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

NCT01942902 | Completed

• 1 other identifier: 2013.01.CE
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Continuous Glucose Measurement

Outcome Measures

Primary Outcomes (2)

• 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

• Number of participants experiencing Serious Adverse Events (SAEs) causally related to the devices

  For at least 30 hours and up to 7 days

Study Arms (1)

Continuous Glucose Monitoring System

EXPERIMENTAL

Device: Continuous Glucose Monitoring System

Interventions

Continuous Glucose Monitoring System DEVICE

Also known as: Glysure

Continuous Glucose Monitoring System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• GlySure: lead

Study Sites (2)

Star Hospital

Banjara Hills, Hyderabad, 500034, India

Location

Care Hospital

Nampally, Hyderabad, 500001, India

Location

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Krishna Prasad, MD

  Care Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: September 16, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 6, 2013

Record last verified: 2013-11

Locations

IN (2)