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New program aims to ease diabetes care transition for teens

NCT ID NCT05639088

Knowledge-focused Sponsor: Virginia Commonwealth University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests a program called SHIFT2 that helps teens and young adults with type 1 diabetes prepare for the switch from pediatric to adult medical care. Participants work with a transition coach and receive messages to encourage self-management. The goal is to see if this support improves blood sugar levels, readiness for adult care, and clinic attendance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transition preparation program (SHIFT2)
What this could lead to
If successful, this program could help teens with type 1 diabetes manage their health better when moving from pediatric to adult care.
What could go wrong
This is a small, early-stage behavioral study (109 participants) testing a coaching program. Results may not apply to all teens, and the program may not improve blood sugar control or clinic attendance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

109 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. Non-English speaking 2. 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) 3. Another member of the home (not AYA) is a participant/staff member on current study 4. Participation in another research study that may interfere with current study 5. Previous participation in SHIFT pilot study

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes

Contacts and locations

Locations

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.