Transdisciplinary Care for Type 1 Diabetes

(TCT Trial)

Recruiting at 2 trial locations

Overseen By Nicole Morales

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Developmental disability, Chronic illness, others

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

Compensation: Varies

Number of Visits: 3

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to assist young adults with type 1 diabetes as they transition from pediatric to adult healthcare. The goal is to determine if a team-based care model, involving a nurse, psychologist, and case manager, can better support patients during this challenging time, improving their health and well-being. This transdisciplinary care model aims to provide comprehensive support. Participants will be randomly assigned to either receive this new care model or continue with standard care. The trial suits those who have had type 1 diabetes for at least six months and are about to leave pediatric care. All activities can be done remotely, allowing participants from anywhere in the U.S. to join. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could transform diabetes management.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this transdisciplinary care model is safe for young adults with type 1 diabetes?

Research has shown that team-based care for young adults with type 1 diabetes (T1D) is generally safe. This care involves a team comprising a diabetes nurse educator, a psychologist, and a case manager. Together, they assist young adults in transitioning from pediatric to adult healthcare.

Studies have not reported any major safety issues with this team-based care. Instead, it focuses on improving communication and support to manage diabetes and related challenges. Although no negative effects are directly mentioned, the team approach aims to enhance overall health and well-being without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transdisciplinary Care for Transition approach because it offers a holistic method to managing Type 1 Diabetes, focusing on seamless collaboration among various healthcare specialists. Unlike traditional care, which often relies on individual doctors addressing separate aspects of the disease, this method integrates expertise from endocrinologists, dietitians, psychologists, and other specialists. The goal is to provide a more comprehensive and coordinated care plan that addresses the medical, nutritional, and psychological needs of patients as they transition to adult care. This could lead to improved health outcomes and a smoother transition for young adults managing their diabetes.

What evidence suggests that this transdisciplinary care model is effective for transitioning young adults with type 1 diabetes?

This trial will compare Transdisciplinary Care for Transition with Standard Clinical Care for young adults with type 1 diabetes (T1D). Research has shown that when a team of healthcare professionals collaborates, it can assist young adults with T1D in transitioning from child to adult care. Studies have found that this team-based care leads to better health outcomes, such as improved blood sugar control. It also prepares young adults for the transition, reducing breaks in care and the risk of health issues. This approach encourages young adults to remain engaged with their healthcare, ensuring they continue their treatment as they enter adult care. Overall, early evidence suggests this method could help young adults with T1D manage their health more effectively. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for young adults with Type 1 Diabetes who are fluent in English and transitioning from pediatric to adult diabetes care. They must have been diagnosed at least 6 months ago and be approaching their last scheduled pediatric diabetes care visit. Those with certain chronic illnesses or developmental disabilities that limit independence cannot participate.

Inclusion Criteria

Approaching discharge from pediatric T1D specialty care as defined by the young adult's pediatric T1D provider verifies that the young adult's upcoming scheduled pediatric T1D specialty care visit is the young adult's last planned pediatric T1D specialty care visit

English fluency

I have been diagnosed with Type 1 Diabetes for over 6 months.

Exclusion Criteria

Developmental disability limiting independent living

I have a chronic illness, but it's not celiac, thyroid issues, kidney problems, high blood pressure, or controlled asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transition Care

Participants receive transdisciplinary care for transition, including visits with a diabetes nurse educator, psychologist, and transition navigator

6 months

3 visits (remote)

Standard Clinical Care

Participants transition to adult T1D care as per their clinic's standard procedures

6 months

Follow-up

Participants are monitored for transition readiness, glycemic levels, and continuity of care

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Transdisciplinary Care for Transition

Trial Overview The study tests a new 'Transdisciplinary Care for Transition' (TCT) model involving a nurse educator, psychologist, and case manager to help manage the healthcare transition. Participants will either receive standard care or three TCT visits over six months after leaving pediatric care.

How Is the Trial Designed?

Group I: Transdisciplinary Care for Transition Experimental Treatment 1 Intervention

Group II: Standard Clinical Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

Published Research Related to This Trial

Transitioning from pediatric to adult care for Type 1 diabetes (T1D) often leads to worsened glycemic control, highlighting the need for better understanding and implementation of transition care practices among healthcare providers.

Current transition of care interventions show promise in improving clinic attendance and reducing hospitalizations for adolescents and young adults with T1D, but more research is needed to optimize these models and address barriers related to race, sex, and insurance status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition From Pediatric to Adult Care for Individuals With Type 1 Diabetes: Opportunities and Challenges. D'Amico, RP., Pian, TM., Buschur, EO.[2023]

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]

Structured transition education programs for Type 1 Diabetes showed improvements in glycaemic control and psychological well-being compared to usual care, indicating their potential effectiveness in supporting emerging adults during the transition to self-management.

While multidisciplinary team support and telehealth models reported some benefits in patient engagement and self-management adherence, the overall health outcomes were mixed, highlighting the need for further research on the implementation and acceptability of these transition care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition models of care for type 1 diabetes: a systematic review. Zurynski, Y., Carrigan, A., Meulenbroeks, I., et al.[2023]

A survey of 53 adult diabetes care providers revealed that less than half were familiar with the American Diabetes Association's guidelines on transition care for young adults with Type 1 diabetes, indicating a knowledge gap in best practices.

Despite a strong interest in improving transition care, significant barriers exist, such as inadequate preparation from pediatric teams and limited access to psychosocial services, which hinder effective implementation of transition strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. Michaud, S., Dasgupta, K., Bell, L., et al.[2019]

A coaching intervention for 10 patients with type 1 diabetes led to a significant reduction in HbA1c levels from 8.0% to 7.78% after 3 months, indicating improved blood sugar control.

The frequency of self-monitoring of blood glucose (SMBG) also increased significantly, from a median of 16.5 tests per week at baseline to 29.0 tests at 3 months, suggesting enhanced self-management among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 diabetes mellitus: can coaching improve health outcomes? Magalhães, TPC., Fóscolo, RB., Soares, AN., et al.[2023]

Multidisciplinary self-management interventions for individuals with type 1 diabetes are designed to improve glycemic control, primarily measured by glycated hemoglobin levels, which is crucial for managing the disease effectively.

The review will also assess the impact of these interventions on quality of life and the frequency of adverse events like hypoglycemia and diabetic ketoacidosis, ensuring a comprehensive understanding of their overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of multidisciplinary led self-management interventions on glycaemic control in people with type 1 diabetes: a systematic review protocol. West, S., Ramis, MA., Burgess, L., 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]

A structured transition program for young adults with type 1 diabetes significantly improved clinic attendance and satisfaction with care during the 18-month intervention, with participants attending an average of 4.1 visits compared to 3.6 in standard care.

While the program reduced diabetes-related distress and showed a trend toward better glycemic control (HbA1c levels), these benefits did not persist 12 months after the intervention ended, indicating the need for ongoing support beyond the initial program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing the Gap: Results of the Multicenter Canadian Randomized Controlled Trial of Structured Transition in Young Adults With Type 1 Diabetes. Spaic, T., Robinson, T., Goldbloom, E., et al.[2022]

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]

Patients with type 2 diabetes view coordinated multidisciplinary team care positively, believing that managing diabetes requires more than one healthcare provider due to its complexity.

Participants expressed a desire for a more comprehensive approach that includes support for exercise and addressing socioeconomic challenges, indicating areas for improvement in current diabetes care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary coordinated care for Type 2 diabetes: A qualitative analysis of patient perspectives. Berkowitz, SA., Eisenstat, SA., Barnard, LS., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40915317/

Transdisciplinary care intervention for young adults with ... We will collect healthcare utilization data, patient-reported outcomes, and glycemic levels at baseline and 6 and 12 months later. We aim to ...

2. breakthrought1d.org breakthrought1d.org/grants/united-states/florida/transdisciplinary-care-for-young-adults-with-type-1-diabetes-transitioning-to-adult-healthcare/

Transdisciplinary Care for Young Adults with Type 1 ... We expect that young adults who receive the transdisciplinary care for transition (TCT) intervention will show improvements in HbA1c, transition readiness and ...

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

Development of a transition program for emerging adults ... A formal transition program can help prevent gaps in care, improve disease self-management skills, decrease disease burden, and reduce diabetes complications.

4. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09644-9

Transition models of care for type 1 diabetes: a systematic ... Four MDT transition care models reported improved health outcomes, and improved engagement with health services, however, three studies reported ...

5. papers.ssrn.com papers.ssrn.com/sol3/Delivery.cfm/0771d201-3b44-444a-bf8d-ddde66c72208-MECA.pdf?abstractid=5251978

Preprint not peer reviewed Transdisciplinary care intervention for young adults with type 1 diabetes transitioning to adult ... coordinator are effective in improving transition outcomes ...

6. researchgate.net researchgate.net/publication/395314367_Transdisciplinary_care_intervention_for_young_adults_with_type_1_diabetes_transitioning_to_adult_healthcare_Rationale_and_trial_design

Transdisciplinary care intervention for young adults with ... Transdisciplinary care intervention for young adults with type 1 diabetes transitioning to adult healthcare: Rationale and trial design.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8603126/

Transdisciplinary Care for Adolescents With Type 1 Diabetes Only 17% of adolescents with type 1 diabetes achieve glycemic control targets (1), and many are at risk for psychological concerns (e.g., depression, ...