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/Simplera Sync 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. Participants will use their current therapy while also wearing the DS5/Simplera sensor for up to 40 days. During this time, they will complete a meal and exercise log. Participants will then be placed into one of three groups by chance and given the NMX8 pump to use for about 90 days. During this time, participants will bolus, not bolus, or bolus at will 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 participants 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 results of a retinal eye examination on record prior to enrollment, per guidelines by the American Diabetes Association according to age, duration of diabetes and type of diabetes:
‣ T1D adults (Age 18-85 years):
‣ I. Initial retinal eye exam within 5 years of diagnosis. II. If the duration of type 1 diabetes is longer than 5 years, a retinal examination should have been performed within the last 12-18 months.
⁃ T2D adults (Age 18-85 years):
‣ I. Results of a retinal eye exam, performed within the last 12-18 months, should be on record.
⁃ T1D pediatric (Age 7-17 years):
• I. No exam is required if under the age of 10 years unless the duration of diabetes is more than 3 years.
• II. For children over the age of 10, a retinal exam should have been performed within 24 months of enrollment in the study.
• Per the investigator's discretion: If a potential participant is deemed to be at high risk, a retinal eye exam, performed within the last 12 months prior to screening, should be on record.
• 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™\* (insulin aspart solution for injection) or an interchangeable biosimilar (for example, Kirsty™\*)
⁃ NovoRapid™\* (insulin aspart solution for injection)
⁃ Admelog™\* (insulin lispro injection)
⁃ Merilog™\* (insulin aspart)
⁃ Fiasp™\* (ultra-rapid-acting insulin aspart)
⁃ Lyumjev™\* (ultra-rapid-acting insulin lispro)
⁃ Authorized generic insulin aspart
⁃ Authorized generic insulin lispro