Mastering Diabetes Program for Type 2 Diabetes

Overseen By David S Drozek, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio University

Must not be taking: Coumadin, Warfarin

Disqualifiers: Dementia, Pregnancy, Renal disease, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a lifestyle program called Mastering Diabetes to assess its effectiveness in controlling prediabetes and type 2 diabetes. The program emphasizes lifestyle changes such as diet, exercise, stress management, and avoiding unhealthy habits. Participants will either join the Mastering Diabetes program or continue with their usual care. Individuals with diabetes or prediabetes who can exercise and are open to a plant-based diet may be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative lifestyle changes that could significantly improve health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people taking Coumadin or warfarin. It's best to discuss with the trial team or your doctor.

What prior data suggests that the Mastering Diabetes program is safe for managing type 2 diabetes?

Research has shown that lifestyle changes, such as those in the Mastering Diabetes program, are generally safe. A retrospective study found that participants in the program significantly improved their blood sugar levels and body weight, indicating the approach is well-tolerated. The program emphasizes a low-fat, plant-based diet and overall healthy living. These changes typically have few side effects. No strong evidence suggests any serious negative effects from the program, as lifestyle changes do not involve drugs or medical procedures, which often cause side effects. Participants can expect a safe way to manage diabetes through dietary and lifestyle adjustments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Mastering Diabetes program is unique because it emphasizes a low-fat, plant-based, whole-foods diet, which stands apart from traditional treatments like medications such as metformin or lifestyle changes focusing primarily on carbohydrate counting. Researchers are excited about this approach because it targets insulin resistance more directly by potentially improving insulin sensitivity through dietary changes, rather than relying solely on medication. This method could lead to better blood sugar control and overall health improvements for individuals with type 2 diabetes, offering a potentially transformative alternative to current standard care options.

What evidence suggests that the Mastering Diabetes program is effective for type 2 diabetes?

Research has shown that the Mastering Diabetes program, available to participants in this trial, can greatly assist individuals with type 2 diabetes and prediabetes in managing their condition. A retrospective study found that past participants significantly improved their HbA1c levels, an important measure of blood sugar control, and reduced their body weight. Some individuals even reported achieving an A1C of 5.8, indicating excellent blood sugar management, after just two months on the program. This program emphasizes lifestyle changes, such as diet and exercise, which have been proven to prevent diabetes from worsening and can even reverse type 2 diabetes. These findings highlight the program's potential to effectively control diabetes through structured lifestyle changes. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with diabetes or prediabetes, who can prepare food at home, participate in physical activity, and are open to a plant-based diet and intermittent fasting. They must have internet access and be willing to engage in an online community.

Inclusion Criteria

Have an email account and an Internet connection at home

You can take part in physical activities.

You are willing to eat a diet focused on plants and to fast for 16-24 hours once a week.

Exclusion Criteria

Inability to use email, a smartphone, or the Internet

I cannot walk a mile due to a health condition.

I am currently taking Coumadin or warfarin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Data Collection

Participants complete online consent and HIPAA release, and baseline data is collected including BMI, blood pressure, and lab tests

Up to 8 weeks

1 visit (in-person) for lab work, online consent

Mastering Diabetes Program

Participants engage in a virtual therapeutic lifestyle change program focusing on a low-fat, plant-based diet, exercise, and stress management

12 weeks

Biweekly virtual Q&A sessions

Follow-up

Participants are monitored for changes in health metrics such as HbA1c, cholesterol, and BMI

12 weeks, then yearly for up to 20 years

Annual in-person lab visits

What Are the Treatments Tested in This Trial?

Interventions

• Mastering Diabetes

Trial Overview The 'Mastering Diabetes' program is being tested for its effectiveness in controlling prediabetes and type 2 diabetes through lifestyle changes such as diet modification, increased physical activity, stress management, and avoiding unhealthy substances.

How Is the Trial Designed?

Group I: Mastering Diabetes Experimental Treatment 1 Intervention

Adults (hospital employees, their spouses, and community members) who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen to participate in Mastering Diabetes. They may or may not be receiving additional usual care.

