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History of Changes for Study: NCT04113694
Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Insulin-Requiring Diabetes
Latest version (submitted September 29, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 1, 2019 None (earliest Version on record)
2 October 14, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 December 12, 2019 Outcome Measures, Contacts/Locations, Study Status, Arms and Interventions, Study Identification, Eligibility, Study Design and Study Description
4 February 18, 2020 Study Status and Contacts/Locations
5 March 11, 2020 Study Status and Contacts/Locations
6 April 10, 2020 Contacts/Locations and Study Status
7 May 12, 2020 Study Status and Contacts/Locations
8 July 13, 2020 Recruitment Status, Study Status and Contacts/Locations
9 August 13, 2020 Study Design and Study Status
10 November 24, 2020 Recruitment Status and Study Status
11 August 10, 2021
Quality Control Review has not concluded Returned: September 2, 2021
Outcome Measures, Study Status, Arms and Interventions, Study Description, Document Section
12 September 29, 2021 Adverse Events, Study Status, Outcome Measures
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Study NCT04113694
Submitted Date:  October 1, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: CEP298
Brief Title: Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Insulin-Requiring Diabetes
Official Title: Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Insulin-Requiring Diabetes
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2019
Overall Status: Not yet recruiting
Study Start: October 2019
Primary Completion: April 2020 [Anticipated]
Study Completion: April 2020 [Anticipated]
First Submitted: October 1, 2019
First Submitted that
Met QC Criteria:
October 1, 2019
First Posted: October 3, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
October 1, 2019
Last Update Posted: October 3, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Medtronic Diabetes
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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).
Detailed Description:
Open or close this module Conditions
Conditions: Diabetes
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • EWIS
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Eileen Sneeden, PhD
Telephone: (818) 576-5203
Email: eileen.sneeden@medtronic.com
Locations: United States, Florida
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401
Contact:Contact: Sean Sullivan 561-802-3060 Ext. 8015 ssullivan@metabolic-institute.com
Contact:Contact: Paula Dear 561-802-3060 Ext. 8045 pdear@metabolic-institute.com
Contact:Principal Investigator: Barry Horowitz, MD
Contact:Sub-Investigator: Kaye William, MD
Contact:Sub-Investigator: Jaime Steinsapir, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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