NCT04398030

Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Capillary Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	coil-reinforced soft polymer indwelling cannula	Insulin infusion set will be used for up to 7 days of continuous use or until failure
DEVICE	soft Teflon indwelling catheter	Insulin infusion set will be used for up to 7 days of continuous use or until failure

Timeline

• Start date: 2020-07-17
• Primary completion: 2021-04-22
• Completion: 2021-04-22
• First posted: 2020-05-21
• Last updated: 2022-08-11
• Results posted: 2022-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study