Group II: Usual care Active Control 1 Intervention

Employees and spouses of the hospital system who are participating in the employee wellness program, who have been identified as having diabetes or prediabetes based on a health risk assessment, who have chosen not to participate in Mastering Diabetes. They may or may not be receiving additional usual care.

Who Is Running the Clinical Trial?

Ohio University

Lead Sponsor

Trials

73

Recruited

17,800+

Memorial Health System

Collaborator

Trials

8

Recruited

1,300+

Published Research Related to This Trial

Educational interventions for healthcare professionals, including a 6-hour standardized course, significantly improved their attitudes and motivation towards monitoring diabetes, which is crucial for patient safety.

The study suggests that these interventions can enhance the control of diabetes in patients, as measured by HbA1c levels, although the specific outcomes on patient control were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. Cabré, JJ., Ripoll, M., Hernández, JM., et al.[2021]

A comprehensive analysis of the National Reporting and Learning System database revealed that patient safety incidents involving insulin are common and lead to significant distress for individuals with diabetes and their families, highlighting a critical area for improvement in diabetes care.

The article discusses ongoing efforts by the National Patient Safety Agency and partner organizations aimed at reducing insulin-related errors, indicating a proactive approach to enhancing patient safety in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin, hospitals and harm: a review of patient safety incidents reported to the National Patient Safety Agency. Cousins, D., Rosario, C., Scarpello, J.[2021]

Incretin-based therapies, such as DPP-4 inhibitors and GLP-1 agonists, provide effective glycemic control for type 2 diabetes patients without the weight gain often seen with traditional treatments, making them a favorable option for many.

Clinical trial data suggest that these therapies are safe, showing no negative effects on cardiovascular health, and their integration into treatment plans can enhance options for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New therapeutic options: management strategies to optimize glycemic control. Freeman, JS.[2022]

An intensive educational control program for 15 insulin-dependent diabetic patients significantly improved metabolic control, as evidenced by a sustained decrease in hemoglobin A1c levels over 24 months.

The program also enhanced patients' knowledge of diabetes and self-monitoring skills without major changes in dietary intake or insulin schedules, indicating a safe and effective approach to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an individual intensive educational control program for insulin-dependent diabetic subjects with poor metabolic control. Conget, I., Jansá, M., Vidal, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8299927/

Retrospective Evaluation of an Online Diabetes Health ... In those responding, this retrospective study demonstrated significant improvements in HbA1c and body weight in participants in the Mastering Diabetes virtual ...

2. masteringdiabetes.org masteringdiabetes.org/results/

Learn How Coaching is Transforming Lives Thanks to finding Mastering Diabetes and their guidance and support I was able to achieve an A1C of 5.8 after just 2 months on the program. Now, eight months ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03743779

NCT03743779 | Mastering Diabetes Pilot Study The data from this study will help develop a prospective study to better evaluate the effectiveness of Mastering Diabetes in controlling diabetes. Future ...

4. masteringdiabetes.org masteringdiabetes.org/

Mastering Diabetes: Reverse Insulin Resistance | Diabetes ... Life was heavy. Thanks to finding Mastering Diabetes and their guidance and support I was able to achieve an A1C of 5.8 after just 2 months on the program.”

5. ctv.veeva.com ctv.veeva.com/study/mastering-diabetes-study

Mastering Diabetes Study - ClinicalTrials.Veeva This is a program evaluation that will evaluate the effectiveness of Mastering Diabetes, a therapeutic lifestyle change (TLC) program to control prediabetes ...

6. masteringdiabetes.org masteringdiabetes.org/bookinfo/

Evidence-Based Scientific References Our extensively-researched method teaches you how to reverse insulin resistance and maximize longevity using almost 100 years of evidence-based research.

7. diabetesjournals.org diabetesjournals.org/clinical/article/42/3/419/154329/Effect-of-a-Dietary-Intervention-on-Insulin

Effect of a Dietary Intervention on Insulin Requirements and ... This study compared the effects of a low-fat vegan diet to those of a portion-controlled diet in people with type 1 diabetes.