Type 1 DiabetesSHIFT2NCT05639088
Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes
A study testing Transition preparation program and Educational materials in people with Type 1 Diabetes, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Transition preparation program and Educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2023to 11 Dec 2026
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- Caregiver:
- Age greater than 18 years
- Provides care to AYA and willing to participate
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2
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.
Read the 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).
- Conditions
- Type 1 Diabetes
- Being tested
- Transition preparation program, Educational materials
- Keywords
- Diabetes Management, 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.
Transition preparation programBehavioural
Also called SHIFT2
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.
Educational materialsOther
AYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C (HbA1C)
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (9)
HbA1C
HbA1C will be assessed using a standard assay from a routine blood draw or an at-home testing kit.
Measured: 12 months
Diabetes-related events
Number of diabetes-related events will be determined from medical records
Measured: 12 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.
Measured: Baseline to 12 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.
Measured: Baseline to 12 months
Attendance at clinic visits
Attendance at routine clinic visits will be determined from medical records.
Measured: 12 months
Change in diabetes support
Diabetes support will be assessed using the Diabetes Social Support Questionnaire - Family Version (DDSQ-Family), which will be completed by AYAs.
Measured: Baseline to 12 months
Change in Diabetes Distress
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.
Measured: Baseline to 12 months
Change in Self Efficacy
Self-efficacy will be measured using the Self-efficacy for Diabetes Self-Management scale (SEDSM), which will be completed by AYAs.
Measured: Baseline to 12 months
Change in Quality of Life
Quality of life will be measured using the T1D and Life (T1DAL), which will be completed by AYA and caregiver.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start24 Aug 2023
- Primary completion11 Jun 2026
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Caccavale, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639088
- Sponsor's protocol ID
- HM20024552
- Other IDs
- 1K23DK131368
- Acronym
- SHIFT2
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40529395Lalji 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.
PubMed 39382077
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2
- ClinicalTrials.gov ID
- NCT05639088
- Acronym / sponsor ID
- SHIFT2 / HM20024552
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes Management, Transition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 6 Dec 2022 (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 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: SHIFT2 | Experimental | Behavioral: Transition preparation programAdolescents 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. |
| Group B: TAU+/Control | Placebo comparator | Other: Educational materialsParticipants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| Transition preparation programAlso: SHIFT2AYA 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. | Behavioural | Group A: SHIFT2 |
| Educational materialsAYA and caregivers will receive educational materials regarding healthcare transition and diabetes management monthly for 6 months | Other | Group B: TAU+/Control |
Primary outcome
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
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.
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.
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.
9 secondary outcomes
HbA1C
Time frame: 12 months
Diabetes-related events
Time frame: 12 months
Change in transition readiness
Time frame: Baseline to 12 months
Change in diabetes adherence
Time frame: Baseline to 12 months
Attendance at clinic visits
Time frame: 12 months
Change in diabetes support
Time frame: Baseline to 12 months
Change in Diabetes Distress
Time frame: Baseline to 12 months
Change in Self Efficacy
Time frame: Baseline to 12 months
Change in Quality of Life
Time frame: Baseline to 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 7 Aug 2026.
- Derived from this study: PubMed 40529395Caccavale 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.
- Derived from this study: PubMed 39382077Lalji 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.
- 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. This study is not recruiting at the moment.
Laura Caccavale principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition preparation program and Educational materials in people with Type 1 Diabetes, run by Virginia Commonwealth University at 1 site 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 9 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (HbA1C) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05639088, which also lists 2 linked publications.
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 7 Aug 2026.