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

• ClinicalTrials.gov Identifier: NCT04863872
• Recruitment Status: Not yet recruiting
• First Posted: April 28, 2021
• Last Update Posted: April 28, 2021
• Sponsor: Kaiser Permanente
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Kaiser Permanente

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Severe Hypoglycemia	Other: Proactive Care Management; Behavioral: my hypo compass education program	Phase 3

Detailed Description:

This study is a two-arm (128 per arm), cluster-randomized, comparative effectiveness study of two evidence-based approaches to preventing severe hypoglycemia. We will use a validated Electronic Health Record (EHR)-based tool to identify patients with type 2 diabetes at intermediate to high risk for severe hypoglycemia. 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 and are 50 years or older. 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 256 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia
• Estimated Study Start Date: July 19, 2021
• Estimated Primary Completion Date: April 30, 2023
• Estimated Study Completion Date: April 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Proactive Care Management	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.
Experimental: Proactive Care Management + my hypo compass education program	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.

Outcome Measures

Primary Outcome Measures :

1. Self-reported severe hypoglycemia [ Time Frame: Baseline and 14 months ]
   Any self-reported severe hypoglycemia in prior 12 months

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age 50 years or older
• Diagnosed with type 2 diabetes
• Receiving primary care at Kaiser Permanente Washington (KPWA)
• Continuously enrolled at KPWA for 24 months prior to baseline and planning to stay with a KPWA health plan for the next 6 months
• At intermediate to high risk for severe hypoglycemia
• 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

Contacts and Locations

Contacts

Contact: Kelly J Ehrlich, MS; 206-287-2381; Kelly.J.Ehrlich@kp.org

Contact: James Ralston, MD, MPH; 206-287-2076; James.D.Ralston@kp.org

Sponsors and Collaborators

Kaiser Permanente

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: James Ralston, MD, MPH; Kaiser Permanente Washington

More Information

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT04863872
• Other Study ID Numbers: IHS-2019C3-17889
• First Posted: April 28, 2021
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaiser Permanente:

Hypoglycemia; Self-management; Diabetes Mellitus, Type 2; Patient Education

Additional relevant MeSH terms:

Hypoglycemia; Glucose Metabolism Disorders; Metabolic Diseases