Pediatric Insulin Plan Calculator for T1DM Management

Sponsor
Sultan Qaboos University
Study ID
NCT07427134
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Flexible Digital Insulin Dose Calculator — BEHAVIORAL
    The 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.

Study Details

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.

Key Dates

First listed
Feb 23, 2026
Start date
May 3, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Flexible Insulin Dose Calculator + Standard Care
    Participants receive standard diabetes care plus access to a flexible digital insulin dose calculator designed to support carbohydrate-based insulin dosing. Caregivers receive structured training on tool use at baseline. The tool integrates individualized insulin-to-carbohydrate ratios, correction factors, and glucose inputs to generate dosing recommendations. Participants are followed for 6 months during routine clinic visits.
  • No Intervention: Standard Care Alone
    Participants receive routine standard diabetes care according to local clinical practice, including insulin dose adjustments based on carbohydrate counting principles, without access to the digital insulin dose calculator. Participants are followed for 6 months during routine clinic visits.

Primary Outcome Measure

Change in HbA1c from Baseline to 6 Months [ Time Frame: Baseline to 6 Months ]

Central Contacts

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