An interventional study of AHEAD Program in Diabetes Mellitus, Type 1 Diabetes, sponsored by University of British Columbia. Recruiting at 1 site in United States. Open to participants aged 16 Years to 19 Years. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 306 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: AHEAD Program
Usual Care participants will receive diabetes care as currently being provided by their primary medical team.
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.
Hemoglobin A1c (HbA1c)
HbA1c laboratory measurement.
Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).
Plan to share: 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.
Supporting information: Sap
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of British Columbia