NCT07427134 Pediatric Insulin Plan Calculator for T1DM Management
| NCT ID | NCT07427134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sultan Qaboos University |
| Condition | Type 1 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2026-05-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2026-05-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07427134 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 12 Years, studying Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07427134 currently recruiting?
Yes, NCT07427134 is actively recruiting participants. Contact the research team at hussaina@squ.edu.om for enrollment information.
Where is the NCT07427134 trial being conducted?
This trial is being conducted at Mosul, Iraq, Lahore, Pakistan.
Who is sponsoring the NCT07427134 clinical trial?
NCT07427134 is sponsored by Sultan Qaboos University. The trial plans to enroll 440 participants.
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