Clincosm LogoSign in Get a demo

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

Sponsor
Better Therapeutics (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04886388
Collaborator
(none)
651
Enrollment
6
Locations
2
Arms
18.3
Anticipated Duration (Months)
108.5
Patients Per Site
5.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BT-001
  • Other: Physician-guided Standard of Care for type 2 diabetes
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
651 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open-Label, Randomized, ControlledOpen-Label, Randomized, Controlled
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label, Randomized, Controlled, Parallel-Group Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
Actual Study Start Date :
Apr 22, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

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
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

Other: Physician-guided Standard of Care for type 2 diabetes
Current ADA Standard of Care Guidelines for type 2 diabetes

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  4. An active eating disorder

  5. The taking of or planning to take (within the next 6 months):

  1. 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

  2. A change in antidepressant or anti-anxiety medication within the past 3 months;

  3. A history of bariatric surgery or planned bariatric surgery during the study;

  4. The current use of marijuana, cocaine, opioid painkillers, or other addictive substances;

  5. The current use of tobacco products or use of tobacco products within the past 6 months;

  6. The consumption of alcohol above defined thresholds:

  7. For women: more than 3 drinks in a single day, or more than 7 drinks per week and

  1. For men: more than 4 drinks in a single day, or more than 14 drinks per week

  1. An unstable or life-threatening medical illness;

  2. Non-resolved, presumed or confirmed COVID-19 diagnosis prior to randomization or during primary study period;

  3. For women only: pregnant (or lactating) or having the intention of becoming pregnant during the time frame of the study.

  1. Has a current HbA1c level ≥11%, at the screening assessment;

  2. Concurrent enrollment in any other clinical trial;

  3. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Study Site New York New York United States 10001
6 Study Site Houston Texas United States 77001

Sponsors and Collaborators

  • Better Therapeutics

Investigators

  • Study Director: Mark Berman, MD, Better Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Better Therapeutics
ClinicalTrials.gov Identifier:
NCT04886388
Other Study ID Numbers:
  • DM2-06
First Posted:
May 14, 2021
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 18, 2022