Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy (BRIGHT)

Better Therapeutics

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Control App; Behavioral: BT-001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05266625

DM2-07-CPC

Details and patient eligibility

About

Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a control application added to usual care and across a broad range of patients in a real-world setting

Full description

This randomized, controlled, multicenter, parallel-arm, pragmatic pivotal trial with extension will evaluate the hypothesis that BT-001 compared to a control application, both on top of usual care, will lower HbA1c in real world clinical practice. Approximately five-hundred (500) adults with type 2 diabetes will be randomized (1:1) to BT-001 or the control application. Most clinical data will be collected via the electronic medical records (EMR) system with limited additional contacts to ascertain adverse device effects (ADEs), adverse events (AEs) and clinical events which may have occurred outside the health system and were not recorded in the EMR. For primary efficacy endpoint assessment, a requisition form for HbA1c at a local laboratory will be provided if HbA1c is not available from the EMR within the 90- and 180-day time windows. During the extension phase, biomarker endpoint data will only be collected from the EMR. For all participants, clinical and healthcare utilization data will be extracted from their EMR for the period from 180 days prior to enrollment to 720 days after enrollment.

Enrollment: 500 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-75 years, inclusive at the time of signing the informed consent
• Type 2 diabetes on stable anti-diabetic regimen for at least three (3) months
• HbA1c 7.0% to 10.9% (within thirty [30] days of signing the informed consent form [ICF])
• Able to use BT-001 e.g., English fluent, smartphone is capable of running the study intervention.

Exclusion criteria

• Current use of outpatient prandial insulin
• In the opinion of the investigator, life expectancy < one (1) year
• COVID-19 diagnosis within thirty (30) days prior to randomization.

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

Experimental group

Description:

Patients in this arm will receive the BT-001 treatment for up to 720 days.

Treatment:

Behavioral: BT-001

Standard of Care

Other group

Description:

Patients will have access to a control mobile application for 180 days and then will have the option to use the treatment for the remainder of the 720 day study

Treatment:

Other: Control App