Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
Purpose
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.
Condition
- Type 2 Diabetes
Eligibility
- Eligible Ages
- Between 30 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomized to individualized routine care (RC) or to individualized RC in addition to post-nutrient glucose excursion minimization (RC+GEM). A Randomized Controlled Trial (RCT) design will be used to assign participants to treatment groups.
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
University of Colorado Department of Family Medicine
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
University of Virginia Center for Diabetes Technology
Charlottesville 4752031, Virginia 6254928 22903
Charlottesville 4752031, Virginia 6254928 22903
More Details
- Status
- Recruiting
- Sponsor
- Chiara Fabris, PhD
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.