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Trial record 2 of 3 for:    medtronic extended wear

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113694
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : December 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 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)
Estimated Enrollment : 300 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 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Contacts
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Contact: Eileen Sneeden, PhD 818 576 5203 eileen.sneeden@medtronic.com
Contact: Emma Pham, MSHS 818 576 4878 emma.pham@medtronic.com

Locations
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United States, Colorado
Barbara Davis Center for Childhood Diabetes Recruiting
Aurora, Colorado, United States, 80045
Contact: Jamie Demmitt    303-724-6758    JAMIE.DEMMITT@CUANSCHUTZ.EDU   
Principal Investigator: Satish Garg         
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         
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Contact: Betsy Childs    404-355-4393 ext 864    BChilds@atlantadiabetes.com   
Principal Investigator: Bruce Bode, MD         
United States, Iowa
Iowa Diabetes and Endocrinology Center Recruiting
West Des Moines, Iowa, United States, 50265
Contact: Kara Turner       kturner@iderc.com   
Principal Investigator: Anuj Bhargava, MD         
United States, Michigan
Grunberger Diabetes Institute Not yet recruiting
Bloomfield Hills, Michigan, United States, 48302
Contact: Igor Kupriyanchik    248-335-7740 ext 101    ikupriyanchik@gdi-pc.com   
Principal Investigator: George Grunberger         
United States, Tennessee
AM Diabetes and Endocrinology Center Not yet recruiting
Memphis, Tennessee, United States, 38133
Contact: Lesley Draffin    901-531-6236    ldraffin@amdiabetes.net   
Principal Investigator: Kashif Latif         
United States, Washington
Rainier Clinical Research Center Not yet recruiting
Renton, Washington, United States, 98057
Contact: Yeshi Taye    425-251-1720 ext 22    YTaye@rainier-research.com   
Principal Investigator: Ronald Brazg         
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: December 16, 2019
Last Verified: December 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
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases