Pediatric Insulin Plan Calculator for T1DM Management
FLEXI-T1D
Prospective, Parallel-Group Randomised Controlled Trial Evaluating a Flexible Insulin Dose Calculator in Paediatric Type 1 Diabetes Management
1 other identifier
interventional
440
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedStudy Start
First participant enrolled
May 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
June 9, 2026
June 1, 2026
8 months
February 15, 2026
June 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 6 Months
Secondary Outcomes (8)
Change in Time in Range (TIR)
Baseline, 3 Months, and 6 Months
Change in Time Below Range (TBR)
Baseline, 3 Months, and 6 Months
Change in Time Above Range (TAR)
Baseline, 3 Months, and 6 Months
Change in Glucose Coefficient of Variation (CV)
Baseline, 3 Months, and 6 Months
Change in Total Daily Insulin Dose (units/kg/day)
Baseline, 3 Months, and 6 Months
- +3 more secondary outcomes
Study Arms (2)
Flexible Insulin Dose Calculator + Standard Care
EXPERIMENTALParticipants 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.
Standard Care Alone
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sultan Qaboos Universitylead
- University of Mosulcollaborator
- University of Child Health Sciences and Children's Hospital, Lahorecollaborator
Study Sites (2)
University of Mosul
Mosul, Iraq
University Child Hospital
Lahore, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 15, 2026
First Posted
February 23, 2026
Study Start
May 3, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 6 months after publication of the primary study results. Up to 2 years after publication of the primary results.
- 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.
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.