Pivotal Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
Public ClinicalTrials.gov record NCT04886388. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-Label, Randomized, Controlled, Parallel-Group Trial of a Digital Therapeutic for the Treatment of Type 2 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04886388
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 668 participants
Conditions and interventions
Conditions
Interventions
Device · Other
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 22, 2021 (Actual)
- Primary completion
- Mar 9, 2022 (Actual)
- Completion
- Sep 27, 2022 (Actual)
- Last update posted
- Sep 28, 2023
2021 – 2022
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Study Site | San Francisco | California | 94110 | — |
| Study Site | Miami | Florida | 33101 | — |
| Study Site | Atlanta | Georgia | 30301 | — |
| Study Site | Chicago | Illinois | 60007 | — |
| Study Site | New York | New York | 10001 | — |
| Study Site | Houston | Texas | 77001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04886388, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04886388 live on ClinicalTrials.gov.