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

November 15, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

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 .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75475
        • Lariboisiere Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Novel strategy

Inserting the CGMS device with use of the results of the device in real time by the health care team

  • Insulin infusion according to the same local guidelines for insulin therapy in ACS
  • Transmission of real-time data to the nurse and use of the alarms of the device
  • Adaptation of insulin according to blood glucose measured by the CGMS device and according to the same protocol as the conventional arm
  • Glycemic range: maintain a blood glucose between 140 and 180 mg / dl
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 .
Active Comparator: Conventional strategy

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)

  • Insulin infusion according to the same local guidelines for insulin therapy in ACS
  • Adaptation of insulin according to the capillary blood glucose levels performed every hourly if insulin dose change, every 2 hours if stable insulin dose according to local recommendations
  • Glycemic range: maintain a blood glucose between 140 and 180 mg / dl
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic variability by the coefficient of variation of blood glucose in percent
Time Frame: 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)
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic variability measured by MAGE index
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 (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
Time Frame: 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)
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Glycemic variability measured by standard deviation
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 of blood glucose
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Number of symptomatic hypoglycemia
Time Frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
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
Time Frame: 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.
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 Frame: 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)
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Mean insulin perfusion rate
Time Frame: 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)
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Failure of CGMS failure
Time Frame: 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)
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Local complications of GGMS
Time Frame: 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
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Usefulness for nurse
Time Frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Usefulness for nurse (survey)
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Patient satisfaction
Time Frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Patient satisfaction (satisfaction questionnaire)
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Jean-Pierre RIVELINE, pr, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180484

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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