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CGM Plus GEM in Prediabetes
Sponsor: University of Colorado, Denver
Summary
This study is designed to look into the effect of a lifestyle management guide called GEM (Glycemic Excursion Minimization) alongside continuous glucose monitoring (CGM) and an activity monitor (FitBit) and the effect this can have on persons with prediabetes.
Official title: Libre 2 CGM Plus Glycemic Excursion mIniMization (GEM) in the Treatment of PrEDiabEtes
Key Details
Gender
All
Age Range
25 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
61
Start Date
2022-11-01
Completion Date
2025-01-15
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
GEM
The intervention group will be given Libre 2 supplies for 4 months, an activity monitor, and the 4-chapter GEM paper guide. The intervention group will complete a virtual or inperson study visit where they will receive instructions on how to apply their unblinded Freestyle Libre and connect it to the study account, as well as how to register their Fitbit to the study account. Participants will receive one telephone call to review use of the GEM Guide and call at two weeks and six weeks later when the probability of dropouts from lifestyle intervention peaks. Participants will follow the self-directed GEM guide for 4 months (a 1-month treatment period followed by a 3-month maintenance period) while wearing a FitBit activity monitor and a Freestyle Libre 2 CGM.
Routine Care
Participant's current prediabetes treatment.
Locations (1)
University of Colorado- Anschutz Medical Campus
Aurora, Colorado, United States