Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT04886388
• Recruitment Status: Completed
• First Posted: May 14, 2021
• Last Update Posted: September 28, 2023
• Sponsor: Better Therapeutics
• Information provided by (Responsible Party): Better Therapeutics

Tracking Information

• First Submitted Date: May 7, 2021
• First Posted Date: May 14, 2021
• Last Update Posted Date: September 28, 2023
• Actual Study Start Date: April 22, 2021
• Actual Primary Completion Date: March 9, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 10, 2021)

The difference in the mean change from baseline in HbA1c at Day 90 between Intervention and Standard of Care groups [ Time Frame: Baseline and Day 90 ]

Hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 10, 2021)

The difference in the mean change from baseline in HbA1c at Day 180 between Intervention and Standard of Care groups [ Time Frame: Baseline and Day 180 ]

Hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
• Official Title: Open-Label, Randomized, Controlled, Parallel-Group Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
• 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 a type of behavioral therapy to patients via a mobile application that targets behaviors related to achieving glycemic control. The effectiveness of BT-001 will be measured by its ability to help patients reduce Hemoglobin A1c, or HbA1c (a marker in the blood that measures blood sugar) compared to standard medical care in patients with type 2 diabetes.

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 alone in patients with type 2 diabetes. The screening period will consist of a run-in during which time HbA1c will be assessed for confirmation of eligibility.

Once confirmed to be eligible, patients will then be randomized 1:1 to the following groups:

Investigational: One half of the participants will be treated with BT-001 plus SOC for 180 days;

Control: One half of the participants will be treated with SOC alone for 180 days.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Open-Label, Randomized, Controlled

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Type 2 Diabetes

Intervention

• Device: BT-001
  BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control.
• Other: Physician-guided Standard of Care for type 2 diabetes
  Current ADA Standard of Care Guidelines for type 2 diabetes

Study Arms

• Experimental: BT-001 + Standard of Care
  BT-001 is a software program used with physician guidance, being investigated to improve glycemic control. Patients randomized to this arm of the study will interact with the BT-001 software program in addition to receiving Standard of Care for type 2 diabetes
  Interventions:

  • Device: BT-001
  • Other: Physician-guided Standard of Care for type 2 diabetes
• Active Comparator: Standard of Care
  Patients randomized to the Standard of Care arm will receive Standard of Care treatment for type 2 diabetes under the guidance of a physician
  Intervention: Other: Physician-guided Standard of Care for type 2 diabetes

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 26, 2023): 668
• Original Estimated Enrollment (submitted: May 10, 2021): 648
• Actual Study Completion Date: September 27, 2022
• Actual Primary Completion Date: March 9, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Between 18 and 75 years old, inclusive at the time of signing the informed consent;
2. Diagnosis of type 2 diabetes, according to the criteria of the American Diabetes Association (ADA), and confirmed at the initial eligibility screening;
3. Body Mass Index ≥25 kg/m2;
4. Possesses a smartphone (iPhone or Android only) capable of running the smartphone applications (Apps) used in the study;
5. 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;
6. Has a current HbA1c level >7%, as determined by both screening assessments;
7. Willing to use an FDA approved glucometer for self-monitoring blood glucose throughout the study;
8. Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).

Exclusion Criteria

1. Are unable to understand, consent to, or comply with the study protocol for any reason;
2. Currently taking prandial (mealtime) insulin;

3. Have self-reported measures, collected during screening interview, that reveal:

   1. An active eating disorder
   2. 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.

4. Has a current HbA1c level ≥11%, at the screening assessment;
5. Concurrent enrollment in any other clinical trial;
6. 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04886388
• Other Study ID Numbers: DM2-06
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Better Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Better Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Mark Berman, MD; Better Therapeutics

• PRS Account: Better Therapeutics
• Verification Date: January 2022