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

NCT04886388 | Completed Phase 3 DMC

• 1 other identifier: DM2-06
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 6

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• The difference in the mean change from baseline in HbA1c at Day 90 between Intervention and Standard of Care groups

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

  Baseline and Day 90

Secondary Outcomes (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

Study Arms (2)

BT-001 + Standard of Care

EXPERIMENTAL

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; Other: Physician-guided Standard of Care for type 2 diabetes

Standard of Care

ACTIVE COMPARATOR

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

Interventions

BT-001 DEVICE

BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control.

BT-001 + Standard of Care

Physician-guided Standard of Care for type 2 diabetes OTHER

Current ADA Standard of Care Guidelines for type 2 diabetes

BT-001 + Standard of Care; Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Better Therapeutics: lead

Study Sites (6)

Study Site

San Francisco, California, 94110, United States

Location

Study Site

Miami, Florida, 33101, United States

Location

Study Site

Atlanta, Georgia, 30301, United States

Location

Study Site

Chicago, Illinois, 60007, United States

Location

Study Site

New York, New York, 10001, United States

Location

Study Site

Houston, Texas, 77001, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mark Berman, MD

  Better Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, Randomized, Controlled

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 14, 2021
• Study Start: April 22, 2021
• Primary Completion: March 9, 2022
• Study Completion: September 27, 2022
• Last Updated: September 28, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)