Goleta

Researchers are evaluating the safety of a new insulin pump called the MiniMed2 NMX8-AID System combined with a continuous glucose monitoring sensor named Disposable Sensor 5/Simplera Sync in people living with diabetes. The study includes participants with Type 1 diabetes aged 7 to 85 years and those with Type 2 diabetes aged 18 to 85 years. Participants will first continue using their current diabetes therapy while wearing the sensor for up to 40 days, during which they will keep a meal and exercise log. After this initial period, participants will be randomly assigned to one of three groups to use the NMX8 pump for 90 days, with differing meal bolusing instructions depending on their group. Those who wish to continue using the pump after the study may join a Continued Access Period. During the treatment phase, participants will use the MiniMed2 NMX8-AID System with the DS5 continuous glucose monitor. The study involves three randomized groups, where participants will either bolus insulin for meals or not, while continuing to log meals and exercise. The initial phase involves wearing the sensor with current therapy for up to 40 days, followed by the randomized 90-day pump usage period. The pump data will be uploaded via an app or computer, and participants must use one of several specified insulins. Participants will be closely monitored throughout approximately 90 days for the percent of time their blood glucose stays within the target range of 70-180 mg/dL and the percent of time spent in hypoglycemia (below 70 mg/dL). They will complete meal and exercise logs and upload pump data regularly. Safety assessments include retinal eye exams and monitoring for adverse events. The study emphasizes adherence to wearing the system continuously and maintaining stable insulin dosing during participation. Overall, participant involvement spans an initial sensor-wearing phase, a randomized pump treatment phase, and possible extended access to the pump.