Clinical trial NCT04863872: Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2)
Official title: Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Hypoglycemia
Keywords: Hypoglycemia
Self-management
Diabetes Mellitus, Type 2
Patient Education
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2021-04-28
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled trial comparing the effectiveness of 2 approaches for preventing severe hypoglycemia among participants with type 2 diabetes who are at risk for severe hypoglycemia. Participants were randomly assigned to one of two interventions: 1) Proactive Care Management, consisting of outreach from Kaiser Permanente Washington (KPWA) nurses using standard KPWA clinical tools; 2) the same Proactive Care Management plus MyHC-T2D, a structured educational intervention.
Primary purpose: PREVENTION

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 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.

Detailed 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 MyHC-T2D, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported Severe Hypoglycemia
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: James Ralston, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karter AJ, Warton EM, Lipska KJ, Ralston JD, Moffet HH, Jackson GG, Huang ES, Miller DR. Development and Validation of a Tool to Identify Patients With Type 2 Diabetes at High Risk of Hypoglycemia-Related Emergency Department or Hospital Use. JAMA Intern Med. 2017 Oct 1;177(10):1461-1470. doi: 10.1001/jamainternmed.2017.3844.
citation: Gold AE, MacLeod KM, Frier BM. Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia. Diabetes Care. 1994 Jul;17(7):697-703. doi: 10.2337/diacare.17.7.697.
citation: Fitzgerald JT, Davis WK, Connell CM, Hess GE, Funnell MM, Hiss RG. Development and validation of the Diabetes Care Profile. Eval Health Prof. 1996 Jun;19(2):208-30. doi: 10.1177/016327879601900205.