Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

When people have severe hypoglycemia, or SH, their blood sugar levels drop so low that they can’t function, and they need help from another person. SH is a serious side effect of medicines used to lower blood sugar levels in patients with diabetes. It can lead to car accidents, serious falls, and death.

To prevent SH, patients need to recognize symptoms of low blood sugar, such as sweating or shakiness. They then need to act to raise their blood sugar. But over time, many patients who take diabetes medicines stop having symptoms of low blood sugar. An educational program called my hypo compass has helped patients with type 1 diabetes improve awareness of low blood sugar and reduce the occurrence of SH. But researchers don’t know if this program works for patients with type 2 diabetes.

In this study, the research team is comparing two ways to prevent SH in patients with type 2 diabetes:

  • Proactive care management. In this approach, a nurse calls once during the 14-month study period to check on the patient. A nurse or doctor then follows up with the patient as needed.
  • Proactive care management plus my hypo compass. My hypo compass lasts three months. It includes two online group education sessions, two follow-up calls from nurses, and a diary to record blood sugar levels.

Who can this research help?

Results may help doctors and healthcare systems when considering ways to prevent SH in patients with type 2 diabetes.

What is the research team doing?

The research team is using electronic health records, or EHRs, from medical centers in one healthcare system in Washington State to identify patients. The team is assigning medical centers by chance to provide proactive care management with or without my hypo compass.

Within the medical centers, the research team is recruiting 256 patients with type 2 diabetes who have had SH in the last 12 months or who are at risk for SH. The team is monitoring patients’ blood sugar levels throughout the study. The team is also surveying patients and collecting information from their EHRs at the start of the study and again 14 months later. Surveys ask about SH events, awareness of low blood sugar, and fear of low blood sugar. In the EHRs, the team is looking at patients’ emergency room visits and hospital admissions for SH.

Patients with type 2 diabetes, family caregivers, primary care doctors, and nurses specializing in diabetes care are helping to plan and conduct this study.

Design Elements Description
Design Randomized controlled trial
Population 256 patients ages 50 and older with type 2 diabetes who are at high risk for SH and who have impaired awareness of hypoglycemia or who had an SH event in the past 12 months
Interventions/
Comparators
  • Proactive care management
  • Proactive care management plus my hypo compass
Outcomes

Primary: self-reported SH events

Secondary: biochemical measures of hypoglycemia, self-reported hypoglycemia awareness, fear of hypoglycemia, emergency room visits and hospitalizations for SH

Timeframe 14-month follow-up for primary outcome

Project Information

James Ralston, MD, MPH
Kaiser Foundation Health Plan of Washington
$2,826,229
Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia

Key Dates

June 2020
November 2024
2020

Study Registration Information

Tags

Award Type
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Funding Opportunity Type
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022