Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery

Critical Illness Clinical Trial

Official title: Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery

Status Completed

Clinical Trial Summary

We hypothesize that measurements of interstitial fluid (ISF) glucose by the FreeStyle Navigator (Abbot Diabetes Care), a continuous glucose monitoring system, will correlate with blood glucose (BG) values in surgical and ICU patients with a clinically useful degree of accuracy.

Clinical Trial Description

Critically ill patients treated with intensive insulin therapy will be monitored for up to 72 hours with the Freestyle Navigator continuous glucose monitor. The device display will be disabled so that continuous glucose monitoring results will not be available to care givers, although low (<60 mg/dL) and high (>250 mg/dL) threshold audio alarms will be enabled. Blood glucose monitoring will be performed according to the usual practice for patients treated with intensive insulin therapy in each intensive care unit, except that additional blood glucose measurements will be performed in response to Freestyle Navigator threshold alarm. All blood glucose management decisions will be made according to intensive insulin therapy protocol in each unit. Freestyle Navigator data will be downloaded from the device after each subject has completed the monitoring period. Blood glucose values obtained in the course of usual care, or in response to Freestyle Navigator threshold alarms, will be compared with time-matched Freestyle Navigator values to assess device accuracy and alarm sensitivity and specificity. ;

Related Conditions & MeSH terms

• Critical Illness

• NCT number: NCT00694473
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Completion date: December 2017