Status:
COMPLETED
Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2)
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Severe Hypoglycemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 as...
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 Hea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT04863872
Start Date
January 26 2022
End Date
June 21 2024
Last Update
May 6 2025
Active Locations (1)
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1
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States, 98101