CGM Plus GEM in Prediabetes

Completed · Not applicable

Conditions studied: PreDiabetes

In brief

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.

Key facts

Study ID: NCT05580978
Run by: University of Colorado, Denver
People needed: 61
Starts: 2022-11-01
Expected to finish: 2025-01-15
Last updated by the study team: 2026-06-03

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

University of Colorado- Anschutz Medical Campus — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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