Trial results for the Diabetes Data-Assisted Remission Trial (DDART), investigating interventions for Obesity and Type 2 Diabetes, were posted on ClinicalTrials.gov on 2026-04-03. The High Intensity Medical Weight Loss (HIWL) group achieved a mean body weight reduction of 10.73 kg among the 64 enrolled participants.
Background
Obesity is a significant risk factor for numerous health conditions, including Type 2 Diabetes (T2DM). Effective weight management is crucial for both preventing and managing T2DM, often leading to improved glycemic control and, in some cases, remission. Current approaches to T2DM care are continuously being evaluated for efficacy and patient support. This trial explored a high-intensity medical weight loss intervention, enhanced by a digital platform, to improve weight loss outcomes and potentially induce T2DM remission, offering a new perspective on managing these interconnected conditions.
Trial design
The Diabetes Data-Assisted Remission Trial (DDART) was a completed study, designated as Phase NA, that enrolled 64 participants. The trial investigated interventions for Type 2 Diabetes and Obesity. It compared a high intensity medical weight loss intervention (HIWL), sometimes paired with a digital platform and continuous glucose monitoring (CGM), against a diabetes self-management education (DSME) intervention. The study aimed to assess the efficacy of these interventions in achieving weight loss and inducing remission of type 2 diabetes.
Key results
The trial reported several key measurements:
- Change in Body Weight:
- HIWL group: -10.73 kg (Standard Deviation 7.10)
- DSME group: -6.15 kg (Standard Deviation 7.99)
- HIWL Plus CGM group: -9.09 kg (Standard Deviation 6.59)
- Change in Hemoglobin A1c:
- HIWL group: -1.00 percentage of change in hemoglobin A1c (Standard Deviation 0.94)
- DSME group: -0.67 percentage of change in hemoglobin A1c (Standard Deviation 0.96)
- HIWL Plus CGM group: -0.65 percentage of change in hemoglobin A1c (Standard Deviation 1.32)
- Number of Subjects in Diabetes Remission:
- HIWL group: 10 Participants
- DSME group: 2 Participants
- HIWL Plus CGM group: 8 Participants
- Continuous Glucose Monitoring (CGM) Time in Range:
- HIWL group: Mean of 11.0 % of time (Standard Deviation 13.1)
- DSME group: Mean of 9.4 % of time (Standard Deviation 11.7)
- HIWL Plus CGM group: Mean of 14.4 % of time (Standard Deviation 18.7)
What this means
The results from the DDART trial indicate that a high intensity medical weight loss intervention can lead to substantial body weight reduction and a higher rate of diabetes remission compared to standard self-management education. The High Intensity Medical Weight Loss group achieved the most significant mean weight loss and the highest number of participants in diabetes remission. While the addition of Continuous Glucose Monitoring to the HIWL intervention also showed positive outcomes, the HIWL alone demonstrated the strongest impact on weight loss. These findings suggest that intensive, structured weight loss programs, potentially supported by digital platforms, could be a valuable strategy for managing obesity and achieving remission in Type 2 Diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04663061, titled "Diabetes Data-Assisted Remission Trial (DDART)", were posted on 2026-04-03 on clinicaltrials.gov.