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

Primary Purpose

Acute Coronary Syndrome, Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Control Glucose Monitoring System
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome with ST-segment elevation, Acute coronary syndrome without ST-segment elevation, type 2 diabetes, Continuous glucose monitoring system (CGMS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bichat Hospital
  • Lariboisière HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novel strategy

Conventional strategy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Glycemic variability measured by MAGE index
Glycemic variability measured by MAGE index (Mean Amplitude of Glycemic Excursions Index)
Glycemic variability measured by LBGI
Glycemic variability measured by LBGI ( (Low Blood Glucose Index)
Glycemic variability measured by standard deviation
Glycemic variability measured by standard deviation of blood glucose
Number of symptomatic hypoglycemia
Number of symptomatic hypoglycemia in both groups.
Number of hypoglycemia during ICU stay
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
Time spent in glycemic target (140-180 mg/dl), in hypoglycemia <50 and < 90 mg/dl), and in hyperglycemia (>180/250 mg/dl)
Mean insulin perfusion rate
Mean insulin perfusion rate (Total insulin dose per total time)
Failure of CGMS failure
Failure of CGMS failure (no or incomplete glucose data)
Local complications of GGMS
Local complications of GGMS: bleeding with CGM withdrawn, cutaneous intolerance, CGM withdrawn
Usefulness for nurse
Usefulness for nurse (survey)
Patient satisfaction
Patient satisfaction (satisfaction questionnaire)

Full Information

First Posted
March 23, 2021
Last Updated
December 8, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04822740
Brief Title
Evaluation of Continuous Glucose Monitoring in Patients With ACS and Type 2 Diabetes in ICU
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
December 7, 2023 (Anticipated)
Study Completion Date
December 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novel strategy
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional strategy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Control Glucose Monitoring System
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Glycemic variability by the coefficient of variation of blood glucose in percent
Description
Glycemic variability assessed by the coefficient of variation of blood glucose in percent ((standard deviation / medium blood glucose) x 100)
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Secondary Outcome Measure Information:
Title
Glycemic variability measured by MAGE index
Description
Glycemic variability measured by MAGE index (Mean Amplitude of Glycemic Excursions Index)
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Title
Glycemic variability measured by LBGI
Description
Glycemic variability measured by LBGI ( (Low Blood Glucose Index)
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Title
Glycemic variability measured by standard deviation
Description
Glycemic variability measured by standard deviation of blood glucose
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Title
Number of symptomatic hypoglycemia
Description
Number of symptomatic hypoglycemia in both groups.
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Title
Number of hypoglycemia during ICU stay
Description
Number of hypoglycemia (<54, <70 and < 90 mg/dl) during ICU stay in both groups.
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Title
Time spent in glycemic target, in hypoglycemia, and in hyperglycemia
Description
Time spent in glycemic target (140-180 mg/dl), in hypoglycemia <50 and < 90 mg/dl), and in hyperglycemia (>180/250 mg/dl)
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Title
Mean insulin perfusion rate
Description
Mean insulin perfusion rate (Total insulin dose per total time)
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Title
Failure of CGMS failure
Description
Failure of CGMS failure (no or incomplete glucose data)
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Title
Local complications of GGMS
Description
Local complications of GGMS: bleeding with CGM withdrawn, cutaneous intolerance, CGM withdrawn
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Title
Usefulness for nurse
Description
Usefulness for nurse (survey)
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Title
Patient satisfaction
Description
Patient satisfaction (satisfaction questionnaire)
Time Frame
From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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 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: Patient with hemodynamic instability (shock, catecholamine use, mechanical ventilation, circulatory assistance ...) Patient admitted to the CICU since more than 24 hours Patient requiring Corticotherapy patient with type 1 diabetes (defined according to the ADA recommendations) Needs to perform MRI during CICU stay Pregnancy or breastfeeding patient under legal protection Patient with no social security Patient participating in another interventional research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Guillaume DILLINGER, DR
Phone
(33) 1 49 95 85 74
Email
jean-guillaume.dillinger@lrb.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre RIVELINE, pr
Organizational Affiliation
APHP
Official's Role
Study Director
Facility Information:
Facility Name
Bichat Hospital
City
Paris
State/Province
ILE De France
ZIP/Postal Code
75018
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory DUCROCQ, Pr
Phone
Tél: (33) 1 40 25 86 61
Email
gregory.ducrocq@aphp.fr
Facility Name
Lariboisière Hospital
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Guillaume DILLINGER, PHD
Phone
01 49 95 86 74
Email
jean-guillaume.dillinger@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

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

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