Suspended

BRIGHTBT-001 for Improved Glycemic Control in Adults with Type 2 Diabetes

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Study Aim

This study aims to evaluate the safety and effectiveness of BT-001 in improving glycemic control, specifically by observing changes in HbA1c levels and monitoring adverse events in adults with Type 2 Diabetes.

What is being tested

BT-001

+ Control App

BehavioralOther
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 75 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorBetter Therapeutics
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 14, 2022

Actual date on which the first participant was enrolled.

This study is a large, multi-center trial focusing on adults with type 2 diabetes. The main goal is to test if a new treatment called BT-001, when used alongside usual care, can improve blood sugar control in real-world settings. The importance of this study lies in its potential to enhance diabetes management, addressing the need for better glycemic control strategies. Approximately 500 adults with type 2 diabetes will participate, randomly assigned to either BT-001 or a control group. During the trial, most clinical data will be gathered from electronic medical records, with limited additional contacts for safety monitoring. The primary outcomes include changes in HbA1c levels, a key indicator of blood sugar control, and occurrences of adverse events. For HbA1c assessment, a lab requisition form will be provided if the data is not available from the records. In the extension phase, biomarker data will only be collected from the records. Clinical and healthcare utilization data will be extracted from the records, covering the period from 180 days before enrollment to 720 days after enrollment.

Official TitleRandomized, Controlled, Multicenter, Pragmatic, Trial With Open-label Extension of BT-001 to Improve Glycemic Control in Adults With Type 2 Diabetes in a Real-world Setting
NCT05266625
Principal SponsorBetter Therapeutics
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
Age 18-75 years, inclusive at the time of signing the informed consent
Type 2 diabetes on stable anti-diabetic regimen for at least three (3) months
HbA1c 7.0% to 10.9% (within thirty [30] days of signing the informed consent form [ICF])
Able to use BT-001 e.g., English fluent, smartphone is capable of running the study intervention.
3 exclusion criteria prevent from participating
Current use of outpatient prandial insulin
In the opinion of the investigator, life expectancy < one (1) year
COVID-19 diagnosis within thirty (30) days prior to randomization.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients in this arm will receive the BT-001 treatment for up to 720 days.

Group II

Patients will have access to a control mobile application for 180 days and then will have the option to use the treatment for the remainder of the 720 day study

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

University of Colorado Hospital

Aurora, United StatesOpen University of Colorado Hospital in Google Maps
Suspended

Ascension DePaul Community Health

New Orleans, United States
Suspended

VA Medical Center-Durham

Durham, United States
Suspended3 Study Centers