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NCT04886388
Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
Phase 3 trial testing BT-001 in Type 2 Diabetes in 668 participants. Completed in 27 September 2022.
9 March 2022
Quick facts
| Lead sponsor | Better Therapeutics |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 668 |
| Start date | 22 April 2021 |
| Primary completion | 9 March 2022 |
| Estimated completion | 27 September 2022 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- BT-001 — full drug profile →
- Physician-guided Standard of Care for type 2 diabetes
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Better Therapeutics
Who can join
Adults 18 to 75, any sex, with Type 2 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) compared to standard medical care in patients with type 2 diabetes.
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 -
Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale, design, and baseline characteristics of a randomized, controlled trial.
Canonico ME, Hsia J, Guthrie NL, Simmons M, et al · · 2022 · cited 14× · PMID 35778834 · DOI 10.1002/clc.23853
Verify or expand the search:
- PubMed search for NCT04886388
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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
- NCT05094401 — Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes · Phase 3 · terminated
- 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 Type 2 Diabetes
Currently open trials in the same condition.
- NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · 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
- NCT05094401 — Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04886388 (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/NCT04886388.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing