Diabetes (DM)FiberSenseNCT06868043
A Study to Investigate a Transdermal Continuous Glucose Monitoring System in Diabetic Patients for a Period of 28 Days
A study testing FiberSense System in people with Diabetes (DM), run by EyeSense GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Jun 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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
- 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 using interstitial fluid (ISF) glucose as an indicator of blood glucose levels by diabetic patients
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | 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. Receives: Device: FiberSense System |
| Cohort B | Experimental | 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. Receives: Device: FiberSense System |
| Cohort C | Experimental | 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. Receives: Device: FiberSense System |
| Cohort D | Experimental | 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. Receives: Device: FiberSense System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short and mid term performance of the transdermal CGM sensor determined as MARD
Mean absolute relative difference (MARD) of FiberSense system to blood glucose
Measured: 0, 3, 7, 14, 21 and 28 days
Incidence of adverse events
Assessment of adverse events and local tolerability occurred during the study
Measured: 0, 3, 7,14, 21, 28 and 35-38 days
Secondary outcomes (6)
Stability of the blood glucose to fluorescence correlation
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)
Measured: 0, 3, 7, 14, 21 and 28 days
Changes in blood glucose to fluorescence lag time over a period of up to 28 days
Lag time (in minutes) between FiberSense readings and corresponding laboratory blood glucose values during glucose excursions
Measured: 0, 3, 7, 14, 21 and 28 days
Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements
Calculation of MARD of FiberSense against a commercial self-monitoring blood glucose meter
Measured: 0, 3, 7, 14, 21 and 28 days
Signal-to-noise ratio
Measured: 0, 3, 7, 14, 21 and 28 days
Signal drift
Drift of the FiberSense fluorescent measurement signals over the wearing time
Measured: 0, 3, 7, 14, 21 and 28 days
User satisfaction assessed by the Likert scale
Subjective impression of the patients assessed by 5-point Likert scale (1- strongly agree to 5 - strongly disagree)
Measured: 35-38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study startJul 2012
- Primary completionOct 2012
- Study completionJun 2014
Why it stopped: One cohort succesfully completed; further cohorts not needed, no safety issue.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 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, Diabetesinstitut Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868043
- Sponsor's protocol ID
- P-4.2-C-0.1
- Acronym
- FiberSense
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 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 10 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 a Transdermal Continuous Glucose Monitoring System in Diabetic Patients (Type 1 and 2) for a Period of 28 Days
- ClinicalTrials.gov ID
- NCT06868043
- Acronym / sponsor ID
- FiberSense / P-4.2-C-0.1
- Conditions
- Diabetes (DM)
- Keywords
- diabetes management, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: One cohort succesfully completed; further cohorts not needed, no safety issue.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- EyeSense GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Mar 2025 (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.
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)
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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Device: FiberSense SystemSubjects 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. |
| Cohort B | Experimental | Device: FiberSense SystemSubjects 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. |
| Cohort C | Experimental | Device: FiberSense SystemSubjects 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. |
| Cohort D | Experimental | Device: FiberSense SystemSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 using interstitial fluid (ISF) glucose as an indicator of blood glucose levels by diabetic patients | Device | Cohort A, Cohort B, Cohort C, Cohort D |
Primary outcome
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
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
6 secondary outcomes
Stability of the blood glucose to fluorescence correlation
Time frame: 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
Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements
Time frame: 0, 3, 7, 14, 21 and 28 days
Signal-to-noise ratio
Time frame: 0, 3, 7, 14, 21 and 28 days
Signal drift
Time frame: 0, 3, 7, 14, 21 and 28 days
User satisfaction assessed by the Likert scale
Time frame: 35-38 days
Results and safety
The study was stopped early (reason given: One cohort succesfully completed; further cohorts not needed, no safety issue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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
Diabetesinstitut Heidelberg
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 10 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 was stopped early (reason given: One cohort succesfully completed; further cohorts not needed, no safety issue.). Results are not available in the source record.
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?
Short and mid term performance of the transdermal CGM sensor determined as MARD (time frame: 0, 3, 7, 14, 21 and 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 10 Mar 2025.