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Effects of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients

NCT03047824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-03-13

No results posted yet for this study

Summary

After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate treatment cohort will then be consecutively enrolled, followed by the tight glycemic control cohort.

After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory evaluations will be determined.

Subjects enrolled in the standard of care cohort will be treated according to the institution's protocol for measuring glucose and managing insulin. These subjects will be monitored on a GlucoClear System but they will not be managed based on the values or trends of the GlucoClear system.

Subjects enrolled in the treatment cohorts will be monitored and managed with a special version of the GlucoClear continuous monitoring system. This system contains the GlucoClear Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to manage patient glucose within pre-specified target levels. These recommendations are presented on screen for a clinical professional to approve or override.

Subjects in the moderate treatment cohort will have their glucose managed in the range of 120 - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in the range of 80 - 120 mg/dl.

After discharge from the ICU, subjects will followed for adverse events and mortality at 30 days, either by telephone contact or office visit.

Conditions

  • Metabolic Stress Hyperglycemia

Interventions

DEVICE

Intravascular continuous monitoring

Bedside usual insulin therapy guided by continuous glucose monitoring

OTHER

Standard of care

Bedside usual insulin therapy guided by intemittent glucose monitoring

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Jean-Louis Vincent, MD PhD · Erasme University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-05-31
Completion
2015-06-30

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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 NCT03047824 on ClinicalTrials.gov