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RECRUITING
NCT05766735
NA

Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

Sponsor: Chiara Fabris, PhD

View on ClinicalTrials.gov

Summary

A Randomized Control Trial (RCT) with 1:1 randomization of adults newly diagnosed with type 2 diabetes (T2D) to Routine Care (RC) and RC + Glycemic Excursion Minimization (RC+GEM); a program that provides RC in addition to continuous glucose monitors (CGM) within a structured, self-directed, and personalized lifestyle program called GEM. Our hypothesis is that RC+GEM will: 1) reduce hemoglobin A1c as much or more, 2) require less diabetes medication, 3) cost less, and 4) have more secondary benefits, (e.g. greater reduction in cardiovascular risk, weight, diabetes distress, depression symptoms), compared to RC alone.

Key Details

Gender

All

Age Range

30 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-08-08

Completion Date

2027-05-31

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Routine Care + Glycemic Excursion Minimization (RC+GEM)

In addition to receiving routine care, participants will receive GEM, a structured, self-directed, and personalized program that will allow participants with pre-diabetes to improve their metabolic status by illustrating the effects of their routine food and physical activity choices on their blood glucose levels and variability.

OTHER

Routine Care (RC)

RC participants will meet with their primary care provider to determine the best diabetes medication and proper dose. The participant will be allowed to change medications, or use a combination of medications, that is best suited for their care during the duration of the study. The study team will not influence these decisions.

Locations (2)

University of Colorado Department of Family Medicine

Aurora, Colorado, United States

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States