Safer Aging With Diabetes Monitoring (SAGE)

Kaiser Permanente

Status: Enrolling

Conditions: Hypoglycemia; Diabetes Mellitus, Type 2

Treatments: Behavioral: SAGE Group Sessions; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06296485

IRB-1996616

R01DK134446 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Group Education Sessions

Experimental group

Description:

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).

Treatment:

Behavioral: SAGE Group Sessions

Usual Care

Active Comparator group

Description:

Participants allocated to the control arm will continue with usual care.

Treatment:

Other: Usual Care