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Trial record 1 of 1 for:    medtronic cep298
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Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113694
Recruitment Status : Active, not recruiting
First Posted : October 3, 2019
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Brief Summary:
This study is a multi-center, non-randomized, prospective single arm study with Type 1 patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Subjects taking Novolog - 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.

  2. Subjects taking Humalog - Rate of infusion set failure at the end of Day 6 [ Time Frame: 144 hours ]
    Independently evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.


Secondary Outcome Measures :
  1. Subjects taking Novolog - 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.

  2. Subjects taking Humalog - Rate of infusion set failure at the end of Day 7. [ Time Frame: 168 hours ]
    Independently evaluate 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 type 1 diabetes for more than one year Study specific inclusion criteria
  3. 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.
  4. Subject is willing and able to perform study procedures as per investigator discretion
  5. 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):

    1. Humalog™* (insulin lispro injection)
    2. 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. 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
  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

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


Locations
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United States, Arkansas
Medical Investigations
Little Rock, Arkansas, United States, 72205
United States, California
AMCR Institute
Escondido, California, United States, 92025
Stanford University
Palo Alto, California, United States, 94304
SoCal Diabetes
West Covina, California, United States, 91790
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, Florida
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Endocrine Research Solutions
Roswell, Georgia, United States, 30076
United States, Iowa
Iowa Diabetes and Endocrinology Center
West Des Moines, Iowa, United States, 50265
United States, Michigan
Grunberger Diabetes Institute
Bloomfield Hills, Michigan, United States, 48302
United States, Minnesota
Mayo Clinic (Rochester MN)
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Diabetes and Endocrinology Consultants of Pennsylvania
Feasterville-Trevose, Pennsylvania, United States, 19053
United States, Tennessee
AM Diabetes and Endocrinology Center
Memphis, Tennessee, United States, 38133
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Sponsors and Collaborators
Medtronic Diabetes
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT04113694    
Other Study ID Numbers: CEP298
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases