U.S., Feb. 24 -- ClinicalTrials.gov registry received information related to the study (NCT07427134) titled 'Pediatric Insulin Plan Calculator for T1DM Management' on Feb. 15.
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...