Recruiting

Glycemic Excursion Minimization

Sponsor:

Catherine Davis

Code:

NCT06236581

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GEM Intervention

Study Details

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.

Conditions

Type 2 Diabetes

Study ID

NCT06236581

Start date

Jun 20, 2024

Status verified date

Jul, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Waitlist

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

Interventions

GEM Intervention

Lifestyle coaching

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Catherine L Davis, PhD

706-721-4534katie.davis@augusta.edu

Locations

Georgia Prevention Institute

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Andre Soares, PT MS

706-721-4534

Principal Investigator:

Catherine L Davis, PhD

More Information

Sponsor

Catherine Davis

Last update posted

Jul 30, 2024

Last verified

Jul, 2024

Keywords

  • Black
  • Continuous glucose monitoring
  • physical activity
  • carbohydrate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Catherine Davis on 2024-07-30.