NCT05094401 is a Phase 3 clinical trial of BT-001 in Type2 Diabetes, sponsored by Better Therapeutics.

Who is sponsoring NCT05094401?

NCT05094401 is sponsored by Better Therapeutics.

What drugs are being tested in NCT05094401?

Interventions in NCT05094401: BT-001.

What condition does NCT05094401 study?

NCT05094401 studies Type2 Diabetes.

Is NCT05094401 still recruiting?

NCT05094401 is currently terminated. Last updated 28 September 2023.

Last reviewed 2023-09-28 · How we verify

NCT05094401

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes

Terminated Phase 3 Last updated 28 September 2023

What this trial tests

Phase 3 trial testing BT-001 in Type2 Diabetes in 76 participants. Terminated before completion.

Timeline

4 October 2021

Primary endpoint
1 April 2023

1 April 2023

Quick facts

Lead sponsor	Better Therapeutics
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	76
Start date	4 October 2021
Primary completion	1 April 2023
Estimated completion	1 April 2023
Sites	1 location across United States

Drugs / interventions tested

BT-001 — full drug profile →

Conditions studied

Type2 Diabetes — all drugs for Type2 Diabetes →

Sponsor

Better Therapeutics

Who can join

Adults 18 to 75, any sex, with Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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) in patients with type 2 diabetes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Randomized, Controlled Trial of a Digital Behavioral Therapeutic Application to Improve Glycemic Control in Adults With Type 2 Diabetes.
Hsia J, Guthrie NL, Lupinacci P, Gubbi A, et al · · 2022 · cited 25× · PMID 36181554 · DOI 10.2337/dc22-1099

Verify or expand the search:

Other trials of BT-001

Trials testing the same drug.

NCT05302050 — A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus · NA · unknown
NCT04886388 — Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes · Phase 3 · completed
NCT04725331 — A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors · Phase 1, PHASE2 · terminated

Other recruiting trials for Type2 Diabetes

Currently open trials in the same condition.

NCT05277558 — Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D) · recruiting
NCT05015283 — Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission · NA · recruiting
NCT05006508 — Prevention With the Health and Lifestyle Tool · NA · active not recruiting
NCT04717050 — Reducing Metabolic Dysregulation in Obese Latina Breast Cancer Survivors Using Physical Activity · NA · active not recruiting
NCT05220917 — Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study · active not recruiting

Other Better Therapeutics trials

Trials by the same sponsor.

NCT05357248 — Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH · NA · completed
NCT05302050 — A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus · NA · unknown
NCT04886388 — Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05094401 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Better Therapeutics
Last refreshed: 28 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05094401.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing