DiabetesNCT05133973
Feasibility Study of a Transdermal Continuous Glucose Monitoring (CGM) System in Diabetic Patients
A study testing FiberSense CGM in people with Diabetes, run by EyeSense GmbH at 1 site in Germany.
Trial summary
A single centered, prospective, double blinded study enrolling 12 Type I diabetic patients (+ up to 4 replacements) in two cohorts. Patients will wear multiple FiberSense CGM systems for 28 days, with total duration of the participation up to 8 weeks (screening + active phase + follow up). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes
- What is being tested?
- FiberSense CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2022to 17 May 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age ≥ 18 and < 65 years old.
- Diabetes mellitus type I requiring insulin in the management of glucose control for at least one year prior to enrollment.
- 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 devices.
- 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.
- For the time of the wearing phase willingness to abstain from taking a sauna, bathing, swimming, diving and contact sport activities.
- Fully vaccinated with EMA approved vaccine against SARS-COV-2 virus or recovered from Covid-19 disease, (status vaccinated or recovered according to current Corona regulations as recommended by STIKO). If applicable, a negative result of a current Corona test (depending on the guidelines of the study center).
- Written informed consent to participate in the study provided by the patient.
Who cannot join
- Persons who use medication containing icodextrine or maltose and which can result in icodextrine or maltose present in blood (dialysis solutions, antibody medications etc.), anamnesis based.
- Persons on peritoneal dialysis.
- 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/or Day00 prior to enrolment.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, might interfere with the performance of this study or would pose an excessive risk to study staff (e.g., Hepatitis B and C, HIV, Covid-19).
- 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).
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- Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
- Blood donation of more than 500 ml within the last three months or hematocrit value <30% or > 50%.
- 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 a flight scheduled during the proposed study participation.
- Has vaccination/booster against COVID-19 scheduled during or less than 2 weeks prior to 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: Effectiveness and Safety Study to Investigate the Improved FiberSense Continuous Glucose Monitoring System in Diabetic Patients
A single centered, prospective, double blinded study enrolling 12 Type I diabetic patients (+ up to 4 replacements) in two cohorts. Patients will wear multiple FiberSense CGM systems for 28 days, with total duration of the participation up to 8 weeks (screening + active phase + follow up).
The primary aims of the study are assessment of the safety and tolerability of the FiberSense CGM system during the wearing time together with characterization of the system performance when compared to capillary blood samples.
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) during in-clinic glucose challenge sessions. At the same time and also at home use the blood glucose values are recorded by comparator system and self-monitoring blood glucose system (SMBG). The safety aspects are also investigated during the wearing time of 28 days.
The two cohorts differ in the measurement scheduled, with intensive measurement week either at week 1 (cohort A) or week 2 (cohort B).
- Conditions
- Diabetes
- Being tested
- FiberSense CGM
- 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 CGMDevice
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 |
|---|---|---|
| Cohort A | Experimental | Subjects will wear 3 FiberSense systems (2x arm and 1x abdomen) and one comparator. The subjects will participate in six clinic in-house sessions on Day 00, 3x between days 01-07, on Days 21 and 28. There will be safety visit at Day 14.
Finger pricking at home use will be intensified during days 00-07. Receives: Device: FiberSense CGM |
| Cohort B | Experimental | Subjects will wear 3 FiberSense systems (2x arm and 1x abdomen) and one comparator. The subjects will participate in six clinic in-house sessions on Day 00, 4x between days 07-14 and on Day 28. There will be safety visit at Day 21.
Finger pricking at home use will be intensified during days 07-14. Receives: Device: FiberSense CGM |
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 (15/15%), for paired samples taken during the in-clinic sessions.
Measured: 6 measurements within 28 days
Incidence and severity of device related adverse events (ADE)
Incidence of reported ADE with focus on number of patients experiencing serious ADE, evaluated according Draize's scale (0 to 4 - for none to severe findings)
Measured: 28 days
Secondary outcomes (8)
FiberSense System agreement to LGSR within different glucose ranges
The percentage of FiberSense CGM system readings within metrics 20/20%, 30/30%, 40/40% and greater than 40% of the laboratory reference values
Measured: 6 measurements within 28 days
Point Clinical accuracy (Consensus and Surveillance Error Grid)
Analyze the proportion of readings in each region of two Grids. Readings in various regions are considered from clinically accurate or with clinically acceptable accuracy to inaccurate to various degrees.
