Pediatric Insulin Plan Calculator for T1DM Management (FLEXI-T1D)

February 21, 2026 updated by: Dr. Hussain Al Saffar, Sultan Qaboos University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hussain Alsaffar, FACE, MSc, FRCPCH, CCT, MBChB
  • Phone Number: 0096896399402
  • Email: hussaina@squ.edu.om

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Insulin Dose Decision-Support Tool
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c from Baseline to 6 Months
Time Frame: 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.
Baseline to 6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Time in Range (TIR)
Time Frame: Baseline, 3 Months, and 6 Months
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.
Baseline, 3 Months, and 6 Months
Change in Time Below Range (TBR)
Time Frame: Baseline, 3 Months, and 6 Months
For participants using CGM, change in the percentage of time glucose is <70 mg/dL (<4 mmol/L) based on CGM reports.
Baseline, 3 Months, and 6 Months
Change in Time Above Range (TAR)
Time Frame: Baseline, 3 Months, and 6 Months
For participants using CGM, change in the percentage of time glucose is >180 mg/dL (>10 mmol/L) based on CGM reports.
Baseline, 3 Months, and 6 Months
Change in Glucose Coefficient of Variation (CV)
Time Frame: Baseline, 3 Months, and 6 Months
For participants using CGM, change in glucose coefficient of variation (CV, %) derived from CGM reports as a measure of glycaemic variability.
Baseline, 3 Months, and 6 Months
Change in Total Daily Insulin Dose (units/kg/day)
Time Frame: Baseline, 3 Months, and 6 Months
Change in total daily insulin dose normalized to body weight (units/kg/day), calculated from clinical records at each assessment time point
Baseline, 3 Months, and 6 Months
Healthcare provider contact frequency during study follow-up
Time Frame: Baseline to 6 Months (assessed at 3 and 6 Months)
Number of diabetes-related healthcare provider contacts (e.g., clinic, telemedicine, phone consultations) recorded over the study period and/or between visits
Baseline to 6 Months (assessed at 3 and 6 Months)
Caregiver diabetes distress
Time Frame: Baseline and 6 Months
Caregiver burden assessed using validated Diabetes Distress Scale instruments, comparing scores over follow-up. PARENT DIABETES DISTRESS SCALE (PARENT-DDS) questionnaire will be used. A mean item score or 0 - 1.9 should be considered "little or no distress," a mean item score between 2.0 - 2.9 should be considered 'moderate distress,' and a mean item score > 3.0 should be considered 'high distress.'
Baseline and 6 Months
Caregiver usability and satisfaction with the insulin dose calculator
Time Frame: 3 Months and 6 Months
Structured caregiver questionnaire assessing usability, satisfaction, and perceived value of the digital tool (intervention arm only). System Usability Scale (SUS) questionnaire will be used, which produces a score from 0 to 100 (not a percentage). The higher score indicates better usability. Below 50 means poor usability and >75 = Acceptable for clinical deployment.
3 Months and 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Qaboos University

Collaborators

University of Mosul
University of Child Health Sciences and Children's Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 15, 2026

First Submitted That Met QC Criteria

February 15, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SultanQU-PEDU-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the published results may be made available upon reasonable request to the principal investigator, subject to institutional approval, data protection regulations, and a data-sharing agreement. Data sharing will not include direct identifiers and will comply with applicable ethical and legal requirements.

IPD Sharing Time Frame

6 months after publication of the primary study results. Up to 2 years after publication of the primary results.

IPD Sharing Access Criteria

De-identified individual participant data underlying the published results (including primary and secondary outcome data, data dictionary, and statistical analysis plan) may be made available to qualified researchers for scientifically sound research purposes. Access will be granted upon reasonable request to the Principal Investigator and subject to institutional review, ethics approval where applicable, and execution of a formal data-sharing agreement. Data will be provided in a de-identified format and shared through secure electronic transfer or a controlled-access repository in accordance with applicable data protection regulations.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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