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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the Mastering Diabetes treatment for Type 2 Diabetes?

Research on similar education programs shows that they can help people with diabetes improve their blood sugar control and feel healthier overall. These programs often focus on teaching patients how to manage their condition better, which can lead to significant improvements in their quality of life. ^{1 2 3 4 5}

Is the Mastering Diabetes Program safe for humans?

The available safety data from clinical trials on incretin-based therapies, which are used to manage type 2 diabetes, suggest they have no apparent adverse impact on important safety parameters like cardiovascular disease and may help with weight management. ^{6 7 8 9 10}

How does the Mastering Diabetes treatment for type 2 diabetes differ from other treatments?

The Mastering Diabetes treatment is unique because it focuses on a comprehensive lifestyle approach, emphasizing diet, exercise, and education to manage type 2 diabetes, rather than relying solely on medication. This approach aims to improve long-term outcomes by empowering patients with knowledge and self-monitoring skills. ^{11 12 13 14 15}

What is the purpose of this trial?

This is a program evaluation that will evaluate the effectiveness of Mastering Diabetes, a therapeutic lifestyle change (TLC) program to control prediabetes and type 2 diabetes. Lifestyle change, focused on dietary change, physical activity, stress management and control of unhealthy substances has been demonstrated effective in preventing the progression of prediabetes, as well as reversal of diabetes and type 2 diabetes mellitus (T2DM).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Diabetes rehabilitation: development and first results of a Multidisciplinary Intensive Education Program for patients with prolonged self-management difficulties. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Continuous monitoring of health status outcomes: experience with a diabetes education program. [2019]

3. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Impact of a multidisciplinary intensive education program on type 2 diabetes mellitus patients' glycemic control and cardiovascular risk factors. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Improving chronic care of type 2 diabetes using teams of interprofessional learners. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of patient-reported outcomes data in structured diabetes education intervention: 2-year follow-up data of patient empowerment programme. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Insulin, hospitals and harm: a review of patient safety incidents reported to the National Patient Safety Agency. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Diabetes medication incidents in the care home setting. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Insulin pump safety meeting: summary report. [2021]

11. Ireland pubmed.ncbi.nlm.nih.gov

Educational program for diabetic patients in Korea--multidisplinary intensive management. [2015]

12. England pubmed.ncbi.nlm.nih.gov

Type 2 diabetes--treat early, treat intensively. [2022]

13. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Perceived Barriers, Benefits, Facilitators, and Attitudes of Health Professionals Towards Multidisciplinary Team Care in Type 2 Diabetes Management: A Systematic Review. [2021]

14. Ireland pubmed.ncbi.nlm.nih.gov

Effects of an individual intensive educational control program for insulin-dependent diabetic subjects with poor metabolic control. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Early and more vigorous detection of diabetes. [2019]