Transition Coordinator for Type 1 Diabetes

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

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

Compensation: Varies

Number of Visits: 3

324 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.

What data supports the effectiveness of the treatment Non-Medical Transition Coordinator for Type 1 Diabetes?

Research highlights the importance of a smooth transition from pediatric to adult care for patients with type 1 diabetes, emphasizing that a well-coordinated transition can lead to better long-term health outcomes. The involvement of a transition coordinator can help manage the challenges of this process, such as unstable metabolic control and the need for continuous care, by ensuring effective communication and planning between pediatric and adult healthcare providers. ^{1 2 3 4 5}

Is the Transition Coordinator for Type 1 Diabetes safe for humans?

The research articles focus on the experiences and outcomes of transition programs for young adults with type 1 diabetes, but they do not provide specific safety data for the Transition Coordinator treatment. ^{6 7 8 9 10}

How is the Non-Medical Transition Coordinator treatment unique for type 1 diabetes?

The Non-Medical Transition Coordinator is unique because it focuses on helping young adults with type 1 diabetes smoothly transition from pediatric to adult care, addressing challenges like unstable metabolic control and social factors, rather than directly managing blood sugar levels like traditional medical treatments. ^{1 2 3 5 11}

What is the purpose of this trial?

The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis. The 3 main aims are: 1. To assess the effects of our transition intervention on clinical and patient-reported outcomes. 2. To implement the transition intervention and evaluate the implementation outcomes. 3. To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care. Researchers will compare a pre-intervention cohort to evaluate the impact of the transition coordinator intervention.

Research Team

Sonia Butalia, MD, MSc

Principal Investigator

University of Calgary

Eligibility Criteria

This study is for young people with Type 1 Diabetes who are transitioning from pediatric to adult healthcare services. Participants will be compared to a group that did not have the transition intervention.

Inclusion Criteria

I am moving from child to adult healthcare in Alberta soon.

I have seen my child's hormone doctor in the past year.

I have been diagnosed with Type 1 Diabetes for over a year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Transition

Participants meet with a transition coordinator to prepare for the transition from pediatric to adult care

1 year

1 visit (in-person or virtual)

Transition

Participants receive support from a transition coordinator during the transition from pediatric to adult care

12 months

Contact every 2 months via phone, text, email, or social media

Follow-up

Participants are monitored for clinical and patient-reported outcomes after the transition

18 months

Treatment Details

Interventions

• Non-Medical Transition Coordinator

Trial Overview The trial tests if having a 'Transition Coordinator' helps improve health and patient satisfaction during the shift from child to adult diabetes care, including looking at cost-effectiveness.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Patients in this arm receive access to and support from a Transition coordinator who will meet with them prior to transition from pediatric to adult care and follow up with them every 2 months throughout the first year of their transition period utilizing phone, text, email, social media.

Group II: Usual Care Group Active Control 1 Intervention

No intervention group used as a control leading into the intervention for comparative analysis. Patients in this arm receive care as usual with no changes and are not aware of the intervention group.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Transitioning from pediatric to adult care for patients with chronic diseases like type 1 diabetes is crucial for maintaining stable metabolic control and ensuring long-term health outcomes.

Factors such as social environment and other health conditions can complicate this transition, highlighting the need for tailored support and strategies to promote effective self-management of diabetes during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diabetes mellitus at the interface between pediatric and adult medicine]. Gallwitz, B., Neu, A.[2019]

Transitioning from pediatric to adult care for patients with type 1 diabetes is often difficult, with unstable metabolic control and the need to address psychiatric and social factors during this period.

Establishing an interdisciplinary transfer clinic and ensuring close collaboration between pediatricians and adult endocrinologists can significantly improve the success of this transition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Building bridges during transition of patients with type 1 diabetes. Adult medical and pediatric point of views]. Busse-Voigt, FP., Kiess, W., Stumvoll, M., et al.[2021]

There is a significant lack of empirical research on health care transition (HCT) outcomes in type 1 diabetes (T1D), which is complicated by methodological issues, highlighting the need for a more comprehensive approach.

The authors propose an expanded model for HCT outcomes that includes multiple stakeholder perspectives, which could lead to the development of a standardized index to better assess HCT readiness and improve the design of future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Review: Advancing Research on the Transition to Adult Care for Type 1 Diabetes. Pierce, JS., Wysocki, T.[2022]

The PATHWAY program is the first structured transition initiative for young individuals with Type 1 diabetes in Delhi, India, designed to improve their transition from pediatric to adult care through a series of educational and behavioral sessions over 15 months.

The program includes a unique 'overlap period' where patients alternate visits between pediatric and adult providers, aiming to enhance self-management and clinic attendance, which is crucial for better health outcomes in emerging adults with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and design of the first structured clinic-based program in lower resource settings to transition emerging adults with type 1 diabetes from pediatric to adult care. Cristello Sarteau, A., Peerzada, A., Goyal, A., et al.[2023]

A structured transition program for young adults with type 1 diabetes who had previously lapsed in care effectively improved their hemoglobin A1C levels and reduced severe hypoglycemia and emergency department visits over 12 months.

Despite these improvements in clinical outcomes, participants who had lapsed care continued to experience elevated depressive symptoms and a decline in life satisfaction, highlighting ongoing psychosocial challenges in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Psychosocial Outcomes of a Structured Transition Program Among Young Adults With Type 1 Diabetes. Pyatak, EA., Sequeira, PA., Vigen, CL., et al.[2019]

A survey of 602 young adults with type 1 diabetes revealed that many in the pediatric group (64%) stayed in pediatric care due to emotional attachment, highlighting the importance of emotional support during the transition to adult care.

Despite receiving counseling on diabetes management, less than half of the participants discussed reproductive health, indicating a gap in comprehensive care that needs to be addressed to improve transition outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Care Transition Preparation and Experiences in a U.S. National Sample of Young Adults With Type 1 Diabetes. Garvey, KC., Foster, NC., Agarwal, S., et al.[2022]

This study evaluates a structured transition program for adolescents with Type 1 diabetes (T1D) to enhance their self-management and empowerment, involving 140 participants aged 16 from two pediatric diabetes clinics.

The effectiveness of this program will be assessed through various outcomes, including patient empowerment and diabetes management, over a period extending to 18.5 years, providing valuable insights into transitional care models for chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol. Brorsson, AL., Bratt, EL., Moons, P., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Diabetes mellitus at the interface between pediatric and adult medicine]. [2019]

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

[Building bridges during transition of patients with type 1 diabetes. Adult medical and pediatric point of views]. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Continuity of care in the transition from child to adult diabetes services: a realistic evaluation study. [2022]

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

Topical Review: Advancing Research on the Transition to Adult Care for Type 1 Diabetes. [2022]

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

Development and design of the first structured clinic-based program in lower resource settings to transition emerging adults with type 1 diabetes from pediatric to adult care. [2023]

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

Clinical and Psychosocial Outcomes of a Structured Transition Program Among Young Adults With Type 1 Diabetes. [2019]

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

Health Care Transition Preparation and Experiences in a U.S. National Sample of Young Adults With Type 1 Diabetes. [2022]

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

Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Experiences of health care transition voiced by young adults with type 1 diabetes: a qualitative study. [2022]

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

Health Care Transition in Young Adults With Type 1 Diabetes: Perspectives of Adult Endocrinologists in the U.S. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Experiences of transition to adulthood and transfer to adult care in young adults with type 1 diabetes: A qualitative study. [2023]