Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00740727 | EASI Access II --- Follow-up Study to the EASI Access Trial | PHASE1 | COMPLETED | 18 | — | — | Feb 1, 2009 | Mar 1, 2009 | Sep 11, 2009 | 1 | United States |
Ability of Basic Life Support (BLS) providers to place EASI access lines. The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed).
Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.
| Arm | Type | Description |
|---|---|---|
| EASI | EXPERIMENTAL | Subjects will undergo placement of EASI catheters. All subjects in whom EASI catheters are placed, will receive Human Recombinant Hyaluronidase (HRH) as part of the EASI placement. (No subject will receive HRH, other than as part of EASI catheter placement.) |
| Name | Type | Description |
|---|---|---|
| Human recombinant hyaluronidase (HRH) | DRUG | 150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water) |
| Enzymatically Augmented Subcutaneous Infusion (EASI) line placement | PROCEDURE | Subjects will under placement of an EASI line. This entails placement of a small (20-gauge) catheter in the upper back, in the subcutaneous space. |
Inclusion Criteria: * Subjects will be at least 18 years of age and have none of the following conditions: * pregnancy (negative urine pregnancy test to be performed before study participation), * diabetes, or coagulopathic (including taking any anticoagulants); * Subjects cannot be taking ste...