PK/PD of an Extended Wear Infusion Set for CSII in T1DM Patients ("PEXIS")

Randomized Crossover Euglycemic Clamp Study in Adult Patients With Type 1 Diabetes to Assess Pharmacokinetics and Pharmacodynamics of Subcutaneously Infused Insulin Using an Investigational Extended Wear Continuous Subcutaneous Insulin Infusion Cannula Compared to a Commercial Infusion Set

This study has been designed as a prospectively enrolled, randomized sequence, 2-way crossover study of device performance, tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer indwelling cannula versus a commercial insulin infusion set using a soft Teflon indwelling cannula, during two 7-day home use periods with 4 in-clinic euglycemic clamp sessions during each of the 7-day periods. After a wash-out period, subjects will cross over into the investigational or control group, respectively.

PK/PD of an Extended Wear Infusion Set for CSII in T1DM Patients ("PEXIS")

Recruitment

Summary

Participation Requirements

Description

Tracking Information