Real-world data from 291 pediatric patients demonstrate that the t:slim X2 with Control-IQ technology can safely and effectively manage blood glucose in children under 6 years of age, according to research presented at the American Diabetes Association’s 85th Scientific Sessions by Dr. Valentino Cherubini of Azienda Ospedaliero-Universitaria delle Marche.
Study Rationale and Design
The multicenter, prospective study tracked outcomes in 131 children under the age of 6 and 190 children aged 6 to 10 years who used the automated insulin delivery system for at least one year. Dr. Cherubini explained that the study addresses a significant gap in pediatric diabetes care, as many parents request an automated insulin delivery system for their younger children, even though the Control-IQ system is currently approved only for patients aged 6 years and older.
Managing type 1 diabetes in very young children is challenging, as toddlers and preschoolers have unpredictable eating patterns, varying activity levels, and difficulty communicating symptoms of hypoglycemia. As such, precise insulin dosing is difficult to achieve with traditional methods.
The Control-IQ technology is a hybrid closed-loop system that automatically adjusts insulin delivery based on continuous glucose monitor readings. The system can predict glucose trends and proactively adjust insulin levels to help prevent both dangerous low blood sugar episodes and prolonged high glucose levels. Despite the off-label use, many pediatric endocrinologists have begun prescribing these systems for younger patients after obtaining informed consent from parents. This study provides the first comprehensive real-world evidence to support this practice.
The research drew participants from 30 pediatric diabetes centers, creating a dataset that reflects diverse clinical practices and patient populations. All children were already using continuous glucose monitoring before starting the Control-IQ system, ensuring that they had experience with diabetes technology.
Safety and Effectiveness of T:slim X2 Control-IQ Technology in Younger Children
The study documented no serious hypoglycemic events in either age group, either before or after implementation of the automated system. Only one episode of diabetic ketoacidosis occurred during the study period, affecting a child in the 6-to-10-year age group.
The study revealed improvements in glucose control in both age groups. Children under 6 years showed progress in time spent in the target glucose range of 70-180 mg/dL, increasing from 61% at baseline to 68% after one year of Control-IQ use. The 6-to-10-year group demonstrated similar improvements, with the time in range increasing from 66% to 69%.
The study also showed a reduction in severe hyperglycemia. Children under 6 years of age spent less time with glucose levels above 250 mg/dL, dropping from 12% to 8% of the time. This improvement occurred alongside better overall glucose stability, as measured by the reduced coefficient of variation in glucose readings. In addition, HbA1c levels improved in both age groups. Children under 6 years of age achieved a reduction in HbA1c from 7.4% to 6.8%, while the older group saw a similar decrease from 7.1% to 6.8%.
Implications
The study provides preliminary, real-world evidence that suggests that the safety and effectiveness of t:slim X2 with Control-IQ technology in children under the age of 6 can match those achieved in older children. The findings may influence regulatory discussions regarding the expansion of age indications for automated insulin delivery systems. FDA approval processes typically require extensive pediatric studies, but real-world evidence from off-label use can provide valuable safety and efficacy data.
Dr. Evangelou has no conflicts of interest to report.
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