Safety and Efficacy Evaluation of the MiniMed 780G System

Automated insulin delivery is a system that takes sensor glucose data and adjusts insulin delivery to achieve certain targets. These systems are considered hybrid, meaning the person wearing the system still needs to bolus for meals. The present study plans to evaluate the safety and effectiveness of the MiniMed 780G system Used in Combination with a new sensor.

The currently commercially available, FDA approved system from Medtronic is the 670G, which primarily works by adjusting basal rates to keep the sensor glucose in a safe range (70-180mg/dL). The Medtonic 780G system, is currently under review by the the FDA. There are a few features that make this system investigational, including:

• The option for a lower system target. The current system targets 120mg/dL, the new one has the option to go down to 110 or 100mg/dL.
• AutoCorrection (or Autobolus) this means the system can give a small bolus to help bring the sensor glucose to the system target if you are over 120mg/dL without requiring you to acknowledge this bolus

The new sensor we will be testing has been assessed in some accuracy studies and is also under review by the FDA. The new sensor has:

• A disposable, integrated transmitter
• Reduced size from prior Medtronic sensors
• No requirement for fingerstick calibrations
• Ability to follow the data remotely

Additionally, you will wear an extended wear infusion set, which means you will change your site every 7 days (though you may need to refill the reservoir with insulin).

We will be recruiting a total of 16 participants at Yale. We will aim to recruit approximately 6 participants between the ages of 18-75 years, 5 participants aged 14-17 years, and 5 aged 7-13 years.

Participation in the study will be up to 4-5 months with use of the investigational equipment for ~3 months’ time.

Many visits can be telephone calls, but you will need to come to the office for visits (or have a virtual visit) on days 28, 60 and 90 days after starting the system with automation. Each of these visits will be ~1 hour.

At visit 15, we will transition you back to your usual pump and your participation in the study will be complete.

You will be compensated up to $940 for participating in the study and the study equipment will be provided to you.

As we only have a few spots in each age group, participation is on a first come, first serve basis.

Inclusion Criteria:

1. Age 7 - 80 years at time of screening.
2. Has a clinical diagnosis of type 1 diabetes:
   1. 14 – 80 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
   2. 7 – 13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
3. Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
4. Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials.
5. Subject and/or legally authorized representative is willing to provide informed consent for participation.
6. Is willing to perform fingerstick blood glucose measurements as needed.
7. Is willing to wear the system continuously throughout the study.
8. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
9. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
   1. Note: All HbA1c blood specimens will be sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
10. Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab’s reference range and Free T4 is within the normal reference range.
11. Uses pump therapy for greater than 6 months prior to screening (with or without CGM experience).
12. 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.
13. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:
    1. Humalog (insulin lispro injection)
    2. NovoLog (insulin aspart injection)
    3. Admelog (insulin lispro injection)

Exclusion Criteria:

1. 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
   3. Seizures
2. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
3. Has had DKA in the last 6 months prior to screening visit.
4. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
6. Is female of child-bearing potential and result of pregnancy test is positive at screening.
7. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
8. Is female and plans to become pregnant during the course of the study.
9. Is being treated for hyperthyroidism at time of screening.
10. Has diagnosis of adrenal insufficiency.
11. 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.
12. Is using hydroxyurea at time of screening or plans to use it during the study.
13. 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.
14. Has used a MiniMed 780G pump prior to screening.
15. Is currently abusing illicit drugs.
16. Is currently abusing marijuana.
17. Is currently abusing prescription drugs.
18. Is currently abusing alcohol.
19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
20. 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.
21. Has elective surgery planned that requires general anesthesia during the course of the study.
22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
23. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
24. Is diagnosed with current eating disorder such as anorexia or bulimia.
25. Has been diagnosed with chronic kidney disease that results in chronic anemia.
26. Has a hematocrit that is below the normal reference range of lab used.
27. Is on dialysis.
28. Has serum creatinine of >2 mg/dL.
29. Has celiac disease that is not adequately treated as determined by the investigator.
30. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances
31. Has had history of cardiovascular event 1 year or more from the time of screening without
    1. a normal EKG and stress test within 6 months prior to screening or during screening or
    2. clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test.
32. Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to screening or during screening or clearance from a qualified physician if there is an abnormal EKG:
    1. Age >35 years
    2. Type 1 diabetes of >15 years’ duration
    3. Presence of any additional risk factor for coronary artery disease
    4. Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
    5. Presence of peripheral vascular disease
    6. Presence of autonomic neuropathy
33. Is a member of the research staff involved with the study.
34. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings)