NCT06236581 · Catherine Davis
Glycemic Excursion Minimization (GEM) to Outshine Health Disparities
(GEM)
What this study is about
The purpose of this study is to see if the GEM intervention is acceptable and helpful to Black adults with type 2 diabetes.
View original scientific description
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.
Interventions
BEHAVIORAL
GEM Intervention
Lifestyle coaching
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Augusta, Georgia
Collaborators
University of Virginia, University of Colorado, Denver
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2024 · Source of record for eligibility and locations