Recruiting

AHEAD Program

Sponsor:

University of British Columbia

Code:

NCT07292558

Conditions

Diabetes Mellitus, Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 16 - 19

Healthy Volunteers: Not accepted

Interventions

AHEAD Program

Study Details

Brief summary:

The goal of this study is to determine whether the Achieving Health in Emerging Adults with Diabetes (AHEAD) Program helps emerging adults with type 1 diabetes improve their blood glucose management during the transition from pediatric to adult care.

Participants will be randomized to receive Usual Care or the AHEAD Program, which provides tailored support to emerging adults to build autonomy and competence to facilitate independent diabetes management. Researchers will compare changes in glycemia and participant-reported outcomes between groups.

Conditions

Diabetes Mellitus, Type 1 Diabetes

Study ID

NCT07292558

Start date

Dec 15, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 16-19 years of age
2. Have had type 1 diabetes ≥ 12 months
3. Had a recent HbA1c ≥7.0%
4. Currently receive outpatient diabetes care at a Seattle Children's Hospital Diabetes Clinic located in Bellevue, Everett, Federal Way, or Seattle
5. Are able to complete written surveys
6. Will be able to receive clinical care in WA State for the next 2 years

Exclusion Criteria:

1. Have had a pilot program AHEAD clinic visit
2. Most recent Usual Care diabetes visit was with a current AHEAD provider

Study Design

Enrollment

306 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AHEAD Program

AHEAD participants will receive support from a team of diabetes providers with expertise in supporting older adolescents and young adults who will work to build autonomy and competence needed to manage diabetes independently.

no intervention: Usual Care

Usual Care participants will receive diabetes care as currently being provided by their primary medical team.

Interventions

AHEAD Program

Participants will complete self-assessments around health care transition readiness and mental health prior to an AHEAD clinic visit. Emerging adults will then received tailored clinical support based on their self-assessments and work to build their autonomy and competence to manage their diabetes and health care independently with the support of their AHEAD providers.

Primary outcome measure

  • Hemoglobin A1c (HbA1c) [ Time Frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months). ]

Central Contacts and Locations

Central contacts

Beth Loots, MPH, MSW

206-884-4488beth.loots@seattlechildrens.org

Faisal S Malik, MD, MSc

604-875-2117faisal.malik@bcchr.ca

Locations

Seattle Children's

Recruiting

Seattle, Washington, United States, 98101

Contacts

Beth Loots, MPH, MSW

206-884-4488beth.loots@seattlechildrens.org

Tian Westland, BS

206-884-2528tian.westland@seattlechildrens.org

Principal Investigator:

Catherine Pihoker, MD

More Information

Sponsor

University of British Columbia

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Keywords

  • Adolescent
  • Young adult
  • Emerging adult
  • Patient transfer
  • Health care transition
  • Transition readiness
  • Diabetes self-management
  • Diabetes distress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-12-30.