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

NCT ID: NCT05766735

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-08
• Study Completion Date: 2027-04-15

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.

Detailed Description

The proposed study will compare individualized self-administered versions of RC+GEM to RC among patients recently diagnosed with type 2 diabetes. We hypothesize that, compared to RC alone, RC+GEM will be at least as effective at improving blood glucose control (A1c), and RC+GEM will do so with less reliance on diabetes medication and with greater secondary benefits such as lower risk of cardiovascular disease, more "good" cholesterol (HDL), greater weight loss, a greater sense of empowerment, and fewer diabetes-related expenses. It is further hypothesized that these benefits will be sustained over 13.5-months of follow-up with no structured maintenance program.

Remote study visits are permitted. Clinic visit and remote visits may include videoconferencing, phone, text messages and emails.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Routine Care (RC)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Routine Care + Glycemic Excursion Minimization (RC+GEM)

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Glucose Everyday Matters

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Chiara Fabris, PhD

OTHER

Sponsor Role: lead

Responsible Party

Chiara Fabris, PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chiara Fabris, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Center for Diabetes Technology

Daniel J. Cox, PhD, AHPP

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Center for Diabetes Technology

Tamara Oser, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Department of Family Medicine

Aurora, Colorado, United States

Site Status: RECRUITING

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jacqueline Rodriguez

Role: CONTACT

ZMT8XG@uvahealth.org

434-422-2653

Matthew Moncrief

Role: CONTACT

MAM8AD@uvahealth.org

434-437-5433

Facility Contacts

Tamara K. Oser, MD

Role: primary

tamara.oser@cuanschutz.edu

303-724-2060

Britney Prince

Role: backup

britney.prince@cuanschutz.edu

303-724-8968

Chiara Fabris, PhD

Role: primary

cf9qe@virginia.edu

434-982-6483

Jacqueline Rodriguez

Role: backup

ZMT8XG@uvahealth.org

434-422-2653

Other Identifiers

R01DK129687

Identifier Type: NIH

Identifier Source: secondary_id

View Link

220259

Identifier Type: -

Identifier Source: org_study_id