N/A
Completed N=64
Diabetes Data-Assisted Remission Trial (DDART)
Source: ClinicalTrials.gov NCT04663061 ↗Enrolled (actual)
64
Serious AEs
1.6%
Results posted
Apr 2026
Primary outcomePrimary: Change in Body Weight — -10.73; -6.15; -9.09 kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight |
-10.73; -6.15; -9.09 | — |
| SECONDARY Change in Hemoglobin A1c |
-1.00; -0.67; -0.65 | — |
| SECONDARY Number of Subjects in Diabetes Remission |
10; 2; 8 | — |
| SECONDARY Continuous Glucose Monitoring (CGM) Time in Range |
11.0; 9.4; 14.4; 20.9; 17.4; 23.7 | — |
| SECONDARY Continuous Glucose Monitoring Time in Range--Post-meal Glucose |
21.6; 17.4; 25.5; 31.7; 28.5; 33.4 | — |
| SECONDARY Continuous Glucose Monitor Time in Range--Fasting Glucose |
1.7; 1.1; 5.9; 8.3; 1.6; 6.9 | — |
| SECONDARY Continuous Glucose Monitor - Episodes of Hypoglycemia |
0.38; 0.05; 0.37; 4.06; 0.21; 2.68 | — |
| SECONDARY Continuous Glucose Monitor - Glucose Variability |
21.72; 21.77; 20.97; 20.31; 19.01; 21.60 | — |
| SECONDARY Continuous Glucose Monitoring - Average Glucose |
139.29; 163.53; 139.16; 135.12; 141.23; 125.13 | — |
| SECONDARY Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake |
— | — |
| SECONDARY ASA24 Macronutrient Composition of Diet |
— | — |
| SECONDARY ASA24 Number of Eating Episodes Per Day |
— | — |
| SECONDARY ASA24 Healthy Eating Index (HEI)-2015 Score |
— | — |
| SECONDARY Daily Step Counts |
2986.52; 2488.95; 4440.5; 4289.33; 5792.25; 6324.63 | — |
| SECONDARY Change in Quality of Life |
0.01; 0.0; 0.03 | — |
| SECONDARY Change in Perceived Health Rating |
2.36; -11.83; 7.19 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04663061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.