Medtronic Extended Infusion Set Wear

Clinical Study Details

Title

Evaluation of Extended Wear Infusion Set (EWIS) in Patients with Type 1 Diabetes

Description

This study is evaluating a novel, long-wear insulin infusion set. The purpose of this study is to collect data to support 6 or 7 days of wear for these infusion sets. 

In this study you must be an adult with type 1 diabetes and be using a Medtronic 670G pump. You will be given 12 Medtronic Extended Wear infusion sets to wear, you will be asked to wear each infusion set for 174 hours (7 days and 6 hours) or until infusion set failure, whichever comes first. 

5 in-office visits, 2 phone call visits

This study will last aproximately 3-4 months. 

Inclusion Criteria

  • Subject is age 18 – 80 years at the time of screening
  • Subject has type 1 diabetes for more than one year
  • Subject is on the MiniMed™ 670G insulin pump therapy within 1 year prior to screening and willing to utilize Auto Mode and CGM with Guardian™ Sensor (3) during the study.
  • Subject is willing and able to perform study procedures as per investigator discretion
  • Subject is willing to take one of the following insulins and can financially support the use of 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):
    a. Humalog™* (insulin lispro injection)
    b. NovoLog™* (insulin aspart)

Exclusion Criteria

  • 1. Subject 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.
  • 2. Subject is female and has a positive pregnancy screening test
  • 3. Subject is female of child bearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator
  • 4. Subject is female and plans to become pregnant during the course of the study
  • 5. Subject has Glycosylated hemoglobin (HbA1c) > 8.5 % at time of screening.
  • 6. Subject has had a history of 1 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
  • 7. Subject has taken any oral, injectable, or 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.
  • 8. Subject is unable to tolerate tape adhesive in the area of infusion set
  • 9. Subject has any unresolved adverse skin condition in the area of infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
  • 10. Subject has infection in the area of infusion set placement at time of screening
  • 11. Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
  • 12. Subject is currently abusing illicit drugs
  • 13. Subject is currently abusing alcohol
  • 14. Subject is on dialysis (for renal failure)
  • 15. Subject has history of adrenal disorder
  • 16. Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening
  • 17. Subject has any condition that the Investigator believes would interfere with study participation
  • 18. Subject 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
  • 19. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
  • 20. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  • 21. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening
  • 22. Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia
  • 23. Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.
  • 24. Subject has hypothyroidism and has out of reference range thyroid-stimulating hormone (TSH) on screening visit (prior labs in the last 3 months are sufficient). Subject may repeat TSH draw to verify eligibility if not in range

More Info

If you're interested in learning more about this study, please reach out to the research coordinator listed on the right. You may also download the consent form, assent form, and any other documents linked on the right.


Study Contact

Eliana Frank

650 721 8782

elianaf@stanford.edu

Study Documents

Consent