NCT04152408

Clinical and Home Use Feasibility Study of a Percutaneous Optical Glucose Fiber Sensor

A Study to Investigate the Function, Safety and Tolerability of the FiberSense System in Diabetic Patients for a Period of Continuous Blood Glucose Monitoring up to 30 Days

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: EyeSense GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-centre, open label (unblinded) prospective study investigating the performance and safety of FiberSense system in diabetic patients (Typ I and II). In the period of up to 30 days the performance of the FiberSense system is evaluated against laboratory gold standard method during 6 in-clinic sessions.

Detailed description

The FiberSense system is intended to be used by diabetic patients in a home use setting as a CGM system using the interstitial fluid (ISF) glucose as an indicator of blood glucose levels.The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges as compared with a laboratory standard reference method in diabetic patients (Type I and II) during in-clinic glucose challenge sessions. At the same time the blood glucose values are recorded by comparator continuous glucose monitoring (CGM) system and self-monitoring blood glucose system (SMBG). The safety aspects are also investigated during the wearing time of up to 30 days.

Conditions

• Diabetes (DM)

Interventions

Type	Name	Description
DEVICE	FiberSense System	FiberSense system, a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2019-11-05
• Last updated: 2025-03-06

Locations

1 site across 1 country: Germany