Pediatric Insulin Dose Calculator to Help Manage Type 1 Diabetes in Under-12s

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial tests a flexible digital insulin dose calculator added to standard care for children under 12 with Type 1 diabetes managed on multiple daily injections. It is a multicenter, prospective, randomized, open-label study that stratifies participants by CGM use and baseline HbA1c. The primary outcome is change in HbA1c at 6 months, with secondary outcomes including CGM metrics, total daily insulin dose, provider contact frequency, and caregiver usability. The aim is to see if structured digital dosing support improves glycemic control and reduces dosing errors in paediatric MDI users. The study excludes those already using an insulin dose calculator and focuses on those not on pump therapy.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Mosul
  Mosul, Iraq Recruiting
• University Child Hospital
  Lahore, Pakistan Recruiting

Study contacts

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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.