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

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?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71990442

Enrollment

306

Registered

2025-11-21

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes in emerging adults Nutritional, Metabolic, Endocrine

Interventions

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 referral

Eligibility

Sex/Gender

All

Age

16 Years to 19 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Have had a pilot program AHEAD clinic visit 2. Most recent Usual Care diabetes visit was with a current AHEAD provider.

Design outcomes

Primary

Measure	Time frame
Glycemia measured using hemoglobin A1c levels approximately every 3 months.	—

Secondary

Measure	Time frame
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 2. Time below range (180 mg/dL) will be measured using continuous glucose monitor sensor glucose values at 3, 6, 9, 12, 15, and 18 months 4. Diabetes distress measured using Problem Areas in Diabetes - Teen and Parent of Teen Version approximately at 3, 6, 9, 12, 15, and 18 months 5. Depression measured using Patient Health Questionnaire – 9 at 3, 6, 9, 12, 15, and 18 months 6. Social needs measured using social needs/determinants of health questionnaire at 3, 6, 9, 12, 15, and 18 months 7. Health care transition readiness and competence measured using Readiness Assessment of Emerging Adults with Type 1 Diabetes tool and Transition Readiness Assessment Questionnaire at 3, 6, 9, 12, 15, and 18 months 8. Disordered eating measured using Disordered Eating Problem Survey – Revised at 3, 6, 9, 12, 15, and 18 months 9. Anxiety measured using Generalized Anxiety Disorder – 7 survey at 3, 6, 9, 12, 15, and 18 months 10. Diabetes self-management measured using Self-Care Inventory-Updated questionnaire at 3, 6, 9, 12, 15, and 18 months 11. Diabetes family conflict measured using Diabetes Family Conflict Scale at 3, 6, 9, 12, 15, and 18 months 12. Autonomy measured using Treatment Self-Regulation Questionnaire at 3, 6, 9, 12, 15, and 18 months 13. Relatedness measured using Health Care Climate Questionnaire at 3, 6, 9, 12, 15, and 18 months	—

Measure

Time frame

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 2. Time below range (180 mg/dL) will be measured using continuous glucose monitor sensor glucose values at 3, 6, 9, 12, 15, and 18 months 4. Diabetes distress measured using Problem Areas in Diabetes - Teen and Parent of Teen Version approximately at 3, 6, 9, 12, 15, and 18 months 5. Depression measured using Patient Health Questionnaire – 9 at 3, 6, 9, 12, 15, and 18 months 6. Social needs measured using social needs/determinants of health questionnaire at 3, 6, 9, 12, 15, and 18 months 7. Health care transition readiness and competence measured using Readiness Assessment of Emerging Adults with Type 1 Diabetes tool and Transition Readiness Assessment Questionnaire at 3, 6, 9, 12, 15, and 18 months 8. Disordered eating measured using Disordered Eating Problem Survey – Revised at 3, 6, 9, 12, 15, and 18 months 9. Anxiety measured using Generalized Anxiety Disorder – 7 survey at 3, 6, 9, 12, 15, and 18 months 10. Diabetes self-management measured using Self-Care Inventory-Updated questionnaire at 3, 6, 9, 12, 15, and 18 months 11. Diabetes family conflict measured using Diabetes Family Conflict Scale at 3, 6, 9, 12, 15, and 18 months 12. Autonomy measured using Treatment Self-Regulation Questionnaire at 3, 6, 9, 12, 15, and 18 months 13. Relatedness measured using Health Care Climate Questionnaire at 3, 6, 9, 12, 15, and 18 months

—

Countries

United States of America

Contacts

Public ContactFaisal Malik

faisal.malik@bcchr.ca604-875-2117

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026