1. Closed-Loop Insulin Delivery in Children <7 Years of Age Closed-Loop Insulin Therapy (CLT) Background Children at increased risk of hypoglycemia, especially at night Neurocognitive effects can result Children have unpredictable eating patterns and erratic activity levels by insulin pump

2. Closed-Loop Insulin Delivery in Children <7 Years of Age Objective The aim of CLT is to achieve tight glucose control and reduce risk of hypoglycemia CLT combines glucose sensing and insulin-delivery components with real-time glucose-responsive insulin administration -Disposable sensor measures interstitial glucose levels -Algorithm controls rapid-acting insulin analog delivery The aim of this study as to test CLT in young children with diabetes

3. Closed-Loop Insulin Delivery in Children <7 Years of Age Children 6 months treated with insulin pump therapy for >6 weeks (n=10) Randomized crosss-over trial comparing CLT with open-loop therapy Two control periods: overnight and daytime Target blood glucose: 10 PM-6 AM – 150 mg/dL; 6 AM-noon – 120 mg/dL Design and Methods

4. Closed-Loop Insulin Delivery in Children <7 Years of Age Study Design

5. Closed-Loop Insulin Delivery in Children <7 Years of Age Results Time at night target increased with CLT but not significantly different from open-loop Time in overnight extreme hyperglycemia and total glycemic excursion significantly reduced No difference in number of interventions for hypoglycemia

6. Closed-Loop Insulin Delivery in Children <7 Years of Age

7. Conclusions CLT decreased the degree of noturnal hyperglycemia in young children without increasing the incidence of hypoglycemia CLT improved prelunch blood glucose CLT has the potential to improve diabetes care in very young children