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Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes | Clinical Trials | Clareo Health

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Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes

Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2

NCT05639088•Virginia Commonwealth University

View on ClinicalTrials.gov

Summary

The purpose of this research study is to evaluate a transition preparation program designed for adolescents and young adults (AYAs) with type 1 diabetes (T1D). This transition program will support AYAs as they prepare to transition from pediatric to adult endocrinology medical care and will also include a caregiver. Results from this study will inform clinical recommendations regarding self-management best practices for AYAs with T1D prior to transitioning to adult medical care.

Detailed Description

Investigators will recruit adolescents and young adults ages 16-22 years with T1D and a parent/guardian. Families will participate in one of two 6-month treatments: 1) SHIFT2, engaging in monthly sessions with transition coaches providing education on diabetes management and healthcare transition, or 2) Enhanced treatment (TAU+), engaging in routine medical care and receiving monthly education (no coaches).

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•AYA:
•1. Type 1 Diabetes diagnosis for at least 1 year (as documented in medical record)
•2. 16-22 years old
•3. English speaking
•4. Children's Hospital of Richmond patient (Division of Pediatric Endocrinology)
•5. must have a caregiver willing to participate
•Caregiver:
•1. Age greater than 18 years
•2. Provides care to AYA and willing to participate

Exclusion Criteria

•AYA:
•1. Non-English speaking
•2. Significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability
•3. Hospitalization for depression, suicidal ideation or other psychiatric disorder within the past 12 months. Life time history of psychotic disorder
•4. Medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes.
•5. Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months.
•6. Another member of the household (other than the participating parent) is a participant or staff member on this study.
•7. Participation in another research study that may interfere with this study.
•8. Previous participation in the SHIFT pilot study
•Caregiver:
+5 more criteria

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Key Dates

Start Date

August 24, 2023

Primary Completion Date

June 30, 2026

Completion Date

December 31, 2026

Last Updated

December 15, 2025

Enrollment

109

ACTUAL participants

Conditions

Type 1 Diabetes

Interventions

Transition preparation program

BEHAVIORAL

Educational materials

OTHER

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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