A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus (ACTION-DM)

Better Therapeutics

Status: Active, not recruiting

Conditions: Diabetes Type 2

Treatments: Device: Control Mobile Application; Device: BT-001

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05302050

DM2-07-MGB

Details and patient eligibility

About

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.

Full description

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

Enrollment: 500 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Intervention BT-001 + Standard of Care

Active Comparator group

Description:

Patients in this arm will receive the BT-001 treatment for up to 18 months.

Treatment:

Device: BT-001

Standard of Care

Other group

Description:

Patients will have access to a control mobile application for 6 months and then will have the option to use the treatment for the remainder of the 18 month study

Treatment:

Device: Control Mobile Application