Evaluation of Continuous Glucose Monitoring in Patients With ACS and Type 2 Diabetes in ICU

Type 2 Diabetes Clinical Trial

— EVASION  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04822740
• Other study ID #: APHP180484
• Status: Terminated
• Phase: N/A
• Start date: December 7, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus, Type 2
• Syndrome
• Type 2 Diabetes

Intervention

Device:
• Control 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 .

Locations

Country	Name	City	State
France	Lariboisière Hospital	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Secondary	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).
Secondary	Glycemic variability measured by LBGI	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	Usefulness for nurse	Usefulness for nurse (survey)	From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Secondary	Patient satisfaction	Patient satisfaction (satisfaction questionnaire)	From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).