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

Continuous Glucose Measurement Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942902
• Other study ID #: 2013.01.CE
• Status: Completed
• Phase: N/A
• First received: August 15, 2013
• Last updated: November 5, 2013
• Start date: July 2013
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: GlySure
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Care Foundation Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Continuous Glucose Measurement

Intervention

Device:
• Continuous Glucose Monitoring System

Locations

Country	Name	City	State
India	Star Hospital	Banjara Hills	Hyderabad
India	Care Hospital	Nampally	Hyderabad

Sponsors (1)

Lead Sponsor	Collaborator
GlySure

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of the CGM system as compared with the Yellow Springs Instrument (YSI) blood sample analysis results	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.	For at least 30 hours and up to 7 days	No
Primary	Number of participants experiencing Serious Adverse Events (SAEs) causally related to the devices		For at least 30 hours and up to 7 days	Yes