NCT05302050 (ACTION-DM) is a NA clinical trial of BT-001 in Diabetes Type 2, sponsored by Better Therapeutics.

Who is sponsoring NCT05302050?

NCT05302050 is sponsored by Better Therapeutics.

What drugs are being tested in NCT05302050?

Interventions in NCT05302050: BT-001, Control Mobile Application.

What condition does NCT05302050 study?

NCT05302050 studies Diabetes Type 2.

Is NCT05302050 still recruiting?

NCT05302050 is currently status unknown. Last updated 30 October 2023.

Last reviewed 2023-10-30 · How we verify

NCT05302050: ACTION-DM

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

A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus

Status unknown NA Last updated 30 October 2023

What this trial tests

NA trial testing BT-001 in Diabetes Type 2 in 500 participants. Status unknown.

Timeline

7 March 2022

Primary endpoint
1 December 2025

1 December 2025

Quick facts

Lead sponsor	Better Therapeutics
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	500
Start date	7 March 2022
Primary completion	1 December 2025
Estimated completion	1 December 2025
Sites	1 location across United States

Drugs / interventions tested

BT-001 — full drug profile →
Control Mobile Application

Conditions studied

Diabetes Type 2 — all drugs for Diabetes Type 2 →

Sponsor

Better Therapeutics

Who can join

Adults 18 to 75, any sex, with Diabetes Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Randomized, controlled, pragmatic trial with open-label extension evaluating BT-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.

Publications & conference data

2 peer-reviewed publications 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
Digital Therapeutic Based Randomized Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy: Rationale, Design, and Baseline Characteristics of the BRIGHT Trial.
Canonico ME, Hsia J, Masoudi FA, Bosworth HB, et al · · 2025 · PMID 40673521 · DOI 10.1161/jaha.124.038737

Verify or expand the search:

Other trials of BT-001

Trials testing the same drug.

NCT05094401 — Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes · Phase 3 · terminated
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 Diabetes Type 2

Currently open trials in the same condition.

NCT07176793 — Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes · recruiting
NCT07485075 — Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical · NA · recruiting
NCT07220213 — FELLAShip to Better Health · NA · recruiting
NCT07350967 — Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel End · NA · recruiting
NCT07149610 — Connected Care for Type 2 Diabetes Self-Management · NA · recruiting

Other Better Therapeutics trials

Trials by the same sponsor.

NCT05357248 — Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH · NA · completed
NCT05094401 — Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes · Phase 3 · terminated
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 NCT05302050 (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: 30 October 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/NCT05302050.

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