Achieving Health in Emerging Adults With Diabetes (AHEAD) Program: A Clinical Trial Designed to Understand if Participation in a Clinical Program Developed Specifically to Support Emerging Adults With Type 1 Diabetes Leads to Improved Diabetes Outcomes.
AHEAD Program
2 other identifiers
interventional
306
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2025
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedFirst Posted
Study publicly available on registry
December 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
December 30, 2025
December 1, 2025
3 years
November 24, 2025
December 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c (HbA1c)
HbA1c laboratory measurement.
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Secondary Outcomes (11)
Time In Ranges
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Diabetes Distress
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Diabetes-Specific Health Care Transition Readiness
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
General Health Care Transition Readiness
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Diabetes Family Conflict
From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
- +6 more secondary outcomes
Study Arms (2)
AHEAD Program
EXPERIMENTALAHEAD 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.
Usual Care
NO INTERVENTIONUsual Care participants will receive diabetes care as currently being provided by their primary medical team.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years of age
- Have had type 1 diabetes ≥ 12 months
- Had a recent HbA1c ≥7.0%
- Currently receive outpatient diabetes care at a Seattle Children's Hospital Diabetes Clinic located in Bellevue, Everett, Federal Way, or Seattle
- Are able to complete written surveys
- Will be able to receive clinical care in WA State for the next 2 years
You may not qualify if:
- Have had a pilot program AHEAD clinic visit
- Most recent Usual Care diabetes visit was with a current AHEAD provider
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Breakthrough T1Dcollaborator
- Seattle Children's Hospitalcollaborator
- University of Washingtoncollaborator
- Kaiser Permanentecollaborator
Study Sites (1)
Seattle Children's
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Faisal S Malik, MD, MSc
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 24, 2025
First Posted
December 18, 2025
Study Start
December 15, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
December 30, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Data requests can be submitted at the end of the funding period and the data will be made accessible for up to 10 years.
- Access Criteria
- Access, distribution, and reuse of the data will require approval from study investigators.
The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (OpenScience Framework: https://osf.io/). To address privacy and confidentiality concerns, sharing of data generated will be limited to de-identified data at the aggregate level.