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

Inclusion Criteria:

1. Age 2-6 years at time of screening.

2. Has a clinical diagnosis of type 1 diabetes for 3 months or more as determined viamedical record or source documentation by an individual qualified to make a medicaldiagnosis.

3. Parent(s)/guardian(s) is/are literate and able to read the language offered in thepump or pump materials.

4. Subject or parent(s)/guardian(s) is/are willing to provide informed consent forparticipation.

5. Is willing to perform fingerstick blood glucose measurements as needed.

6. Is willing to wear the system continuously throughout the study.

7. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than orequal to 6 units on average.

8. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) attime of screening visit. Note: All HbA1c blood specimens will be collected via fingerstick and sent to andtested by a National Glycohemoglobin Standardization Program (NGSP) certifiedCentral Laboratory. HbA1c testing must follow NGSP standards.

9. Is willing to upload data from the study pump, must have Internet access, and acomputer system, or compatible smartphone that meets the requirements for uploadingthe study pump.

10. Is willing to take one of the following insulins and can financially support the useof insulin preparations as required by the study per manufacturers labeling:

11. Humalog (insulin lispro injection)

12. Authorized generic insulin lispro

13. NovoLog (insulin aspart injection)

14. Authorized generic insulin aspart

15. Admelog (insulin lispro injection) - for subjects aged 3 years and older only

16. Has 1 month or more of CGM experience at time of screening.

17. If subject has been diagnosed with hyperthyroidism or hypothyroidism, he/she musthave a TSH within 3 months prior to screening or at time of screening.

Exclusion Criteria:

1. Has a history of 1 or more episodes of severe hypoglycemia during the 3 months priorto screening.

2. Has been hospitalized or has visited the emergency room (ER) in the 3 months priorto screening resulting with a primary diagnosis of uncontrolled diabetes.

3. Has had DKA in the last 3 months prior to screening visit.

4. Will not tolerate tape adhesive in the area of sensor placement as assessed by aqualified individual.

5. Has any unresolved adverse skin condition in the area of sensor placement (e.g.,psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

6. Has diagnosis of adrenal insufficiency.

7. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeksfrom time of screening visit, or plans to take any oral, injectable, or IVglucocorticoids during the course of the study.

8. Is using hydroxyurea at time of screening or plans to use it during the study.

9. Is actively participating in an investigational study (drug or device) whereinhe/she has received treatment from an investigational study drug or investigationalstudy device in the last 2 weeks.

10. Is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time ofscreening.

11. Parent(s)/guardian(s) has a history of visual impairment which would not allowsubject to participate in the study and perform all study procedures safely, asdetermined by the investigator.

12. Has elective surgery planned that requires general anesthesia during the course ofthe study.

13. Has sickle cell disease, hemoglobinopathy; or has received red blood celltransfusion or erythropoietin within 3 months prior to time of screening.

14. Plans to receive red blood cell transfusion or erythropoietin over the course ofstudy participation.

15. Is diagnosed with current eating disorder such as anorexia or bulimia.

16. History of chronic renal disease or currently on hemodialysis

17. Has hemophilia or any other bleeding disorder.

18. Has celiac disease that is not adequately treated as determined by the investigator.

19. Has a cardiovascular condition which the investigator determines must exclude thesubject.

20. Has hyperthyroidism or hypothyroidism that is not adequately treated as determinedby the investigator.

21. Is an immediate family member of a Medtronic Diabetes employee.