Pediatric Insulin Plan Calculator for T1DM Management

This is a multi-centre, prospective, randomized, open-label controlled trial designed to evaluate the effectiveness of a flexible digital insulin dose calculator in children under 12 years of age with Type 1 Diabetes Mellitus (T1DM) managed with multiple daily injections (MDI). Participants will be stratified by continuous glucose monitoring (CGM) use and baseline HbA1c, and randomised to receive either standard care alone or standard care plus the insulin dose calculator tool for 6 months. The primary outcome is the change in HbA1c from baseline to 6 months. Secondary outcomes include CGM-derived glycaemic metrics (Time in Range, Time Below Range, Time Above Range, and Coefficient of Variation), total daily insulin dose (units/kg/day), healthcare provider contact frequency, and caregiver-reported usability and satisfaction. The study aims to determine whether the use of a structured digital decision-support tool improves glycaemic control and supports safer insulin dosing in paediatric patients with T1DM.

NCT Number	NCT07427134
Lead Sponsor	Sultan Qaboos University Collaborators: University of Mosul, University of Child Health Sciences and Children's Hospital, Lahore
Conditions	Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus (T1DM), T1DM, T1DM - Type 1 Diabetes Mellitus
Enrollment	440 participants
Start Date	2026-05-03
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-09