Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes

The study will utilize an open-label, randomized, parallel-group design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) when compared to SOC alone in patients with type 2 diabetes. The screening period will consist of a run-in during which time HbA1c will be assessed for confirmation of eligibility.

Once confirmed to be eligible, patients will then be randomized 1:1 to the following groups:

Investigational: One half of the participants will be treated with BT-001 plus SOC for 180 days;

Control: One half of the participants will be treated with SOC alone for 180 days.

Inclusion criteria

• Between 18 and 75 years old, inclusive at the time of signing the informed consent;
• Diagnosis of type 2 diabetes, according to the criteria of the American Diabetes Association (ADA), and confirmed at the initial eligibility screening;
• Body Mass Index ≥25 kg/m2;
• Possesses a smartphone (iPhone or Android only) capable of running the smartphone applications (Apps) used in the study;
• Has had no change in the last 4 months prior to randomization (3 months prior to initial screening plus 30-day run-in screening period) in antihyperglycemic medications;
• Has a current HbA1c level >7%, as determined by both screening assessments;
• Willing to use an FDA approved glucometer for self-monitoring blood glucose throughout the study;
• Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).

Exclusion criteria

• Are unable to understand, consent to, or comply with the study protocol for any reason;
• Currently taking prandial (mealtime) insulin;
• Have self-reported measures, collected during screening interview, that reveal:

• An active eating disorder
• The taking of or planning to take (within the next 6 months):

i. Oral steroids (planned, or within the past 3 months) ii. Chemotherapy (planned, or within the past 6 months) iii. Weight loss medications or iv. Atypical antipsychotic medications

c. A change in antidepressant or anti-anxiety medication within the past 3 months;

d. A history of bariatric surgery or planned bariatric surgery during the study;

e. The current use of marijuana, cocaine, opioid painkillers, or other addictive substances;

f. The current use of tobacco products or use of tobacco products within the past 6 months;

g. The consumption of alcohol above defined thresholds:

i. For women: more than 3 drinks in a single day, or more than 7 drinks per week and ii. For men: more than 4 drinks in a single day, or more than 14 drinks per week

h. An unstable or life-threatening medical illness;

i. Non-resolved, presumed or confirmed COVID-19 diagnosis prior to randomization or during primary study period;

j. For women only: pregnant (or lactating) or having the intention of becoming pregnant during the time frame of the study.

• Has a current HbA1c level ≥11%, at the screening assessment;
• Concurrent enrollment in any other clinical trial;
• Is considered unreliable by the investigator, or having any condition which, in the opinion of the investigator, would not allow safe participation in the study.