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
| ISRCTN | ISRCTN71990442 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71990442 |
| Protocol serial number | 4-SRA-2024-1580-M-B |
| Sponsor | University of British Columbia |
| Funder | Breakthrough T1D |
- Submission date
- 18/11/2025
- Registration date
- 21/11/2025
- Last edited
- 20/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Many emerging adults with type 1 diabetes find it difficult to maintain their blood sugar 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 the skills, motivation, and confidence needed to manage their diabetes independently. The program is based on the self-determination theory and best practices for supporting successful healthcare transitions.
This study will test the effectiveness of the AHEAD Program.
Who can participate?
Emerging adults between the ages of 16-19 who have had type 1 diabetes for more than one year, a recent A1C ≥7.0%, can complete written surveys, and can receive care at Seattle Children’s Diabetes Clinics for the next 2 years.
What does the study involve?
Participants are randomly allocated into Usual Care or AHEAD. Participants will have 6 clinic visits and complete surveys around the time of their clinic visits. Usual Care participants will continue to receive the diabetes care they currently receive every three months. AHEAD participants will receive support from a team of diabetes providers who have expertise in supporting emerging adults living with diabetes.
What are the possible benefits and risks of participating?
The findings from this study may help us understand how to best support emerging adults with type 1 diabetes. By taking part in this study, there are no risks of physical injury or harm.
Where is the study run from?
University of British Columbia (Canada) and Seattle Children's Hospital (United States of America)
When is the study starting and how long is it expected to run for?
December 2025 to August 2029
Who is funding the study?
BreakthroughT1D
Who is the main contact?
Dr. Faisal Malik, faisal.malik@bcchr.ca
Contact information
Public, Scientific, Principal investigator
4480 Oak Street
Vancouver
V6H 3V4
Canada
 ORCID ID |
0000-0002-2543-4214 |
|---|---|
| Phone | 604-875-2117 |
| faisal.malik@bcchr.ca |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Parallel | |
| Purpose | Supportive care, Treatment | |
| Scientific title | Achieving Health in Emerging Adults with Diabetes (AHEAD) Program: In emerging adults with type 1 diabetes, does the AHEAD Program when compared to usual care improve glycemia, diabetes distress, and health care transition readiness? | |
| Study acronym | AHEAD Program | |
| Study objectives | 1. Determine the AHEAD Program’s effectiveness in improving diabetes outcomes in a pragmatic randomized controlled trial. HYPOTHESIS: The AHEAD Program will be associated with improved glycemia, reduced diabetes distress, and higher health care transition readiness compared to usual care. 2. Evaluate the impact of the AHEAD Program on self-determination theory constructs and their potential mediating role in improving diabetes outcomes. HYPOTHESIS 1: The AHEAD Program will improve autonomy, competence, and relatedness compared to usual care. HYPOTHESIS 2: Self-determination theory constructs will mediate the effect of the AHEAD Program on glycemia. 3. To evaluate the costs and cost-effectiveness of the AHEAD Program. HYPOTHESIS: The AHEAD Program will be cost-effective relative to usual care. | |
| Ethics approval(s) |
Approved 06/02/2025, Seattle Children’s Institutional Review Board (MS 818-RI PO Box 5371, Seattle, 98145, United States of America; +1 206-987-7804; IRB@seattlechildrens.org), ref: STUDY00005176 | |
| Health condition(s) or problem(s) studied | Type 1 diabetes in emerging adults | |
| Intervention | This is a pragmatic randomized controlled trial that will use a hybrid type 1 effectiveness-implementation study design. This study is a single-centre. Participants will be recruited through referrals or direct approach from Seattle Children’s diabetes clinics. After providing informed consent, participants will be randomized in a 1:1 ratio to either the Usual Care arm or the AHEAD arm. Randomization is performed using a computer-generated sequence within the REDCap randomization module. Participants in each arm will attend six diabetes clinic visits, scheduled approximately every three months. Before each clinic visit, participants will complete brief electronic surveys. Glycemia data will be collected as part of diabetes clinic visit. Usual Care participants will continue to receive diabetes care from their current medical team. AHEAD participants will continue to come to their usual medical facility for diabetes care but instead of receiving care from their current medical team, they will be seen by a new team of AHEAD providers during their clinic visit. The AHEAD team consists of providers who specialize in the care of emerging adults with diabetes and who focus on preparing and supporting participants with independence with their diabetes management. Total participant involvement is approximately 18 months, ending after completion of their sixth clinic visit and final surveys. Some participants may be in the study for longer than 18 months if they are unable to schedule clinic visits every 3 months because of participant scheduling conflicts or medical team capacity constraints. | |
| Intervention type | Mixed | |
| Primary outcome measure(s) |
Glycemia measured using hemoglobin A1c levels approximately every 3 months. | |
| Key secondary outcome measure(s) |
1. Time in range (70-180 mg/dL) will be measured using continuous glucose monitor sensor glucose values at 3, 6, 9, 12, 15, and 18 months | |
| Completion date | 31/08/2029 |
Eligibility
| Participant type(s) | Carer, Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 19 Years |
| Sex | All |
| Target sample size at registration | 306 |
| Key inclusion criteria | 1. 16-19 years-old 2. Have had type 1 diabetes≥ 12 months 3. Had a recent A1C ≥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 |
| Key exclusion criteria | 1. Have had a pilot program AHEAD clinic visit 2. Most recent Usual Care diabetes visit was with a current AHEAD provider. |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 01/06/2027 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Seattle
98105
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (OpenScience Framework: https://osf.io/). Shared data generated from this project will be available no later than the time of publication of the analyses examining the study's primary aims. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period. To address privacy and confidentiality concerns, sharing of data generated will be limited to de-identified data at the aggregate level and access, distribution, and reuse of the data be controlled by the study investigators. |
Editorial Notes
19/11/2025: Study’s existence confirmed by the Seattle Children’s Institutional Review Board, USA.
