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.
Children and adolescents < 12 years
Diagnosed with Type 1 Diabetes Mellitus (T1DM)
Duration of diagnosis > 1 year
Using a multiple daily injection (MDI) regimen
Use of an existing insulin dose calculator (e.g., mobile application or bolus advisor) within the last 3 months
Diagnosis of other types of diabetes (e.g., Type 2 diabetes mellitus, monogenic diabetes)
Use of insulin regimens other than multiple daily injections (MDI) (e.g., insulin pump therapy)
Sultan Qaboos University
Lead sponsor
University of Mosul
Collaborator
University of Child Health Sciences and Children's Hospital, Lahore
Collaborator