Your session is about to expire
← Back to Search
Digital-Assisted Weight Loss for Type 2 Diabetes
N/A
Recruiting
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
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
Individuals with T2DM diagnosed within the past 6 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, and 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can exercise, change my diet, and attend counseling.
Select...
I was diagnosed with type 2 diabetes in the last 6 years.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Body Weight
Secondary outcome measures
ASA24 Healthy Eating Index (HEI)-2015 score
ASA24 Macronutrient Composition of Diet
ASA24 Number of Eating Episodes Per Day
+13 moreTrial 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
~580
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,117 Total Patients Enrolled
UnitedHealth GroupIndustry Sponsor
12 Previous Clinical Trials
10,721 Total Patients Enrolled
Jamy Ard, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
258 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a non-skin cancer diagnosis within the last 5 years.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.I have end-stage kidney disease.I have had surgery for weight control or liposuction.I have had a heart-related event in the last 6 months.I was diagnosed with type 2 diabetes in the last 6 years.I take oral corticosteroids more than 5 days a month.My depression is not well-managed.I need extra oxygen due to severe lung problems.I cannot walk for 6 minutes or do basic exercises.You have had a significant change in weight, gaining or losing 15 pounds recently.You stopped smoking less than 6 months ago.I have not had major liver problems in the last 2 years.I have not taken weight loss medications in the last 3 months.You were recently in the hospital for psychosis or bipolar disorder.My blood pressure is not higher than 159/99.I can attend all required visits and follow the study rules.Your HbA1c level should be between 6.5% and 11.9%.Your body mass index (BMI) is between 30 and 39.9.
Research Study Groups:
This trial has the following groups:- Group 1: High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)
- Group 2: High intensity medical weight loss (HIWL)
- Group 3: Diabetes self-management education (DSME)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04663061 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant count for this research project?
"Affirmative, clinicaltrials.gov data signals that this study is currently enrolling individuals. It was first published on June 9th 2021 and the most recent amendment took place July 29th 2022. 90 people are in need of recruitment at a single site."
Answered by AI
Is participation in this trial available to patients at the present time?
"Clinicaltrials.gov presents that this clinical trial is currently open to new participants, with initial posting occuring on June 9th 2021 and the most recent edit occurring July 29th 2022."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What site did they apply to?
Wake Forest Univesity Health Sciences
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I enjoy doing trials, especially for diabetes to help find a cure.
PatientReceived 1 prior treatment
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger