Digital Insulin Calculator Tested in Children With Type 1 Diabetes
Tests a dose calculator app for insulin in children up to age 12.
Plain-language title generated from the registry record
Registry title: Pediatric Insulin Plan Calculator for T1DM Management
Key facts
- Where
- Lahore, PakistanSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 12 years old?
Source: NCT07427134, who can take part
Where in Pakistan
- University Child HospitalLahore, PakistanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sultan Qaboos University
- Trial code
- NCT07427134
- Record updated
- 9 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Use of insulin regimens other than multiple daily injections (MDI) (e.g., insulin pump therapy); Diagnosis of other types of diabetes (e.g., Type 2 diabetes mellitus, monogenic diabetes); Use of an existing insulin dose calculator (e.g., mobile application or bolus advisor) within the last 3 months.