A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring

A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring Using the Yellow Springs Blood Glucose Analyser for Conformité Européenne (CE) Marking Purposes in a Total of Thirty Patients Admitted to The Surgical Intensive Care Unit (SICU)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01942902

Enrollment

Registered

2013-09-16

Start date

2013-07-31

Completion date

2013-10-31

Last updated

2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Continuous Glucose Measurement

Brief summary

The purpose of this study is to evaluate the system performance of the GlySure Continuous Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit.

Interventions

DEVICEContinuous Glucose Monitoring System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient or legal representative MUST be willing to sign an informed consent document 2. Male and female aged 18 years and above 3. Require Central Venous Catheter (CVC) into the right internal Jugular vein as part of disease management and treatment 4. Expected to remain in the Surgical Intensive Care Unit (SICU) for at least 30 hours and up to 7 days-

Exclusion criteria

1. Patient or legal representative unable to provide written informed consent 2. Patient who is pregnant 3. Patient who is currently being administered Mannitol 4. Patient with history of Pulmonary Embolism (PE) 5. Patient with history of thrombosis 6. Patient with known hyper-coagulation 7. Patient with known history of heparin hypersensitivity 8. Patient with history of heparin induced thrombocytopenia 9. Participation in a clinical study involving an unlicensed pharmaceutical product and/or device within the 3 months prior to enrolment in this study 10. Patient with known hypersensitivity/allergy to adhesive I.V. dressings such as 3M Tegaderm film 11. Patient likely to require an MRI scan during their stay in the SICU 12. Patients likely to require treatment with Mannitol during time in the SICU

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of the CGM system as compared with the Yellow Springs Instrument (YSI) blood sample analysis results	For at least 30 hours and up to 7 days	The study is designed to evaluate the comparative accuracy between measured blood glucose results obtained from the GlySure Continuous Glucose Monitoring System (CGM) and the YSI, and to determine if any condition or treatment affects the sensor's measured values.
Number of participants experiencing Serious Adverse Events (SAEs) causally related to the devices	For at least 30 hours and up to 7 days	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026