Safety Evaluation of the MiniMed NMX8 Automated Insulin Delivery System with DS5Simplera Sensor in Children and Adults Aged 7 to 85 with Type 1 or Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the safety of a new insulin pump called the MiniMed NMX8 Automated Insulin Delivery AID System combined with the DS5Simplera continuous glucose monitoring sensor in children and adults living with Type 1 or Type 2 diabetes aged 7 to 85 years. The study aims to understand how well the pump works with this sensor and its safety profile across different ways of managing insulin boluses during meals. Participants will continue their current diabetes therapy while using the study devices. Participants will first wear the DS5Simplera sensor for up to 40 days while maintaining a meal and exercise log. Then, they will be randomly assigned to one of three groups for about 90 days one group will not bolus insulin for meals using the pump, another will bolus at every meal, and the third can bolus at will. After this period, participants may choose to join a Continued Access Period to keep using the NMX8 pump if they wish. During the study, participants will be monitored by recording their insulin use and maintaining logs of meals and exercise. The main outcomes measured include the percentage of time blood glucose levels stay within the target range 70-180 mgdL and the percentage of time spent in low blood sugar hypoglycemia over approximately 90 days. Participants must wear the system continuously and upload pump data via an app or computer. The study includes assessments like retinal eye exams and requires participants to use specific insulin types throughout the trial.

GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes