Active — Not RecruitingNot Applicable

The REST Study for CGM Use in Older Adults With Insulin-treated Diabetes

United States122 participantsStarted 2022-04-20

Plain-language summary

To assess the efficacy of the REST model in facilitating adoption and sustained use of CGM, in older adults with Type 1 diabetes (T1D) or Type 2 Diabetes (T2D) on complex insulin regimens. To examine barriers and enablers for the implementation feasibility of the REST intervention model using a mixed-methods approach. To assess the impact of REST model on economic factors and quality of life measures. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Older adults age ≥65 years * T1D or T2D with duration longer than 1 year * Insulin treatment includes: ≥3 insulin injections/day or on insulin pump therapy * CGM naïve and/or CGM users (Dexcom G6) who are not meeting glycemic goals (per CGM metrics): * ≥4% hypoglycemia (sensor glucose ≤70 mg/dL) or * time in range (70-180 mg/dL) TIR ≤40 % * Willing to wear CGM Dexcom at all times while in the study * Willing to use/carry personal or loaned smart phone device to use as Dexcom receiver for continual data upload to cloud Exclusion Criteria: * Life expectancy \<1 year * End-stage renal disease (eGFR\< 30ml/min) * On acetaminophen \>4 gr/day due to interference with Dexcom G6 sensor readings * On hydroxyurea therapy due to interference with Dexcom G6 sensor readings * Impaired vision and hearing which would interfere with participation in remote video visits * Use of hybrid closed-loop systems (this may require different and additional focused education and will not be addressed in this study).

What they're measuring

The co-primary effectiveness outcomes

Timeframe: Baseline to 6 months

The co-primary implementation outcomes

Timeframe: Baseline vs 6 months

Trial details

NCT IDNCT05337826

SponsorJoslin Diabetes Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-11