DiabetesFiberSenseNCT06867965
Feasibility Study of a Novel Subcutaneous Continuous Glucose Monitoring System in Diabetics
A study testing BellySense in people with Diabetes, run by EyeSense GmbH at 1 site in Germany.
Trial summary
Mono-centre, open label (unblinded). 8 patients + 2 potential replacements. Duration up to 9 weeks: up to 6 weeks screening (42 days), 2 weeks of treatment (14 days, depending on sensor functionality) and 1 week of follow up (7 days) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- BellySense
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Nov 2011
- 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
- Signed written Informed Consent
Who cannot join
- Inability to follow the protocol schedule
- Participating in another clinical trial, if it is not a "non-investigational clinical study (NICS)
- Pregnant or lactating females,
- Any known hypersensitivity to any of the products used in the study, including preservatives etc.
- 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
Show all 10Show fewer
- Acute severe infection disease at the time of enrolment
- Alcohol and/or drug abuses
- 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 Subcutaneous Continuous Glucose Monitoring System in Diabetic Patients (Type 1 and 2)
Mono-centre, open label (unblinded). 8 patients + 2 potential replacements. Duration up to 9 weeks: up to 6 weeks screening (42 days), 2 weeks of treatment (14 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.
As soon as the eligibility of the patient is confirmed the patient is enrolled. 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: 6 weeks (42 days), 1 visit
Insertion/Measurement phase: Up to 2 weeks (14days), up to 6 measurement visits
Follow-up Phase: 1 week (7 days), 1 visit
- Conditions
- Diabetes
- Being tested
- BellySense
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BellySenseDevice
BellySense is a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.
| Study group | Role | What they receive |
|---|---|---|
| BellySense system | Experimental | 8 diabetic patients will wear a BellySense system at the upper arm or abdomen for up to 14 days. Receives: Device: BellySense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between blood glucose and interstitial fluid (ISF) glucose concentration
Mean absolute relative difference (MARD) of fluorescence sensor values and laboratory blood glucose values
Measured: 6 measurements within 14 days
Adverse event reporting
Incidence of reported ADE, with focus on number of SADE
Measured: 14 days
Secondary outcomes (6)
Lag time
Determine changes in blood glucose to fluorescence lag time (in minutes)
Measured: 6 measurements within 14 days
Stability of measurements
Stability of the FiberSense fluorescence measurement signals over the wearing time
Measured: 6 measurements within 14 days
Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements
Mean absolute relative difference (MARD) of fluorescence sensor values and capillary blood glucose values
Measured: 6 measurements within 14 days
Signal to noise ratio
Measured: 6 measurements within 14 days
Signal drift
Measured: 6 measurements within 14 days
Patient impression
Subjective impression of the patients assesed by 5/6-point scale
Measured: after 14 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 startMar 2010
- Primary completionNov 2011
- Study completionNov 2011
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT06867965
- Sponsor's protocol ID
- P-4.1-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 Subcutaneous Continuous Glucose Monitoring System in Diabetic Patients (Type 1 and 2)
- ClinicalTrials.gov ID
- NCT06867965
- Acronym / sponsor ID
- FiberSense / P-4.1-C-0.1
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- EyeSense GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2010 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (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.
Mono-centre, open label (unblinded). 8 patients + 2 potential replacements. Duration up to 9 weeks: up to 6 weeks screening (42 days), 2 weeks of treatment (14 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.
As soon as the eligibility of the patient is confirmed the patient is enrolled. 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: 6 weeks (42 days), 1 visit
Insertion/Measurement phase: Up to 2 weeks (14days), up to 6 measurement visits
Follow-up Phase: 1 week (7 days), 1 visit
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BellySense system | Experimental | Device: BellySense8 diabetic patients will wear a BellySense system at the upper arm or abdomen for up to 14 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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
- Signed written Informed Consent
Key exclusion criteria (10 listed)
- Inability to follow the protocol schedule
- Participating in another clinical trial, if it is not a "non-investigational clinical study (NICS)
- Pregnant or lactating females,
- Any known hypersensitivity to any of the products used in the study, including preservatives etc.
- Malignancies requiring therapy during the study
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 |
|---|---|---|
| BellySenseBellySense is a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient. | Device | BellySense system |
Primary outcome
Correlation between blood glucose and interstitial fluid (ISF) glucose concentration
Time frame: 6 measurements within 14 days
Mean absolute relative difference (MARD) of fluorescence sensor values and laboratory blood glucose values
Adverse event reporting
Time frame: 14 days
Incidence of reported ADE, with focus on number of SADE
6 secondary outcomes
Lag time
Time frame: 6 measurements within 14 days
Stability of measurements
Time frame: 6 measurements within 14 days
Correlation between the fluorescence readings of the sensor and capillary blood glucose measurements
Time frame: 6 measurements within 14 days
Signal to noise ratio
Time frame: 6 measurements within 14 days
Signal drift
Time frame: 6 measurements within 14 days
Patient impression
Time frame: after 14 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 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 BellySense 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 4 inclusion and 10 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 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 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?
Correlation between blood glucose and interstitial fluid (ISF) glucose concentration (time frame: 6 measurements within 14 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.