Acute Coronary Syndrome, Type 2 Diabetes
Conditions
Keywords
Acute coronary syndrome with ST-segment elevation, Acute coronary syndrome without ST-segment elevation, type 2 diabetes, Continuous glucose monitoring system (CGMS)
Brief summary
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 .
Detailed description
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)
Interventions
DEVICEControl Glucose Monitoring System
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 .
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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: * Symptoms of ischemia * Recent modification of the ST or wave segment T to ECG * Appearance of a wave q at ECG * Loss of segmental viability of myocardial imaging * intracoronal thrombus in angiography 2. patient with type 2 diabetes (defined according to the American Diabetes Association (ADA) recommendations) known with: * be a hyperglycemia\> 180 mg / dl to admission that requires intravenous insulin therapy * Either chronic insulin treatment before admission 3. Patient who has not yet received insulin therapy with intravenous insulin since admission 4. Signed informed consent 5. oral and written comprehension of the French language
Exclusion criteria
1. Patient with hemodynamic instability (shock, catecholamine use, mechanical ventilation, circulatory assistance ...) 2. Patient admitted to the CICU since more than 24 hours 3. Patient requiring Corticotherapy 4. patient with type 1 diabetes (defined according to the ADA recommendations) 5. Needs to perform MRI during CICU stay 6. Pregnancy or breastfeeding 7. patient under legal protection 8. Patient with no social security 9. Patient participating in another interventional research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic variability by the coefficient of variation of blood glucose in percent | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Glycemic variability assessed by the coefficient of variation of blood glucose in percent ((standard deviation / medium blood glucose) x 100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic variability measured by LBGI | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Glycemic variability measured by LBGI ( (Low Blood Glucose Index) |
| Glycemic variability measured by standard deviation | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Glycemic variability measured by standard deviation of blood glucose |
| Number of symptomatic hypoglycemia | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Number of symptomatic hypoglycemia in both groups. |
| Number of hypoglycemia during ICU stay | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Number of hypoglycemia (\<54, \<70 and \< 90 mg/dl) during ICU stay in both groups. |
| Time spent in glycemic target, in hypoglycemia, and in hyperglycemia | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Time spent in glycemic target (140-180 mg/dl), in hypoglycemia \<50 and \< 90 mg/dl), and in hyperglycemia (\>180/250 mg/dl) |
| Glycemic variability measured by MAGE index | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Glycemic variability measured by MAGE index (Mean Amplitude of Glycemic Excursions Index) |
| Failure of CGMS failure | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Failure of CGMS failure (no or incomplete glucose data) |
| Local complications of GGMS | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Local complications of GGMS: bleeding with CGM withdrawn, cutaneous intolerance, CGM withdrawn |
| Usefulness for nurse | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Usefulness for nurse (survey) |
| Patient satisfaction | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Patient satisfaction (satisfaction questionnaire) |
| Mean insulin perfusion rate | From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours). | Mean insulin perfusion rate (Total insulin dose per total time) |
Countries
France
Outcome results
None listed