Type 2 DiabetesNCT04663061
Diabetes Data-Assisted Remission Trial (DDART)
A study testing Medical weight loss, Diabetes education and Continuous glucose monitoring in people with Type 2 Diabetes and Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Medical weight loss, Diabetes education and Continuous glucose monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 14 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 17Show fewer
- 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
- Inability to attend visits and adhere to study protocols
- Pregnancy or currently lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Univesity Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Data-Assisted Approach for High Intensity Medical Weight Loss for Diabetes Remission
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.
Read the detailed description
This project will determine if a data-assisted, high intensity medical weight loss intervention (HIWL) will lead to significant weight loss and diabetes remission in individuals with a Body Mass Index (BMI) 30-39.9 kg/m2 with T2DM of less than 6 years as compared to a diabetes self-management education intervention (DSME). Complete diabetes remission is considered to be achieved when the patient is not taking any anti-diabetes medication for at least 12 months, and the Glycated Hemoglobin (HbA1c) is < 5.7%. Partial remission is achieved when the patient is not taking any anti-diabetes medication and has an HbA1c of 5.7-6.4% for at least 12 months.Using a randomized controlled study design, we will randomly assign 90 participants to HIWL, HIWL + continuous glucose monitoring (CGM), or DSME. Participants assigned to HIWL will receive a high intensity behavioral weight loss intervention delivered using a digital patient engagement platform. Participants will be prescribed a low calorie dietary plan and a recommended physical activity program designed to produce 15-20% weight loss over 12 months. Those assigned to HIWL + CGM will receive the same intervention as HIWL; in addition we will provide them with CGM to use as part of their remote monitoring on a daily basis. Those assigned to DSME will participate in a comprehensive diabetes education program designed to provide education and skills for optimal diabetes management plus lifestyle modification counseling to produce 5% weight loss over the same timeframe. The primary outcome of weight loss will be assessed at 12 months.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Medical weight loss, Diabetes education, Continuous glucose monitoring
- Keywords
- Diabetes, Obesity, Weight management, Diabetes education, Diabetes remission
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical weight lossBehavioural
Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Diabetes educationBehavioural
Participants will receive standard of care diabetes education
Continuous glucose monitoringBehavioural
Participants will use CGM devices to track blood glucose levels in near real time
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Medical weight loss; Behavioral: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change in weight from baseline
Measured: baseline through 12 months
Secondary outcomes (15)
Change in Hemoglobin A1c
Change in hemoglobin A1c
Measured: baseline through 12 months
Number of Subjects in Diabetes Remission
Number of participants achieving A1c <6.5% and no anti-diabetes medications
Measured: 12 months
Continuous Glucose Monitoring (CGM) Time in Range
Average time spent at an average glucose of 100 mg/dL or lower collected by FreeStyle Libre.
Measured: baseline and month 12
Continuous Glucose Monitoring Time in Range--Post-meal Glucose
Average time spent at a post-meal glucose level of 110 mg/dL or lower collected by FreeStyle Libre.
Measured: baseline through 12 months
Continuous Glucose Monitor Time in Range--Fasting Glucose
Average time spent in normal fasting glucose between 72-85 mg/dL collected by FreeStyle Libre.
Measured: baseline through 12 months
Continuous Glucose Monitor - Episodes of Hypoglycemia
Number of episodes hypoglycemia (<70 mg/dL) episodes collected by FreeStyle Libre.
Measured: baseline and month 12
Continuous Glucose Monitor - Glucose Variability
Coefficient of variance collected by FreeStyle Libre.
Measured: baseline and month 12
Continuous Glucose Monitoring - Average Glucose
Average glucose (mg/dL) collected by FreeStyle Libre.
Measured: baseline and 12 months
Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake
kilocalories averaged across 3 days
Measured: baseline, 3 months, 6 months, and 12 months
ASA24 Macronutrient Composition of Diet
%Carbohydrate/Fat/Protein; averaged across 3 days
Measured: baseline, 3 months, 6 months, and 12 months
ASA24 Number of Eating Episodes Per Day
averaged across 3 days
Measured: baseline, 3 months, 6 months, and 12 months
ASA24 Healthy Eating Index (HEI)-2015 Score
A validated summary measure of dietary quality, rated on a 100-point scale with a higher score denoting better diet quality
Measured: baseline, 3 months, 6 months, and 12 months
Daily Step Counts
Collected by pedometer over 7 days during each period. At the end of the 7th day, participants will record the final step count, and return the pedometer to the study team via a pre-stamped mail envelope.
Measured: baseline, 3 months, 6 months, and 12 months
Change in Quality of Life
The EuroQol's EQ-5D-5L will be used to measure quality of life. This instrument takes responses to five questions on mobility, self-care, ability to perform usual activities, pain, and anxiety/depression to produce a validated quality score. Total score range is 5-25 with a lower score indicating a better quality of life.
