Risk Related to Serious Hypoglycemia among Diabetics is Under-stated by Current Guidelines and Performance Measurements

SUMMARY:
Rapidly evolving evidence from clinical trials and observational studies indicates that serious hypoglycemia is frequent among individuals with type 2 diabetes. Notwithstanding the absence of proven causality between hypoglycemia and mortality, the risks and consequences of hypoglycemia are significant. Despite the significant health burden associated with hypoglycemia, its risks appear to be understated by guideline and performance measurement groups. To increase public and professional awareness about this risk – and to decrease its occurrence, several recommendations are suggested, including, but not limited to:

• Collaboration among federal and state agencies to improve reporting and surveillance of serious hypoglycemic events;
• Comparative effectiveness research to evaluate the magnitude of the hypoglycemic problem and its risk factors in non-trial populations in clinical practice;
• Good coordination of care, inherent in the "patient-centered medical home," should characterize the multidisciplinary teams that can initiate and monitor insulin therapy; and
• Organizations that develop performance measures should include specific exclusion criteria for patients at greatest risk for hypoglycemia, and stratify results by age and insulin use to minimize overtreatment to "meet a measure."

BACKGROUND:
Recent clinical trials have provided new evidence regarding the relationship among severe hypoglycemia, glycemic control, and mortality among individuals with type 2 diabetes. In addition, questions have arisen about whether current healthcare policies, guidelines, measurement tools, and educational interventions are sufficient to monitor the rates and decrease the risk of serious hypoglycemia in ambulatory clinical practice. Even prior to recent trial results, guidelines from the American Geriatric Society, VA/DoD, as well as clinical recommendations from the American College of Physicians emphasized evaluation of comorbid illness and individualization of hemoglobin A1c goals in patients with type 2 diabetes. This Commentary discusses the issues surrounding glycemic control among these patients, and proposes several action steps as part of a public health effort to promote awareness of hypoglycemia risk and decrease its occurrence.

IMPLICATIONS:

• The authors recommend a multi-pronged approach to insulin safety that has as its cornerstones both improved surveillance and informed patient, shared decision-making for glycemic control, which is based on the best available data of benefits and risks applicable to each individual. They also suggest a proactive public health effort to restore a more balanced approach in addressing hypoglycemia guidelines, policy, measures, and practice.

AUTHOR/FUNDING INFORMATION:
Drs. Pogach and Aron are part of VA/HSR&D’s Diabetes Mellitus Quality Enhancement Research Initiative (DM-QUERI).

Pogach L and Aron D. Balancing Hypoglycemia and Glycemic Control: A Public Health Approach for Insulin Safety. Commentary, JAMA. May 26, 2010;303(20):2076-77.