At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Libre 2 CGM Plus Glycemic Excursion mIniMization (GEM) in the Treatment of PrEDiabEtes
In Brief
A clinical study evaluating GEM and Routine Care for PreDiabetes. Completed, enrolled 61 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
GEM plus CGM and Activity Monitor (FitBit)
Usual care already being received for prediabetes as treated by their care team.
Interventions
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.
Participant's current prediabetes treatment.