Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05639088

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

AYA:

  • Type 1 Diabetes diagnosis for at least 1 year (as documented in medical record)
  • 16-22 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: SHIFT2

Educational Materials

Other

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

Primary outcomes

  1. Hemoglobin A1C (HbA1C)

    Time frame: 6 months

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

  2. Change in transition readiness

    Time frame: Baseline to 6 months

    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.

  3. Change in diabetes adherence

    Time frame: Baseline to 6 months

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

  4. Attendance at clinic visits

    Time frame: 6 months

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

Secondary outcomes

  1. HbA1C

    Time frame: 12 months

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

  2. Diabetes-related events

    Time frame: 12 months

    Number of diabetes-related events will be determined from medical records

  3. Change in transition readiness

    Time frame: Baseline to 12 months

    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.

  4. Change in diabetes adherence

    Time frame: Baseline to 12 months

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

  5. Attendance at clinic visits

    Time frame: 12 months

    Attendance at routine clinic visits will be determined from medical records.

  6. Change in diabetes support

    Time frame: Baseline to 12 months

    Diabetes support will be assessed using the Diabetes Social Support Questionnaire - Family Version (DDSQ-Family), which will be completed by AYAs.

  7. Change in Diabetes Distress

    Time frame: Baseline to 12 months

    Diabetes distress will be assessed using the Diabetes Distress Scale (DDS) for Type 1 Diabetes (DDS), which will be completed by both AYA and caregivers. AYA will complete specific versions corresponding to age (>18 or <18) and caregivers complete their own version of the measure.

  8. Change in Self Efficacy

    Time frame: Baseline to 12 months

    Self-efficacy will be measured using the Self-efficacy for Diabetes Self-Management scale (SEDSM), which will be completed by AYAs.

  9. Change in Quality of Life

    Time frame: Baseline to 12 months

    Quality of life will be measured using the T1D and Life (T1DAL), which will be completed by AYA and caregiver.

Other outcomes

  1. Transition Status

    Time frame: Baseline to 12 months

    AYAs that transition from pediatric to adult T1D care will be assessed.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: SHIFT2

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2022
Registry last updated
Apr 16, 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.

Related clinical trials

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