Diabetes Data-Assisted Remission Trial (DDART)

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04663061
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Medical weight loss — BEHAVIORAL
    Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
  • Diabetes education — BEHAVIORAL
    Participants will receive standard of care diabetes education
  • Continuous glucose monitoring — BEHAVIORAL
    Participants will use CGM devices to track blood glucose levels in near real time

Study Details

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.

Key Dates

Start date
Jun 9, 2021
Status verified
May 2024
Primary completion
Nov 14, 2024
Completion
Nov 14, 2024

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High intensity medical weight loss (HIWL)
    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.
  • Active Comparator: Diabetes self-management education (DSME)
    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.
  • Experimental: High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)
    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.

Primary Outcome Measure

Change in Body Weight [ Time Frame: baseline through 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Univesity Health SciencesWinston-SalemNorth Carolina27157-

Find similar trials in Winston-Salem, NC

By condition
Obesity / overweightType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Wake Forest Univesity Health Sciences· Winston-Salem, NC

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