Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2)

Summary

Severe hypoglycemia is the most feared complication of medications used to lower blood glucose levels in patients with diabetes. Severe hypoglycemia, 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. Each year, approximately 11% of patients with type 2 diabetes self-report severe hypoglycemia episodes. An estimated 14% of emergency hospitalizations of older Americans for adverse drug events implicate insulin and 11% implicate oral hypoglycemic agents. One in four diabetes-related hospital admissions is for hypoglycemia.

This study will compare two ways to reduce severe hypoglycemia in people with type 2 diabetes. The two methods to be compared are:

1. Proactive care management. This will be a nurse outreach call which is similar to the usual care that people with type 2 diabetes get to reduce their risk of severe hypoglycemia, but given in advance rather than in response to a recent severe hypoglycemia event.
2. The same proactive care management (nurse outreach call) plus enrollment in MyHC-T2D, a health education program aimed at improving awareness of hypoglycemia and preventing severe hypoglycemia. This program has been shown to reduce severe hypoglycemia in people with type 1 diabetes but has not been tested in persons with type 2.

Our hypothesis is that proactive care management plus MyHC-T2D will be more effective than proactive care management alone at preventing self-reported severe hypoglycemia in adults with type 2 diabetes at high risk for severe hypoglycemia. The primary outcome will be measured using surveys at the beginning of the study and 14-months later.

Conditions

• Severe Hypoglycemia

Interventions

OTHER

Proactive Care Management

Participants will receive one telephone nurse outreach call with follow up by the nurse or their primary care provider as clinically indicated.

BEHAVIORAL

MyHC-T2D education program

Participants will be enrolled in a structured education program designed to improve hypoglycemia awareness and reduce severe hypoglycemia. The structured program will include 2 online group education sessions, 2 nurse follow up calls and use of glucose and hypoglycemia diaries, delivered over approximately 3 months.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Kaiser Permanente

  lead OTHER

Principal Investigators

• James Ralston, MD, MPH · Kaiser Permanente

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-26

Primary Completion

2024-04-24

Completion

2024-06-21

Countries

• United States

Study Locations