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The purpose of this study is to compare the in-line fluid pressure (pressure of the fluid going through the tubing) and leakage (observation of fluid on and around the device) during and after subcutaneous infusion using two types of infusion sets. One infusion set is investigational, developed by BD, and the other is the Quick-set (Medtronic), which is commercially available. These infusion sets will be used with a commercially available insulin pump to deliver insulin diluent (an inactive liquid with no medication) for approximately 4 1/2 hours. During this time pressure and leakage will be continuously monitored.
This is a single center, open label study.
Each subject is to receive up to 4 basal/bolus diluent infusions in the abdomen with the BD Scarlett and the Medtronic Quick-set®; 2 Scarlett infusion sets and 2 Quick-set infusion sets. The order of device placement will be randomized.
After insertion, insulin diluent will be delivered at a rate of 0.01 mL/hour (equivalent in volume and rate to 1.0 unit/hour of U-100 insulin) via the insulin pump for a minimum of 3 hours. After 3 hours of basal infusion, a bolus of 0.1 mL (equivalent to 10 units) will be delivered via the insulin pump and basal infusion continued for a minimum of 1 additional hour.
At the end of the final basal infusion period, the infusion set tubing will be clamped to mimic an occlusion event and allowed to run until either an occlusion alert ("no delivery") is signaled by the pump, or a minimum of 30 minutes, whichever comes first. Infusion pressure data will be collected during the entire infusion period, including the time the tubing is clamped. After removal of the device from the body, the presence of fluid on the application site skin (Leakage) will be determined by visual assessment then measured using gravimetric analysis, if applicable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infusion set | Each subject will receive a total of 4 simultaneous subcutaneous infusions of insulin diluent, two using the investigational device (BD Scarlett Infusion Set) and two using the the comparator (Medtronic QuickSet Infusion Set). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD Scarlett Infusion set | Device | Each subject will receive subcutaneous infusion from two investigational BD Scarlet infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| In-line fluid pressure | Infusion pressure profiles will be measured by an inline pressure transducer and recorded by a data logger. Pressure profiles will be evaluated by type of infusion set. The occurrence of pressure events (continuous pressure rises or flow interruptions of at least 30 minutes) will be assessed. | Continuous measure for 4-5 hours after insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Leakage | Upon removal of the infusion set, the infusion site and device will be checked for fluid leakage. If leakage is observed, the infusion site device hub/skin interface will be swabbed for fluid with a pre-weighed swab. The swab will be re-weighed to determine the amount of fluid. Fluid collected at infusion site and the device/skin interface will not be classified as leakage if the measured volume is less than 0.005 mL (equivalent to 0.5 units U-100 insulin). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | During the study visit subjects will be asked about adverse events that may have occurred. All adverse events, e.g. skin irritation, allergic reaction, excessive pain, will be evaluated, appropriately treated and followed up as appropriate. | Approximately 6 hours from device application until study completion. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip LaStella, MD | TKL Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research | Fair Lawn | New Jersey | 07410 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Medtronic QuickSet Infusion Set | Device | Each subject will receive subcutaneous infusion from two Medtronic infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours. |
|
| Immediately upon device removal |