Diabetes (DM)NCT04152408
Clinical and Home Use Feasibility Study of a Percutaneous Optical Glucose Fiber Sensor
A study testing FiberSense System in people with Diabetes (DM), run by EyeSense GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (DM)
- What is being tested?
- FiberSense System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes (DM)
- Being tested
- FiberSense System
- Keywords
- diabetes management, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberSense SystemDevice
FiberSense system, a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.
| Study group | Role | What they receive |
|---|---|---|
| FiberSense System | Experimental | 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). Receives: Device: FiberSense System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the FiberSense system as compared with laboratory gold standard reference (LGSR)
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.
Measured: at 1, 3, 7, 14, 21 and 28 days
Duration of use of the FiberSense system
Duration of use of the FiberSense device in average and by individual patients
Measured: 30 days
Incidence of (Serious) Adverse Events
Adverse Events reporting and local tolerability as assessed by Draize's scale
Measured: 30 days
Secondary outcomes (9)
Mean and Median Relative Differences in FiberSense measured glucose from LGSR
Measured: at 1, 3, 7, 14, 21 and 28 days
Mean and Median Absolute Relative Differences in FiberSense measured glucose from reference laboratory standard
Measured: at 1, 3, 7, 14, 21 and 28 days
Hypoglycemia (<75 mg/dl (14)) and hyperglycemia (>180 mg/dl (14)) detection rates
Measured: at 1, 3, 7, 14, 21 and 28 days
Hypoglycemia (<75 mg/dl) and hyperglycemia (>180 mg/dl,) missed detection rates
Measured: 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
Measured: at 1, 3, 7, 14, 21 and 28 days
Lag time between FiberSense readings and reference laboratory standard results during induced glucose excursions
Measured: at 1, 3, 7, 14, 21 and 28 days
Agreement and accuracy relative to SMBG readings (same model to be used by all patients)
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(%)
Measured: weekly - Days 7, 14, 21, 28
Stability of the FiberSense fluorescence measurements
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(%)
Measured: weekly - Days 7, 14, 21, 28
User satisfaction assessed by the Likert scale
Subjective impression of the patients on the scale of 1 (strongly agree) to 5 (strongly disagree)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study startJan 2017
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeSense GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Hasslacher, Prof. Dr., Principal investigator, Diabetes Institut Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152408
- Sponsor's protocol ID
- P-4.3-C-01
- Status last verified
- Mar 2025
- First submitted
- 22 Oct 2018
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04152408
- Acronym / sponsor ID
- P-4.3-C-01
- Conditions
- Diabetes (DM)
- Keywords
- diabetes management, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- EyeSense GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FiberSense System | Experimental | Device: FiberSense System6 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiberSense SystemFiberSense system, a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient. | Device | FiberSense System |
Primary outcome
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.
Duration of use of the FiberSense system
Time frame: 30 days
Duration of use of the FiberSense device in average and by individual patients
Incidence of (Serious) Adverse Events
Time frame: 30 days
Adverse Events reporting and local tolerability as assessed by Draize's scale
9 secondary outcomes
Mean and Median Relative Differences in FiberSense measured glucose from LGSR
Time frame: 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
Hypoglycemia (<75 mg/dl (14)) and hyperglycemia (>180 mg/dl (14)) detection rates
Time frame: 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
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
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
Agreement and accuracy relative to SMBG readings (same model to be used by all patients)
Time frame: weekly - Days 7, 14, 21, 28
Stability of the FiberSense fluorescence measurements
Time frame: weekly - Days 7, 14, 21, 28
User satisfaction assessed by the Likert scale
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Hasslacher, Prof. Dr. principal investigator
Diabetes Institut Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FiberSense System in people with Diabetes (DM), run by EyeSense GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the FiberSense system as compared with laboratory gold standard reference (LGSR) (time frame: at 1, 3, 7, 14, 21 and 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.