Glycemic Excursion Minimization (GEM) to Outshine Health Disparities

Catherine Davis

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: GEM Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06236581

1974851

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

GEM Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: GEM Intervention

Waitlist

No Intervention group

Description:

Participants will be invited to receive the GEM intervention after they posttest, the next time it is offered.