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Report for Clinical Trial NCT00878891

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Real Time Continuous Glucose Monitoring With Glucoday® as an Assistant for Intensive Insulin Therapy in Diabetic Cardiothoracic Surgery Patients: a Randomized Study Comparing Blood Glucose Measurements Alone or Associated to Continue Glucose Monitoring

An increased risk of adverse outcome is noted for diabetic patients admitted in surgery intensive care units (ICU). Tight glycemic control with intensive insulin therapy dramatically reduces in-hospital mortality and adverse outcome. Devices recording continuously interstitial glucose monitoring (CGM) may be an aid in patients of ICU in whom normoglycemia become a target. The mini-invasive device (Glucoday®) should provide real-time glucose concentrations in order to quickly adjust insulin infusion rates. The objective of MARGE study is to compare percent of time in normoglycemia based on conventional monitoring (discontinuous glucose monitoring) and Glucoday to conventional monitoring alone. The MARGE study is a multicenter (2 centers), randomized, single blind trial. Several studies have shown that hyperglycemia is associated with poor outcomes in hospitalized patients. Postoperative glucose levels are a significant predictor of infection rates after cardiac surgery and death rate. Based on these observational studies, a randomized controlled intervention trial in surgical ICU patients demonstrated that intensive insulin therapy reduced the overall in-hospital mortality by 34 % and stream infection by 46 %. Using continuous glycemic monitoring (CGM) it has been shown that intensive insulin therapy based on discontinuous glucose monitoring revealed that normoglycemia is achieved only 22 % of time. The researchers' aim is to determine if real time CGM with a new generation mini invasive device, Glucoday® S, would allow quickly adjusting insulin infusions rates according to interstitial glucose levels and decreasing both hyperglycemic and hypoglycemic excursions. This study will further investigate whether application of real time CGM to titrate insulin therapy to target glycemia in a tight range (80-110 mg/dl) can improve diabetic patient outcome after coronary artery bypass grafting (CABG).

NCT00878891 Diabetes

1 Interventions

Name: Continuous glucose monitoring for immediate correction of abnormal glycemia

Description: Prevention of hyper and hypo glycemia

Type: Device

1. Conventional glucose monitoring 2. Conventional glucose monitoring + Glucoday

Primary Outcomes

Measure: Percent of time in normoglycemia (0.8 - 1.10 g/L)

Time: Between the hour of the end of the intervention (CABG) and T48 hours after the first calibration of the Glucoday or while battery last

Secondary Outcomes

Measure: Percent of post CABG time in hyperglycemia (>1.8 g/l) and hypoglycemia (<0.5 g/l)

Time: Between the hour of the end of the intervention (CABG) and T48 hours after the first calibration of the Glucoday or while battery last

Measure: Clinical outcomes incidence : death rate, cardiovascular events (acute coronary syndromes, heart failure, arrhythmia) stream infections, neurologic events

Time: during 30 days after CABG

Measure: Agreement between CGM with Glucoday and conventional capillary blood glucose monitoring in the setting of CABG and surgical ICU

Time: During 48 hours

Measure: During of stay in ICU and in tyhe surgical care unit

Time: During the hospitalisation

Measure: Adverse events due to the device

Time: During the hospitalization

Purpose: Prevention

Allocation: Randomized

Parallel Assignment

There is one SNP


1 T24H

3: agreement between CGM with Glucoday® and conventional capillary blood glucose monitoring using coupled data recorded at the same time except couples of data corresponding to calibration time (T0, T24H). --- T24H ---

HPO Nodes