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

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.

Inclusion criteria

• Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months
• Age ≥30.0 and ≤80 years
• Hemoglobin A1c = ≥6.5-≤11% (medical record value <6 month-old is acceptable)
• Access to smartphone throughout the study
• Diabetes management visit with medical provider within 12 months of screening date
• 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
• Any psychotropic medication that could raise blood glucose, per study physicians' opinion
• Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
• Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
• 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
• Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies
• 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
• Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study
• Renal impairment (for example eGFR < 45 mL/min/1.73 meters squared; CKD-3b)
• Currently pregnant or contemplating pregnancy within the next 14 months
• Currently breastfeeding
• Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.