NCT05133973

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

Completed NA Last updated 6 March 2025

What this trial tests

NA trial testing FiberSense CGM in Diabetes in 15 participants. Completed in 17 May 2023.

Timeline

10 October 2022

Primary endpoint
1 December 2022

17 May 2023

Quick facts

Lead sponsor	EyeSense GmbH
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	15
Start date	10 October 2022
Primary completion	1 December 2022
Estimated completion	17 May 2023
Sites	1 location across Germany

Drugs / interventions tested

• FiberSense CGM

Conditions studied

• Diabetes — all drugs for Diabetes →

Sponsor

EyeSense GmbH

Who can join

Adults 18 to 65, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Patent analysis of digital sensors for continuous glucose monitoring.
   Litvinova O, Eitenberger M, Bilir A, Yeung AWK, et al · · 2023 · cited 8× · PMID 37621612 · DOI 10.3389/fpubh.2023.1205903