2026-10-12T05:28:21Z https://api.figshare.com/v2/oai

oai:figshare.com:article/34022517 2026-09-29T10:05:42Z category_7 portal_147 item_type_3 month_year_09_2026

Supplemental Material for: Development and Pilot Clinical Evaluation of DiaBuddy, a Point-of-Care Decision Support Tool for Children and Adolescents with Insulin-Treated Diabetes figshare admin karger (2628495) Alapan Mahapatra (25136429) Sandeep Paimode (25136430) Sayan Banerjee (8641302) Prashant Shukla (1790095) Nimisha Sachan (25136436) Vibha Yadav (25136439) Anurag Bajpai (9204186) Medicine Medicine <p dir="ltr">Introduction— Optimal management of insulin-treated pediatric and adolescent diabetes, particularly 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 clinical changes observed during pilot evaluation in children and adolescents with insulin-treated diabetes.</p><p dir="ltr">Methods — The 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 explored changes over 12 weeks in 20 children and adolescents with insulin-treated diabetes. HbA1c was the primary clinical outcome; CGM-derived metrics, PedsQL quality-of-life scores, application use, and satisfaction were exploratory secondary outcomes. </p><p dir="ltr">Results — In 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 ≥90% accuracy across all sick-day domains versus 27–70% for families; and provided a guideline-concordant response in 94.5% of instances in which family responses were erroneous, including all instances involving an incorrect family hospitalisation decision. In the clinical study, HbA1c declined from 9.18 ± 1.99% to 8.48 ± 1.44% (p = 0.049) and the PedsQL 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 most wishing to continue using it.</p><p dir="ltr">Conclusion— DiaBuddy delivered guideline-aligned guidance in vignette testing. In this single-centre, uncontrolled pilot, observed changes in HbA1c and PedsQL are hypothesis-generating and require evaluation in an adequately powered multicentre randomised controlled trial. </p> 2026-09-29T10:05:42Z Dataset Dataset 10.6084/m9.figshare.34022517.v1 https://figshare.com/articles/dataset/Supplemental_Material_for_Development_and_Pilot_Clinical_Evaluation_of_DiaBuddy_a_Point-of-Care_Decision_Support_Tool_for_Children_and_Adolescents_with_Insulin-Treated_Diabetes/34022517 CC BY 4.0