Measured: from baseline to month 12
Change in Perceived Health Rating
The EuroQol's EQ-5D-5L visual analog scale will be used to measure participants perceived health. On a scale of 0-100 participants will rate their health. 0 means the worst health you can imagine. 100 means the best health you can imagine.
Measured: from baseline to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start9 Jun 2021
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- UnitedHealth Group
- Responsible party
- Sponsor
- Investigators
- Jamy Ard, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663061
- Sponsor's protocol ID
- IRB00067950
- Status last verified
- May 2024
- First submitted
- 9 Dec 2020
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of any reported manuscripts after deidentification will be made available for the specified timeframes. Researchers who provide a methodologically sound proposal for analysis will be granted access.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data-Assisted Approach for High Intensity Medical Weight Loss for Diabetes Remission
- ClinicalTrials.gov ID
- NCT04663061
- Acronym / sponsor ID
- IRB00067950
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Diabetes, Obesity, Weight management, Diabetes education, Diabetes remission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- UnitedHealth Group
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Posted 3 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project will determine if a data-assisted, high intensity medical weight loss intervention (HIWL) will lead to significant weight loss and diabetes remission in individuals with a Body Mass Index (BMI) 30-39.9 kg/m2 with T2DM of less than 6 years as compared to a diabetes self-management education intervention (DSME). Complete diabetes remission is considered to be achieved when the patient is not taking any anti-diabetes medication for at least 12 months, and the Glycated Hemoglobin (HbA1c) is < 5.7%. Partial remission is achieved when the patient is not taking any anti-diabetes medication and has an HbA1c of 5.7-6.4% for at least 12 months.Using a randomized controlled study design, we will randomly assign 90 participants to HIWL, HIWL + continuous glucose monitoring (CGM), or DSME. Participants assigned to HIWL will receive a high intensity behavioral weight loss intervention delivered using a digital patient engagement platform. Participants will be prescribed a low calorie dietary plan and a recommended physical activity program designed to produce 15-20% weight loss over 12 months. Those assigned to HIWL + CGM will receive the same intervention as HIWL; in addition we will provide them with CGM to use as part of their remote monitoring on a daily basis. Those assigned to DSME will participate in a comprehensive diabetes education program designed to provide education and skills for optimal diabetes management plus lifestyle modification counseling to produce 5% weight loss over the same timeframe. The primary outcome of weight loss will be assessed at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| High intensity medical weight loss (HIWL) | Experimental | Behavioral: Medical weight lossParticipants 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. |
| Diabetes self-management education (DSME) | Active comparator | Behavioral: Diabetes educationThe 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. |
| High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM) | Experimental | Behavioral: Medical weight loss, Behavioral: Continuous glucose monitoringParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical weight lossParticipants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight | Behavioural | High intensity medical weight loss (HIWL), High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM) |
| Diabetes educationParticipants will receive standard of care diabetes education | Behavioural | Diabetes self-management education (DSME) |
| Continuous glucose monitoringParticipants will use CGM devices to track blood glucose levels in near real time | Behavioural | High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM) |
Primary outcome
Change in Body Weight
Time frame: baseline through 12 months
Change in weight from baseline
15 secondary outcomes
Change in Hemoglobin A1c
Time frame: baseline through 12 months
Number of Subjects in Diabetes Remission
Time frame: 12 months
Continuous Glucose Monitoring (CGM) Time in Range
Time frame: baseline and month 12
Continuous Glucose Monitoring Time in Range--Post-meal Glucose
Time frame: baseline through 12 months
Continuous Glucose Monitor Time in Range--Fasting Glucose
Time frame: baseline through 12 months
Continuous Glucose Monitor - Episodes of Hypoglycemia
Time frame: baseline and month 12
Continuous Glucose Monitor - Glucose Variability
Time frame: baseline and month 12
Continuous Glucose Monitoring - Average Glucose
Time frame: baseline and 12 months
Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake
Time frame: baseline, 3 months, 6 months, and 12 months
ASA24 Macronutrient Composition of Diet
Time frame: baseline, 3 months, 6 months, and 12 months
ASA24 Number of Eating Episodes Per Day
Time frame: baseline, 3 months, 6 months, and 12 months
ASA24 Healthy Eating Index (HEI)-2015 Score
Time frame: baseline, 3 months, 6 months, and 12 months
Daily Step Counts
Time frame: baseline, 3 months, 6 months, and 12 months
Change in Quality of Life
Time frame: from baseline to month 12
Change in Perceived Health Rating
Time frame: from baseline to month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of any reported manuscripts after deidentification will be made available for the specified timeframes. Researchers who provide a methodologically sound proposal for analysis will be granted access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamy Ard, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical weight loss, Diabetes education and Continuous glucose monitoring in people with Type 2 Diabetes and Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: baseline through 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.