Transition Coordinator for Type 1 Diabetes

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: None

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to ease the transition from pediatric to adult care for young people with type 1 diabetes. It will evaluate whether a dedicated transition coordinator (a non-medical professional) improves health outcomes, patient satisfaction, and overall costs. One group of participants will receive regular support from a transition coordinator, while the other group will continue with their usual care. Individuals who have had type 1 diabetes for at least a year and are soon transitioning from pediatric to adult care in Alberta may be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance the transition process 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.

What prior data suggests that this transition intervention is safe?

Research has shown that programs assisting young people with type 1 diabetes (T1D) in transitioning from child to adult healthcare can be beneficial. A transition coordinator, unlike medical treatments, poses no safety concerns associated with new drugs. Instead, the coordinator aids patients in managing their care during this change.

Studies have found that a coordinator can ease the transition and improve patients' ability to manage their condition. This support reduces the stress and confusion often associated with switching healthcare providers. No reports indicate harm from using a transition coordinator, as their role is to guide and support, not to provide medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transition Coordinator for Type 1 Diabetes because it offers a new approach to helping young patients move from pediatric to adult care. Unlike standard care, which typically involves routine medical management without additional support, this approach provides personalized assistance through regular contact via phone, text, email, and social media. This method aims to ease the transition and improve continuity of care, addressing a critical period that can be challenging for patients. By providing consistent, tailored support, researchers hope to enhance patient outcomes and satisfaction during this crucial life stage.

What evidence suggests that this transition coordinator intervention is effective for Type 1 Diabetes?

This trial will evaluate the effectiveness of a Non-Medical Transition Coordinator for young people with type 1 diabetes (T1D) transitioning from pediatric to adult healthcare. Research has shown that transition coordinators can greatly assist in this process. One review found that having a support person during this change improved both health management and patient satisfaction. Young adults with T1D often struggle to manage their blood sugar levels, which can worsen during a busy transition. A transition coordinator helps keep things organized, leading to better health outcomes. Overall, evidence supports that these coordinators make the transition easier and healthier. ^{1 2 5 6 7}

Who Is on the Research Team?

Sonia Butalia, MD, MSc

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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 been diagnosed with Type 1 Diabetes for over a year.

English proficiency (for surveys)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12228552/

A Systematic Review of Interventions for the Transition to Adult ... Our study aimed to systematically review the literature and identify studies evaluating the effectiveness of interventions designed to improve transition ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06300047

NCT06300047 | Diabetes Transition Coordinator Study 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 ...

3. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-1-3-2024-5cb6e

Transition Coordinator for Type 1 Diabetes · Info for Participants 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949923224000333

Development of a transition program for emerging adults ... Emerging adults with type 1 diabetes (T1D) struggle with glycemic management that can be exacerbated by a disorganized transition process.

5. drc.bmj.com drc.bmj.com/content/13/4/e004921

Transition and transfer experiences and their correlates in ... Abstract. Introduction Emerging adults with chronic conditions, such as type 1 diabetes (T1D), face vulnerability during transition to adulthood ...

6. diabetesjournals.org diabetesjournals.org/spectrum/article/35/1/57/139034/Opportunities-for-Enhanced-Transition-of-Care

Opportunities for Enhanced Transition of Care Preparation for ... Opportunities for enhanced transition of care preparation for adolescents and emerging adults with type 1 diabetes: use of the READDY transition tool.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10360292/

Transition models of care for type 1 diabetes - PubMed Central A diverse range of models of care have been implemented to improve safety and quality of care during transition between paediatric and adult services.