Diabetes Data-Assisted Remission Trial (DDART)

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Behavioral: Medical weight loss; Behavioral: Diabetes education; Behavioral: Continuous glucose monitoring

• Registration Number: NCT04663061
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Study Start: 2021-06-09
• Status Verified: 2024-05
• Primary Completion: 2024-11-14
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity medical weight loss (HIWL)	Medical weight loss	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.
High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)	Continuous glucose monitoring	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.
Diabetes self-management education (DSME)	Diabetes education	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.
High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM)	Medical weight loss	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.

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	baseline through 12 months	Change in weight from baseline

Secondary Outcome Measures

Name	Time	Method
Daily Step Counts	baseline, 3 months, 6 months, and 12 months	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.
ASA24 Healthy Eating Index (HEI)-2015 score	baseline, 3 months, 6 months, and 12 months	A validated summary measure of dietary quality, rated on a 100-point scale with a higher score denoting better diet quality
Continuous Glucose Monitoring (CGM) Time in Range	baseline through 12 months	Collected by FreeStyle Libre. Average time spent at an average glucose of 100 mg/dL or lower.
CGM Time in Range--Fasting Glucose	baseline through 12 months	Collected by FreeStyle Libre. Average time spent in normal fasting glucose between 72-85 mg/dL.
ASA24 Number of Eating Episodes Per Day	baseline, 3 months, 6 months, and 12 months	averaged across 3 days
CGM Average Glucose	baseline through 12 months	Collected by FreeStyle Libre.
Number of Subjects in Diabetes Remission	12 months	Achieving A1c \<6.5% and no anti-diabetes medications
CGM Episodes of Hypoglycemia	baseline through 12 months	Collected by FreeStyle Libre. Number of episodes.
CGM Glucose Variability	baseline through 12 months	Collected by FreeStyle Libre. Coefficient of variance
Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake	baseline, 3 months, 6 months, and 12 months	kilocalories averaged across 3 days
International Physical Activity Questionnaire (IPAC) short form: moderate-vigorous physical activity minutes	baseline, 3 months, 6 months, and 12 months	A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of moderate and vigorous physical activity. Outcome is average total minutes/week.
Change in Hemoglobin A1c	baseline through 12 months	Change in hemoglobin A1c
CGM Time in Range--Post-meal Glucose	baseline through 12 months	Collected by FreeStyle Libre. Average time spent at a post-meal glucose level of 110 mg/dL or lower.
ASA24 Macronutrient Composition of Diet	baseline, 3 months, 6 months, and 12 months	%Carbohydrate/Fat/Protein; averaged across 3 days
International Physical Activity Questionnaire (IPAC) short form: sitting time	baseline, 3 months, 6 months, and 12 months	A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of sitting time. Outcome is average total minutes/week.
International Physical Activity Questionnaire (IPAC) short form: walking minutes	baseline, 3 months, 6 months, and 12 months	A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of walking for exercise. Outcome is average total minutes/week.

Trial Locations

Locations (1)

Wake Forest Univesity Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States