Diabetes Data-Assisted Remission Trial (DDART)

NCT04663061 | Completed

• 1 other identifier: IRB00067950
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Obesity

Keywords

Diabetes; Obesity; Weight management; Diabetes education; Diabetes remission

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Change in weight from baseline

  baseline through 12 months

Secondary Outcomes (16)

• Change in Hemoglobin A1c

  baseline through 12 months

• Number of Subjects in Diabetes Remission

  12 months

• Continuous Glucose Monitoring (CGM) Time in Range

  baseline through 12 months

• CGM Time in Range--Post-meal Glucose

  baseline through 12 months

• CGM Time in Range--Fasting Glucose

  baseline through 12 months

Study Arms (3)

High intensity medical weight loss (HIWL)

EXPERIMENTAL

Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.

Behavioral: Medical weight loss

Diabetes self-management education (DSME)

ACTIVE COMPARATOR

The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings. The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.

Behavioral: Diabetes education

High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)

EXPERIMENTAL

Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.

Behavioral: Medical weight loss; Behavioral: Continuous glucose monitoring

Interventions

Medical weight loss BEHAVIORAL

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

High intensity medical weight loss (HIWL); High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)

Diabetes education BEHAVIORAL

Participants will receive standard of care diabetes education

Diabetes self-management education (DSME)

Continuous glucose monitoring BEHAVIORAL

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

High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• UnitedHealth Group: collaborator

Study Sites (1)

Wake Forest Univesity Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Jamy Ard, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 10, 2020
• Study Start: June 9, 2021
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: March 3, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following any publication.
• Access Criteria: Proposals will need to be sent to jard@wakehealth.edu for review and approval. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)