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

March 5, 2025 updated by: EyeSense GmbH

A Study to Investigate the Function, Safety and Tolerability of a Transdermal Continuous Glucose Monitoring System in Diabetic Patients (type 1 and 2) for a Period of 28 Days

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)

Study Overview

Status

Status

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

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

This study is an investigational study, which will be conducted only at one site in Germany. The investigators, the patient and the sponsor will be unblinded.

The eligibility of the patient is determined in up to two steps, a screening (see inclusion criteria) and in case of women of childbearing potential a urine pregnancy test at the day of sensor insertion (independent of any re-screening). Women of childbearing potential are only enrolled after a negative outcome of the urine pregnancy test. The screening results are valid up to 42 days. Within that time the first measurement visit including the insertion of the device should be performed. If the first measurement visit is delayed a re-screening has to be performed. Should the patient not pass the re-screening, the patient is considered as a screening failure and must be excluded.

The trial is structured into three phases, the screening/enrolment phase, the insertion/measurement phase and the follow-up phase.

Screening/Enrolment Phase: Up to 6 weeks (42 days), 1 visit

Insertion/Measurement phase: Up to 4 weeks (28 days), up to 6 in-house measurement visits

Follow-up Phase: 1 week (7 days), 1 visit

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.
10

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 Instiut 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body mass index within the range of 19-40 kg/m2, inclusive
  • Diabetes type 1 and 2
  • Females (if of childbearing potential) 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 during the study
  • Negative urine pregnancy test immediately before sensor insertion (only women of childbearing potential)
  • Signed written Informed Consent

Exclusion Criteria:

  • Inability to follow the protocol schedule
  • Participating in another clinical trial
  • Pregnant or lactating females, , including positive urine pregnancy test immediately before sensor insertion
  • Any known hypersensitivity to any of the products used in the study, including preservatives etc. Especially hypersensitivity against legumes
  • Tattoos at the abdominal or upper arm skin area where the fiber sensor is supposed to be placed
  • Malignancies requiring therapy during the study
  • Severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study
  • Acute severe infection disease at the time of enrolment
  • Alcohol and/or drug addiction
  • Vulnerable patients (e.g. persons kept in detention)
  • Poorly controlled diabetes mellitus with hemoglobin A1C higher than 10%

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: Non-Randomized
  • Interventional Model: Sequential 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: Cohort A

Subjects will wear 2 FiberSense systems (arm and abdomen) inserted on day 00 and a comparator continuous glucose monitoring (CGM) system on abdomen, changed on weekly basis. They will participate in six clinic in-house sessions on days 00, 03, 07, 14, 21 and 28.

There will be no home use days, solely several hours of extended use blood glucose readings after selected in-clinic sessions.
Device: FiberSense System
FiberSense system, a novel CGM system using interstitial fluid (ISF) glucose as an indicator of blood glucose levels by diabetic patients
Experimental: Cohort B

Subjects will wear 2 FiberSense systems (arm and abdomen) inserted on day 00 and a comparator CGM system on abdomen, changed on weekly basis. They will participate in six clinic in-house sessions on days 00, 03, 07, 14, 21 and 28.

Home use measurement days will be scheduled to wear FiberSense systems for 8-12 hours on days directly before and after a measurement visit day - day 6, 8, 13, 15, 20, 22, and 27.
Device: FiberSense System
FiberSense system, a novel CGM system using interstitial fluid (ISF) glucose as an indicator of blood glucose levels by diabetic patients
Experimental: Cohort C

Subjects will wear 2 FiberSense systems (arm and abdomen) inserted on day 00 and a comparator CGM system on abdomen, changed on weekly basis. They will participate in six clinic in-house sessions on days 00, 03, 07, 14, 21 and 28.

Home use measurement days will be scheduled to handle and wear FiberSense systems independently on daily basis (min. 8 hours) between measurement visit days - day 4-6, 8-13, 15-20, and 22-27.

In addition, interim visits are scheduled at Day 10, 17, and 24 for sensor site and adverse event assessment.
Device: FiberSense System
FiberSense system, a novel CGM system using interstitial fluid (ISF) glucose as an indicator of blood glucose levels by diabetic patients
Experimental: Cohort D

Subjects will wear 2 FiberSense systems (arm and abdomen) inserted on day 00 and a comparator CGM system on abdomen, changed on weekly basis. They will participate in six clinic in-house sessions on days 00, 03, 07, 14, 21 and 28.

Home use measurement days will be scheduled to handle and wear FiberSense systems independently on daily basis (min. 8 hours) between measurement visit days - day 4-6, 8-13, 15-20, and 22-27.

In addition, interim visits are scheduled at Day 10, 17, and 24 for sensor site and adverse event assessment.
Device: FiberSense System
FiberSense system, a novel CGM system using interstitial fluid (ISF) glucose as an indicator of blood glucose levels by diabetic patients

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
Short and mid term performance of the transdermal CGM sensor determined as MARD
Time Frame: 0, 3, 7, 14, 21 and 28 days
Mean absolute relative difference (MARD) of FiberSense system to blood glucose
0, 3, 7, 14, 21 and 28 days
Incidence of adverse events
Time Frame: 0, 3, 7,14, 21, 28 and 35-38 days
Assessment of adverse events and local tolerability occurred during the study
0, 3, 7,14, 21, 28 and 35-38 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
Stability of the blood glucose to fluorescence correlation
Time Frame: 0, 3, 7, 14, 21 and 28 days
FiberSense fluorescence measurement signals calculated in glucose values and compared to glucose values measured with: a: SMBG device (Bayer Contour next USB), b: CGM device (Dexcom Seven plus), c: Laborat orysystem (Hitado Super GL compact)
0, 3, 7, 14, 21 and 28 days
Changes in blood glucose to fluorescence lag time over a period of up to 28 days
Time Frame: 0, 3, 7, 14, 21 and 28 days
Lag time (in minutes) between FiberSense readings and corresponding laboratory blood glucose values during glucose excursions
0, 3, 7, 14, 21 and 28 days
Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements
Time Frame: 0, 3, 7, 14, 21 and 28 days
Calculation of MARD of FiberSense against a commercial self-monitoring blood glucose meter
0, 3, 7, 14, 21 and 28 days
Signal-to-noise ratio
Time Frame: 0, 3, 7, 14, 21 and 28 days
0, 3, 7, 14, 21 and 28 days
Signal drift
Time Frame: 0, 3, 7, 14, 21 and 28 days
Drift of the FiberSense fluorescent measurement signals over the wearing time
0, 3, 7, 14, 21 and 28 days
User satisfaction assessed by the Likert scale
Time Frame: 35-38 days
Subjective impression of the patients assessed by 5-point Likert scale (1- strongly agree to 5 - strongly disagree)
35-38 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., Diabetesinstitut Heidelberg

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.
July 1, 2012

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.
October 1, 2012

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.
June 1, 2014

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).
March 4, 2025

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.
March 5, 2025

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.
March 25, 2025

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 5, 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-4.2-C-0.1

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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