The investigators hypothesize that the use of a continuous glucose monitoring system (CGMS) can reduce glycemic variability assessed by coefficient of variation (CV) during the acute phase of acute coronary syndrome (ACS) in patients with diabetes treated by insulin infusion. The purpose of this project is to assess the impact of the use of CGMS on glycemic variability in diabetic patients with ACS . This is a randomized, multicenter (2 centers), open study. The patients included, as soon as possible, after admission will be randomized before the beginning of insulin therapy with intravenous insulin .
The aim of this study is to assess the impact of the use of a continuous glucose monitoring system (CGMS) on glycemic variability in diabetic patients admitted in Intensive care unit (ICU) for an acute coronary syndrome ( ST Segment Elevation Myocardial Infarction (STEMI) or Non-ST segment elevation myocardial infarction (NSTEMI)) and treated with insulin infusion with a standardized protocol. 60 patients in 2 centers will be included, and all patient will have the CGMS. Randomization will be done in the 12 hours after admission. Participants will be randomized in two groups : * Conventional strategy: management of hyperglycemia with standard of care, glycemia monitoring with capillary blood glucose measurement. The goal is to maintain glycemia between 140-180mg/dL. CGMS will be blinded in this group. * Novel strategy: management of hyperglycemia using CGMS. Measurements of CGMS will be transmitted in real time to medical staff and use to maintain glycemia between 140-180mg/dL. Alarms will be set to warn medical staff in case of glycemia outside the range. The duration of follow-up for each patient will be 72 hours or until discharge from Intensive care unit (if \<72 hours)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2
With a sensor, transmitter and display device (receiver and/or compatible smart device). The CGMS sends glucose readings to a compatible smart device every 5 minutes. In this study the CGMS for all patients with use of the results of the device in real time by the health care team for the Experimental arm and without the use of the results by the health care team for Active Comparator (Conventional strategy .
Lariboisière Hospital
Paris, Île-de-France Region, France
Glycemic variability by the coefficient of variation of blood glucose in percent
Glycemic variability assessed by the coefficient of variation of blood glucose in percent ((standard deviation / medium blood glucose) x 100)
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Glycemic variability measured by MAGE index
Glycemic variability measured by MAGE index (Mean Amplitude of Glycemic Excursions Index)
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Glycemic variability measured by LBGI
Glycemic variability measured by LBGI ( (Low Blood Glucose Index)
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Glycemic variability measured by standard deviation
Glycemic variability measured by standard deviation of blood glucose
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Number of symptomatic hypoglycemia
Number of symptomatic hypoglycemia in both groups.
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Number of hypoglycemia during ICU stay
Number of hypoglycemia (\<54, \<70 and \< 90 mg/dl) during ICU stay in both groups.
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Time spent in glycemic target, in hypoglycemia, and in hyperglycemia
Time spent in glycemic target (140-180 mg/dl), in hypoglycemia \<50 and \< 90 mg/dl), and in hyperglycemia (\>180/250 mg/dl)
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Mean insulin perfusion rate
Mean insulin perfusion rate (Total insulin dose per total time)
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Failure of CGMS failure
Failure of CGMS failure (no or incomplete glucose data)
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Local complications of GGMS
Local complications of GGMS: bleeding with CGM withdrawn, cutaneous intolerance, CGM withdrawn
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Usefulness for nurse
Usefulness for nurse (survey)
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Patient satisfaction
Patient satisfaction (satisfaction questionnaire)
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
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