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

March 4, 2025 updated by: EyeSense GmbH

A Study to Investigate the Function, Safety and Tolerability of the FiberSense System in Diabetic Patients for a Period of Continuous Blood Glucose Monitoring Up to 30 Days

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 and II) during in-clinic glucose challenge sessions. At the same time the blood glucose values are recorded by comparator continuous glucose monitoring (CGM) system and self-monitoring blood glucose system (SMBG). The safety aspects are also investigated during the wearing time of up to 30 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69115
        • Diabetes Institut Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female age ≥ 18 years old.
  • Type I or II diabetes mellitus.
  • Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study. If of child bearing potential, the patient must agree to abstain from sexual intercourse or use reliable forms of contraception (e.g. condom or diaphragm with spermicide or oral contraceptives) to prevent pregnancy for the length of the clinical study.
  • Willingness, ability and commitment to comply with the testing procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits, use of pre-specified glucose monitoring device.
  • Willingness to abstain from swimming during their participation in the measurement phase.
  • Willingness to abstain from air travelling during their participation in the measurement phase.
  • Willingness to avoid strong magnetic and electrical fields as well as proximity to sensitive medical devices due to the possible electromagnetic interference during their participation in the measurement phase.
  • In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
  • Written informed consent to participate in the study provided by the patient.

Exclusion Criteria:

  • Poorly controlled diabetes mellitus with HbA1C >10%.
  • Known microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as e.g. history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (with glomerular filtration rate (eGFR) < 45 ml/min) or neuropathy requiring treatment.
  • History of significant hypoglycemia unawareness, or a history of severe hypoglycemia (requiring emergency medical intervention) within the last 6 months.
  • Currently pregnant, as demonstrated by a positive pregnancy test at screening and prior to enrollment.
  • Impaired hepatic function measured as aspartate aminotransferase (AST) ≥ three times the upper reference limit.
  • Impaired renal function measured as creatinine > 1.2 times above the upper limit of normal.
  • Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
  • Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
  • Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
  • Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
  • Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
  • Known current or recent alcohol or drug abuse
  • Blood donation of more than 500 ml within the last three months
  • Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
  • Has a MRI scan, CT scan, diathermy or flight scheduled during the proposed study participation.
  • An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FiberSense System
6 diabetic patients will wear a FiberSense system at the upper arm for up to 30 days. and a comparator CGM system at the abdomen (replaced every 7 days).
Device: FiberSense System
FiberSense system, a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Performance of the FiberSense system as compared with laboratory gold standard reference (LGSR)
Time Frame: at 1, 3, 7, 14, 21 and 28 days
Point accuracy of the FiberSense system as determined by proportion of CGM readings within ≤15% of the LGSR reading for blood glucose levels >100 mg/dl, and within ≤15 mg/dl of the LGSR reading for blood glucose levels ≤100 mg/dl, for paired samples taken during the in-clinic sessions.
at 1, 3, 7, 14, 21 and 28 days
Duration of use of the FiberSense system
Time Frame: 30 days
Duration of use of the FiberSense device in average and by individual patients
30 days
Incidence of (Serious) Adverse Events
Time Frame: 30 days
Adverse Events reporting and local tolerability as assessed by Draize's scale
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean and Median Relative Differences in FiberSense measured glucose from LGSR
Time Frame: at 1, 3, 7, 14, 21 and 28 days
at 1, 3, 7, 14, 21 and 28 days
Mean and Median Absolute Relative Differences in FiberSense measured glucose from reference laboratory standard
Time Frame: at 1, 3, 7, 14, 21 and 28 days
at 1, 3, 7, 14, 21 and 28 days
Hypoglycemia (<75 mg/dl (14)) and hyperglycemia (>180 mg/dl (14)) detection rates
Time Frame: at 1, 3, 7, 14, 21 and 28 days
at 1, 3, 7, 14, 21 and 28 days
Hypoglycemia (<75 mg/dl) and hyperglycemia (>180 mg/dl,) missed detection rates
Time Frame: at 1, 3, 7, 14, 21 and 28 days
at 1, 3, 7, 14, 21 and 28 days
Accuracy of glucose rate of change of FiberSense sensor compared to glucose rate of change of reference laboratory standard
Time Frame: at 1, 3, 7, 14, 21 and 28 days
at 1, 3, 7, 14, 21 and 28 days
Lag time between FiberSense readings and reference laboratory standard results during induced glucose excursions
Time Frame: at 1, 3, 7, 14, 21 and 28 days
at 1, 3, 7, 14, 21 and 28 days
Agreement and accuracy relative to SMBG readings (same model to be used by all patients)
Time Frame: weekly - Days 7, 14, 21, 28
Performance of SMBG evaluated as percentage of system readings within 15%, 20%, 30% and 40% of LGSR values and by means of MARD and MedARD(%)
weekly - Days 7, 14, 21, 28
Stability of the FiberSense fluorescence measurements
Time Frame: weekly - Days 7, 14, 21, 28
The stability of sensor performance over the 30-day time period evaluated as percentage of FiberSense system readings within 15%, 20%, 30% and 40% of LGSR values and by means of MARD and MedARD(%)
weekly - Days 7, 14, 21, 28
User satisfaction assessed by the Likert scale
Time Frame: 30 days
Subjective impression of the patients on the scale of 1 (strongly agree) to 5 (strongly disagree)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EyeSense GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christoph Hasslacher, Prof. Dr., Diabetes Institut Heidelberg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P-4.3-C-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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