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

NCT03008239 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-09-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Principal Investigators

  • Elaine Chow, Dr. · Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2019-07-10
Completion
2019-10-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03008239 on ClinicalTrials.gov