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

NCT04152408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

  • Diabetes (DM)

Interventions

DEVICE

FiberSense System

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

  • Christoph Hasslacher, Prof. Dr. · Diabetes Institut Heidelberg, Germany

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Germany

Study Locations

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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 NCT04152408 on ClinicalTrials.gov