GlySure Acute Care Settings Study

April 17, 2015 updated by: GlySure

A Clinical Study to Evaluate the Safety of the GlySure Continuous Intravascular Glucose Monitoring System, and Its Performance in Comparison to Intermittent Blood Glucose Monitoring in Adult Intensive Care Unit Patients

The company who have developed the GlySure product have previously carried out a study to be able to show that the GlySure system is accurate in measuring blood sugar (glucose) levels. This was done with patients in the intensive care unit (ICU) after heart surgery.

The company now want to confirm that the GlySure product is accurate at measuring blood glucose levels on all patients who stay in the ICU.

This clinical study requires 40 patients and is to check the safety of a continuous Glucose Monitoring System (GlySure) and it's performance in comparison to separate individual blood glucose testing using a hand held blood tester called i-STAT. Each patient must be in the study for at least 36 hours.

The main benefit of continuous blood glucose monitoring is that it gives a true picture of the glucose status of a patient and this can potentially help avoid the glucose level dropping too low (hypoglycaemic) or staying too high (hyperglycaemia) as clinicians can intervene based on 'real-time' data on the glucose levels.

In this study patient treatment is not dictated by the data measured during the study. Clinicians are blind to the results on the GlySure monitor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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. Patient is male or female aged 18 years or above
  3. Patient requires a Central Venous Catheter (CVC) to be inserted as part of disease management and treatment
  4. Patient is expected to remain in the intensive care unit for at least 36 hours post enrolment to the study

Exclusion Criteria:

  1. Patient or legal representative is unable to provide written informed consent
  2. Patient who is pregnant
  3. Patient who is currently being administered Mannitol and/or may require the administration of Mannitol whilst in the ICU
  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 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 or StatLock® devices
  11. Patient who is being managed in a cardiac ICU setting after cardiac surgery

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

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: all patients
Other: Glysure CGM
Other: iStat intermittent testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety as assessed by serious adverse events attributed to the study investigational product
Time Frame: 0-7 days
0-7 days
mean absolute relative difference (MARD) % (accuracy)
Time Frame: 0-7 days
0-7 days

Collaborators and Investigators

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

Sponsor

GlySure

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

April 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2015

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

April 17, 2015

First Posted (ESTIMATE)

April 20, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

April 20, 2015

Last Update Submitted That Met QC Criteria

April 17, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2014.02.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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