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GlySure Acute Care Settings Study

NCT02421107 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-04-20

No results posted yet for this study

Summary

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.

Conditions

  • Adult Intensive Care Patients

Interventions

OTHER

Glysure CGM

OTHER

iStat intermittent testing

Sponsors & Collaborators

  • GlySure

    lead INDUSTRY

Study Design

Allocation
NA
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421107 on ClinicalTrials.gov