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CGM Plus GEM in Prediabetes

NCT05580978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-03

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Abbott Diabetes Care

    collaborator INDUSTRY

  • University of Virginia

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Tamara Oser, MD · Associate Professor, Dept. Family Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-01-15
Completion
2025-01-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580978 on ClinicalTrials.gov