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

NCT05639088 | Active Not Recruiting

• 2 other identifiers: HM200245521K23DK131368
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

Diabetes Management; Transition

Outcome Measures

Primary Outcomes (4)

• Hemoglobin A1C (HbA1C)

  HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit

  6 months

• Change in transition readiness

  Transition readiness will be measured using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) scale, which will be completed by AYAs.

  Baseline to 6 months

• Change in diabetes adherence

  Diabetes adherence will be assessed using the Self-Care Inventory-Revised, which will be completed by both AYA and caregivers.

  Baseline to 6 months

• Attendance at clinic visits

  Attendance at routine clinic visits will be determined from medical records and will be assessed by the number of regularly scheduled visits attended.

  6 months

Secondary Outcomes (9)

• HbA1C

  12 months

• Diabetes-related events

  12 months

• Change in transition readiness

  Baseline to 12 months

• Change in diabetes adherence

  Baseline to 12 months

• Attendance at clinic visits

  12 months

Other Outcomes (1)

• Transition Status

  Baseline to 12 months

Study Arms (2)

Group A: SHIFT2

EXPERIMENTAL

Adolescents and young adults will engage in routine medical visits and attend 6 sessions (1x/month) focused on transition preparation and diabetes management with a transition coach and will receive bi-weekly messages during these 6-months that encourage self-management behaviors. Parents will attend 2 sessions (month 1 and 6) with a transition coach and will receive materials, complementing their child's lesson, 1x/month for months 2-5 that focus on transition their role and supporting their child's diabetes management.

Behavioral: Transition preparation program

Group B: TAU+/Control

PLACEBO COMPARATOR

Participants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management.

Other: Educational materials

Interventions

Transition preparation program BEHAVIORAL

AYA will participate in virtual or in-person sessions with a transition coach and receive bi-weekly messages that encourage self-management. Caregivers will attend a virtual or in-person session with a transition coach.

Also known as: SHIFT2

Group A: SHIFT2

Educational materials OTHER

AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months

Group B: TAU+/Control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• AYA:
• Non-English speaking
• 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
• Hospitalization for depression, suicidal ideation or other psychiatric disorder within the past 12 months. Life time history of psychotic disorder
• Medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes.
• Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months.
• Another member of the household (other than the participating parent) is a participant or staff member on this study.
• Participation in another research study that may interfere with this study.
• Previous participation in the SHIFT pilot study
• Caregiver:
• Non-English speaking
• Significant psychiatric, cognitive, developmental conditions that would impair their ability to complete assessments and/or engage in supporting the AYA with diabetes self-care behaviors (e.g., psychosis, intellectual disability)
• Another member of the home (not AYA) is a participant/staff member on current study
• Participation in another research study that may interfere with current study
• Previous participation in SHIFT pilot study

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

• Caccavale LJ, Streisand R, LaRose JG, Wickham EP 3rd, Hilliard ME, Thornton LM, Bean MK. A clinic-based healthcare transition preparation program for adolescents and young adults with type 1 diabetes: Study protocol for the SHIFT randomized clinical trial. Contemp Clin Trials Commun. 2025 May 27;46:101500. doi: 10.1016/j.conctc.2025.101500. eCollection 2025 Aug.

  PMID: 40529395 DERIVED

• Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.

  PMID: 39382077 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laura Caccavale

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 6, 2022
• Study Start: August 24, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)