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

Brief summary (registry, in English)

Type 1 Diabetes Mellitus (T1DM) in children requires precise insulin dose adjustments and reliable sick-day decision-making on a daily basis. In real-world practice, families frequently make errors in both domains, predisposing children to hypoglycemia, suboptimal glycemic control, and diabetic ketoacidosis (DKA). Access to structured diabetes education and specialist support is limited in India, creating an unmet need for accessible point-of-care decision support. DiaBuddy™ is a comprehensive mobile decision-support application for pediatric T1DM developed at Regency Center for Diabetes, Endocrinology and Research, Kanpur. It integrates seven modules aligned with ISPAD 2022 clinical practice guidelines: Insulin Wizard (basal titration, bolus dosing, and correction doses), Sick-Day Guide (stepwise intercurrent illness management), Sugar Tracker (glucose logging with alerts), EatRite (meal planning with carbohydrate quantification using an India-specific food database of 10,245 foods), PlayRite (physical activity guidance), SleepRite (sleep hygiene monitoring), and Knowledge Base (patient and family education). This study evaluated DiaBuddy™ in two sequential phases. Phase 1 was a preclinical vignette-based validation in which 37 families of children with T1DM independently completed 40 standardized clinical scenarios - 20 insulin-dosing and 20 sick-day - with responses compared against a blinded independent pediatric endocrinologist gold standard. Phase 2 was a prospective single-arm pilot clinical study in which 25 children aged 5 to 18 years with T1DM received structured DiaBuddy™ training and unrestricted home access for three months, with hemoglobin A1c, continuous glucose monitoring metrics, and health-related quality of life assessed at baseline and at three months. The study aimed to establish whether DiaBuddy™ produces guideline-aligned insulin dosing and sick-day recommendations, whether it outperforms unaided family decision-making, and whether its use over three months is associated with improvements in glycemic control and quality of life in children with T1DM

What you commit to

• Study type: Interventional
• Participants enrolled: 25
• From Jul 2025 to the primary completion date, Dec 2025
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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