Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring
NCT Number: NCT06473480
Acronym: GLUCOSENS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus
Interventions: DEVICE: Abott FreeStyle Libre System 2|DEVICE: Abott Freestyle Libre Pro
Sponsor: Odense University Hospital
Collaborators: Zealand University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 377
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-17
Completion Date: 2025-06-01
Locations: Department of Surgery, Zealand University Hospital, Køge, 4600, Denmark|The Department of Surgery, Odense Univeristy Hospital, Odense, 5000, Denmark

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 study's 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.

Primary Outcome Measures: Substudy 1: Mean daytime and nocturnal glucose levels, Glucose levels measured by continuous glucose monitoring system (CGMS) or point-of-care fingerstick capillary glucose monitoring (FSGM)

Arm allocation:

Period 1 + 2: FSGM Period 3: CGMS Number of measurements: five to eight times daily. Blood glucose measurement: mmol/L, During hospitalization (up to 28 days)|Substudy 2: DTSQ-IP, Patient experience of the convenience of glucose monitoring, Using the validated Danish version of the 22-item questionnaire: The Diabetes Treatment Satisfaction Questionnaire for Inpatients (DTSQ-IP), item 4: How convenient did you think the diabetes treatment was at hospitalization?

Ranging from 0 - 6

0 represents 'At no time' 6 represents 'At most of the time', During hospitalization (up to 28 days)|Substudy 3: The mean minutes spent on bedside glucose monitoring, The mean time it takes for the surgical nurse to start the procedure until the nurse leaves the room is measured.

Mean time: minutes.

Data includes:

* Profession
* Preparation (gathering materials, handwashing and/or disinfecting hands, putting on gloves, or other tasks)
* Time for performing fingerstick or using the scanner at the continuous glucose sensor
* Time when the glucose level is displayed on the device
* The glucose level (mmol/L)
* Actions taken after measurement (such as insulin injection, handwashing, documentation, disinfection, or other actions)
* Time when the room is vacated
* Time when the entire procedure is completed
* Observations made during the measurement, During hospitalization (up to 28 days)|Substudy 5: CGMS, time in range daytime (TIRd) 3.9-10.0 mmol/l, Percentage of time in range during daytime, During hospitalization (up to 28 days)|Substudy 5: Time in range night-time (TIRn) 3.9-10 mmol/l, Percentage of time in range during night-time, During hospitalization (up to 28 days)|Substudy 6: Accuracy of CGMS measurements, Blood glucose levels from CGMS are compared to FSGM and plasma glucose data, which are co-analyzed in blood tests. Measurements are in mmol/L. Bland-Altman plot and error grid analysis are used, During hospitalization (up to 28 days)
Secondary Outcome Measures: Substudy 1: Mean dose of long-acting insulin, Unit: International units (IE), During hospitalization (up to 28 days)|Substudy 1: Mean dose of short-acting insulin, Unit: International units (IE), During hospitalization (up to 28 days)|Substudy 1: Presence of sepsis during hospitalization, Defined as suspected or confirmed infection, as well as organ damage, During hospitalization (up to 28 days)|Substudy 1: Presence of acute kidney injury during hospitalization, Plasma creatinine, μmol/L, During hospitalization (up to 28 days)|Substudy 1: First transfer to intensive care unit, The date for the first transfer to the intensive care unit and back to the surgical ward The number of days at the intensive care unit

Unit: Days, During hospitalization (up to 28 days)|Substudy 1: Second transfer to intensive care unit, The date for the second transfer to the intensive care unit and back to the surgical ward The number of days at the intensive care unit

Unit: Days, During hospitalization (up to 28 days)|Substudy 1: Complications related to hospitality - bedsore, Presence of bedsore during hospitalization: yes/no, During hospitalization (up to 28 days)|Substudy 1: Complications related to hospitality - diabetes ketoacidosis, Presence of bedsore during hospitalization: yes/no Diabetes ketoacidosis, defined as: pH \< 7.30 and blood ketones \> 3 mmol/L, During hospitalization (up to 28 days)|Substudy 1: Complications related to hospitality - anastomotic leak, Presence of anastomotic leak during hospitalization: yes/no, During hospitalization (up to 28 days)|Substudy 1: Readmission, Assesment of 30-day numbers of readmissions, 30-days after discharge from hospital|Substudy 1: Mortality after discharge from hospital, Assesment of 90-day numbers of mortality., 90-days after discharge from hospital|Substudy 1: Mortality during hospitalization, Yes or no, During hospitalization (up to 28 days)|Substudy 1: HbA1c three months after discharge, mmol/mol, 90-days after discharge from hospital|Substudy 2: DTSQ-IP, experience with hyper- and hypoglycemia (items 2-3), Ranging from 0 - 6

0 represents 'At no time' 6 represents 'At most of the time', During hospitalization (up to 28 days)|Substudy 2: DTSQ-IP, treatment surveillance and flexibility (items 5+9),, Ranging from 0 - 6

0 represents 'At no time' 6 represents 'At most of the time', During hospitalization (up to 28 days)|Substudy 2: DTSQ-IP, treatment information, knowledge, and communication (items 15-18), Ranging from 0 - 6

0 represents 'At no time' 6 represents 'At most of the time', During hospitalization (up to 28 days)|Substudy 2: DTSQ-IP, contact with specialized diabetes nurses (items 20-21), Ranging from 0 - 6

0 represents 'At no time' 6 represents 'At most of the time', During hospitalization (up to 28 days)|Substudy 3: Nursing staff glucose management, Measurement: Mean minutes, Through study completion, an average of one and a half year|Substudy 3: Nursing staff reporting glucose levels and management to diabetes nurses, Measurement: Mean minutes, Through study completion, an average of one and a half year|Substudy 3: Daily mean minutes the diabetes nurse spends, The mean minutes diabetes nurses spent collecting information about glucose levels and management, supervising patients and surgical professionals, and being supervised by endocrinologists., During hospitalization (up to 28 days)|Substudy 5: CGMS, time above rang (TAR) >10 mmol/l, Percentage of time above range \>10 mmol/l, During hospitalization (up to 28 days)|Substudy 5: CGMS, time above range (TAR) >13.9 mmol/l, Percentage of time above range \>13.9 mmol/l, During hospitalization (up to 28 days)|Substudy 5: CGMS, time below range <3.9, Percentage of time below range \<3.9 mmol/l, During hospitalization (up to 28 days)|Substudy 5: CGMS, time below range <3.0, Percentage of time below range \<3.0 mmol/l, During hospitalization (up to 28 days)|Substudy 5: CGMS, standard deviation (SD), mmol/l, During hospitalization (up to 28 days)|Substudy 5: CGMS, coefficient of variation (CV), SD divided by mean glucose level, During hospitalization (up to 28 days)|Substudy 5: CGMS, mean glucose level daytime, mmol/l, During hospitalization (up to 28 days)|Substudy 5: CGMS, mean glucose level night-time, mmol/l, During hospitalization (up to 28 days)|Substudy 5: CGMS, hypoglycemia level 1 <3.9 mmol/l, Duration more than 15 consecutive minutes, During hospitalization (up to 28 days)|Substudy 5: CGMS, hypoglycemia level 2 <3.0 mmol/l, Duration more than 15 consecutive minutes, During hospitalization (up to 28 days)|Substudy 5: CGMS, number of hypoglycemic events, Number, During hospitalization (up to 28 days)