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

Completed · Not applicable

Conditions studied: Diabetes

In brief

The purpose of this study is to collect confirmatory clinical data to support 6 or 7 days wear of EWIS (Extended Wear Infusion Set).

Key facts

Study ID

NCT04113694

Run by

Medtronic MiniMed, Inc.

People needed

291

Starts

2019-10-14

Expected to finish

2020-11-05

Last updated by the study team

2021-10-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is age 18 - 80 years at the time of screening
• Subject has type 1 diabetes for more than one year Study specific inclusion criteria
• 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):
• Humalog™* (insulin lispro injection)
• NovoLog™* (insulin aspart)

You may not qualify if…

• 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.
• Subject is female and has a positive pregnancy screening test
• 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
• Subject is female and plans to become pregnant during the course of the study
• Subject has Glycosylated hemoglobin (HbA1c) > 8.5 % at time of screening. Note: All HbA1c blood specimens will be sent to and tested by a NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
• 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
• Medical assistance (i.e. Paramedics, Emergency Room [ER] or Hospitalization)
• Coma
• Seizures
• 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.
• Subject is unable to tolerate tape adhesive in the area of infusion set
• Subject has any unresolved adverse skin condition in the area of infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
• Subject has infection in the area of infusion set placement at time of screening
• Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
• Subject is currently abusing illicit drugs
• Subject is currently abusing alcohol
• Subject is on dialysis (for renal failure)
• Subject has history of adrenal disorder
• Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening
• Subject has any condition that the Investigator believes would interfere with study participation
• 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
• Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
• Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
• Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening
• Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia

Where it is running

• Medical Investigations — Little Rock, Arkansas, United States
• AMCR Institute — Escondido, California, United States
• Stanford University — Palo Alto, California, United States
• SoCal Diabetes — West Covina, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• Metabolic Research Institute — West Palm Beach, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Endocrine Research Solutions — Roswell, Georgia, United States
• Iowa Diabetes and Endocrinology Center — West Des Moines, Iowa, United States
• Grunberger Diabetes Institute — Bloomfield Hills, Michigan, United States
• Mayo Clinic (Rochester MN) — Rochester, Minnesota, United States
• Diabetes and Endocrinology Consultants of Pennsylvania — Feasterville-Trevose, Pennsylvania, United States
• AM Diabetes and Endocrinology Center — Memphis, Tennessee, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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