Clinical trial NCT04663061: Diabetes Data-Assisted Remission Trial (DDART)
Official title: Data-Assisted Approach for High Intensity Medical Weight Loss for Diabetes Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Keywords: Diabetes
Obesity
Weight management
Diabetes education
Diabetes remission
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: UnitedHealth Group
First posted: 2020-12-10
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion:

* 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.

Exclusion criteria:

* 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)
* 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: baseline through 12 months
Secondary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: baseline through 12 months
measure: Number of Subjects in Diabetes Remission
timeFrame: 12 months
measure: Continuous Glucose Monitoring (CGM) Time in Range
timeFrame: baseline through 12 months
measure: CGM Time in Range--Post-meal Glucose
timeFrame: baseline through 12 months
measure: CGM Time in Range--Fasting Glucose
timeFrame: baseline through 12 months
measure: CGM Episodes of Hypoglycemia
timeFrame: baseline through 12 months
measure: CGM Glucose Variability
timeFrame: baseline through 12 months
measure: CGM Average Glucose
timeFrame: baseline through 12 months
measure: Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: ASA24 Macronutrient Composition of Diet
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: ASA24 Number of Eating Episodes Per Day
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: ASA24 Healthy Eating Index (HEI)-2015 score
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: Daily Step Counts
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: International Physical Activity Questionnaire (IPAC) short form: moderate-vigorous physical activity minutes
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: International Physical Activity Questionnaire (IPAC) short form: walking minutes
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: International Physical Activity Questionnaire (IPAC) short form: sitting time
timeFrame: baseline, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Univesity Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jamy Ard, MD
role: PRINCIPAL_INVESTIGATOR
References: