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

Not Applicable

Completed

• Conditions: Continuous Glucose Measurement

• Registration Number: NCT01942902
• Lead Sponsor: GlySure

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Star Hospital; 🇮🇳 Banjara Hills, Hyderabad, India

Care Hospital; 🇮🇳 Nampally, Hyderabad, India