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

NCT ID: NCT03008044

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-06-30

Brief Summary

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.

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FiberSense system

Intervention Type: DEVICE

A novel CGM system based on a FiberSense system placed through the dermis of the patient.

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.

Group Type: EXPERIMENTAL

FiberSense system

Intervention Type: DEVICE

A novel CGM system based on a FiberSense system placed through the dermis of the patient.

Interventions

FiberSense system

A novel CGM system based on a FiberSense system placed through the dermis of the patient.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lee's Pharmaceutical Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elaine Chow, Dr.

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

P-4.4-C-01

Identifier Type: -

Identifier Source: org_study_id