Diabetes Mellitus, Type 1 DiabetesAHEAD ProgramNCT07292558
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.
A study testing AHEAD Program in people with Diabetes Mellitus, Type 1 Diabetes, run by University of British Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 19 years
- Conditions the study is for
- Diabetes Mellitus, Type 1 Diabetes
- What is being tested?
- AHEAD Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to Dec 2028
- Phase
- Interventional
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 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16-19 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
Who cannot join
- Have had a pilot program AHEAD clinic visit
- Most recent Usual Care diabetes visit was with a current AHEAD provider
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's
Seattle, Washington, 98101
Beth Loots, MPH, MSW, 206-884-4488, beth.loots@seattlechildrens.org
Tian Westland, BS, 206-884-2528, tian.westland@seattlechildrens.org
About this study
Official title: Achieving Health in Emerging Adults With Diabetes (AHEAD) Study
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.
Read the detailed description
Many emerging adults with type 1 diabetes find it difficult to maintain their blood glucose levels within the recommended range most of the time. This can increase their risk for serious short- and long-term diabetes-related health problems. Managing diabetes becomes especially difficult during the transition from pediatric care to adult care when emerging adults are expected to manage their condition on their own.
The Achieving Health in Emerging Adults with Diabetes (AHEAD) Program was developed to support emerging adults with their transition to independence. It focuses on helping them build autonomy and competence needed to manage their diabetes independently. The program is based on self-determination theory and best practices for supporting successful health care transition to adult care.
In this study, 306 emerging adults will be randomly assigned to either the AHEAD Program or Usual Care arms. Participants will have 6 clinic visits and complete surveys prior to their clinic visits. AHEAD participants will receive support from a team of diabetes providers who have expertise in supporting emerging adults living with diabetes every three months. Usual Care participants will continue to receive the diabetes care as they do currently every three months.
Researchers will evaluate changes in glycemia and participant-reported outcomes (e.g., diabetes distress, transition readiness). The study will also assess the cost and cost-effectiveness of AHEAD, as well as factors related to its implementation.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes
- Being tested
- AHEAD Program
- Keywords
- Adolescent, Young adult, Emerging adult, Patient transfer, Health care transition, Transition readiness, Diabetes self-management, Diabetes distress
- 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.
AHEAD ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AHEAD Program | Experimental | 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. Receives: Behavioral: AHEAD Program |
| Usual Care | No intervention | Usual Care participants will receive diabetes care as currently being provided by their primary medical team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c)
HbA1c laboratory measurement.
Measured: 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
Continuous glucose monitor sensor glucose measurements that are in range (70-180 mg/dL), above range (>180 mg/dL), and below range (<70 mg/dL).
Measured: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Diabetes Distress
Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (score: 14-84).
Measured: 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
Diabetes-specific health care transition readiness will be assessed with the Readiness Assessment of Emerging Adults with Type 1 Diabetes tool. Higher scores (mean topic area score: 1-5) indicate higher diabetes-specific transition readiness.
Measured: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
General Health Care Transition Readiness
General health care transition readiness will be assessed with the Transition Readiness Assessment Questionnaire. Higher scores (mean topic area score: 1-5) indicate higher transition readiness.
Measured: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Diabetes Family Conflict
Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict (score: 19-57).
Measured: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Relatedness
Relatedness will be measured using the Health Care Climate Questionnaire. Higher scores indicate more supportive health care practitioner(s) (score: 15-105).
Measured: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Autonomy Treatment Self-Regulation Questionnaire
Autonomy will be measured using the Treatment Self-Regulation Questionnaire. Higher scores indicate higher autonomy (score: 15-105).
Measured: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Disordered eating
Disordered eating will be measured using the Disordered Eating Problem Survey - Revised. Higher scores indicate increase disordered eating behaviors (score: 0-80).
Measured: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Depression
Depression will be measured using the Patient Health Questionnaire-9. Higher scores indicate higher depression severity (score: 0-27).
Measured: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Generalized Anxiety
Anxiety will be measured using the Generalized Anxiety Disorder-7 questionnaire. Higher scores indicate higher severity of anxiety (score: 0-21).
Measured: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Social needs
Social needs will be measured using the social needs questionnaire. Endorsement of financial insecurity, food insecurity, transportation challenges, and housing insecurity, will indicate higher social need(s) (score: N/A).
Measured: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start15 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Breakthrough T1D, Seattle Children's Hospital, University of Washington, Kaiser Permanente
- Responsible party
- Principal investigator, Faisal Malik, University of British Columbia
- Investigators
- Faisal S Malik, MD, MSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292558
- Sponsor's protocol ID
- H25-03574
- Other IDs
- 4-SRA-2024-1580-M-B
- Acronym
- AHEAD Program
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.