A research team led by Kaiser Permanente developed and authenticated a tool with the Food and Drug Administration (FDA), as part of the Safe Use Initiative. This tool identified diabetes patients who were at utmost risk for being admitted to an emergency department due to severe hypoglycemia, findings published in JAMA Internal Medicine.

Although advances are made in the care of patients with diabetes, patients sometimes experience extremely low blood sugar level associated with the diabetes medications, especially after skipping a meal or exercising harder than usual.

Andrew J. Karter, PhD, senior research scientist says patients with diabetes may not realize when their blood sugar is dropping and can progress quickly into severe hypoglycemia, which in turn lead to falling, automobile accidents, heart attacks, coma, and even death.

There were about 100,000 hypoglycemia-related adverse events resulting in emergency room visits each year in the U.S. and these were more likely seen in older patients and those with a long history of type 2 diabetes.

To study the risk factors associated with diabetes, hypoglycemia risk stratification tool was developed. The tool aided in identifying 156 possible risk factors for hypoglycemia from about 200,000 patients with type 2 diabetes receiving care from Kaiser Permanente in Northern California.

In addition, a model to predict a patient's 12-month risk of the hypoglycemia-related emergency department or hospital use was also developed. The model included 6 variables: number of prior episodes of hypoglycemia-related emergency department visits; use of insulin; use of sulfonylurea; severe or end-stage kidney disease; the number of emergency room visits for any reason in the past year; and age.

Based on this the practical tool was created to categorize patients into high (>5 %), intermediate (1-5 %) or low (< 1%) annual risk of the hypoglycemia-related emergency department or hospital utilization. Later, the tool was validated with data from more than 1.3 million members of the U.S. Veterans Health Administration and about 15,000 Kaiser Permanente members with type-2 diabetes.

The U.S. FDA funded the development of this tool under their Safe Use Initiative. The results are being propagated with help from the Centers for Medicare and Medicaid Services (CMS). Currently, many public and private healthcare systems and organizations are looking for the tool’s use to increase awareness about hypoglycemia so as to avoid the risk in patients with type 2 diabetes.

"This work is an example of how federal agencies can work with private researchers to reduce preventable adverse drug events," said John Whyte, MD, MPH, Director of Professional Affairs and Stakeholder Engagement for the FDA. "The goal is to identify the patients who are at highest hypoglycemic risk; so that healthcare providers can focus their attention on the specific needs of these patients and reduce preventable hypoglycemia harm."