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

NCT05133973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

FiberSense CGM

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

Sponsors & Collaborators

  • EyeSense GmbH

    lead INDUSTRY

Principal Investigators

  • Guido Freckmann, Dr.med. · Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2022-12-01
Completion
2023-05-17

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133973 on ClinicalTrials.gov