NCT04503564

"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)

Feasibility of an Investigational Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Participants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Capillary Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using continuous subcutaneous insulin infusion with an infusion set that needs to be changed every 3 days. This study will assess the feasibility and device performance of the study device, the Achilles infusion set over three periods during routine insulin infusion. This study will include 20 participants and has 3 periods: Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7 days): participants will manage their blood glucose solely with their insulin pump and the Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose monitoring (CGM) device. Period 3 (up to 7 days): Participants will return to study center to receive a fresh Achilles infusion set and continue blood glucose management at home until infusion set failure or 7 days.

Detailed description

This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM). The CapBio Achilles infusion set is a sterile single use device designed to be used with commercially available infusion pumps (e.g., Medtronic MiniMed). The investigational Achilles infusion set contains a coil reinforced soft polymer indwelling cannula with one distal and three proximal holes. The primary objective of this study is to determine feasibility and device performance of the CapBio Achilles infusion set over 2 extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion. Feasibility is evidenced by the absence of uncontrolled hyperglycemia and/or suspected infusion set cannula occlusion.

Conditions

• Diabetes Mellitus, Type 1
• Type 1 Diabetes
• Type 1 Diabetes Mellitus
• Diabetes Mellitus, Insulin-Dependent, 1

Interventions

Type	Name	Description
DEVICE	coil-reinforced soft polymer indwelling cannula	This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).

Timeline

• Start date: 2019-11-13
• Primary completion: 2020-11-11
• Completion: 2020-11-11
• First posted: 2020-08-07
• Last updated: 2023-03-07
• Results posted: 2023-03-07

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study