Development and Preclinical Validation of DiaBuddy, a Point-of-Care Decision Support Tool for Children with Type 1 Diabetes: A Pilot Clinical Study

BackgroundOptimal management of Type 1 diabetes (T1D) requires precise insulin dosing and sick-day decision-making; deficiencies in either predispose to hypoglycemia, suboptimal glycaemic control, and diabetic ketoacidosis. We developed DiaBuddy, a guideline-aligned mobile decision support tool, and evaluated its accuracy versus expert guidance and its clinical impact in children with T1D. MethodsThe preclinical validation compared DiaBuddy and family recommendations (N = 37) for 20 insulin-dosing and 20 sick-day vignettes against a pediatric endocrinologist gold standard. The prospective single-arm pilot study evaluated its impact on HbA1c, CGM metrics, and quality of life in 20 children. ResultsIn the preclinical study, DiaBuddy showed lower absolute relative deviation for basal (5.0 {+/-} 6.7% vs 24.2 {+/-} 25.9%), bolus (6.9 {+/-} 10.9% vs 45.3 {+/-} 48.8%), and combined doses (6.3 {+/-} 9.3% vs 39.0 {+/-} 37.8%; all P < 0.001) than families. DiaBuddy achieved [&ge;]90% accuracy across all sick-day domains versus 27-70% for families; adherence would have prevented 94.5% of family errors including all hospitalization decision errors. In the clinical study, HbA1c declined from 9.18 {+/-} 1.99% to 8.48 {+/-} 1.44% (P = 0.049), PedsQL QOL score increased from 76.5 {+/-} 8.6 to 89.1 {+/-} 7.1 (+12.6 points, P < 0.001) with no change in CGM metrics. Application satisfaction was high (mean score 44.1 {+/-} 4.1 out of 50) with 96% wishing to continue using it. ConclusionsDiaBuddy delivers guideline-aligned guidance, substantially outperforming family decisions in preclinical vignette testing and showing preliminary signals of improvement in glycaemic control and quality of life in a small uncontrolled pilot study. The results support the conduct of larger randomised controlled trials.