The REST Study for CGM Use in Older Adults With Insulin-treated Diabetes (NCT05337826) | Clinical Trial Compass
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 range
65 Years
Sex
ALL
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.