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NCT04863872Completed

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

Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia

Source: ClinicalTrials.gov · Last updated 6 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
259 (actual)
First submitted
26 Apr 2021
Start date
26 Jan 2022
Primary completion date
24 Apr 2024
Lead sponsor
Kaiser Permanente
NCT number
NCT04863872

What you commit to

  • Study type: Interventional
  • Participants enrolled: 259
  • From 26 Jan 2022 to the primary completion date, 24 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Lab values

  • Current use at baseline of Continuous Glucose Monitor

Other

  • 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
  • Currently living in a nursing home or under hospice care
  • Pregnant or planning to become pregnant

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kaiser Permanente Washington Health Research Institute
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.