Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645873
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Exploration of Continuous Glucose Monitoring on the Intensive Care Unit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Continuous Glucose Monitoring and Point-of-Care Measurements on the Intensive Care Unit an Exploratory Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CGM-IC
Brief Summary:
Both hyperglycemia and hypoglycemia in patients at the intensive care unit ICU are strongly associated with increased morbidity and mortality Accurate and timely measurements of glucose levels in this population are therefore crucial Continuous glucose monitoring CGM appears promising for this purpose but it is not yet used in the ICU due to insufficient knowledge about its reliability in critically ill patients The aim of this study is to investigate the discrepancy between CGM and point-of-care measurements in ICU patients and whether this discrepancy is consistent across all ICU patient groupscharacteristics
This study investigates whether continuous glucose monitoring can be used in the intensive care setting
This study investigates whether continuous glucose monitoring can be used in the intensive care setting
Detailed Description:
Hyperglycemia is present in up to 50 of patients admitted to an intensive care unit ICU and is strongly associated with elevated morbidity and mortality rates Therefore it is important to monitor glucose levels closely In the ICU glucose monitoring primarily relies on periodic measurements through point-of-care POC meters which involve invasive blood sampling from venous or arterial lines To maintain blood glucose concentrations within acceptable ranges a possible improvement is continuous glucose monitoring CGM which is now used to manage glucose levels in diabetic patients in general settings and has shown significant benefits Studies on the use of CGM in the ICU setting are limited If CGM reliably measures glucose levels in critically ill patients it enables earlier intervention and might help to predict hypo- or hyperglycemia based on measurement trends
Objective To investigate the discrepancy between CGM and POC measurements in insulin-dependent ICU patients and to study whether these potential discrepancies between CGM and POC vary across patient-related factors like gender age comorbidities medication use disease severity scores treatment in ICU
Study design Prospective multi-centre single-arm intervention exploratory study
Intervention All study participants receive one CGM sensor to monitor glucose levels A second CGM sensor will only be applied if the first CGM sensor needed to be replaced within 8 days after insertion The measurements will be blinded to all except the research team
Objective To investigate the discrepancy between CGM and POC measurements in insulin-dependent ICU patients and to study whether these potential discrepancies between CGM and POC vary across patient-related factors like gender age comorbidities medication use disease severity scores treatment in ICU
Study design Prospective multi-centre single-arm intervention exploratory study
Intervention All study participants receive one CGM sensor to monitor glucose levels A second CGM sensor will only be applied if the first CGM sensor needed to be replaced within 8 days after insertion The measurements will be blinded to all except the research team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None