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NCT04663061 · ClinicalTrials.gov registry record · NA
Diabetes Data-Assisted Remission Trial (DDART)
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT04663061: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT04663061 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04663061, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study Summary
The study team will study the efficacy of a high intensity medical weight loss intervention paired with a digital platform to create weight loss and induce remission of type 2 diabetes mellitus (T2DM) compared to a diabetes self-management education intervention. The digital platform provides the capability to tailor the treatment plan, provide automated support, and alert providers when a participant may need more support from the clinical team. If shown to be efficacious, this research could be highly impactful, causing us to rethink our approach to care for those with T2DM and shift the paradigm for millions of individuals in the United States. Furthermore, this approach will demonstrate the feasibility of helping people engage in metabolic treatment strategies in a way that is scalable leveraging digital and mobile solutions that extend the patient-provider relationship, shift care from episodic approaches to more of an on-going model that extends into the life of the patient, while also integrated within the healthcare system workflows.
Primary Outcome
Change in weight from baseline
Interventions
- BEHAVIORAL Diabetes education
- BEHAVIORAL Medical weight loss
- BEHAVIORAL Continuous glucose monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-06-09 |
| Est. Completion | 2024-11-14 |
| Phase | NA |
What the finished NCT04663061 record still lists
NCT04663061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Diabetes education is the first listed.
NCT04663061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04663061 about?
NCT04663061 is a clinical study titled "Diabetes Data-Assisted Remission Trial (DDART)". The study team will study the efficacy of a high intensity medical weight loss intervention paired with a digital platform to create weight loss and induce remission of type 2 diabetes mellitus (T2DM) compared to a diabetes self-management education intervention. The digital platform provides the ca...
What is the current status of trial NCT04663061?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2021-06-09. Estimated completion is 2024-11-14.
What interventions are being tested in trial NCT04663061?
The interventions under investigation include: Diabetes education (BEHAVIORAL), Medical weight loss (BEHAVIORAL), Continuous glucose monitoring (BEHAVIORAL).
Who is sponsoring clinical trial NCT04663061?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04663061's enrollment target sits among peer trials
64 1147th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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