AHEAD Program to support 16–19-year-olds with type 1 diabetes as they move to adult care

Achieving Health in Emerging Adults With Diabetes (AHEAD) Study

This project will test whether the AHEAD Program helps 16–19-year-olds with type 1 diabetes keep their blood sugar under better control while moving from pediatric to adult care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 306 (estimated)
• Ages: 16 Years to 19 Years
• Sex: All
• Sponsor: University of British Columbia (other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT07292558 on ClinicalTrials.gov

What this trial studies

This randomized study will enroll 306 emerging adults with type 1 diabetes (ages 16–19) and a recent HbA1c ≥7.0% who receive care at Seattle Children’s clinics. Participants are randomly assigned to the AHEAD Program — a tailored, theory-based transition support intervention delivered every three months — or to usual care, with six clinic visits and surveys completed before visits. Primary outcomes include changes in glycemia and participant-reported measures such as diabetes distress and transition readiness; the study also measures cost and cost-effectiveness. AHEAD focuses on building autonomy and competence through coordinated team support to promote independent diabetes self-management.

Who should consider this trial

Good fit: Ideal candidates are 16–19-year-olds with type 1 diabetes for at least 12 months, a recent HbA1c ≥7.0%, currently receiving outpatient diabetes care at a Seattle Children’s Diabetes Clinic, able to complete written surveys, and able to receive clinical care in Washington State for the next two years.

Not a fit: Patients with well-controlled blood sugar (HbA1c below 7.0%), those who already had an AHEAD pilot visit or whose most recent visit was with a current AHEAD provider, and people who cannot attend Seattle Children’s clinics or remain in Washington State for two years are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, AHEAD could help young people gain independence, lower average blood sugar, reduce diabetes-related distress, and make the move to adult care smoother, potentially lowering long-term complications.

How similar studies have performed: Other transition-support programs grounded in self-determination theory have shown improvements in transition readiness and self-management in smaller or nonrandomized studies, but large randomized evidence for clinic-delivered transition programs remains limited.

Eligibility criteria

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

Where this trial is running

Seattle, Washington

• Seattle Children's — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Faisal S Malik, MD, MSc — University of British Columbia
• Study coordinator: Beth Loots, MPH, MSW

Conditions: Diabetes Mellitus, Type 1 Diabetes, Adolescent, Young adult, Emerging adult, Patient transfer, Health care transition, Transition readiness, Diabetes self-management