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NCT06172166Recruiting

Transdisciplinary Care for Young Adults With Type 1 Diabetes

Transdisciplinary Care for Young Adults With Type 1 Diabetes Transitioning to Adult Healthcare

Source: ClinicalTrials.gov · Last updated 29 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
7 Dec 2023
Start date
17 Apr 2024
Primary completion date
30 Apr 2028
Lead sponsor
Nemours Children's Clinic
NCT number
NCT06172166

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 17 Apr 2024 to the primary completion date, 30 Apr 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Another systemic chronic medical illness except celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma

Other

  • Developmental disability limiting independent living
    • We are recruiting eligible individuals through Nemours and remotely.

Who the study is looking for

  • Diagnosed with type 1 diabetes for at least 6 months
  • Approaching their last visit with their pediatric type 1 diabetes healthcare provider. They will have their final visit with their pediatric T1D provider within about a month of enrollment in the study.
  • English fluency

Age in the registry: 17 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nemours Children's Health, Florida
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Nemours Children's Health, Delaware
Coordinator of this site? Confirm its status
WilmingtonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.