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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 :
The duration of follow-up for each patient will be 72 hours or until discharge from Intensive care unit (if <72 hours)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel strategy | Experimental | Inserting the CGMS device with use of the results of the device in real time by the health care team
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| Conventional strategy | Active Comparator | Inserting the CGMS device without the use of the results by the health care team: blinded CGMS (use of these results only at the end of the participation to analyze the main criterion)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Glucose Monitoring System | Device | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability measured by MAGE index | Glycemic variability measured by MAGE index (Mean Amplitude of Glycemic Excursions Index) | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). |
| Glycemic variability measured by LBGI |
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Inclusion Criteria:
Patient over 18 years old admitted to Cardiac Intensive Care Unit (CICU for acute coronary syndrome (ACS):
ACS with STsegment elevation (STEMI), defined by thoracic pain of more than 30 minutes and sus-offset persist of the ST segment at ECG in two contiguous derivations.
ACS without ST segment elevation (NSTEMI), defined by a significant elevation of the troponin (> 99th percentile) with one of the following signs:
patient with type 2 diabetes (defined according to the American Diabetes Association (ADA) recommendations) known with:
Patient who has not yet received insulin therapy with intravenous insulin since admission
Signed informed consent
oral and written comprehension of the French language
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre RIVELINE, pr | APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lariboisière Hospital | Paris | Île-de-France Region | 75475 | France |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
Glycemic variability measured by LBGI ( (Low Blood Glucose Index) |
| 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 | 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. | 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. | 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) | 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) | 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) | 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 | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). |
| Usefulness for nurse | Usefulness for nurse (survey) | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). |
| Patient satisfaction | Patient satisfaction (satisfaction questionnaire) | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). |
| D003920 |
| Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |