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Safety and Efficacy of 7-day Wear Infusion Set vs. Control Infusion Set.

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: NCT04208282
Recruitment Status : Completed
First Posted : December 23, 2019
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr. Jacob Ilany MD, Sheba Medical Center

Brief Summary:
The purpose of this study is to evaluate the Extended Wear (EW) infusion set seven day functioning in patients with Type 1 diabetes compared to the Quick-set infusion set. The study will be carried out in adults with type 1 diabetes.

Condition or disease Intervention/treatment Phase
Type1diabetes Device: 7 day infusion set Not Applicable

Detailed Description:

This is a 1-center, prospective, open label randomized, crossover controlled study.

40 patients will be using 4 infusion sets (a total of 160 sets) that will serve as an exploratory pilot study to assess the SD of 7 day use for future study design.

Eligible patients meeting the enrollment and randomization criteria will be randomized into 2 arms, each arm will undergo 2 phases. In each phase a different type of infusion set will be evaluated. Each evaluation will be for4 sets (up to 28 days). The order will be determined by the randomization process:

  • Arm 1: Quick-EWIS. First phase Quickset, second phase EWIS.
  • Arm 2: EWIS-Quick. First phase EWIS, second phase Quickset.

Following screening and informed consenting to the trial, a randomized procedure will define the subject trial arm:

  • Trial Arm A: Subjects will be randomized to a group who will be using the Quickset infusion system for the Phase 1. All patients will be retrained on the use of the Quickset infusion set by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 7 days or at set failure (replace with another Quick-set). At day 28 or after using 4 sets (set used defined as a set that was used for more than 6 hours), the patients will return to a visit, return all the extracted catheters sets and will switch to the X infusion set, entering Phase 2. All patients will be trained at this visit on the use of the X EW infusion set by site staff and demonstrate proficiency in the use of the EW infusion set. After 28 days or after using 4 sets, the patients will return all the extracted catheters sets .
  • Trial Arm B: Subjects will be randomized to a group who will be using the EWIS set infusion system for the initial Phase. All patients will be trained on the use of the EWIS infusion set by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 7 days or at set failure (replace with another Quick-set). At day 28 or after using 4 sets (set used defined as a set that was used for more than 6 hours), the patients will return to a visit, return all the extracted catheters sets and will switch to the Quickset infusion set, entering Phase 2. All patients will then be retrained on the use of the Quickset infusion set by site staff and demonstrate proficiency. After 28 days or after using 4 sets, the patients will all the extracted catheters sets .

An extension phase for additional one month (4 sets) will be conducted as a single arm to assess the seven day durability of sets.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of 7-day Wear Infusion Set vs. Control Infusion Set.
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Trial Arm A
Quickset infusion system for the Phase 1. At day 28 or after using 4 sets , the patients will return to a visit, return all the extracted catheters sets and will switch to the 7 day set infusion set, entering Phase 2.
Device: 7 day infusion set
7 days survival of the sets

Active Comparator: Trial Arm B
7 day set infusion set for the Phase 1. At day 28 or after using 4 sets , the patients will return to a visit, return all the extracted catheters sets and will switch to the Quickset infusion systems , entering Phase 2.
Device: 7 day infusion set
7 days survival of the sets




Primary Outcome Measures :
  1. Primary [ Time Frame: 8 weeks ]
    • Percent of catheters reaching 4, 5, 6, 7 days use without set failure.


Secondary Outcome Measures :
  1. Exploratory outcomes [ Time Frame: 8 weeks ]
    • Exploratory investigation of correlation between glycemia as measured by CGM records and pressure measurements, as recorded by the insulin pump.
    • Descriptive of site reactions. Pain at the infusion site device related issues (leakage, occlusion in fluid path, etc.).
    • Descriptive of set failure cases: accidental pull out, adhesive tape issues, infection, erythema and/or induration.
    • Descriptive of catheter explants:

      • Gross examination for cannula kinking and crimping.


Other Outcome Measures:
  1. Adverse Events [ Time Frame: 8 weeks ]
    • Diabetic ketoacidosis (DKA)
    • Severe hypoglycemia
    • Severe hyperglycemia
    • Serious adverse events (SAEs)
    • Unanticipated adverse device effects (UADEs)



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. Clinical diagnosis of type 1 diabetes for at least one year
  2. Using a MiniMed™ VEO pump or 640G Insulin pump with or without using an Enlite™ Sensor .
  3. Age 18 to 80 years
  4. Hemoglobin A1c level less than or equal to 10%
  5. Not currently known to be pregnant, nor planning pregnancy during the study.
  6. Willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

  1. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
  2. Pregnant or lactating females

    -


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): NCT04208282


Locations
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Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Medtronic
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Responsible Party: Dr. Jacob Ilany MD, M.D., Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04208282    
Other Study ID Numbers: 1.0
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases