Type 1 DiabetesTCTNCT06172166
Transdisciplinary Care for Young Adults With Type 1 Diabetes
A study testing Transdisciplinary Care for Transition in people with Type 1 Diabetes, run by Nemours Children's Clinic at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Transdisciplinary Care for Transition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2024to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Nemours Children's Health, Florida
Orlando, Florida, 32827
Jessica Pierce, PhD, jessica.pierce@nemours.org
- Recruiting
Nemours Children's Health, Delaware
Wilmington, Delaware, 19803
Jessica Pierce, jessica.pierce@nemours.org
About this study
Official title: Transdisciplinary Care for Young Adults With Type 1 Diabetes Transitioning to Adult Healthcare
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Transdisciplinary Care for Transition
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdisciplinary Care for TransitionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Transdisciplinary Care for Transition | Experimental | Not described Receives: Behavioral: Transdisciplinary Care for Transition |
| Standard Clinical Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic level
HbA1c via mailed dried blood spot (DBS) kits
Measured: Baseline, 6-months, 12-months
Transition readiness
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.
Measured: Baseline, 6-months, 12-months
Transition outcomes
Healthcare Transition Outcomes Inventory (HCTOI): self-report of perceived level of success on multiple dimensions of healthcare transition outcomes
Measured: 6-months, 12-months
Time to First Adult Care Visit
Self-report and medical record review of the time between the last pediatric T1D care visit and the first adult T1D care visit
Measured: 6-months, 12-months
Continuity of care
Self-report and medical record review of the number of visits in adult T1D care since last study visit
Measured: 6-months, 12-months
Secondary outcomes (4)
Diabetes distress
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
Measured: Baseline, 6-months, 12-months
Acute care utilization
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
Measured: 6-months, 12-months
Level 3 (Severe) Hypoglycemia
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
Measured: 6-months, 12-months
Diabetic Ketoacidosis
Self-report and medical record review of the number of episodes of DKA since last study visit.
Measured: 6-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start17 Apr 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Jessica Pierce, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172166
- Sponsor's protocol ID
- JDRF_TCT
- Acronym
- TCT
- Status last verified
- Jun 2026
- First submitted
- 7 Dec 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdisciplinary Care for Young Adults With Type 1 Diabetes Transitioning to Adult Healthcare
- ClinicalTrials.gov ID
- NCT06172166
- Acronym / sponsor ID
- TCT / JDRF_TCT
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Juvenile Diabetes Research Foundation
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdisciplinary Care for Transition | Experimental | Behavioral: Transdisciplinary Care for Transition |
| Standard Clinical Care | No intervention | – |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdisciplinary Care for TransitionYoung 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. | Behavioural | Transdisciplinary Care for Transition |
Primary outcome
Glycemic level
Time frame: Baseline, 6-months, 12-months
HbA1c via mailed dried blood spot (DBS) kits
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.
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
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
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
4 secondary outcomes
Diabetes distress
Time frame: Baseline, 6-months, 12-months
Acute care utilization
Time frame: 6-months, 12-months
Level 3 (Severe) Hypoglycemia
Time frame: 6-months, 12-months
Diabetic Ketoacidosis
Time frame: 6-months, 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdisciplinary Care for Transition in people with Type 1 Diabetes, run by Nemours Children's Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Pierce, PhD (954-815-5481, jessica.pierce@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic level (time frame: Baseline, 6-months, 12-months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.