is very good at driving such quality metrics to success, which probably leads to higher rates of overtreatment. It’s basically a case of good intentions and good systems gone awry.”

The announcement of VA’s new initiative notes that 1 in 4 veterans has diabetes and that “recent clinical studies indicate that when diet, exercise and stress reduction are not successful, the benefits of achieving intensive blood sugar control with medication are less effective. This is especially true for hypoglycemic agents (pills or insulin) used for those patients who have had diabetes for many years and those who have additional serious health conditions.”

HSI will make sure veterans better understand the health information provided by their VA healthcare team, including a “teach-back method” where patients and caregivers are asked questions to be certain they understand and can act on key elements of self-management, including diet, exercise, glucose monitoring, managing medications and insulin injections.

“The focus of the HSI is to help raise awareness among patients who may be at risk,” according to the VA.

  1. Intensive blood-glucose control with sulphonylureas or insulin compared with

conventional treatment and risk of complications in patients with type 2 diabetes

(UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep

12;352(9131):837-53. Erratum in: Lancet 1999 Aug 14;354(9178):602. PubMed PMID:

9742976.

2.    Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ,Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME,Henderson WG, Huang GD; VADT Investigators. Glucose control and vascularcomplications in veterans with type 2 diabetes. N Engl J Med. 2009 Jan8;360(2):129-39. doi: 10.1056/NEJMoa0808431. Epub 2008 Dec 17. Erratum in: N EnglJ Med. 2009 Sep 3;361(10):1024-5. N Engl J Med. 2009 Sep 3;361(10):1028. PubMedPMID: 19092145.3.    Tseng CL, Soroka O, Maney M, Aron DC, Pogach LM. Assessing potential glycemic overtreatment in persons at hypoglycemic risk. JAMA Intern Med. 2014 Feb1;174(2):259-68. doi: 10.1001/jamainternmed.2013.12963. PubMed PMID: 24322626.

  1. Andrews MA, O’Malley PG. Diabetes overtreatment in elderly individuals: risky

business in need of better management. JAMA. 2014 Jun 11;311(22):2326-7. doi:10.1001/jama.2014.4563. PubMed PMID: 249152644

  1. Lipska K, Warton EM, Huang ES, Moffet HH, Inzucchi SE, et al. “HbA1c and the Risk of Severe Hypoglycemia in Type 2 Diabetes,” Diabetes Care, online before print July 30, 2013.

6. Zoungas S, Chalmers J, Neal B, Billot L, Li Q, Hirakawa Y, Arima H, MonaghanH, Joshi R, Colagiuri S, Cooper ME, Glasziou P, Grobbee D, Hamet P, Harrap S,Heller S, Lisheng L, Mancia G, Marre M, Matthews DR, Mogensen CE, Perkovic V,Poulter N, Rodgers A, Williams B, MacMahon S, Patel A, Woodward M; ADVANCE-ONCollaborative Group. Follow-up of blood-pressure lowering and glucose control in type 2 diabetes. N Engl J Med. 2014 Oct 9;371(15):1392-406. doi:10.1056/NEJMoa1407963. Epub 2014 Sep 19. PubMed PMID: 25234206.

  1. Yaffe K, Falvey CM, Hamilton N, Harris TB, Simonsick EM, et al. “Association between hypoglycemia and dementia in a biracial cohort of older adults with diabetes mellitus,” JAMA Internal Medicine. July 2013;173(14)1300-1306.

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