N/A
N=109
Improving Diabetes in Emerging Adulthood
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT04066959 ↗Enrolled (actual)
109
Serious AEs
29.4%
Results posted
May 2026
Primary outcome: Primary: Hemoglobin A1c — 9.6; 9.8; 8.5; 10.9 Percentage (%) of glycated hemoglobin — p=.219
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motivational Enhancement System (MES) (Behavioral); Question Prompt List (QPL) (Behavioral); Text Message Reminders (TXT) (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Wayne State University
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c |
9.6; 9.8; 8.5; 10.9; 9.6; 9.1 | .219 |
| SECONDARY Diabetes Management Scale |
69.81; 33.17; 72.19; 58.32; 67.12; 68.95 | .016 sig |
Summary
This project will test the efficacy of a multi-component behavioral intervention to improve metabolic control among older adolescents and emerging adults (16-21) with T1D, a group with chronic poor metabolic control. This intervention is grounded in self-determination theory which states that a youth who believes their diabetes management is self-directed, competent, and supported by others is more likely to consistently complete their diabetes self-care. This theory-driven intervention will be scalable to a variety of chronic illness contexts and the knowledge gained from this research will inform self-determination theory and different interventions targeting this population (currently there are no interventions that directly target emerging adults).
Eligibility Criteria
Inclusion:
- Age 16 years, 0 months - 25 years, 11 months
- Type 1 diabetes (T1D)
- HbA1c ≥7.5% currently and averaged over the previous 6 months
- Duration of diabetes ≥6 months
- English fluency, both verbal and written
- Cell phone access with texting capability
Exclusion:
- Psychosis (e.g., schizophrenia or bipolar disorder)
- Suicidal
- Developmental delay (moderate or severe mental retardation, or autism) or reading level below sixth grade
- The presence of another physical health condition that results in atypical diabetes management (e.g., cystic fibrosis)
Data sourced from ClinicalTrials.gov (NCT04066959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.