Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297850
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-26
Brief Title:
Accuracy of Continuous Glucose Monitoring in Patients With Diabetes A Prospective Observational Study
Sponsor:
University Hospital Bispebjerg and Frederiksberg
Organization:
University Hospital Bispebjerg and Frederiksberg
Study Overview
Official Title:
Validation of the Accuracy of Continuous Glucose Monitoring Using the Dexcom G7 in Patients With Diabetes in Situations With Circulatory Impairment A Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring CGM compared to standard point-of-care POC blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment
The main questions it aims to answer are
Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment
Participants will be asked to wear a blinded CGM device Dexcom G7 Dexcom Inc during their stay in the hospital but will receive standard care of their diabetes The CGM device will be worn for up to 10 days
The main questions it aims to answer are
Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment
Participants will be asked to wear a blinded CGM device Dexcom G7 Dexcom Inc during their stay in the hospital but will receive standard care of their diabetes The CGM device will be worn for up to 10 days
Detailed Description:
This is a prospective observational study on patients living with diabetes who a undergo surgery at the Department of Vascular Surgery Rigshospitalet Denmark and the Surgical Department and Department of Orthopedic Surgery and Traumatology Bispebjerg and Frederiksberg Hospital Denmark or b are admitted to the intensive care unit ICU at Bispebjerg and Frederiksberg Hospital with circulatory impairment
The study aim is to investigate the accuracy of the Dexcom G7 CGM in patients with diabetes undergoing surgery and in patients at the ICU with circulatory impairment The glucose readings will be compared to standard practice with POC blood glucose measurements
Included patients will be asked to wear the CGM device Dexcom G7 for up 10 days
The study will include 60 patients
This study is part of an overall project that aims to investigate the use of CGM and continuous wireless monitoring of vital signs in patients with diabetes undergoing major surgery Using this technology postoperative complications including dysglycaemia can potentially be detected and treated earlier thus improving the perioperative care
The study aim is to investigate the accuracy of the Dexcom G7 CGM in patients with diabetes undergoing surgery and in patients at the ICU with circulatory impairment The glucose readings will be compared to standard practice with POC blood glucose measurements
Included patients will be asked to wear the CGM device Dexcom G7 for up 10 days
The study will include 60 patients
This study is part of an overall project that aims to investigate the use of CGM and continuous wireless monitoring of vital signs in patients with diabetes undergoing major surgery Using this technology postoperative complications including dysglycaemia can potentially be detected and treated earlier thus improving the perioperative care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None