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

NCT04886388 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 668

Last updated 2023-09-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Better Therapeutics

    lead INDUSTRY

Principal Investigators

  • Mark Berman, MD · Better Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2022-03-09
Completion
2022-09-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04886388 on ClinicalTrials.gov