Safety Evaluation of MiniMed™ 780G System With DS5 CGM in Children

Prior treatment

• Has a history of 1 or more episodes of severe hypoglycemia during the 3 months prior to screening.
• Has been hospitalized or has visited the emergency room (ER) in the 3 months prior to screening resulting with a primary diagnosis of uncontrolled diabetes.
• Has had DKA in the last 3 months prior to screening visit.
• Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
• Is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
• Has elective surgery planned that requires general anesthesia during the course of the study.
• Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
• History of chronic renal disease or currently on hemodialysis

Other illness

• Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Has diagnosis of adrenal insufficiency.
• Parent(s)/guardian(s) has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
• Is diagnosed with current eating disorder such as anorexia or bulimia.
• Has hemophilia or any other bleeding disorder.
• Has celiac disease that is not adequately treated as determined by the investigator.
• Has a cardiovascular condition which the investigator determines must exclude the subject.
• Is an immediate family member of a Medtronic Diabetes employee.

Other

• Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
• Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
• Is using hydroxyurea at time of screening or plans to use it during the study.
• Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
• Has hyperthyroidism or hypothyroidism that is not adequately treated as determined by the investigator.

• Age 2-6 years at time of screening.
• Has a clinical diagnosis of type 1 diabetes for 3 months or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
• Parent(s)/guardian(s) is/are literate and able to read the language offered in the pump or pump materials.
• Subject or parent(s)/guardian(s) is/are willing to provide informed consent for participation.
• Is willing to perform fingerstick blood glucose measurements as needed.
• Is willing to wear the system continuously throughout the study.
• Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 6 units on average.
• Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
  • Note: All HbA1c blood specimens will be collected via fingerstick and sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
• Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.
• Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study per manufacturers labeling:
  • Humalog (insulin lispro injection)
  • Authorized generic insulin lispro
  • NovoLog (insulin aspart injection)
  • Authorized generic insulin aspart
  • Admelog (insulin lispro injection) - for subjects aged 3 years and older only
• Has 1 month or more of CGM experience at time of screening.
• If subject has been diagnosed with hyperthyroidism or hypothyroidism, he/she must have a TSH within 3 months prior to screening or at time of screening.