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N/A N=259 Randomized Double-blind Prevention

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

Severe Hypoglycemia

Enrolled (actual)
259
Serious AEs
39.4%
Results posted
May 2025
Primary outcome: Primary: Self-reported Severe Hypoglycemia — 99; 99; 19; 13 Participants — p=0.27

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Proactive Care Management (Other); MyHC-T2D education program (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Kaiser Permanente
Primary completion
Apr 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Self-reported Severe Hypoglycemia
99; 99; 19; 13 0.27

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04863872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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