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A Pilot Randomized Controlled Clinical Trial to Improve Adherence Barriers for Adolescents with Type 1 Diabetes - 09/07/26

Doi : 10.1016/j.jpeds.2026.115155 
Avani C. Modi, PhD 1, , Constance A. Mara, PhD 1, Holly O'Donnell, PhD 2, Matthew Schmidt, PhD 3, Jessica C. Kichler, CDCES, PhD, CPsych 4, Laura B. Smith, PhD 1, Sarah C. Westen, PhD 5, Laura Jacobsen, MD 6, Sarah D. Corathers, MD 7, Desireé N. Williford, PhD, MPH 1, Paige J. Trojanowski, PhD 2, Erin Flynn, BA 1, Emily R. Shaffer, BS 5, Bailey Tanner, BS 2, Kimberly A. Driscoll, PhD 5
1 Cincinnati Children's Hospital Medical Center, Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH 
2 Department of Pediatrics, Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, School of Medicine, Aurora, CO 
3 University of Georgia, College of Education, Athens, GA 
4 Department of Psychology, University of Windsor, Windsor, Ontario, Canada 
5 Department of Clinical and Health Psychology, University of Florida, Gainesville, FL 
6 Division of Pediatric Endocrinology, Department of Pediatrics, College of Medicine, University of Florida, Gainesville, FL 
7 Cincinnati Children's Hospital Medical Center, Division of Endocrinology, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH 

Reprint requests: Avani C. Modi, PhD, Cincinnati Children's Hospital Medical Center, Division of Behavioral Medicine and Clinical Psychology, Department of Pediatrics, University of Cincinnati College of Medicine, 3333 Burnet Ave, Cincinnati, OH 45229. Cincinnati Children's Hospital Medical Center Division of Behavioral Medicine and Clinical Psychology Department of Pediatrics University of Cincinnati College of Medicine 3333 Burnet Ave Cincinnati OH 45229

Abstract

Objective

To examine feasibility, acceptability, satisfaction, and preliminary efficacy of Diabetes Journey (DJ), a randomized controlled clinical trial for 12- to 17-year-old adolescents with type 1 diabetes (T1D).

Study design

Adolescents (n = 162; M age = 14.8 ± 1.6 years; 56.4% female) who exceeded the clinical cut-point on the Barriers to Diabetes Adherence (BDA) questionnaire were randomized to DJ (amusement park-themed web modules) or enhanced standard of care (ESC; T1D education toolkit). Data were collected across 9 months, including baseline, posttreatment, follow-up 1 (3 months posttreatment), and follow-up 2 (6 months posttreatment). Primary outcomes were acceptability, feasibility, satisfaction, and BDA Stress/Burnout and Time Pressure/Planning scores at follow-up 1. Secondary outcomes were glycosylated hemoglobin A1c and quality of life.

Results

The group × time interaction was significant for the BDA Stress/Burnout subscale. Compared with ESC, the DJ group demonstrated a modest but statistically significant reduction in Stress/Burnout ( b = −0.36, P < .05, 95% CI −0.72 to −0.01) and improvements in T1D quality of life ( b = 7.09, P = .03, 95% CI 0.59-13.59). No significant differences occurred between groups for time pressure/planning. Adolescents and caregivers in DJ reported greater satisfaction than those in ESC.

Conclusions

Our preliminary findings suggest that DJ had high acceptability, feasibility, and satisfaction. Adolescents randomized to DJ showed signals of reduced stress and burnout and improved quality of life at later follow-up, although these findings should be interpreted cautiously given attrition and the optional nature of the final follow-up assessment.

Trial registration

www.clinicaltrials.gov NCT04404556.

Il testo completo di questo articolo è disponibile in PDF.

Keywords : executive functioning, health-related quality of life, satisfaction, self-management, teenagers

Abbreviations : BDA, CCHMC, CEFIS, CGM, DJ, EF, ESC, GEE, HbA1c, MAR, QOL, RCT, T1D, T1DAL


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© 2026  The Author(s). Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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