P-159: From pilot to implementation: the evolution of a digital platform for routine pediatric type 1 diabetes care
S Amed, M Sweeney Magee, K Charbonneau, S Muralidharan, T Tang, G Dominguez-MenendezAbstract
Introduction
Despite the promise of digital health tools for pediatric type 1 diabetes (T1D), few successfully transition into routine clinical care. This gap demands a validation pathway: pilot evidence to inform design, trials to assess impact, and commercialization to support long-term access.
Objectives
To present the evolution of an integrated digital platform for personalized, proactive pediatric T1D care, from the TrustSphere pilot study to an implementation-effectiveness trial, and commercialization via Haibu Health, a spin-off company.
Methods
We conducted the TrustSphere pilot (n=19 families, 6-months) to assess usability, engagement, and clinical value. Building on these findings, we launched a type 2 hybrid implementation-effectiveness trial in a tertiary pediatric T1D clinic. The trial evaluates glycemic, self-management, and implementation, using the Implementation Research Logic Model, RE-AIM, and Proctor-defined outcomes.
Results
The TrustSphere pilot demonstrated strong usability (System Usability Scale 71.9), high caregiver engagement (83% retention; 89% use before clinic visits), and clinical value (90% clinician satisfaction; 56% of caregivers reported improved care personalization). Qualitative findings revealed three success factors: convenience, caregiver empowerment, and healthcare team engagement. Caregivers identified unmet needs for better between-visit support and closer workflow alignment. These findings informed the new digital platform’s features, implementation strategy, and integration architecture. Trial enrollment is ongoing.
Conclusions
This new digital platform moves beyond feasibility toward evaluation as a model for integrating digital tools into pediatric T1D care. The trial will generate evidence on clinical effectiveness, implementation, and readiness for scale-up. Commercialization through Haibu Health supports sustained access beyond research settings and broader implementation across pediatric diabetes care.