Randomized Study of a Digital Insulin Dose Calculator to Improve Treatment in Children Under 12 with Type 1 Diabetes Using Multiple Daily Injections

What this Trial Is About

Researchers are evaluating a flexible digital insulin dose calculator to help children under 12 years of age with Type 1 Diabetes Mellitus T1DM who use multiple daily insulin injections MDI. This trial aims to see if adding this calculator to standard care improves blood sugar control compared to standard care alone. The study also looks at how the tool affects insulin dosing accuracy, healthcare visits, and caregiver satisfaction. Participants are randomly assigned to one of two groups one receiving standard diabetes care plus access to the insulin dose calculator with structured training, and the other receiving standard care alone without the calculator. The calculator supports caregivers by combining personalized insulin-to-carbohydrate ratios, correction factors, and glucose information to recommend insulin doses. The study lasts 6 months and is conducted during routine clinic visits across multiple centers. During the study, participants are monitored through regular clinical assessments, including measurements of HbA1c and glucose levels using continuous glucose monitoring CGM when available. Researchers will track changes in blood sugar control, insulin doses, healthcare provider contacts, and caregiver feedback on usability and distress. The primary outcome is the change in HbA1c from the start to the end of the 6-month period, with secondary outcomes covering various glucose metrics and participant experiences throughout the trial.

Pediatric Insulin Plan Calculator for T1DM Management