Severe hypoglycemia (SH) is a serious complication of medications used to lower blood glucose levels in patients with diabetes. SH, defined as plasma glucose low enough to require assistance, has been linked to poor health-related quality of life, emotional and interpersonal challenges, car accidents, serious falls, cardiovascular events, dementia, and death. Older adults with type 2 diabetes are particularly vulnerable to the complications of severe hypoglycemia. Up to 14 percent of all emergency hospitalizations of older Americans for problems with medications involve insulin or other diabetes drugs. One in four diabetes-related hospital admissions is for hypoglycemia.
To avoid severe hypoglycemia, people need to recognize when hypoglycemia is about to happen and act to increase blood sugar levels. Many people who are at risk for severe hypoglycemia, though, no longer have reactions such as shakiness or sweating that should alert them to low blood sugar. Losing this awareness of low blood sugar happens over time in people taking some diabetes medications, putting them in danger of severe hypoglycemia. Ways to restore awareness of low blood sugar and reduce severe hypoglycemia in people with type 1 diabetes are known, but it is not known whether these methods work for people with type 2 diabetes.
This clinical trial compares two ways to reduce severe hypoglycemia in people with type 2 diabetes. The trial was developed in a healthcare system in Washington State by working with partners including patients with type 2 diabetes, their family caregivers, and primary care doctors and nurses specializing in diabetes care. Using information in the electronic health record, the trial will first identify people with type 2 diabetes who are at high risk for severe hypoglycemia. People in this group will be invited to participate if they are 50 years or older and have lost awareness of low blood sugar or had severe hypoglycemia in the previous 12 months.
The trial will compare two approaches to reducing severe hypoglycemia. One approach is the usual care that people with type 2 diabetes get to reduce their risk of severe hypoglycemia, but it will be given in advance rather than in response to a recent severe hypoglycemia event. The second approach includes this usual care plus a special health educational program with coaching from trained nurses. This program has been shown to greatly reduce severe hypoglycemia in people with type 1 diabetes.
Patient, family caregiver, and healthcare provider partners will help guide the entire study, including evaluating the clinical trial after it is finished, finding the elements that worked to reduce hypoglycemia, and telling patients and the people who care for them what was learned. The goal is to help healthcare systems and providers find effective ways to reduce severe hypoglycemia in patients with type 2 diabetes.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.