Safer Aging With Diabetes Monitoring

Not Applicable

Recruiting

• Conditions: Hypoglycemia; Diabetes Mellitus, Type 2
• Interventions: Behavioral: SAGE Group Sessions; Other: Usual Care

• Registration Number: NCT06296485
• Lead Sponsor: Kaiser Permanente

Brief Summary

Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes.

Detailed Description

The overarching goal of this pragmatic randomized clinical trial is to support safer diabetes care in older adults (age ≥ 75) with type 2 diabetes (T2D) who require insulin therapy. Many of these older adults are at high risk for severe hypoglycemia due to symptom unawareness and/or nocturnal hypoglycemia. Effective and safe management in this population requires close glucose monitoring coupled with proactive medication and diet adjustment to avoid severe iatrogenic consequences. This study proposes to achieve this goal through a patient-oriented intervention program that incorporates the use of alarm-enabled continuous glucose monitoring (CGM). There are currently no major randomized trials directly assessing the use of CGM to reduce severe hypoglycemia among the oldest adults with T2D. The study team will conduct a 2-arm trial: 1) Group-based, three-session education intervention (CGM provided to participants) vs. 2) usual care (no CGM provided to participants). The primary outcome is an aggregate measure of clinically significant hypoglycemia. The study will also examine differences in patient-reported diabetes distress, fear of hypoglycemia, and self-efficacy using validated survey measures.

Study Timeline

• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-06
• Study Start: 2024-05-01
• Status Verified: 2024-10
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Primary Completion: 2027-03-30
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Age 75 years and older
• Diagnosis of Type 2 Diabetes
• Current treatment with insulin
• Increased hypoglycemia risk (prior year hypoglycemia by self-report or utilization)
• Able to communicate in English
• Able to access email and the Internet

Exclusion Criteria

• On renal dialysis
• Dementia
• Pacemaker or Automatic Implantable Cardioverter Defibrillator
• Using insulin pump
• Severe Mental Illness
• Severe Visual Impairment
• In Hospice
• Current or recent CGM use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Education Sessions	SAGE Group Sessions	Participants will participate in 3 educational sessions designed to teach about applying and using continuous glucose monitors \[CGMs\] (Session 1) and how to prevent hypoglycemia episodes based on CGM readings and hypoglycemia journal entries (Sessions 2 \& 3).
Usual Care	Usual Care	Participants allocated to the control arm will continue with usual care.

Primary Outcome Measures

Name	Time	Method
Hypoglycemia aggregate outcome	6 and 12 months after study start date	This outcome will compare the proportion of patients in the three study arms with self-reported hypoglycemia (symptomatic and/or requiring help from others) and/or hypoglycemia-related utilization (emergency department, hospital or outpatient new events) 6- and 12-months after enrollment

Secondary Outcome Measures

Name	Time	Method
Diabetes Distress	6 and 12 months after study start date	This outcome will compare responses to the 2-item, validated Diabetes Distress survey
Hypoglycemia Distress	6 and 12 months after study start date	This outcome will compare responses to the 3-item, validated Hypoglycemia Distress survey
Self-reported hypoglycemia	6 and 12 months after study start date	This outcome will compare the proportion of patients in the three study arms with self-reported hypoglycemia (symptomatic and/or requiring help from others)
Hypoglycemia-related utilization	6 and 12 months after study start date	This outcome will compare the proportion of patients in the three study arms with hypoglycemia-related utilization (emergency department, hospital or outpatient new events)
Hypoglycemia Confidence	6 and 12 months after study start date	This outcome will compare responses to the 9-item, validated Hypoglycemia Confidence survey

Trial Locations

Locations (4)

Kaiser Permanente San Jose; 🇺🇸 San Jose, California, United States

Kaiser Permanente Fremont; 🇺🇸 Fremont, California, United States

Kaiser Permanente San Leandro; 🇺🇸 San Leandro, California, United States

Kaiser Permanente - Union City; 🇺🇸 Union City, California, United States