Digital-Assisted Weight Loss for Type 2 Diabetes

Overseen By Joseph Aloi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Weight loss medications, Corticosteroids

Disqualifiers: Depression, Cardiovascular, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jamy Ard, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

The DDART is for individuals with Type 2 Diabetes diagnosed in the last 6 years, who are overweight (BMI of 30-39.9) and have an HbA1c level between 6.5-11.9%. Participants should be able to exercise, change their diet, and attend counseling sessions. Exclusions include recent use of weight loss meds, severe diseases like heart or lung conditions, certain mental health issues, extreme recent weight changes, uncontrolled blood pressure or depression.

Inclusion Criteria

Your body mass index (BMI) is between 30 and 39.9.

I can exercise, change my diet, and attend counseling.

I can exercise, change my diet, and attend counseling.

Exclusion Criteria

I have had a non-skin cancer diagnosis within the last 5 years.

I have end-stage kidney disease.

I have had surgery for weight control or liposuction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a high intensity medical weight loss intervention or diabetes self-management education intervention over 12 months

12 months

Regular virtual and in-person visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous glucose monitoring
• Diabetes education
• Medical weight loss

Trial Overview This trial tests a high-intensity medical weight loss program combined with a digital platform against standard diabetes self-management education. The goal is to see if this approach can cause significant weight loss and help put Type 2 Diabetes into remission by tailoring treatment plans and providing ongoing support through technology.

How Is the Trial Designed?

Group I: High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM) Experimental Treatment 2 Interventions

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.

Group II: High intensity medical weight loss (HIWL) Experimental Treatment 1 Intervention

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.

Group III: Diabetes self-management education (DSME) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

UnitedHealth Group

Industry Sponsor

Trials

14

Recruited

11,600+