Eligibility
65+
All Sexes
What conditions do you have?
Select
Study 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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 6 Secondary · Reporting Duration: 6 months vs 12 months
12 months
Cost Effectivness
6 months
Cost effectivness
Month 12
Resource utilization
Time spent in hypoglycemia
Baseline to 6 months
The co-primary effectiveness outcomes
Baseline vs 6 months
Diabetes health related quality of life measures
The co-primary implementation outcomes
Month 12
Visits to maintain CGM use
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Single Arm
1 of 1
Experimental Treatment
120 Total Participants · 1 Treatment Group
Primary Treatment: Continuous Glucose Monitor · No Placebo Group · N/A
Single Arm
Device
Experimental Group · 1 Intervention: Continuous Glucose Monitor · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitor
2021
Completed Early Phase 1
~760
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months vs 12 months
Closest Location: SUNY Upstate Medical University · Syracuse, NY
2011First Recorded Clinical Trial
17 TrialsResearching Diabetes Mellitus
220 CompletedClinical Trials
Who is running the clinical trial?
Joslin Diabetes CenterLead Sponsor
90 Previous Clinical Trials
19,954 Total Patients Enrolled
36 Trials studying Diabetes Mellitus
5,212 Patients Enrolled for Diabetes Mellitus
State University of New York - Upstate Medical UniversityOTHER
154 Previous Clinical Trials
23,744 Total Patients Enrolled
6 Trials studying Diabetes Mellitus
2,132 Patients Enrolled for Diabetes Mellitus
Cecilia HealthUNKNOWN
Eligibility Criteria
Age 65+ · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have diabetes for more than 1 year.
Subjects are not meeting glycemic goals (per the ADA criteria).
You are willing to wear CGM Dexcom at all times while in the study.
You have a sensor glucose level of ≤70 mg/dL or a time in range of 70-180 mg/dL.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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