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Completed NCT05580978

CGM Plus GEM in Prediabetes

Conditions: PreDiabetes

Sex: All
Ages: 25 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 61
Sponsor: University of Colorado, Denver

Location: University of Colorado- Anschutz Medical Campus Aurora Colorado

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.

Eligibility Criteria

Inclusion Criteria: * Age 25-70 years * A1C 6.0-6.4 * Documented diagnosis of prediabetes * Have a smart phone * Able to read English, as the GEM guide is currently only available in English * Willing and able to follow the study procedures as instructed Exclusion Criteria: * Diagnosis of diabetes mellitus * Currently taking any diabetes medication * Currently taking medication that promotes insulin resistance or otherwise interferes with metabolic control (e.g., prednisone) * Has a condition that precludes a low carbohydrate diet, such as gastroparesis * Has a physical or medical condition that precludes walking 120 steps per minute for 10 minutes or longer * Has documented kidney disease that would preclude participation in study per PI discretion * Active or planned cancer treatment * Extreme visual or hearing impairment that would impair ability to use real-time CGM * Pregnant or anticipates becoming pregnant in the next 4 months * Anticipates moving within the next 4 months * Treating physician, for any reason, considers their patient inappropriate for the study (e.g., uncontrolled bipolar disease)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05580978). StuddyBuddy aggregates publicly available trial information.