Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473480
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-14
Brief Title:
Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Continuous GLUCOse Monitoring System With a SENSor Compared to Fingerstick Glucose Monitoring in Surgical Wards GLUCOSENS
Status:
NOT_YET_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:
GLUCOSENS
Brief Summary:
The purpose of this trial is to compare a continuous glucose blood sugar monitoring system with a sensor to traditional fingerstick capillary glucose monitoring The aim of the study is to investigate whether adult inpatients in general surgical wards who require blood glucose monitoring throughout the day due to diabetes mellitus or as a result of surgery benefit from a continuous glucose monitoring system compared to traditional fingerstick glucose monitoring The comparison is conducted to determine whether a continuous glucose monitoring system is superior to traditional fingerstick glucose monitoring in terms of better glucose level management patient satisfaction and experience nursing staff workload and management experience as well as in preventing complications Furthermore the accuracy of blood glucose values for continuous blood glucose monitoring is compared to fingerstick glucose monitoring and blood samples The studys hypothesis is that continuous glucose monitoring systems are accurate and usable for measuring glucose levels in patients in a surgical ward This will result in better glycemic control thereby reducing complications and shortening hospital stays It will also improve experience and satisfaction for patients and decrease workload while enhancing the experience for nursing staff
Detailed Description:
Glucose control in surgical patients with diabetes is essential to prevent hyper- and hypoglycemia which can lead to infections poor surgical outcomes prolonged hospital stays and death The prevalence of diagnosed diabetes among patients in Denmark in 2022 was 62 The global incidence of diabetes is increasing resulting in a rising number of patients requiring glucose control during admission to surgical wards
Glucose control through point-of-care fingerstick capillary glucose monitoring FSGM is standard in many hospitals However FSGM can be painful disrupt sleep and increase patients postoperative stress Additionally it can be time-consuming and require up to two hours of work for nurses per patient daily Consequently maintaining timely and prescribed glucose monitoring can be challenging in busy surgical wards leading to untreated hyper- and hypoglycemia Furthermore FSGM provides only a snapshot of glucose concentration and does not indicate whether glucose levels are stable increasing or decreasing
An alternative to FSGM is continuous glucose monitoring systems CGMS which measure glucose levels via a subcutaneous sensor every few minutes CGMS is primarily used in ambulatory settings and studies have reported improved regulation of glucose levels In surgical and medical wards several studies have confirmed the accuracy of CGMS compared to FSGM with reported mean absolute relative differences ranging from 94 to 129 making CGMS suitable for surgical wards
Other studies on CGMS in surgical and medical wards have reported a decrease in mean glucose levels increased detection of daytime hyperglycemia and decreased occurrences of nocturnal and prolonged hypoglycemia compared to FSGM monitoring
Some studies have explored patients perspectives on CGMS mainly in everyday life and outpatient settings One study showed that women with type 2 diabetes monitored their glucose levels more closely with CGMS and took more initiative to regulate food intake activity and stress levels consistent with findings from a review of the same patient group using CGMS In another study involving patients with type 2 diabetes aged 53-72 years patients found the technology helpful in disease management but also considered it an unpleasant reminder of disease progression and the sensor could cause discomfort
A few case reports have described nurses experiences with CGMS in hospital wards with patients with type 1 diabetes Nurses reported an increased workload because the device receiver next to the patient was difficult to hear leading to more frequent patient observations than usual
In summary studies of CGMS have shown safety and benefits in ambulatory settings but challenges and knowledge gaps in hospital wards remain To date no studies have compared glucose levels from CGMS with those from a laboratory plasma glucose analyzer as the reference
Seven substudies will be conducted
Substudy 1 - Glucose levels and management for surgical patients in relation to hospitalization Compares glucose levels and management using point-of-care FSGM and point-of-care CGMS during hospitalization and FSGM and continuous glucose monitoring CGM up to three months after discharge
Substudy 2 - Patient satisfaction with glucose monitoring and management in surgical wards Compares patient satisfaction with glucose monitoring and management for surgical patients using point-of-care FSGM and point-of-care CGMS during hospitalization
Substudy 3 - Nursing staffs glucose monitoring and management workload in the surgical ward Compares the nursing staffs workload with point-of-care FSGM to point-of-care CGMS for surgical patients
