Status:
UNKNOWN
A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus
Lead Sponsor:
Better Therapeutics
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Diabetes Type 2
Eligibility:
All Genders
18-75 years
Phase:
NA
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 contro...
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05302050
Start Date
March 7 2022
End Date
December 1 2025
Last Update
October 30 2023
Active Locations (1)
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1
Mass General Brigham Hospital and Clinics
Boston, Massachusetts, United States, 02199