Diabetes Data-Assisted Remission Trial (DDART)

Wake Forest University Health Sciences64 enrolled

Overview

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.

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 Type

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Body Weight

Change in weight from baseline

Time frame: baseline through 12 months

Secondary Outcomes

Change in Hemoglobin A1c

Change in hemoglobin A1c

Time frame: baseline through 12 months

Number of Subjects in Diabetes Remission

Number of participants achieving A1c \<6.5% and no anti-diabetes medications

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: baseline through 12 months

Continuous Glucose Monitor - Episodes of Hypoglycemia

Number of episodes hypoglycemia (\<70 mg/dL) episodes collected by FreeStyle Libre.

Time frame: baseline and month 12

Continuous Glucose Monitor - Glucose Variability

Coefficient of variance collected by FreeStyle Libre.

Time frame: baseline and month 12

Continuous Glucose Monitoring - Average Glucose

Average glucose (mg/dL) collected by FreeStyle Libre.

Time frame: baseline and 12 months

Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake

kilocalories averaged across 3 days