At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Crossover Euglycemic Clamp Study in Adult Patients With T1DM 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
In Brief
A clinical study evaluating coil-reinforced soft polymer indwelling cannula and soft Teflon indwelling catheter for Diabetes Mellitus, Type 1 and Type 1 Diabetes. Completed, enrolled 7 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Insulin infusion set will be used for up to 7 days of continuous use or until failure
Insulin infusion set will be used for up to 7 days of continuous use or until failure