CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Medical weight loss +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04663061
NCT04663061N/ACompleted

Data-Assisted Approach for High Intensity Medical Weight Loss for Diabetes Remission

Wake Forest University Health Sciences·interventional·Posted Dec 10, 2020·Updated Apr 3, 2026

In Brief

A clinical study evaluating Medical weight loss, Diabetes education, and 1 other intervention for Type 2 Diabetes and Obesity. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsUnitedHealth Group

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 10, 2020
Enrollment StartJun 9, 2021
Primary CompletionNov 14, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.6 years ago

Interventions

Medical weight lossbehavioral

Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight

Diabetes educationbehavioral

Participants will receive standard of care diabetes education

Continuous glucose monitoringbehavioral

Participants will use CGM devices to track blood glucose levels in near real time