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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

• Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months

• Age ≥30.0 and ≤80 years

• Hemoglobin A1c = ≥6.5-≤11% (medical record value \<6 month-old is acceptable)

• Access to smartphone throughout the study

• Diabetes management visit with medical provider within 12 months of screening date

• If on weight altering medications (e.g., GLP-1, GIP), on a stable dose for about four weeks

Locations
United States
Colorado
University of Colorado Department of Family Medicine
RECRUITING
Aurora
Virginia
University of Virginia Center for Diabetes Technology
RECRUITING
Charlottesville
Contact Information
Primary
Jacqueline Rodriguez
ZMT8XG@uvahealth.org
434-422-2653
Backup
Matthew Moncrief
MAM8AD@uvahealth.org
434-437-5433
Time Frame
Start Date: 2023-08-08
Estimated Completion Date: 2027-04-15
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.
Leads: Chiara Fabris, PhD

This content was sourced from clinicaltrials.gov