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Pediatric Insulin Plan Calculator for T1DM Management

RecruitingNAAges 1 Year - 12 YearsAllSultan Qaboos University
NCT07427134 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 di

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📋 Eligibility rules (as published)
Inclusion Criteria: * Children and adolescents \< 12 years * Diagnosed with Type 1 Diabetes Mellitus (T1DM) * Duration of diagnosis \> 1 year * Using a multiple daily injection (MDI) regimen * Practising carbohydrate counting for at least 1 month before enrolment Exclusion Criteria: * 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)
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What it tests

  • Flexible Digital Insulin Dose Calculator
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Where

2 sites
University of Mosul
Mosul, Iraq
University Child Hospital
Lahore, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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