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COMPLETED
NCT05580978
NA

CGM Plus GEM in Prediabetes

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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

BEHAVIORAL

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.

OTHER

Routine Care

Participant's current prediabetes treatment.

Locations (1)

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, United States