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A Study to Investigate a Transdermal Continuous Glucose Monitoring System in Diabetic Patients for a Period of 28 Days

NCT06868043 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-10

No results posted yet for this study

Summary

Single-centre, open label (unblinded). A maximum of 48 patients will be enrolled in 4 Cohorts of 10 patients and 2 potential replacements each. Diabetic patients (type 1 and 2). Duration up to 11 weeks: up to 6 weeks of screening phase (42 days); 4 weeks of treatment/measurement phase (28 days, depending on sensor functionality) and 1 week of follow up (7 days)

Conditions

  • Diabetes (DM)

Interventions

DEVICE

FiberSense System

FiberSense system, a novel CGM system using interstitial fluid (ISF) glucose as an indicator of blood glucose levels by diabetic patients

Sponsors & Collaborators

  • EyeSense GmbH

    lead INDUSTRY

Principal Investigators

  • Christoph Hasslacher, Prof. Dr. · Diabetesinstitut Heidelberg

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-10-31
Completion
2014-06-30

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 NCT06868043 on ClinicalTrials.gov