Medtronic CIP335 study for Type I Diabetes

Are you currently living with Type 1 Diabetes?

Yale University is performing a study evaluating the use of Lyumjev insulin, in the MiniMed 780G Insulin Pump from Medtronic. Lyumjev is a rapid acting mealtime insulin with a faster onset of action when compared to Humalog. After a run-in period using the MiniMed 780G pump with your usual insulin (either Humalog, Novolog, or Admelog), participants will use the MiniMed 780G pump and Lyumjev insulin for 3 months.

You may qualify if you are…

• Between the ages of 7-17
• Have an A1c level less than 10%
• You have been using insulin pump therapy for at least 6 months

The study requires several in-person visits to Yale in New Haven and 2 blood tests at the beginning and end of the study. We may be able to provide additional financial support for transportation if you live a significant distance from Yale. Compensation is $75-$125 for office/virtual visits and $30 for telephone visits.

Inclusion Criteria

1. Age 7-17 years at time of screening.

2. Has a clinical diagnosis of type 1 diabetes:

a. 14–17 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.

b. 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 and a maximum total daily dose of 250 units or less.

9. 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 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 (with or without CGM experience) prior to screening

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 either of the 2 insulin preparations as required during the run-in period: a. Humalog (insulin lispro injection)

b. NovoLog (insulin aspart injection)

c. Admelog (insulin lispro injection)

14. Is willing to take Lyumjev insulin during the study period (supplied via Sponsor).

Exclusion Criteria

1. Has a hypersensitivity to insulin lispro or one of the excipients in Lyumjev

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: a. Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)

b. Coma

c. Seizures

3. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.

4. Has had DKA in the last 6 months prior to screening visit.

5. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.

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

7. Is female of child-bearing potential and result of pregnancy test is positive at screening.

8. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.

9. Is female and plans to become pregnant during the course of the study.

10. Is being treated for hyperthyroidism at time of screening.

11. Has diagnosis of adrenal insufficiency.

12. 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.

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

14. 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.