Glycemic Excursion Minimization (GEM) to Outshine Health Disparities
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT06236581
- Lead Sponsor
- Catherine Davis
- Brief Summary
The purpose of this study is to see if the GEM intervention is acceptable and helpful to Black adults with type 2 diabetes. The GEM intervention (coaching to reduce carbohydrate intake and increase physical activity after meals, with feedback from a continuous glucose monitor, CGM) might improve blood glucose levels, reduce diabetes distress, and increase empowerment and confidence in managing diabetes.
- Detailed Description
The purpose of the study is to test the feasibility, acceptability, and initial efficacy of the tailored GEM intervention among adult Black patients with type 2 diabetes, who are not on insulin or secretagogues.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- type 2 diabetes
- capable of making dietary and physical activity changes
- on insulin or secretagogue
- on medications that impede weight loss (e.g., prednisone)
- pregnant or planning pregnancy in the next 2 months
- no history of moderate to severe hypoglycemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline on percent time in range from continuous glucose monitor at post-intervention Baseline week and post-intervention week. From baseline week to the week after end of intervention or waitlist period, up to 6 weeks Difference in percent of time in range (70-180 mg/dL) from continuous glucose monitor data. Change = post intervention week minus baseline week.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Georgia Prevention Institute
🇺🇸Augusta, Georgia, United States
Georgia Prevention Institute🇺🇸Augusta, Georgia, United StatesAndre Soares, PT MSContact706-721-4534Catherine L Davis, PhDPrincipal Investigator