Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense System)

Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense) Across the Glycemic Range With Rapid Glucose Excursions Using the Glucose Clamp

This is a single center prospective study. The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: FiberSense system

Detailed Description

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 (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Sha Tin, Hong Kong
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female age ≥ 18 years old.
• Nondiabetic subjects with normal fasting plasma glucose and HbA1c (≤5.6%)
• Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
• Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
• Willingness to abstain from bathing and swimming during their participation in the measurement phase.
• In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
• Written informed consent to participate in the study provided by the patient.

Exclusion Criteria:

• Currently pregnant, as demonstrated by a positive pregnancy test at screening and on day of first sensor insertion
• Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit.
• Impaired renal function measured as serum creatinine > 1.2 times above the upper limit of normal.
• Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
• Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
• Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
• Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
• Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
• Known current or recent alcohol or drug abuse
• Blood donation of more than 500 ml within the last three months
• Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
• History of epilepsy
• History of cardiac arrhythmias
• Clinically significant abnormality on ECG at screening
• An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device: FiberSense system; 10 subjects will wear 2 FiberSense system in abdomen and upper arm respectively and Dexcom G4 Platinum CGM sensor for 1 day.	Device: FiberSense system; A novel CGM system based on a FiberSense system placed through the dermis of the patient.
Experimental: Extension Phase; 2 subjects will extend the wearing of the sensors up to 14 days (2 FiberSense systems to Day 14 and Dexcom sensor to Day 7±1) after the glucose clamp study.	Device: FiberSense system; A novel CGM system based on a FiberSense system placed through the dermis of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall performance of the FiberSense device as compared with YSI	Proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels >100 mg/dl (5.55 mmol/l), and the proportion of FiberSense readings within ≤15 mg/dl (0.83 mmol/l) of the YSI reading for blood glucose levels ≤100 mg/dl.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)		1 day
Mean Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)		1 day
Accuracy of glucose rate of change measured by FiberSense sensor compared to glucose rate of change measured using the reference laboratory method (YSI)		1 day
Lag time between FiberSense readings and reference laboratory method (YSI) results during induced glucose excursions		1 day
Precision of FiberSense system readings: Precision Absolute Relative Differences with comparison of FiberSense system locations (inter and intra)		1 day
Percentage of readings that are within 15% of the YSI values	Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.	1 day
Percentage of readings that are within 20% of the YSI values	Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.	1 day
Percentage of readings that are within 30% of the YSI values	Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.	1 day
Percentage of readings that are within 40% of the YSI values	Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.	1 day
Percentage of readings that are greater than 40% of the YSI values	Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.	1 day
Adverse Event Reporting		14 days
Median relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)		1 day
Median Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)		1 day

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited
• Investigators: Principal Investigator: Elaine Chow, Dr., Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: P-4.4-C-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No