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

Running, not enrolling · Not applicable

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT05337826

Run by

Joslin Diabetes Center

People needed

122

Starts

2022-04-20

Expected to finish

2026-05-01

Last updated by the study team

2026-04-17

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States
• SUNY Upstate Medical University — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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