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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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:
Following screening and informed consenting to the trial, a randomized procedure will define the subject trial arm:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial Arm A | Experimental | 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. |
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| Trial Arm B | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7 day infusion set | Device | 7 days survival of the sets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary | • Percent of catheters reaching 4, 5, 6, 7 days use without set failure. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events |
| 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
Pregnant or lactating females
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | Israel |
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| 8 weeks |