Transdisciplinary Care for Type 1 Diabetes
(TCT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The incidence of type 1 diabetes (T1D) is increasing globally with the most substantial increases occurring in the youngest age groups. A growing number of youths with T1D must therefore transition their healthcare from pediatric to adult T1D care settings as they approach young adulthood. This healthcare transition introduces many challenges because it coincides with a developmental period that is fraught with social, financial, residential, school/work and other changes/demands. Thus, it is not surprising that young adults (YA) with T1D are at risk for suboptimal glycemic levels, the development of diabetes-related complications, and psychosocial issues such as depression, anxiety, and disordered eating. Yet, few evidence-based interventions to assist YA with T1D with this complex healthcare transition exist.In this study, we are testing the feasibility, acceptability, and initial efficacy of a novel transdisciplinary model of care (Transdisciplinary Care for Transition; TCT) in which a diabetes nurse educator, psychologist, and transition navigator (case manager) co-deliver transitional care. TCT addresses the psychological and systems barriers to transition and aims to improve outcomes via better assessment of YA needs and resources, better cross-discipline and YA-provider communication, and better collaboration with YA to resolve problems that cross pediatric and adult healthcare settings.We will recruit 80 YA with T1D during their final visit in pediatric T1D specialty care to participate in a pilot randomized controlled trial during which we will randomize YA to a standard care control group (SCC) or to receive three TCT visits during the 6 months post discharge from pediatric T1D care. In SCC, participants will transition to adult T1D care as usual per their clinic's standard transition procedures.All study procedures can be completed remotely. This includes enrollment, study evaluations, and TCT visits for those randomized to TCT. Thus, we are recruiting individuals from across the United States.Aim 1: Examine the feasibility, acceptability, and fidelity of TCT in YA with T1D.Aim 2: Examine the preliminary efficacy of TCT versus SCC on YA HbA1c, transition readiness and success, and continuity of care and explore for an effect on diabetes distress and acute care utilization.
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.
Is Transdisciplinary Care for Type 1 Diabetes safe for humans?
What makes the Transdisciplinary Care for Transition treatment unique for Type 1 Diabetes?
The Transdisciplinary Care for Transition treatment is unique because it focuses on a coordinated approach involving multiple healthcare professionals to support young adults as they move from pediatric to adult diabetes care. This approach aims to address both medical and psychosocial challenges during this critical transition period, which is often marked by unstable blood sugar control and other difficulties.23678
What data supports the effectiveness of the treatment Transdisciplinary Care for Transition for Type 1 Diabetes?
Research shows that structured transition programs for young adults with type 1 diabetes can improve clinic attendance, glycemic control (blood sugar management), and quality of life. Additionally, multidisciplinary self-management interventions have been found effective in managing blood sugar levels in people with type 1 diabetes.1291011
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Transition Care
Participants receive transdisciplinary care for transition, including visits with a diabetes nurse educator, psychologist, and transition navigator
Standard Clinical Care
Participants transition to adult T1D care as per their clinic's standard procedures
Follow-up
Participants are monitored for transition readiness, glycemic levels, and continuity of care
What Are the Treatments Tested in This Trial?
Interventions
- Transdisciplinary Care for Transition
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nemours Children's Clinic
Lead Sponsor
Juvenile Diabetes Research Foundation
Collaborator
Albert Einstein College of Medicine
Collaborator