Georgia Prevention Institute
Augusta, Georgia, 30912, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06236581
Glycemic Excursion Minimization (GEM) to Outshine Health Disparities
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
GEM Intervention
BehavioralLifestyle coaching
Primary outcomes
-
Change from baseline on percent time in range from continuous glucose monitor at post-intervention
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Catherine Davis
Other
Collaborators
- University of Colorado, Denver
- University of Virginia
Registry information
Official study title
Glycemic Excursion Minimization (GEM) to Outshine Health Disparities: RCT
Acronym: GEM
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Feb 1, 2024
- Registry last updated
- Jul 30, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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