Safer Aging With Diabetes Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2028-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-arm pragmatic randomized clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Participant randomization status will be masked during data collection (baseline and follow-up surveys) by research assistants

Study Groups

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Group Education 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).

Group Type EXPERIMENTAL

SAGE Group Sessions

Intervention Type BEHAVIORAL

Participants enroll in 3 educational group sessions and receive CGMs

Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Participants continue to receive usual care (Control Arm)

Interventions

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SAGE Group Sessions

Participants enroll in 3 educational group sessions and receive CGMs

Intervention Type BEHAVIORAL

Usual Care

Participants continue to receive usual care (Control Arm)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No