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Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Insulin-Requiring Diabetes

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ClinicalTrials.gov Identifier: NCT04113694
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Brief Summary:
This study is a multi-center, non-randomized, prospective single arm study with insulin-requiring patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM).

Condition or disease Intervention/treatment Phase
Diabetes Device: Extended Wear Infusion Set Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Insulin-Requiring Diabetes
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Extended Wear Infusion Set
Each subject will be given 12 Extended Wear Infusion Sets to wear.
Device: Extended Wear Infusion Set
Subjects will perform each Extended Wear Infusion Set wear for at least 174 hours.
Other Name: EWIS




Primary Outcome Measures :
  1. Rate of infusion set failure at the end of Day 6 [ Time Frame: 144 hours ]
    Rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6


Secondary Outcome Measures :
  1. Rate of infusion set failure at the end of Day 7. [ Time Frame: 168 hours ]
    Rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is age 18 - 80 years at the time of screening
  2. Subject has insulin requiring diabetes for more than one year
  3. Subject is currently on the MiniMed™ 670G insulin pump therapy with Auto Mode and utilizing CGM with Guardian™ Sensor (3) for greater than 3 months prior to screening, but has been on insulin pump for at least 6 months.
  4. Subject is willing and able to perform study procedures as per investigator discretion
  5. Subject is currently using and will continue to use one of the following insulins and can financially afford to use one of the following insulins throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount)

    1. Humalog™* (insulin lispro injection)
    2. NovoLog™* (insulin aspart)
  6. Subject is currently using and will continue to use Guardian Sensor (3) and can financially afford to use the Guardian Sensor (3) throughout the course of the study (i.e. co-payments for sensors with insurance or able to pay full amount)

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) > 8.0 % 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.
  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

    1. Medical assistance (i.e. Paramedics, Emergency Room [ER] or Hospitalization)
    2. Coma
    3. 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 or marijuana
  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 at 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113694


Contacts
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Contact: Eileen Sneeden, PhD (818) 576-5203 eileen.sneeden@medtronic.com

Locations
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United States, Florida
Metabolic Research Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Sean Sullivan    561-802-3060 ext 8015    ssullivan@metabolic-institute.com   
Contact: Paula Dear    561-802-3060 ext 8045    pdear@metabolic-institute.com   
Principal Investigator: Barry Horowitz, MD         
Sub-Investigator: Kaye William, MD         
Sub-Investigator: Jaime Steinsapir, MD         
Sponsors and Collaborators
Medtronic Diabetes

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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT04113694     History of Changes
Other Study ID Numbers: CEP298
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs