NCT07427134

Pediatric Insulin Plan Calculator for T1DM Management

Prospective, Parallel-Group Randomised Controlled Trial Evaluating a Flexible Insulin Dose Calculator in Paediatric Type 1 Diabetes Management

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Sultan Qaboos University · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Type 1 Diabetes Mellitus (T1DM) in children requires intensive insulin therapy and frequent dose adjustments based on carbohydrate intake, glucose levels, and individualised insulin parameters. Although carbohydrate counting is widely practised in paediatric diabetes management, translating these principles into accurate insulin dosing remains complex. Caregivers must integrate insulin-to-carbohydrate ratios, correction factors, pre-meal glucose values, and -when applicable- continuous glucose monitoring (CGM) trend information. This process is prone to calculation errors and variability, which may contribute to suboptimal glycaemic outcomes. While advanced technologies such as insulin pumps and hybrid closed-loop systems can automate insulin delivery, many children worldwide continue to use multiple daily injections (MDI). For this population, structured digital decision-support tools may help standardise insulin dose calculations and reduce caregiver burden. However, high-quality prospective evidence evaluating such tools in paediatric MDI users remains limited. This study is a multi-centre, prospective, randomised, open-label controlled trial evaluating the clinical impact of a flexible digital insulin dose calculator in children under 12 years of age with established T1DM managed with MDI and carbohydrate counting. Participants will be stratified according to CGM use and baseline glycaemic control, then randomised to either standard care alone or standard care plus access to the insulin dose calculator for a 6-month period. The intervention consists of structured training in the use of the digital calculator, which integrates individualised insulin-to-carbohydrate ratios, correction factors, and glucose inputs to generate dosing recommendations. The study will assess whether integration of this tool into routine care improves overall glycaemic control and glycaemic stability compared with standard practice alone. In addition, the study will explore effects on insulin titration patterns, healthcare utilisation, and caregiver experience. The trial is designed to reflect real-world paediatric diabetes practice across multiple international sites. Data will be collected during routine clinical encounters over a 6-month follow-up period. The findings are expected to provide evidence regarding the effectiveness, feasibility, and scalability of a non-invasive digital decision-support intervention aimed at improving insulin dosing accuracy and supporting families managing paediatric T1DM.

Conditions

• Type 1 Diabetes Mellitus
• Type 1 Diabetes Mellitus (T1DM)
• T1DM
• T1DM - Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Flexible Digital Insulin Dose Calculator	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-02-23
• Last updated: 2026-02-24