Glycemic Excursion Minimization (GEM) to Outshine Health Disparities

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: GEM Intervention

• 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.

Study Timeline

• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-01
• Study Start: 2024-06-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GEM Intervention	GEM Intervention	A lifestyle coach will deliver the GEM intervention over 4 weeks in person and/or virtually (synchronously) to permit interaction with participants. A pocket-sized manual will be provided with 4 units corresponding to session topics, and diary pages to record glucose responses to food and physical activity (PA). Session 1: Introduce GEM, identify personal motivation, learn about foods that cause glucose to go high (high glycemic load (GL) foods) and those that do not (low GL foods), learn how physical activity affects glucose, and begin monitoring how these choices affect glucose. Session 2: Replacement, substitution, and portion control to reduce consumption of high GL foods. Session 3: Increasing PA and reducing sedentary behavior, esp. after a meal. Session 4: Ways to continue lifestyle changes over a lifetime, handle relapses, and thank loved ones for their support. Text message reminders may be sent to participants between sessions to prompt diary entries and for encouragement.

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.

Trial Locations

Locations (1)

Georgia Prevention Institute; 🇺🇸 Augusta, Georgia, United States