Clinical trial NCT04822740: Evaluation of Continuous Glucose Monitoring in Patients With ACS and Type 2 Diabetes in ICU
Official title: Evaluation of the Use of a Continuous Glucose Monitoring System on Glycemic Equilibrium and Hypoglycemia in Diabetic Patients With Acute Coronary Syndrome Admitted in Intensive Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Coronary Syndrome
Type 2 Diabetes
Keywords: Acute coronary syndrome with ST-segment elevation
Acute coronary syndrome without ST-segment elevation
type 2 diabetes
Continuous glucose monitoring system (CGMS)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic variability by the coefficient of variation of blood glucose in percent
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Secondary outcomes:
measure: Glycemic variability measured by MAGE index
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
measure: Glycemic variability measured by LBGI
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
measure: Glycemic variability measured by standard deviation
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
measure: Number of symptomatic hypoglycemia
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
measure: Number of hypoglycemia during ICU stay
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
measure: Time spent in glycemic target, in hypoglycemia, and in hyperglycemia
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
measure: Mean insulin perfusion rate
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
measure: Failure of CGMS failure
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
measure: Local complications of GGMS
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
measure: Usefulness for nurse
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
measure: Patient satisfaction
timeFrame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Other outcomes:
Locations:
city: Paris
country: France
facility: Lariboisière Hospital
state: Ile De France
Study officials:
affiliation: APHP
name: Jean-Pierre RIVELINE, pr
role: STUDY_DIRECTOR
References: