4T Education and Care for Type 1 Diabetes

Recruiting at 1 trial location

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-T1D diabetes, Over 21, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

316 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the 4T Education and Care treatment for Type 1 Diabetes?

Research shows that structured education programs for people with Type 1 diabetes can improve diabetes control and quality of life. These programs help patients manage their condition better, leading to improved long-term health outcomes. ^{1 2 3 4 5}

Is the 4T Education and Care program safe for humans?

The 4T Education and Care program focuses on teamwork, targets, technology, and tight control to manage type 1 diabetes, and it involves education and continuous glucose monitoring. There is no specific safety data mentioned, but the program is designed to improve diabetes management and quality of life, suggesting it is generally safe for humans. ^{6 7 8 9 10}

How does the 4T Education and Care treatment for Type 1 Diabetes differ from other treatments?

The 4T Education and Care treatment is unique because it focuses on providing comprehensive education and support for managing Type 1 Diabetes, emphasizing patient empowerment and self-management. It involves a multidisciplinary approach, where patients are educated to make informed decisions about their care, including exercise and diet, which is not typically the focus of standard treatments. ^{6 11 12 13 14}

What is the purpose of this trial?

The 4T program encompasses: Teamwork, Targets, Technology, and Tight Range. These methods will help patients better manage their condition of Type 1 Diabetes with improved patient-reported outcomes.

Research Team

David M Maahs, MD, PhD

Principal Investigator

Lucile Packard Children's Hospital; Stanford University, School of Medicine

Eligibility Criteria

The trial is for children and young adults under 21 with newly diagnosed Type 1 Diabetes. Participants must have an Apple device to use specific apps for monitoring, agree to continuous glucose monitoring (CGM) data sharing, and plan to receive care at the Stanford Children's Diabetes Clinic.

Inclusion Criteria

I am between 6 months and 21 years old and have been diagnosed with Type 1 Diabetes.

You have been diagnosed with type 1 diabetes within the last month at the Stanford Children's Diabetes Clinic.

I am between six months and 21 years old.

Exclusion Criteria

You plan to get diabetes treatment at a different clinic.

I have been diagnosed with a type of diabetes that is not Type 1.

I am older than 21 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the 4T intervention, including wearing a Continuous Glucose Monitor (CGM) with remote data monitoring

12 months

Weekly to monthly remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 4T Education and Care

Trial Overview The '4T' program being tested includes Teamwork, Targets, Technology, and Tight Control strategies aimed at improving self-management of Type 1 Diabetes in pediatric patients through education and advanced care techniques.

Participant Groups

Group I: T1D Patients Experimental Treatment 1 Intervention

Participants will wear a Continuous Glucose Monitor (CGM) with remote data monitoring

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

A 5-day structured education program for Type 1 diabetes significantly improved diabetes control, with a notable reduction in glycated hemoglobin (HbA1c) by 0.42% in 63 patients after one year, especially among those with initially high HbA1c levels.

The program also led to a significant decrease in severe hypoglycemia incidents, dropping from 10 episodes in the year prior to just 1 episode after the course, alongside improvements in quality of life measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hub-and-spoke model for a 5-day structured patient education programme for people with Type 1 diabetes. Rogers, H., Turner, E., Thompson, G., et al.[2022]

Effective diabetes education is crucial for type-I diabetic patients, as it empowers them to self-manage their condition and achieve better metabolic control.

Studies have shown that well-structured diabetes education programs can significantly enhance long-term metabolic control and reduce acute complications, highlighting the importance of patient involvement in their own care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of education of the diabetic. Quality control in diabetes therapy]. Berger, M., Mühlhauser, I., Jörgens, V.[2007]

In a study of 262 adults with type 1 diabetes, the structured education program Dose Adjustment For Normal Eating (DAFNE) led to significant improvements in glycemic control, with HbA1c levels decreasing from 9.1% to 8.6% at 6 months and 8.8% at 12 months for those with initially suboptimal control.

Quality of life (QoL) scores also significantly improved by 3 months and were maintained at both 6 and 12 months, demonstrating that structured education can enhance both health outcomes and patient well-being in routine healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structured type 1 diabetes education delivered within routine care: impact on glycemic control and diabetes-specific quality of life. Cooke, D., Bond, R., Lawton, J., et al.[2022]

The DAFNE programme significantly improves diabetes management outcomes, such as HbA1c levels and rates of severe hypoglycaemia, for up to 12 months after completion, highlighting its efficacy in educating individuals with Type 1 diabetes.

This study compares group follow-up versus traditional one-to-one visits for DAFNE graduates, aiming to determine the best method to maintain the benefits of the programme, with outcomes measured at 6, 12, and 18 months to ensure comprehensive evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Irish DAFNE study protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes. Dinneen, SF., O' Hara, MC., Byrne, M., et al.[2023]

A study involving 14 patients with type 1 diabetes and 11 healthcare providers highlighted that effective education and support for exercise are influenced by both patient engagement and the consistency of information from care providers.

To improve exercise support for patients with type 1 diabetes, any educational program should be tailored to individual patient needs, delivered early after diagnosis, and include peer stories to enhance relatability, while also ensuring healthcare staff receive proper training to provide consistent advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Healthcare Professionals Perspectives on the Delivery of Exercise Education for Patients With Type 1 Diabetes. Litchfield, I., Andrews, RC., Narendran, P., et al.[2021]

The study developed interactive games to educate children with type-1 diabetes about managing their condition, focusing on the relationship between food, glucose levels, exercise, and insulin.

Out of 58 testers, over 90% found the games entertaining and engaging, with around 60% believing they offered a more appealing educational experience compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Edutainment tools for initial education of type-1 diabetes mellitus: initial diabetes education with fun. Aoki, N., Ohta, S., Masuda, H., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Hub-and-spoke model for a 5-day structured patient education programme for people with Type 1 diabetes. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Evaluation of education of the diabetic. Quality control in diabetes therapy]. [2007]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Nursing Diabetes Self-Management Education on Glycemic Control and Self-Care in Type 1 Diabetes: Study Protocol. [2022]

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

Structured type 1 diabetes education delivered within routine care: impact on glycemic control and diabetes-specific quality of life. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Irish DAFNE study protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Patient and Healthcare Professionals Perspectives on the Delivery of Exercise Education for Patients With Type 1 Diabetes. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Improving Clinical Outcomes in Newly Diagnosed Pediatric Type 1 Diabetes: Teamwork, Targets, Technology, and Tight Control-The 4T Study. [2021]

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

Roadmap to Continuous Glucose Monitoring Adoption and Improved Outcomes in Endocrinology: The 4T (Teamwork, Targets, Technology, and Tight Control) Program. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Edutainment tools for initial education of type-1 diabetes mellitus: initial diabetes education with fun. [2022]

10. France pubmed.ncbi.nlm.nih.gov

Evaluation of a new training program to reassure primary school teachers about glucagon injection in children with type 1 diabetes during the 2017-2018 school year. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Factors Included in T1DM Continuing Education for Korean School Nurses: A Systematic Review. [2021]

12. Poland pubmed.ncbi.nlm.nih.gov

[The degree of health knowledge in children with type 1 diabetes affects the metabolic control only in patients with an optimum or suboptimum level of HbA1c]. [2017]

13. Germany pubmed.ncbi.nlm.nih.gov

Education and multidisciplinary team care concepts for pediatric and adolescent diabetes mellitus. [2019]

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

Empowering Staff Nurses as Primary Educators to Children with Type 1 Diabetes. [2019]