NCT04663061Completed
Diabetes Data-Assisted Remission Trial (DDART)
Data-Assisted Approach for High Intensity Medical Weight Loss for Diabetes Remission
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 9 Dec 2020
- Start date
- 9 Jun 2021
- Primary completion date
- 14 Nov 2024
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT04663061
What you commit to
- Study type: Interventional
- Participants enrolled: 64
- From 9 Jun 2021 to the primary completion date, 14 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior surgical procedure for weight control or liposuction
- Use of weight loss medications in previous 3 months
- Current use of oral corticosteroids more than 5days/month
- Recently quit smoking less than 6 months prior
Other illness
- Recent hospitalization for psychosis or bipolar disorder
- Cardiovascular disease event within the past 6 months
- Severe pulmonary disease requiring supplemental oxygen
- Renal failure (end stage renal disease)
- History of non-skin cancer in the past 5 years
Other
- Poorly controlled depression
- Poorly controlled blood pressure (\>159/99)
- Unable to make changes to their diet
- Unable to exercise (walk for at least 6 minutes and perform simple strength and stretch exercise tests)
- Recent self-reported weight change (+/- 15lbs)
- Major liver dysfunction within the last 2 years
- Inability to attend visits and adhere to study protocols
- Pregnancy or currently lactating
Criteria the registry did not label
- Inclusion:
- Individuals with T2DM diagnosed within the past 6 years
- Body Mass Index (BMI) of 30-39.9 kg/m2.
- Participants must have an HbA1c between 6.5-11.9%.
- Participants should be able to participate in all aspects of the recommended interventions, including being able to participate in exercise, make recommended dietary changes, and engage in individual and group counseling.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest Univesity Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.