Diabetes Mellitus Clinical Trial
Official title:
Effectiveness and Safety Study of the Percutaneous Optical Fibre Glucose Sensor (FiberSense) for Home Use in Diabetic and Prediabetic Individuals
This study evaluates the performance and safety of the fluorescence based fibre optic glucose sensor for home usage.24 subjects will take part in the study, including 4 pre-diabetic subjects, 8 Type I diabetic patients, 8 Type II diabetic patients and 4 diabetic patients who require continuous ambulatory peritoneal dialysis (CAPD). Type 1, Type 2 and prediabetic subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other side of the abdomen for 7 days in one of the four study weeks. In all 4 CAPD subjects, one FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator sensor will be placed in CAPD subjects.
The FiberSense system is a glucose-monitoring device indicated for continually recording
interstitial fluid glucose levels in patients ages 18 and older with insulin dependent
diabetes mellitus for the purpose of improving diabetes management. The System is intended
for use by patients at home and in health care facilities.
The FiberSense system is indicated for use as an adjunctive device to complement, not
replace, information obtained from standard home glucose monitoring devices.
The FiberSense system aids in the detection of episodes of hyperglycemia and hypoglycemia,
facilitating both acute and long-term therapy adjustments, which may minimize these
excursions.
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