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

November 5, 2013 updated by: GlySure

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Hyderabad
      • Banjara Hills, Hyderabad, India, 500034
        • Star Hospital
      • Nampally, Hyderabad, India, 500001
        • Care hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Continuous Glucose Monitoring System
Device: Continuous Glucose Monitoring System
Other Names:
  • Glysure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the CGM system as compared with the Yellow Springs Instrument (YSI) blood sample analysis results
Time Frame: 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.
For at least 30 hours and up to 7 days
Number of participants experiencing Serious Adverse Events (SAEs) causally related to the devices
Time Frame: For at least 30 hours and up to 7 days
For at least 30 hours and up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlySure

Investigators

  • Principal Investigator: Krishna Prasad, MD, Care hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (ESTIMATE)

September 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 2013.01.CE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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