Measured: 6 measurements within 28 days
Accuracy of glucose rate of change of FiberSense System during glucose excursions
Mean and Median Absolute Relative Differences (MARD, MedRD) of FiberSense measured glucose from laboratory reference values, evaluated at various glucose dynamics
Measured: 6 measurements within 28 days
Agreement and accuracy relative to SMBG readings at home use
Performance of FiberSense System evaluated as percentage of system readings within 15%, 20%, 30% and 40% of SMBG values
Measured: 6 measurements within 28 days
Precision of the FiberSense System (PARD) for arm-arm and arm-abdomen positions
Precision Absolute Relative Difference (PARD) of two simultaneously worn FiberSense Systems by one patient, for same body parts and two different insertion sites
Measured: 6 measurements within 28 days
FiberSense System stability
Percentage of FiberSense System readings within various % of the LGSR values
Measured: weekly during 28 days
FiberSense System Longevity
Duration of use of the individual FiberSense devices
Measured: 28 days
User satisfaction questionnaire score
Subjective impression of the patients assessed by 5-point Likert scale (1 - strongly agree to 5 - strongly disagree)
Measured: after 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start10 Oct 2022
- Primary completion1 Dec 2022
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeSense GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guido Freckmann, Dr.med., Principal investigator, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133973
- Sponsor's protocol ID
- P-4.7-C-01
- Status last verified
- Oct 2022
- First submitted
- 5 Nov 2021
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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
- Effectiveness and Safety Study to Investigate the Improved FiberSense Continuous Glucose Monitoring System in Diabetic Patients
- ClinicalTrials.gov ID
- NCT05133973
- Acronym / sponsor ID
- P-4.7-C-01
- Conditions
- Diabetes
- Keywords
- diabetes management, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- EyeSense GmbHIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 24 Nov 2021 (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.
A single centered, prospective, double blinded study enrolling 12 Type I diabetic patients (+ up to 4 replacements) in two cohorts. Patients will wear multiple FiberSense CGM systems for 28 days, with total duration of the participation up to 8 weeks (screening + active phase + follow up).
The primary aims of the study are assessment of the safety and tolerability of the FiberSense CGM system during the wearing time together with characterization of the system performance when compared to capillary blood samples.
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) during in-clinic glucose challenge sessions. At the same time and also at home use the blood glucose values are recorded by comparator system and self-monitoring blood glucose system (SMBG). The safety aspects are also investigated during the wearing time of 28 days.
The two cohorts differ in the measurement scheduled, with intensive measurement week either at week 1 (cohort A) or week 2 (cohort B).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Device: FiberSense CGMSubjects will wear 3 FiberSense systems (2x arm and 1x abdomen) and one comparator. The subjects will participate in six clinic in-house sessions on Day 00, 3x between days 01-07, on Days 21 and 28. There will be safety visit at Day 14. Finger pricking at home use will be intensified during days 00-07. |
| Cohort B | Experimental | Device: FiberSense CGMSubjects will wear 3 FiberSense systems (2x arm and 1x abdomen) and one comparator. The subjects will participate in six clinic in-house sessions on Day 00, 4x between days 07-14 and on Day 28. There will be safety visit at Day 21. Finger pricking at home use will be intensified during days 07-14. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female age ≥ 18 and < 65 years old.
- Diabetes mellitus type I requiring insulin in the management of glucose control for at least one year prior to enrollment.
- 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 devices.
- 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.
Key exclusion criteria (12 listed)
- Persons who use medication containing icodextrine or maltose and which can result in icodextrine or maltose present in blood (dialysis solutions, antibody medications etc.), anamnesis based.
- Persons on peritoneal dialysis.
- 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/or Day00 prior to enrolment.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, might interfere with the performance of this study or would pose an excessive risk to study staff (e.g., Hepatitis B and C, HIV, Covid-19).
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 CGMFiberSense system, a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient. | Device | Cohort A, Cohort B |
Primary outcome
Performance of the FiberSense system as compared with laboratory gold standard reference (LGSR)
Time frame: 6 measurements within 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 (15/15%), for paired samples taken during the in-clinic sessions.
Incidence and severity of device related adverse events (ADE)
Time frame: 28 days
Incidence of reported ADE with focus on number of patients experiencing serious ADE, evaluated according Draize's scale (0 to 4 - for none to severe findings)
8 secondary outcomes
FiberSense System agreement to LGSR within different glucose ranges
Time frame: 6 measurements within 28 days
Point Clinical accuracy (Consensus and Surveillance Error Grid)
Time frame: 6 measurements within 28 days
Accuracy of glucose rate of change of FiberSense System during glucose excursions
Time frame: 6 measurements within 28 days
Agreement and accuracy relative to SMBG readings at home use
Time frame: 6 measurements within 28 days
Precision of the FiberSense System (PARD) for arm-arm and arm-abdomen positions
Time frame: 6 measurements within 28 days
FiberSense System stability
Time frame: weekly during 28 days
FiberSense System Longevity
Time frame: 28 days
User satisfaction questionnaire score
Time frame: after 28 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.
Guido Freckmann, Dr.med. principal investigator
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
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 CGM in people with Diabetes, 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 8 inclusion and 12 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: 6 measurements within 28 days). The study lists 2 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.