Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04822740
Status:
TERMINATED
Last Update Posted:
2023-11-18
First Post:
2021-03-23
Brief Title:
Evaluation of Continuous Glucose Monitoring in Patients With ACS and Type 2 Diabetes in ICU
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
loss of equipment supplier
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVASION
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
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 140-180mgdL 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 140-180mgdL 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
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 140-180mgdL 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 140-180mgdL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None