RecruitingType 1 Diabetes MellitusType 2 Diabetes Mellitus

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

Eligible age

7–85 yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

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.

Sponsor: Medtronic MiniMed, Inc.

You may qualify if…

✓ 1. Age at time of screening according to diabetes type:
✓ 1. T1D: Age 7-85 years
✓ 2. T2D: Age 18-85 years
✓ 2. Has a clinical diagnosis of diabetes for a minimum per diabetes type below:
✓ 1. 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.
✓ 2. 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
✓ 3. Is willing to provide informed consent/assent for participation.
✓ 4. Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.

You may not qualify if…

✕ 1. Unable to consent due to a mental or intellectual disability.
✕ 2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:
✕ 1. Medical assistance (i.e., Paramedics, Emergency Room \[ER\] or Hospitalization)
✕ 2. Coma or
✕ 3. Seizures
✕ 3. Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.
✕ 4. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
✕ 5. Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).