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)
Parallel
Flexible Digital Insulin Dose Calculator
BehavioralThe flexible digital insulin dose calculator is a structured decision-support tool designed specifically for children with Type 1 Diabetes Mellitus managed with multiple daily injections and carbohydrate counting. Unlike basic insulin calculation applications that consider limited variables, this tool integrates individualised insulin-to-carbohydrate ratios, correction factors (insulin sensitivity), pre-meal glucose values, and glucose trends (when available) to generate dosing recommendations. The tool is non-automated and does not deliver insulin; it supports caregiver decision-making. It is intended for real-world clinical use and is implemented alongside routine diabetes care with standardised training at baseline. The intervention focuses on improving dosing accuracy and consistency rather than replacing clinician oversight or insulin therapy.
Change in HbA1c from Baseline to 6 Months
The primary outcome is the difference in glycated haemoglobin (HbA1c) levels between baseline and 6 months. HbA1c will be measured as part of routine clinical care and analysed to compare changes between the intervention (digital insulin dose calculator plus standard care) and control (standard care alone) groups.
Change in Time in Range (TIR)
For participants using CGM, change in the percentage of time glucose is within 70-180 mg/dL (4-10 mmol/L) based on CGM reports.
Change in Time Below Range (TBR)
For participants using CGM, change in the percentage of time glucose is \<70 mg/dL (\<4 mmol/L) based on CGM reports.
Change in Time Above Range (TAR)
For participants using CGM, change in the percentage of time glucose is \>180 mg/dL (\>10 mmol/L) based on CGM reports.
Change in Glucose Coefficient of Variation (CV)
For participants using CGM, change in glucose coefficient of variation (CV, %) derived from CGM reports as a measure of glycaemic variability.
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Sultan Qaboos University
Lead sponsor
University of Mosul
Collaborator
University of Child Health Sciences and Children's Hospital, Lahore
Collaborator