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

NCT04822740 | Terminated

• 1 other identifier: APHP180484
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 .

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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 LBGI

  From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).

• Glycemic variability measured by standard deviation

  From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).

• Number of symptomatic hypoglycemia

  From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).

• Number of hypoglycemia during ICU stay

  From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).

Study Arms (2)

Novel strategy

EXPERIMENTAL

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

Conventional strategy

ACTIVE COMPARATOR

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

Interventions

Control Glucose Monitoring System DEVICE

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 .

Conventional strategy; Novel strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Lariboisière Hospital

Paris, Île-de-France Region, 75475, France

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jean-Pierre RIVELINE, pr

  APHP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 30, 2021
• Study Start: December 7, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)