NCT05133973

Feasibility Study of a Transdermal Continuous Glucose Monitoring (CGM) System in Diabetic Patients

Effectiveness and Safety Study to Investigate the Improved FiberSense Continuous Glucose Monitoring System in Diabetic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: EyeSense GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A single centered, prospective, double blinded study enrolling 12 Type I diabetic patients (+ up to 4 replacements) in two cohorts. Patients will wear multiple FiberSense CGM systems for 28 days, with total duration of the participation up to 8 weeks (screening + active phase + follow up). The primary aims of the study are assessment of the safety and tolerability of the FiberSense CGM system during the wearing time together with characterization of the system performance when compared to capillary blood samples.

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) during in-clinic glucose challenge sessions. At the same time and also at home use the blood glucose values are recorded by comparator system and self-monitoring blood glucose system (SMBG). The safety aspects are also investigated during the wearing time of 28 days. The two cohorts differ in the measurement scheduled, with intensive measurement week either at week 1 (cohort A) or week 2 (cohort B).

Conditions

• Diabetes

Interventions

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

Timeline

• Start date: 2022-10-10
• Primary completion: 2022-12-01
• Completion: 2023-05-17
• First posted: 2021-11-24
• Last updated: 2025-03-06

Locations

1 site across 1 country: Germany