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

Status unconfirmed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT05266625

Run by

Better Therapeutics

People needed

500

Starts

2022-02-14

Expected to finish

2025-11-01

Last updated by the study team

2023-10-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States
• Ascension DePaul Community Health — New Orleans, Louisiana, United States
• VA Medical Center-Durham — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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