Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs

Prior treatment

• Unstable cardiac disease (myocardial infarction, heart failure, or stroke in previous 6 months, currently participating in cardiac rehabilitation).
• Receiving treatment for iron-deficiency anemia, vitamin B12 deficiency, or folate d efficiency.
• Blood transfusion in previous 4 months.
• On dialysis or active organ transplant list.
• Treated with erythropoietin.
• Currently attending or attended a diabetes prevention program in the previous 2 years.
• Had bariatric surgery within the 12 months prior randomization or is planning to undergo bariatric surgery during the study.

Other illness

• Medical conditions that prevent adoption of moderate physical activity (per primary care clinician).
• Active malignancy of any type or diagnosed with or treated for cancer within the past 2 years. Individuals with basal and squamous cell carcinoma of the skin that has been successfully treated will be allowed to participate.
• Diagnosis of diabetes mellitus.
• Hemoglobinopathy (HbS or HbC disease).
• Major psychiatric disorder (schizophrenia) or use of antipsychotic medications within the past 1 year.
• Dementia or Alzheimer's disease.
• Diagnosed with an eating disorder (anorexia nervosa, avoidant/restrictive food intake disorder, binge eating disorder, bulimia nervosa, Pica, rumination disorder, other specified or unspecified feeding or eating disorder)
• Known allergy to steel.
• Participation in another clinical trial related to lifestyle management or diabetes prevention.

Lab values

• Use of any glucose-lowering medications, weight loss medications, or any systemic glucocorticoids within the previous 3 months.

Other

• Aortic stenosis.
• Has a pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted electronic device.
• Pregnancy or planned pregnancy in the next 12 months.
• Anemia.
• Diagnosed or self-reported alcohol or substance abuse.
• Unwilling to accept random assignments.

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Laboratory evidence of prediabetes, defined as any of the following lab results, in the past year:
  • Hemoglobin A1C 5.7% to 6.4%
  • Fasting glucose 100-125 mg/dL
  • Plasma glucose of 140-199 mg/dL measured 2 hours after a 75 gm glucose load
• Body mass index (BMI) ≥25 kg/m2 (or≥23 kg/m2 for Asians).
• Proficiency in reading English.
• Smartphone user (Android Operating System (OS) 9.0 or iOS 13.3 or newer).
• Plans to reside in recruitment area for the next 12 months (participant's zip code of residence is within \~45 miles of the study recruitment site.