Acute Coronary SyndromeEVASIONNCT04822740
Evaluation of Continuous Glucose Monitoring in Patients With ACS and Type 2 Diabetes in ICU
A study of Acute Coronary Syndrome and Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Type 2 Diabetes
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- patient under legal protection
- Patient with no social security
- Patient participating in another interventional research
Trial locations and contacts
1 site in 1 country.
About this study
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
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 .
Read the 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)
- Conditions
- Acute Coronary Syndrome, Type 2 Diabetes
- Being tested
- Control Glucose Monitoring System
- Keywords
- Acute coronary syndrome with ST-segment elevation, Acute coronary syndrome without ST-segment elevation, type 2 diabetes, Continuous glucose monitoring system (CGMS)
- Medical subject headings
- Acute Coronary Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Glucose Monitoring SystemDevice
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Control Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Glycemic variability measured by MAGE index (Mean Amplitude of Glycemic Excursions Index)
Measured: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Glycemic variability measured by LBGI
Glycemic variability measured by LBGI ( (Low Blood Glucose Index)
Measured: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Glycemic variability measured by standard deviation
Glycemic variability measured by standard deviation of blood glucose
Measured: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Number of symptomatic hypoglycemia
Number of symptomatic hypoglycemia in both groups.
Measured: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Number of hypoglycemia during ICU stay
Number of hypoglycemia (<54, <70 and < 90 mg/dl) during ICU stay in both groups.
Measured: 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 spent in glycemic target (140-180 mg/dl), in hypoglycemia <50 and < 90 mg/dl), and in hyperglycemia (>180/250 mg/dl)
Measured: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Mean insulin perfusion rate
Mean insulin perfusion rate (Total insulin dose per total time)
Measured: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Failure of CGMS failure
Failure of CGMS failure (no or incomplete glucose data)
Measured: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Local complications of GGMS
Local complications of GGMS: bleeding with CGM withdrawn, cutaneous intolerance, CGM withdrawn
Measured: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Usefulness for nurse
Usefulness for nurse (survey)
Measured: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Patient satisfaction
Patient satisfaction (satisfaction questionnaire)
Measured: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start7 Dec 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Why it stopped: loss of equipment supplier
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre RIVELINE, pr, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822740
- Sponsor's protocol ID
- APHP180484
- Acronym
- EVASION
- Status last verified
- Nov 2023
- First submitted
- 23 Mar 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04822740
- Acronym / sponsor ID
- EVASION / APHP180484
- 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)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: loss of equipment supplier
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel strategy | Experimental | Device: Control Glucose Monitoring SystemInserting 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 |
| Conventional strategy | Active comparator | Device: Control Glucose Monitoring SystemInserting 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient over 18 years old admitted to Cardiac Intensive Care Unit (CICU for acute coronary syndrome (ACS):
- patient with type 2 diabetes (defined according to the American Diabetes Association (ADA) recommendations) known with:
- Patient who has not yet received insulin therapy with intravenous insulin since admission
- Signed informed consent
- oral and written comprehension of the French language
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Glucose Monitoring SystemWith 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 . | Device | Conventional strategy, Novel strategy |
Primary outcome
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)
11 secondary outcomes
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 LBGI
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
Time frame: 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 hypoglycemia during ICU stay
Time frame: 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).
Mean insulin perfusion rate
Time frame: 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).
Local complications of GGMS
Time frame: 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).
Patient satisfaction
Time frame: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Results and safety
The study was stopped early (reason given: loss of equipment supplier). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre RIVELINE, pr study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Coronary Syndrome and Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: loss of equipment supplier). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.