Recruiting

Lifestyle Modification

Sponsor:

Chiara Fabris, PhD

Code:

NCT05766735

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Routine Care + Glycemic Excursion Minimization (RC+GEM)

Routine Care (RC)

Study Details

Brief 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.

Conditions

Type 2 Diabetes

Study ID

NCT05766735

Start date

Aug 8, 2023

Status verified date

May, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months
2. Age ≥30.0 and ≤80 years
3. Hemoglobin A1c = ≥6.5-≤11% (medical record value <6 month-old is acceptable)
4. Access to smartphone throughout the study
5. Diabetes management visit with medical provider within 12 months of screening date
6. If on weight altering medications (e.g., GLP-1, GIP), on a stable dose for about four weeks

Exclusion Criteria:

1. Medications that impede weight loss within the last 3 months, per study physicians' discretion
2. Any psychotropic medication that could raise blood glucose, per study physicians' opinion
3. Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
4. Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
5. Conditions that prevent doing the self-directed GEM program, such as inability to read English, mental health conditions that prevent engagement in treatment, such as active substance abuse, severe depression
6. Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies
7. Severe vision impairment that at PI discretion would preclude ability to read the GEM manual or see the information on the CGM or activity tracker
8. Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study
9. Renal impairment (for example eGFR < 45 mL/min/1.73 meters squared; CKD-3b)
10. Currently pregnant or contemplating pregnancy within the next 14 months
11. Currently breastfeeding
12. Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Routine Care + Glycemic Excursion Minimization (RC+GEM)

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)

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.

Primary outcome measure

  • Change in Hemoglobin A1c at 4.5-months of follow-up [ Time Frame: 4.5 months ]
  • Change in Hemoglobin A1c at the 13.5-months of follow-up [ Time Frame: 13.5 months ]
  • Change in Metformin at 4.5-months of follow-up [ Time Frame: 4.5 months ]
  • Change in Metformin at 13.5-months of follow-up [ Time Frame: 13.5 months ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado Department of Family Medicine

Recruiting

Aurora, Colorado, United States, 80045

Contacts

University of Virginia Center for Diabetes Technology

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Principal Investigator:

Chiara Fabris, PhD

More Information

Sponsor

Chiara Fabris, PhD

Last update posted

Apr 9, 2026

Last verified

May, 2025

Keywords

  • Routine Care (RC)
  • Routine Care + Glycemic Excursion Minimization (RC+GEM)
  • Continuous Glucose Monitor (CGM)
  • Randomized Controlled Trial (RCT)
  • Blood Glucose (BG)
  • Newly Diagnosed Type 2 Diabetes
  • Type 2 diabetes (T2D)
  • Primary Care Provider (PCP)
  • Remote Study Visits

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Chiara Fabris, PhD on 2026-04-09.