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

Severe Hypoglycemia Clinical Trial

— PHT2  

Official title:

Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04863872
• Other study ID #: IHS-2019C3-17889
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 26, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 my hypo compass, 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 my hypo compass 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.

Description:

This study is a two-arm, individually-randomized, comparative effectiveness study of two evidence-based approaches to preventing severe hypoglycemia. We will identify participants using Electronic Health Record (EHR) data. They will be identified for potential recruitment if they are age 18 and older, diagnosed with type 2 diabetes, receiving primary care at Kaiser Permanente Washington and have a current prescription for insulin or identified using an EHR-based risk stratification tool as being at intermediate to high risk for a severe hypoglycemia event. Within this population, we will recruit participants who either have impaired awareness of hypoglycemia or self-report a severe hypoglycemia event in the prior 12 months. Participants must be members of Kaiser Permanente Washington and identified by the study.

Following randomization, we will compare patients who receive proactive care management from nurses to patients receiving proactive care management plus my hypo compass, a structured educational intervention that reduces the frequency of severe hypoglycemia in individuals with type 1 diabetes. In both groups, we will use proactive care management to assess and provide evidence-based care for impaired awareness of hypoglycemia and other potential contributors to severe hypoglycemia risk.

Our primary outcome is participant-reported severe hypoglycemia, to capture all events, including those not involving clinical care. We will also examine biochemical measures of hypoglycemia measured using continuous glucose monitoring (CGM), participant-reported hypoglycemia awareness, fear of hypoglycemia, and emergency department visits and hospitalizations for severe hypoglycemia. We will conduct a process evaluation to assess the fidelity of implementation and clarify the causal pathway.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 259
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Diagnosed with type 2 diabetes

• Receiving primary care at Kaiser Permanente Washington (KPWA)

• Enrollment in KPWA at baseline and planning to stay with a KPWA health plan for the next 6 months

• Current prescription for insulin or at intermediate to high risk for severe hypoglycemia episode using the hypoglycemia risk stratification tool developed by Karter et. al.

• History of severe hypoglycemia in the prior 12 months or impaired awareness of hypoglycemia

Exclusion Criteria:

• Inability to give informed consent

• Unable to speak or read English

• Inability or unwillingness to attend online or telephone educational sessions, follow up calls, or to complete outcome assessments

• Prior diagnosis of dementia, severe psychiatric conditions with psychosis, severe cognitive impairment

• Currently living in a nursing home or under hospice care

• Current use at baseline of Continuous Glucose Monitor

• Pregnant or planning to become pregnant

Related Conditions & MeSH terms

• Hypoglycemia
• Severe Hypoglycemia

Intervention

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:
• my hypo compass 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported severe hypoglycemia	Any self-reported severe hypoglycemia in prior 12 months	Baseline and 14 months