Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home

Inclusion Criteria

1. Subject is age 2-80 years at time of screening

2. US, Canada, Australia and New Zealand: Subjects 2-80 years of age will beallowed to enroll in the post approval study.

3. Europe: Only subjects ≥7 years of age are allowed to enroll in the post-marketstudy.

4. Subjects who are 2-21 years are determined by the investigator to have theappropriate, requisite support (family, caregiver or social network) to successfullyparticipate in this study

5. Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal toor greater than 8 units/day

6. Subjects who are determined by the investigator to be psychologically sound in orderto successfully participate in this study

7. Subject has been diagnosed with type 1 diabetes for at least three months Note:Determination of classification for diabetes will be based on American DiabetesAssociation Clinical Practice Guidelines accounting for several patientcharacteristics such as: age of onset, patient's weight or BMI, history of diabeticketoacidosis, history of therapy management, if available in the medical records.

8. Subject must be on one of the following management therapies:

9. Multiple daily injections defined by use of rapid analogue with meals andapproved long acting analogue (e.g. detemir or glargine) with or without CGM

10. Insulin pump therapy with or without CGM

11. Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily

12. Subject is willing to perform required study procedures

13. Subject is willing to wear the system continuously throughout the study for at least 80% of the time.

14. Subject is willing to upload data at least weekly from the study pump/meter, musthave Internet access and a computer system that meets the requirements for uploadingthe study pump/meter for data collection

15. Subject must be willing to use the study glucose meter system (i.e. along with studymeter strips).

16. If subject has celiac disease, it has been adequately treated as determined by theinvestigator

17. Subject with the diagnosis of myocardial infarction, unstable angina, coronaryartery bypass surgery, coronary artery stenting, transient ischemic attack,cerebrovascular accident, angina, congestive heart failure, ventricular rhythmdisturbances or thromboembolic disease, within 1 year of screening, will be includedin the study with the consent of the Investigator

18. Subject is willing to take one of the following insulins and can financially affordto use either of the 2 insulin preparations throughout the course of the study (i.e.co-payments for insulin with insurance or able to pay full amount)

19. Humalog® (insulin lispro injection)

20. NovoLog® (insulin aspart)

Exclusion Criteria:

1. Subject participated in any Closed Loop study in the past.

2. Subject is unable to tolerate tape adhesive in the area of sensor placement

3. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection) or area of infusion set placement

4. Women of child-bearing potential who have a positive pregnancy test at screening orplan to become pregnant during the course of the study

5. Subject is being treated for hyperthyroidism at time of screening

6. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. TSH is not required for subjects 2-13 years ofage.

7. Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks fromtime of screening visit, or plans to take any oral, injectable, or IVglucocorticoids during the course of the study.

8. Subject is actively participating in an investigational study (drug or device)wherein he/she has received treatment from an investigational study drug orinvestigational study device in the last 2 weeks

9. Subject is currently abusing illicit drugs or marijuana

10. Subject is currently abusing prescription drugs

11. Subject is currently abusing alcohol

12. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides,DPP-4 inhibitors or sulfonylureas at time of screening

13. Subject is using hydroxyurea at the time of screening or plans to use it during thestudy

14. Subject has a history of visual impairment which would not allow subject toparticipate in the study and perform all study procedures safely, as determined bythe investigator

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

16. Subject plans to receive red blood cell transfusion or erythropoietin over thecourse of study participation

17. Subject diagnosed with current moderate to severe eating disorder such as anorexiaor bulimia

18. Subject has been diagnosed with chronic kidney disease requiring dialysis orresulting in chronic anemia

19. Subjects who are currently being actively treated for cancer.

20. Subject who is designated as a research staff member for this study