clinical trial · NCT05302050
A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus
Diabetes Type 2BT-001Control Mobile Application
brief summary
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.
started
Mar 7, 2022
primary completion
Dec 1, 2025
completion
Dec 1, 2025
last updated
Oct 30, 2023
detailed 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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol