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OpenTrials
Completed

NCT Number: NCT01942902

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Star Hospital, Banjara Hills, Hyderabad, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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-

Exclusion criteria

  • 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

Treatment and study plan

Continuous Glucose Monitoring System

Device

Other names: Glysure

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

GlySure

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2013
Registry last updated
Nov 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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