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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03008239
• Other study ID #: P-4.5-C-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: October 2019

Study information

• Verified date: September 2019
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: October 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type I or II diabetes mellitus requiring insulin in the management of glucose control for at least one year prior to enrollment or diabetes on continuous ambulatory peritoneal dialysis or prediabetic individuals with impaired fasting glucose or impaired glucose tolerance by OGTT

• Male or female age = 18 years old and = 70 year old.

• 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 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:

• Poorly controlled diabetes mellitus with HbA1C >11%.

• Currently pregnant, as demonstrated by a positive pregnancy test at screening and on Day00 .

• Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = three times the upper reference limit.

• 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.

• Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.

• An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

• Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• Dexcom Sensor
Dexcom is a continuous glucose monitoring (CGM) system. The display device shows the glucose readings and the trend.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose	The primary endpoint is the proportion of FiberSense readings within =15% of the reference (YSI) reading for blood glucose levels >100 mg/dl, and the proportion of FiberSense readings within =15 mg/dl of the YSI reading for blood glucose levels =100 mg/dl, for paired samples taken during the in-clinic sessions.	28 days
Primary	Adverse Events reporting		35 days
Secondary	Mean Relatives Differences from YSI		28 days
Secondary	Median Relatives Differences from YSI		28 days
Secondary	Mean Absolute Relative Differences from YSI		28 days
Secondary	Median Absolute Relative Differences from YSI		28 days
Secondary	Hypoglycemia detection rates		28 days
Secondary	Hyperglycemia detection rates		28 days
Secondary	Accuracy of glucose rate of change of FiberSense sensor compared to glucose rate of change of YSI		28 days
Secondary	Lag time between FiberSense readings and YSI results during induced glucose excursions		28 days
Secondary	Agreement and accuracy relative to SMBG readings (same model to be used by all subjects)		28 days
Secondary	Calibration stability		28 days
Secondary	Sensor stability		28 days
Secondary	Sensor life		28 days
Secondary	User satisfaction questionnaire score		28 days
Secondary	Blood maltose concentrations	Measured in CAPD subjects during the V1 in-clinic session	28 days