NCT03008239

Effectiveness and Safety Study of the Percutaneous Optical Fibre Glucose Sensor (FiberSense)

Effectiveness and Safety Study of the Percutaneous Optical Fibre Glucose Sensor (FiberSense) for Home Use in Diabetic and Prediabetic Individuals

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	FiberSense sensor	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.
DEVICE	Dexcom Sensor	Dexcom is a continuous glucose monitoring (CGM) system. The display device shows the glucose readings and the trend.

Timeline

• Start date: 2017-11-14
• Primary completion: 2019-07-10
• Completion: 2019-10-01
• First posted: 2017-01-02
• Last updated: 2019-09-24

Locations

1 site across 1 country: Hong Kong