GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
The purpose of this study is to check that a new insulin pump, called NMX8, is safe when used with a continuous glucose monitoring sensor called Disposable Sensor 5 in people with diabetes. The study will include people with Type 1 diabetes who are 7-85 years old and people with Type 2 diabetes who are 18-85 years old. Patients will use their current therapy while also wearing the DS5 for up to 40 days. During this time, they will complete a meal and exercise log. Patients will then be put into one of three groups by a computer by chance and given the NMX8 pump to use for 90 days. During this time, patients will either bolus or not bolus for meals and continue to complete a meal and exercise log depending on the group they are in. Once their part in the study is over, if patients like the pump and want to keep using it, they may be able to join a Continued Access Period to keep using the NMX8 pump.
• Age at time of screening according to diabetes type:
‣ T1D: Age 7-85 years
• Has a clinical diagnosis of diabetes for a minimum per diabetes type below:
‣ T1D (Age 7-85 years): Diagnosis of T1D for at least 6 months, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
⁃ T2D (Age 18-85 years): Diagnosis of insulin-requiring T2D for 1 year or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
• Is willing to provide informed consent/assent for participation.
• Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.
• Is willing to wear the system continuously throughout the study.
• Has a retinal eye examination prior to enrollment (if needed) per guidelines by the local professional society/hospital guidelines according to age, duration of diabetes and type of diabetes. Entry into the study is permitted at the investigators' discretion, depending on their interpretation of the findings.
• Is willing to upload study pump data via an app or computer.
• Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:
‣ Humalog™\* (insulin lispro injection)
⁃ NovoLog™\*/NovoRapid™\* (insulin aspart solution for injection)
⁃ Admelog™\* (insulin lispro injection)
⁃ Merilog™\* (insulin aspart)
⁃ Authorized generic insulin aspart
⁃ Authorized generic insulin lispro