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Clinical Trial 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.


Clinical Trial Description

The proposed study will compare individualized self-administered versions of RC+GEM to RC among patients recently diagnosed with type 2 diabetes. We hypothesize that, compared to RC alone, RC+GEM will be at least as effective at improving blood glucose control (A1c), and RC+GEM will do so with less reliance on diabetes medication and with greater secondary benefits such as lower risk of cardiovascular disease, more "good" cholesterol (HDL), greater weight loss, a greater sense of empowerment, and fewer diabetes-related expenses. It is further hypothesized that these benefits will be sustained over 13.5-months of follow-up with no structured maintenance program. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05766735
Study type Interventional
Source University of Virginia
Contact Corey Rynders, MEd, PhD
Phone 434-422-2653
Email car2r@uvahealth.org
Status Recruiting
Phase N/A
Start date August 8, 2023
Completion date January 31, 2027

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