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

Chiara Fabris, PhD

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Other: Routine Care (RC); Behavioral: Routine Care + Glycemic Excursion Minimization (RC+GEM)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05766735

R01DK129687 (U.S. NIH Grant/Contract)

220259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Clinical diagnosis, based on investigator assessment, of type 2 diabetes diagnosed within the past 12 months
2. Age ≥30.0 and ≤80 years old at time of consent
3. Hemoglobin A1c = ≥6.5-≤9% (medical record value <6-months is acceptable)
4. Access to Smartphone throughout the study
5. Diabetes management visit with PCP within six months of screening date

Exclusion Criteria:

1. Medications that have affected participant's weight (e.g., prednisone) within the last 3 months
2. Participation in an exercise program to lose weight since last hemoglobin A1c blood test
3. Currently taking psychotropic medications that raise blood glucose (e.g., atypical antipsychotics) such as clozapine, olanzapine, risperidone, quetiapine, asenapine, arirprazole, brexpiprazole, iloperidone, lurasidone, paliperidone, and ziprasidone
4. Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
5. Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
6. 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
7. Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies
8. 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
9. Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study
10. No marked renal impairment (for example eGFR < 45 mL/min/1.73 meters squared; CKD-3b)
11. Currently pregnant or contemplating pregnancy within the next 14 months
12. Currently breastfeeding
13. Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Routine Care (RC)

Active Comparator group

Description:

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.

Treatment:

Other: Routine Care (RC)

Routine Care + Glucose Excursion Minimization (RC+GEM)

Experimental group

Description:

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.

Treatment:

Behavioral: Routine Care + Glycemic Excursion Minimization (RC+GEM)