Type 2 Diabetes
Conditions
Keywords
Black, Continuous glucose monitoring, physical activity, carbohydrate
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.
Interventions
BEHAVIORALGEM Intervention
Lifestyle coaching
Sponsors
University of Virginia
University of Colorado, Denver
Catherine Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial, intervention vs. waitlist
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes * capable of making dietary and physical activity changes
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactCatherine L Davis, PhD
Outcome results
None listed