4T Education and Care for Type 1 Diabetes

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young patients with Type 1 Diabetes better manage their condition through the 4T Education and Care program, which emphasizes teamwork, targets, technology, and maintaining a tight glucose range. Participants will use a Continuous Glucose Monitor (CGM) that sends data remotely to doctors, enabling real-time blood sugar level tracking. This trial is ideal for those diagnosed with Type 1 Diabetes within the last month who plan to continue care at the Stanford Children's Diabetes Clinic. Participants must be between six months and 21 years old and have access to an Apple device for data monitoring. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management strategies and improve care for future patients.

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 prior data suggests that the 4T Education and Care program is safe for managing Type 1 Diabetes?

Research shows that the 4T Education and Care program helps people with Type 1 Diabetes manage their condition more effectively. The program uses tools like Continuous Glucose Monitors (CGMs) to track blood sugar levels in real-time. Studies have found that CGMs are generally safe and well-tolerated by patients.

In previous research, participants in the 4T program demonstrated better control over their blood sugar levels, experiencing fewer episodes of dangerously high or low blood sugar. Importantly, no significant harmful side effects have been reported from the program. The program focuses on teamwork, setting clear health goals, using technology, and maintaining healthy blood sugar levels.

Overall, the 4T program appears to be a safe way to manage Type 1 Diabetes, yielding better results for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 4T Education and Care approach for Type 1 Diabetes because it emphasizes the use of Continuous Glucose Monitors (CGMs) with remote data monitoring. Unlike traditional methods that rely heavily on routine blood sugar checks and insulin injections, this method allows for real-time monitoring and more proactive management of blood sugar levels. This remote monitoring capability can lead to more personalized treatment adjustments and potentially better outcomes for patients. By providing continuous data, it aims to improve patient engagement and overall diabetes management, making it a promising advancement in diabetes care.

What evidence suggests that the 4T Education and Care program is effective for managing Type 1 Diabetes?

Research shows that the 4T Education and Care program can help people with Type 1 Diabetes manage their condition more effectively. In this trial, participants will wear a Continuous Glucose Monitor (CGM) with remote data monitoring as part of the 4T program. Studies have found that this can lead to improved blood sugar levels. Specifically, one study showed that participants in the program experienced a 0.5% improvement in their A1C levels (a measure of average blood sugar) 12 months after diagnosis. The program also includes exercise education, which is linked to better blood sugar control. Overall, the 4T program's approach, combining teamwork, goals, technology, and maintaining a stable blood sugar range, appears promising for those with Type 1 Diabetes. ^{1 2 4 6 7}

Who Is on the Research Team?

David M Maahs, MD, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9298953/

Improving Clinical Outcomes in Newly Diagnosed Pediatric ... In summary, the 4T study has leveraged CGM remote data review and novel telemedicine workflows to improve T1D patient care. Novel, open-source dashboards ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/10/1752/162863/Physical-Activity-Is-Associated-With-Improved

Physical Activity Is Associated With Improved Glycemic ... Physical Activity is Associated with Improved Glycemic Outcomes in Newly Diagnosed Youth with Type 1 Diabetes: 4T Exercise Program. Showing 1/2: ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10654131/

Roadmap to Continuous Glucose Monitoring Adoption and ... In the pilot 4T study, youth in the 4T cohort had a 0.5% improvement in A1C 12 months after diabetes diagnosis compared with those in the ...

4. diabetesjournals.org diabetesjournals.org/spectrum/article/37/2/153/154159/Role-and-Perspective-of-Certified-Diabetes-Care

Role and Perspective of Certified Diabetes Care and ... In the 4T program, youth with new-onset type 1 diabetes are started on CGM in the first month of diagnosis and receive weekly remote CGM data ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1056872723002490

A mixed methods study of youth and parent experiences ... 4T Exercise assesses structured exercise education in youth with new onset type 1 diabetes (T1D) and their parents. •. 4T Exercise involved four tele-health ...

6. reporter.nih.gov reporter.nih.gov/search/NAbEa6pSg02bWH_EleN2wA/project-details/10771231

4T Study - NIH RePORTER The primary outcome will be to implement 4T education and care in newly diagnosed T1D patients to reduce the rise in HbA1c observed 6 months post-diagnosis. We ...

7. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2020.00360/full

Improving Clinical Outcomes in Newly Diagnosed Pediatric ... In this review, we will describe the 4T (teamwork, targets, technology, and tight control) approach to improving outcomes in youth with T1D.