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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
7
FiberSense system, a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.
Diabetes Institut Heidelberg
Heidelberg, Germany
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.
Time frame: 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
Time frame: 30 days
Incidence of (Serious) Adverse Events
Adverse Events reporting and local tolerability as assessed by Draize's scale
Time frame: 30 days
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
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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)
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(%)
Time frame: 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(%)
Time frame: 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)
Time frame: 30 days