Substudy 4 qualitative study - Patient experience of glucose monitoring and management in relation to hospitalization in surgical wards Compares the patient experience with point-of-care FSGM to point-of-care CGMS and glucose management during hospitalization in the surgical ward and compares the patient experience of FSGM with CGM after discharge
Substudy 5 - Continuous glucose level for surgical patients during hospitalization in the surgical ward Compares the continuous glucose levels when glucose monitoring and management are performed by point-of-care FSGM and point-of-care CGMS respectively
Substudy 6 - Accuracy of CGMS for surgical patients during hospitalization Investigates the accuracy of CGMS by comparing CGMS data with FSGM and plasma glucose data
Substudy 7 qualitative study - Nursing staffs experience with fingerstick monitoring and CGSM for surgical patients Compares the nursing staffs experience with point-of-care FSGM to point-of-care CGMS and glucose management for surgical patients
Glucose control through point-of-care fingerstick capillary glucose monitoring FSGM is standard in many hospitals However FSGM can be painful disrupt sleep and increase patients postoperative stress Additionally it can be time-consuming and require up to two hours of work for nurses per patient daily Consequently maintaining timely and prescribed glucose monitoring can be challenging in busy surgical wards leading to untreated hyper- and hypoglycemia Furthermore FSGM provides only a snapshot of glucose concentration and does not indicate whether glucose levels are stable increasing or decreasing
An alternative to FSGM is continuous glucose monitoring systems CGMS which measure glucose levels via a subcutaneous sensor every few minutes CGMS is primarily used in ambulatory settings and studies have reported improved regulation of glucose levels In surgical and medical wards several studies have confirmed the accuracy of CGMS compared to FSGM with reported mean absolute relative differences ranging from 94 to 129 making CGMS suitable for surgical wards
Other studies on CGMS in surgical and medical wards have reported a decrease in mean glucose levels increased detection of daytime hyperglycemia and decreased occurrences of nocturnal and prolonged hypoglycemia compared to FSGM monitoring
Some studies have explored patients perspectives on CGMS mainly in everyday life and outpatient settings One study showed that women with type 2 diabetes monitored their glucose levels more closely with CGMS and took more initiative to regulate food intake activity and stress levels consistent with findings from a review of the same patient group using CGMS In another study involving patients with type 2 diabetes aged 53-72 years patients found the technology helpful in disease management but also considered it an unpleasant reminder of disease progression and the sensor could cause discomfort
A few case reports have described nurses experiences with CGMS in hospital wards with patients with type 1 diabetes Nurses reported an increased workload because the device receiver next to the patient was difficult to hear leading to more frequent patient observations than usual
In summary studies of CGMS have shown safety and benefits in ambulatory settings but challenges and knowledge gaps in hospital wards remain To date no studies have compared glucose levels from CGMS with those from a laboratory plasma glucose analyzer as the reference
Seven substudies will be conducted
Substudy 1 - Glucose levels and management for surgical patients in relation to hospitalization Compares glucose levels and management using point-of-care FSGM and point-of-care CGMS during hospitalization and FSGM and continuous glucose monitoring CGM up to three months after discharge
Substudy 2 - Patient satisfaction with glucose monitoring and management in surgical wards Compares patient satisfaction with glucose monitoring and management for surgical patients using point-of-care FSGM and point-of-care CGMS during hospitalization
Substudy 3 - Nursing staffs glucose monitoring and management workload in the surgical ward Compares the nursing staffs workload with point-of-care FSGM to point-of-care CGMS for surgical patients
Substudy 4 qualitative study - Patient experience of glucose monitoring and management in relation to hospitalization in surgical wards Compares the patient experience with point-of-care FSGM to point-of-care CGMS and glucose management during hospitalization in the surgical ward and compares the patient experience of FSGM with CGM after discharge
Substudy 5 - Continuous glucose level for surgical patients during hospitalization in the surgical ward Compares the continuous glucose levels when glucose monitoring and management are performed by point-of-care FSGM and point-of-care CGMS respectively
Substudy 6 - Accuracy of CGMS for surgical patients during hospitalization Investigates the accuracy of CGMS by comparing CGMS data with FSGM and plasma glucose data
Substudy 7 qualitative study - Nursing staffs experience with fingerstick monitoring and CGSM for surgical patients Compares the nursing staffs experience with point-of-care FSGM to point-of-care CGMS and glucose management for surgical patients
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