Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06172166

Transdisciplinary Care for Young Adults With Type 1 Diabetes

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Health, Delaware, Wilmington, Delaware, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Another systemic chronic medical illness except celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma
  • Developmental disability limiting independent living

We are recruiting eligible individuals through Nemours and remotely.

Treatment and study plan

Transdisciplinary Care for Transition

Behavioral

Young adults with T1D will participate in three visits during which they will see a diabetes nurse educator, psychologist, and transition navigator/social worker who will co-deliver care. TCT Visits 1 and 2 will be before the first adult diabetes healthcare visit, during trial months 1 and 2 respectively. These visits will focus on improving transition readiness, establishing care with an adult T1D specialist, and navigating psychosocial barriers to successful transition. TCT Visit 3 will occur after the first adult T1D healthcare visit, within one month of the first adult T1D care visit or during trial month 7 if the visit has not yet occurred. TCT Visit 3 will focus on overcoming barriers to satisfactory adult T1D healthcare.

Primary outcomes

  1. Glycemic level

    Time frame: Baseline, 6-months, 12-months

    HbA1c via mailed dried blood spot (DBS) kits

  2. Transition readiness

    Time frame: Baseline, 6-months, 12-months

    Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY): self-report of confidence of T1D health knowledge and skills needed for transition.

  3. Transition outcomes

    Time frame: 6-months, 12-months

    Healthcare Transition Outcomes Inventory (HCTOI): self-report of perceived level of success on multiple dimensions of healthcare transition outcomes

  4. Time to First Adult Care Visit

    Time frame: 6-months, 12-months

    Self-report and medical record review of the time between the last pediatric T1D care visit and the first adult T1D care visit

  5. Continuity of care

    Time frame: 6-months, 12-months

    Self-report and medical record review of the number of visits in adult T1D care since last study visit

Secondary outcomes

  1. Diabetes distress

    Time frame: Baseline, 6-months, 12-months

    Diabetes Distress Scale for Adults with T1D (T1-DDS): self-report of emotional distress associated with the ongoing worries, burdens, and concerns of living with T1D

  2. Acute care utilization

    Time frame: 6-months, 12-months

    Self-report and medical record review of the number of T1D-related emergency department visits, urgent care visits, and hospital admissions (and reason why) since last study visit

  3. Level 3 (Severe) Hypoglycemia

    Time frame: 6-months, 12-months

    Self-report and medical record review of the number of severe hypoglycemic events characterized by altered mental status and/or physical status requiring assistance since last study visit

  4. Diabetic Ketoacidosis

    Time frame: 6-months, 12-months

    Self-report and medical record review of the number of episodes of DKA since last study visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Pierce, PhD

CONTACT

[email protected]

954-815-5481

Nicole Morales

CONTACT

[email protected]

407-632-5559

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • Albert Einstein College of Medicine
  • Juvenile Diabetes Research Foundation

Registry information

Official study title

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

Acronym: TCT

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 15, 2023
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.