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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlySure
ClinicalTrials.gov Identifier:
NCT01942902
First received: August 15, 2013
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Continuous Glucose Measurement
Device: Continuous Glucose Monitoring System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by GlySure:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: For at least 30 hours and up to 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: July 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous Glucose Monitoring System Device: Continuous Glucose Monitoring System
Other Name: Glysure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942902

Locations
India
Star Hospital
Banjara Hills, Hyderabad, India, 500034
Care Hospital
Nampally, Hyderabad, India, 500001
Sponsors and Collaborators
GlySure
Investigators
Principal Investigator: Krishna Prasad, MD Care Hospital
  More Information

No publications provided

Responsible Party: GlySure
ClinicalTrials.gov Identifier: NCT01942902     History of Changes
Other Study ID Numbers: 2013.01.CE
Study First Received: August 15, 2013
Last Updated: November 5, 2013
Health Authority: India: Care Foundation Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on September 15, 2014