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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 : Completed
First Posted : October 3, 2019
Results First Posted : October 1, 2021
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Tracking Information
First Submitted Date  ICMJE October 1, 2019
First Posted Date  ICMJE October 3, 2019
Results First Submitted Date  ICMJE August 10, 2021
Results First Posted Date  ICMJE October 1, 2021
Last Update Posted Date October 1, 2021
Actual Study Start Date  ICMJE October 14, 2019
Actual Primary Completion Date November 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2021)
  • Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6 [ Time Frame: 144 hours ]
    Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.
  • Novolog Subjects - 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2021)
  • Humalog Subject - Rate of Infusion Set Failure at the End of Day 7. [ Time Frame: 168 hours ]
    Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
  • Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7. [ Time Frame: 168 hours ]
    Independently evaluated rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
Official Title  ICMJE Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
Brief Summary The purpose of this study is to collect confirmatory clinical data to support 6 or 7 days wear of EWIS (Extended Wear Infusion Set).
Detailed Description 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). A total of up to 300 subjects age 18-80 will be enrolled at up to 20 investigational centers in the US. Each subject will wear their own MiniMed™ 670G insulin system. Each subject will be given 12 infusion sets to wear (each infusion set for at least 174 hours, or until infusion set failure if this occurs before 174 hours). Subjects will change insulin reservoirs at least every 174 hours. The time of infusion set insertion will be taken from Daily Log. Subjects can expect to participate for approximately 12-16 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes
Intervention  ICMJE Device: Extended Infusion Set
Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.
Other Name: Extended Wear Infusion Set
Study Arms  ICMJE Experimental: Extended Wear Infusion Set
Each subject is given 12 Extended Wear Infusion Sets to wear.
Intervention: Device: Extended Infusion Set
Publications * Brazg R, Garg SK, Bhargava A, Thrasher JR, Latif K, Bode BW, Bailey TS, Horowitz BS, Cavale A, Kudva YC, Kaiserman KB, Grunberger G, Reed JC, Chattaraj S, Zhang G, Shin J, Chen V, Lee SW, Cordero TL, Rhinehart AS, Vigersky RA, Buckingham BA. Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial. Diabetes Technol Ther. 2022 Aug;24(8):535-543. doi: 10.1089/dia.2021.0540. Epub 2022 Mar 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2020)
291
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2019)
150
Actual Study Completion Date  ICMJE November 5, 2020
Actual Primary Completion Date November 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04113694
Other Study ID Numbers  ICMJE CEP298
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Medtronic Diabetes
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medtronic Diabetes
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medtronic Diabetes
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP