CompletedNot Applicable

Diabetes Data-Assisted Remission Trial (DDART)

United States64 participantsStarted 2021-06-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. Exclusion criteria: * Poorly controlled depression * Recent hospitalization for psychosis or bipolar disorder * Poorly controlled blood pressure (\>159/99) * Prior surgical procedure for weight control or liposuction * Unable to make changes to their diet * Unable to exercise (walk for at least 6 minutes and perform simple strength and stretch exercise tests) * Use of weight loss medications in previous 3 months * Recent self-reported weight change (+/- 15lbs) * Current use of oral corticosteroids more than 5days/month * 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 * Major liver dysfunction within the last 2 years * Recently quit smoking less than 6 months prior * Inability to attend visits and adhere to study protocols * Pregnancy or currently lactating

What they're measuring

Change in Body Weight

Timeframe: baseline through 12 months

Trial details

NCT IDNCT04663061

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-14

Results submitted2025-12-08