Status:
COMPLETED
Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
Lead Sponsor:
Better Therapeutics
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control (i.e., levels of blood sugar). The BT-001 software delivers...
Detailed Description
The study will utilize an open-label, randomized, parallel-group design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) when compared to SOC al...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Between 18 and 75 years old, inclusive at the time of signing the informed consent;
- Diagnosis of type 2 diabetes, according to the criteria of the American Diabetes Association (ADA), and confirmed at the initial eligibility screening;
- Body Mass Index ≥25 kg/m2;
- Possesses a smartphone (iPhone or Android only) capable of running the smartphone applications (Apps) used in the study;
- Has had no change in the last 4 months prior to randomization (3 months prior to initial screening plus 30-day run-in screening period) in antihyperglycemic medications;
- Has a current HbA1c level \>7%, as determined by both screening assessments;
- Willing to use an FDA approved glucometer for self-monitoring blood glucose throughout the study;
- Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- Exclusion Criteria
- Are unable to understand, consent to, or comply with the study protocol for any reason;
- Currently taking prandial (mealtime) insulin;
- Have self-reported measures, collected during screening interview, that reveal:
- An active eating disorder
- The taking of or planning to take (within the next 6 months):
- i. Oral steroids (planned, or within the past 3 months) ii. Chemotherapy (planned, or within the past 6 months) iii. Weight loss medications or iv. Atypical antipsychotic medications
- c. A change in antidepressant or anti-anxiety medication within the past 3 months;
- d. A history of bariatric surgery or planned bariatric surgery during the study;
- e. The current use of marijuana, cocaine, opioid painkillers, or other addictive substances;
- f. The current use of tobacco products or use of tobacco products within the past 6 months;
- g. The consumption of alcohol above defined thresholds:
- i. For women: more than 3 drinks in a single day, or more than 7 drinks per week and ii. For men: more than 4 drinks in a single day, or more than 14 drinks per week
- h. An unstable or life-threatening medical illness;
- i. Non-resolved, presumed or confirmed COVID-19 diagnosis prior to randomization or during primary study period;
- j. For women only: pregnant (or lactating) or having the intention of becoming pregnant during the time frame of the study.
- Has a current HbA1c level ≥11%, at the screening assessment;
- Concurrent enrollment in any other clinical trial;
- Is considered unreliable by the investigator, or having any condition which, in the opinion of the investigator, would not allow safe participation in the study.
Exclusion
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2022
Estimated Enrollment :
668 Patients enrolled
Trial Details
Trial ID
NCT04886388
Start Date
April 22 2021
End Date
September 27 2022
Last Update
September 28 2023
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Study Site
San Francisco, California, United States, 94110
2
Study Site
Miami, Florida, United States, 33101
3
Study Site
Atlanta, Georgia, United States, 30301
4
Study Site
Chicago, Illinois, United States, 60007