Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Chiara Fabris, PhD
Study ID
NCT05766735
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Routine Care + Glycemic Excursion Minimization (RC+GEM) — BEHAVIORAL
    In addition to receiving routine care, participants will receive GEM, a structured, self-directed, and personalized program that will allow participants with pre-diabetes to improve their metabolic status by illustrating the effects of their routine food and physical activity choices on their blood glucose levels and variability.
  • Routine Care (RC) — OTHER
    RC participants will meet with their primary care provider to determine the best diabetes medication and proper dose. The participant will be allowed to change medications, or use a combination of medications, that is best suited for their care during the duration of the study. The study team will not influence these decisions.

Study Details

A Randomized Control Trial (RCT) with 1:1 randomization of adults newly diagnosed with type 2 diabetes (T2D) to Routine Care (RC) and RC + Glycemic Excursion Minimization (RC+GEM); a program that provides RC in addition to continuous glucose monitors (CGM) within a structured, self-directed, and personalized lifestyle program called GEM. Our hypothesis is that RC+GEM will: 1) reduce hemoglobin A1c as much or more, 2) require less diabetes medication, 3) cost less, and 4) have more secondary benefits, (e.g. greater reduction in cardiovascular risk, weight, diabetes distress, depression symptoms), compared to RC alone.

Key Dates

Start date
Aug 8, 2023
Status verified
May 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Routine Care (RC)
    Participants will be actively working with their primary care provider during the study and will attend appointments with their provider as needed. The study team will monitor their progress at the scheduled Assessment Visits. The participants should discuss any concerns they have, including side effects or cost, in order to adjust the medication regime with their primary care team. Their physician/clinician may recommend additional things, like weight loss, exercise programs and/or diabetes education programs.
  • Experimental: Routine Care + Glucose Excursion Minimization (RC+GEM)
    Participants will actively work with their primary care provider and receive personalized routine care (RC). In addition, participants will receive GEM, an individualized, person-centered, empowerment program, not a behavior modification program. GEM provides individuals with personally relevant information to make choices that will help them achieve their diabetes goals. It focuses on techniques - eating low glycemic load foods, increasing moderate and vigorous exercise, and monitoring blood glucose (BG) to educate individuals about the impact of high glycemic load nutrients and vigorous exercise. The emphasis is on minimizing glucose excursions by any practical means, e.g., nutrient selection, timing and combinations of nutrient intake, time restricted eating, eating carbohydrates after protein and fat, post prandial physical activity, whatever is personally affirmed by BG feedback.

Primary Outcome Measure

Change in Hemoglobin A1c at 4.5-months of follow-up [ Time Frame: 4.5 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Department of Family MedicineAuroraColorado80045
Tamara K. Oser, MD
[email protected]
303-724-2060
Britney Prince
[email protected]
303-724-8968
University of Virginia Center for Diabetes TechnologyCharlottesvilleVirginia22903
Chiara Fabris, PhD
[email protected]
434-982-6483
Jacqueline Rodriguez
[email protected]
434-422-2653
Chiara Fabris, PhD (PRINCIPAL_INVESTIGATOR)
Anthony McCall, MD, PhD (SUB_INVESTIGATOR)
Wen Yu, PhD (SUB_INVESTIGATOR)
Mark Conaway, PhD (SUB_INVESTIGATOR)
Daniel Cox, PhD (PRINCIPAL_INVESTIGATOR)
Catherine Varney, DO (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Colorado Department of Family Medicine· Aurora, COUniversity of Virginia Center for Diabetes Technology· Charlottesville, VA

Related Studies