Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314061
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-03-10
Brief Title:
The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes
Sponsor:
Christian S Meyhoff
Organization:
University Hospital Bispebjerg and Frederiksberg
Study Overview
Official Title:
The Effect of Continuous Glucose Monitoring With Real-time Alerts on Glycaemic Control in Surgical Patients With Diabetes A Randomised Clinical Multicentre Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
WARD-glucose
Brief Summary:
The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring CGM compared to standard point-of-care POC blood glucose measurements in surgical patients with diabetes in patients
The main question it aims to answer is
Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes
Participants will be asked to wear a CGM device Dexcom G7 Dexcom Inc during their stay in the hospital For patients in the intervention group deviations of glucose levels will provide the nursing staff with alerts All patients will receive standard care of their diabetes The CGM device will be worn for up to 10 days or until discharge
The main question it aims to answer is
Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes
Participants will be asked to wear a CGM device Dexcom G7 Dexcom Inc during their stay in the hospital For patients in the intervention group deviations of glucose levels will provide the nursing staff with alerts All patients will receive standard care of their diabetes The CGM device will be worn for up to 10 days or until discharge
Detailed Description:
This is a prospective randomised controlled multicentre trial on patients living with diabetes who undergo surgery at Rigshospitalet Copenhagen University Bispebjerg and Frederiksberg Hospital Copenhagen University and Zealand University Hospital Køge Denmark
The study aims to investigate the effect of the CGM-device Dexcom G7 CGM in patients with diabetes undergoing surgery on the diabetic control The Dexcom G7 provides glucose readings every 5 minutes and can send alerts on dysglycaemia hypo- and hyperglycaemia to mobile devices held by the nursing staff
Patients will wear the CGM before during and up to 10 days postoperatively
The study will include 200 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 aims to investigate the effect of the CGM-device Dexcom G7 CGM in patients with diabetes undergoing surgery on the diabetic control The Dexcom G7 provides glucose readings every 5 minutes and can send alerts on dysglycaemia hypo- and hyperglycaemia to mobile devices held by the nursing staff
Patients will wear the CGM before during and up to 10 days postoperatively
The study will include 200 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