A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus

A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus

Randomized, controlled, pragmatic trial with open-label extension evaluating BT-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.

The study intervention, BT-001 (the App), will be dispensed at enrollment to the Immediate Intervention App Use arm of the trial. Patients randomized to the Delayed Intervention App Use arm will be provided a "control App" with diabetes control, and then the BT-001 App after 180 days. Each participant is assigned to one 90-day treatment cycle of BT-001. Over the 12-month intervention period, study participants will be able to opt into up to 3 additional treatment cycles of BT-001. Study schema is included at the end of this section

Inclusion Criteria:

• Current (within 3 months prior to enrollment) HbA1c >=7.01%
• Possession of and ability to use Android or iPhone mobile phone
• Speaks and reads in English
• Willing to measure frequent fasting finger glucose measurements as part of the App utilization

Exclusion Criteria:

• Current use of insulin other than a long-acting insulin analogue or human NPH insulin
• HbA1c >=11%
• Cognitive impairment or degenerative neuropsychiatric condition (e.g. Alzheimer's, dementia, mixed dementia, other significant memory loss, schizophrenia), or any other condition that in the Investigator's opinion may prevent patient from completing study activities
• Any terminal medical condition with life expectancy of < 1 year.