An interventional study of FiberSense System in Diabetes (DM), sponsored by EyeSense GmbH. Terminated at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by EyeSense GmbH · Not applicable, Interventional, and Device feasibility
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)
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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 10 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →EyeSense GmbH is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
Short and mid term performance of the transdermal CGM sensor determined as MARD
Mean absolute relative difference (MARD) of FiberSense system to blood glucose
Time frame: 0, 3, 7, 14, 21 and 28 days
Incidence of adverse events
Assessment of adverse events and local tolerability occurred during the study
Time frame: 0, 3, 7,14, 21, 28 and 35-38 days
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)
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
Lag time (in minutes) between FiberSense readings and corresponding laboratory blood glucose values during glucose excursions
Time frame: 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
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
Drift of the FiberSense fluorescent measurement signals over the wearing time
Time frame: 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)
Time frame: 35-38 days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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