GEM: Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification
Study Details
Study Description
Brief Summary
A Randomized Consent Design (RCD) trial of our hypothesis that self-administered, individualized Glycemic Excursion Minimization (GEM) treatment for adults newly diagnosed with Type 2 Diabetes (T2D), compared to individualized medication management (MM), 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The proposed study will compare individualized self-administered versions of GEM to individualized MM among patients recently diagnosed with type 2 diabetes. We hypothesize that, compared to MM, GEM will be at least as effective at improving blood glucose control (A1c), and 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Medication Management (MM) Participants will be actively working with their personal physician during the study and will attend appointments with their physician 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. |
Other: Medication Management (MM)
MM participants will meet with their personal physician 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.
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| Experimental: Glucose Excursion Minimization (GEM) GEM is 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. |
Behavioral: Glycemic Excursion Minimization (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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in Hemoglobin A1c at 4.5-months of follow-up [4.5 months]
Repeated measures models, using the baseline Hemoglobin A1c, as a covariate, will be used to compare groups with respect to Hemoglobin A1c levels at the 4.5-month assessment.
- Change in Hemoglobin A1c at the 13.5-months of follow-up [13.5 months]
Repeated measures models, using the baseline Hemoglobin A1c, as a covariate, will be used to compare groups with respect to Hemoglobin A1c levels at the 13.5-month assessment.
- Change in Metformin at 4.5-months of follow-up [4.5 months]
Repeated measures models, using baseline Metformin, as a covariate, will be used to compare groups with respect to Metformin at the 4.5-month assessment.
- Change in Metformin at 13.5-months of follow-up [13.5 months]
Repeated measures models, using baseline Metformin, as a covariate, will be used to compare groups with respect to Metformin at the 13.5-month assessment.
Eligibility Criteria
Criteria
Inclusion Criteria
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Clinical diagnosis, based on investigator assessment, of type 2 diabetes diagnosed within the past 12 months; pilot participants may have diabetes for up to 14 months.
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Age ≥30.0 and ≤80 years old at time of consent
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Hemoglobin A1c = 6.5-11% (medical record value <6-month is acceptable)
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Access to Smartphone throughout the study
Exclusion Criteria:
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Currently taking diabetes medication unless off medication for six weeks
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Medications that impede weight loss (e.g., prednisone) within the last 3 months
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Participation in an exercise program to lose weight since last hemoglobin A1c blood test
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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
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Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
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Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, Chronic obstructive pulmonary disease (COPD)/emphysema, severe osteoarthritis, stroke)
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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
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Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies
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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
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Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study
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No marked renal impairment (for example: Estimated Glomerular Filtration Rate (eGFR)< 45 mL/min/1.73 meters squared; Chronic kidney disease (CKD)-3b)
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Currently pregnant or contemplating pregnancy within the next 14 months
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Currently breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Department of Family Medicine | Aurora | Colorado | United States | 80045 |
| 2 | University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | United States | 22903 |
Sponsors and Collaborators
- Daniel Cox, PhD
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- DexCom, Inc.
Investigators
- Principal Investigator: Daniel J. Cox, PhD, AHPP, University of Virginia Center for Diabetes Technology
- Principal Investigator: Chiara Fabris, PhD, University of Virginia Center for Diabetes Technology
- Principal Investigator: Tamara Oser, MD, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 220259
- R01DK129687