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Digital-Assisted Weight Loss for Type 2 Diabetes

N/A

Waitlist Available

Led By Jamy Ard, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of non-skin cancer in the past 5 years

Renal failure (end stage renal disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a high-intensity weight loss intervention, when paired with a digital platform, is more effective at inducing remission of type 2 diabetes than a diabetes self-management education intervention.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical reactions related to lifestyle changes such as fatigue from increased exercise; digestive discomfort from dietary adjustments; stress or anxiety during behavioral therapy; and skin irritation or other minor issues from continuous glucose monitoring devices.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have end-stage kidney disease.

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I have had surgery for weight control or liposuction.

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I have had a heart-related event in the last 6 months.

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I take oral corticosteroids more than 5 days a month.

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My depression is not well-managed.

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I need extra oxygen due to severe lung problems.

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I cannot walk for 6 minutes or do basic exercises.

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My blood pressure is not higher than 159/99.

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I can attend all required visits and follow the study rules.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Body Weight

Secondary study objectives

ASA24 Healthy Eating Index (HEI)-2015 score

ASA24 Macronutrient Composition of Diet

ASA24 Number of Eating Episodes Per Day

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)Experimental Treatment2 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 Treatment1 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 Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous glucose monitoring

2019

N/A

~610

0 / 10Eligibility criteria met