Digital-Assisted Weight Loss for Type 2 Diabetes

Overseen By Joseph Aloi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Weight loss medications, Corticosteroids

Disqualifiers: Depression, Cardiovascular, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a high-intensity medical weight loss program combined with digital tools to improve management of type 2 diabetes. It compares this approach to a traditional diabetes education program. Participants may use meal replacements and continuous glucose monitors, which track blood sugar levels, to guide their treatment. Individuals with type 2 diabetes for less than six years and a BMI between 30-39.9 may be suitable candidates. As an unphased trial, this study provides an opportunity to explore innovative approaches to diabetes management.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using weight loss medications or oral corticosteroids frequently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that high-intensity medical weight loss programs, which often include meal replacements and guidance from dietitians, are well-received by participants. Research indicates that even a small amount of weight loss can help control blood sugar and reduce the need for diabetes medications in people with type 2 diabetes. These programs have not demonstrated a significant increase in negative side effects compared to standard treatments.

Studies have also shown that continuous glucose monitoring (CGM), which tracks blood sugar levels in real time, is safe and beneficial. People using CGM spent less time with dangerously high or low blood sugar levels than those who did not use it. CGM has been linked to lower death rates in people with type 2 diabetes, suggesting it is both effective and safe.

Both the medical weight loss programs and CGM have demonstrated safety and positive results in past research. Participants in these studies did not experience significant negative effects, indicating these approaches are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the digital-assisted weight loss approach for Type 2 diabetes because it combines high-intensity medical weight loss (HIWL) with continuous glucose monitoring (CGM), offering a unique and personalized approach. Unlike traditional treatments that might focus solely on medication or basic lifestyle advice, this method uses meal replacements alongside real-time glucose data to guide patients' daily management. The integration of CGM with a mobile app allows patients to see immediate feedback on their blood sugar levels, which can help tailor their actions and decisions effectively. This personalized, tech-enabled approach could lead to better disease management and weight loss outcomes.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that intensive medical weight loss can be very effective for people with type 2 diabetes. One study found that losing just 5% of body weight improved blood sugar, cholesterol, and blood pressure over a year. This indicates that even a small amount of weight loss can significantly help manage diabetes. In this trial, some participants will receive high-intensity medical weight loss (HIWL) alone, while others will receive HIWL combined with continuous glucose monitoring (CGM).

Continuous glucose monitoring (CGM) also shows promise. It helps people with type 2 diabetes control their blood sugar levels by providing real-time feedback. Studies have demonstrated that using CGM can increase the time blood sugar stays in a healthy range and reduce episodes of high blood sugar. Together, these methods could support better diabetes management. Additionally, another group in this trial will receive diabetes self-management education (DSME) to help integrate diabetes management strategies into their daily lives. ^{2 6 7 8 9}

Who Is on the Research Team?

Jamy Ard, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

I have had a non-skin cancer diagnosis within the last 5 years.

I have end-stage kidney disease.

I have had surgery for weight control or liposuction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a high intensity medical weight loss intervention or diabetes self-management education intervention over 12 months

12 months

Regular virtual and in-person visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous glucose monitoring
• Diabetes education
• Medical weight loss

Trial Overview 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.

How Is the Trial Designed?

Group I: High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM) Experimental Treatment 2 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 Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

UnitedHealth Group

Industry Sponsor

Trials

14

Recruited

11,600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37987208/

Effectiveness of Continuous Glucose Monitoring on Metrics ... Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840797

Duration of Continuous Glucose Monitoring and Glycemic ... Diabetes and Endocrinology. Duration of Continuous Glucose Monitoring and Glycemic Outcomes in Type 2 Diabetes. Peter Lommer Kristensen, MD, PhD.

3. nature.com nature.com/articles/s41598-024-83548-4

Continuous glucose monitoring among adults with type 2 ... Patients showed improvements in time in range (39.7–61.9%, p < 0.0001), time > 180 mg/dL (60.1–37.9%, p < 0.001), time > 250 mg/dL (27.6–8.5%, p ...

4. diabetesjournals.org diabetesjournals.org/clinical/article/43/1/139/157329/Continuous-Glucose-Monitoring-in-Individuals-With

Continuous Glucose Monitoring in Individuals With Type 2 ... The use of CGM in the population of people with type 2 diabetes has been shown to improve patients' ability to use real-time glycemic ...

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.70008

Continuous glucose monitoring in noninsulin‐treated type 2 ... CGM use in noninsulin-treated individuals living with T2DM was associated with improved glycaemic outcomes and patient experience, reduced ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7957379/

Type 2 Diabetes and the Use of Real-Time Continuous ... When compared with control subjects, the CGM group spent 21% less time in hypoglycemia (<55 mg/dL), 23% less time in hyperglycemia (≥240 mg/dL), and 26% more ...

7. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) Real-time continuous glucose monitoring has led to tremendous outcomes for people with diabetes who, without a CGM, may have experienced potentially life- ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40432529/

Initiation of Continuous Glucose Monitoring and Mortality in ... Conclusion: In a large national cohort, initiation of CGM was associated with lower mortality in T2D patients using insulin and indicates use of ...

9. diabetesjournals.org diabetesjournals.org/care/article/47/1/169/154009/Efficacy-and-Safety-of-Continuous-Glucose

Efficacy and Safety of Continuous Glucose Monitoring and ... Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.