Status:
ACTIVE_NOT_RECRUITING
The REST Study for CGM Use in Older Adults With Insulin-treated Diabetes
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
State University of New York - Upstate Medical University
Cecilia Health
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 ...
Detailed Description
Older adults with diabetes on multiple insulin injections are at greater risk of hypoglycemia and its poor outcomes. Use of continuous glucose monitoring (CGM) has shown to improve glycemic control an...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05337826
Start Date
April 20 2022
End Date
May 1 2026
Last Update
January 10 2025
Active Locations (2)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
2
SUNY Upstate Medical University
Syracuse, New York, United States, 13210