Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring
- Conditions
- Hypoglycemia (Diabetic)Hypoglycemia NightHyperglycemiaDiabetes Mellitus
- Interventions
- Device: Abott Freestyle Libre ProDevice: Abott FreeStyle Libre System 2
- Registration Number
- NCT06473480
- Lead Sponsor
- Odense University Hospital
- Brief Summary
This clinical trial aims to compare a continuous glucose monitoring system with traditional fingerstick blood glucose monitoring. The study focuses on adult patients in general surgical wards who need regular blood glucose checks due to the risk of low or high blood sugar levels.
The goal is to learn if using a continuous glucose monitoring system is better than fingerstick monitoring in managing glucose levels, preventing complications, improving patient satisfaction and experience, reducing nursing staff workload, and improving nursing staff' experience. The study also compares the accuracy of glucose readings from the continuous glucose monitoring system with those from fingerstick tests and blood samples.
The hypothesis is that CGMS is accurate and effective for monitoring glucose levels in surgical patients. This could lead to better blood sugar control, fewer complications, shorter hospital stays, and improved experiences for both patients and nursing staff.
- Detailed Description
Glucose control in surgical patients at risk of hyperglycemia and hypoglycemia is essential, as these conditions can lead to infections, poor surgical outcomes, prolonged hospital stays, and death. In 2022, the prevalence of diagnosed diabetes in Denmark was 6.2%. With the global incidence of diabetes on the rise, the number of patients requiring glucose control during surgical admissions is increasing.
Point-of-care (POC) fingerstick capillary glucose monitoring (FSGM) is standard in many hospitals; however, FSGM can be painful, disrupt sleep, and increase postoperative stress for patients. Additionally, it can be time-consuming, requiring up to two hours of nursing work per patient daily. This makes timely and prescribed glucose monitoring challenging in busy surgical wards, potentially leading to untreated hyperglycemia and hypoglycemia. Moreover, FSGM provides only a snapshot of glucose levels, without indicating whether glucose is stable, rising, or falling.
An alternative to FSGM is continuous glucose monitoring systems (CGMS), which measure glucose levels via a subcutaneous sensor every few minutes. CGMS is predominantly used in ambulatory settings and has been shown to improve glucose regulation. Several studies have confirmed the accuracy of CGMS compared to FSGM in surgical and medical wards, reporting an overall mean absolute relative difference ranging from 9.4 to 12.9, making it acceptable for use in surgical wards. Other studies have reported that CGMS in surgical and medical wards results in superior glycemic control, reduced hypoglycemia, insulin usage, and in-hospital complications, and detected significant duration of both hypo- and hyperglycemia despite protocolized perioperative diabetes management compared to FSGM.
Studies on patients' perspectives of CGMS have been limited to everyday life and outpatient settings. One review on patients with type 1 and 2 diabetes experienced improved convenience, control, and freedom by the use of CGMS but were also overwhelmed by data and frustrated by inaccuracy, and technical issues, which is consistent with findings from another review of patients with diabetes type 2. Another study reported that patients with type 2 diabetes found the technology helpful for disease management, although it could also serve as an unpleasant reminder of disease progression and cause discomfort.
One case report has described nurses' experiences with CGMS in hospital wards for patients with type 1 diabetes. The nurses experienced an increased workload due to difficulties hearing the device receiver, leading to more frequent patient observations.
In summary, CGMS has been reported to be safe and beneficial in ambulatory settings, while challenges and knowledge gaps remain in hospital wards. To date, no studies have compared glucose levels from CGMS with those from a laboratory plasma glucose analyzer as the reference. This study aims to investigate the effect of CGMS compared to FSGM in patients with hyperglycemia in general surgical wards on glucose levels, complications, length of hospital stay, and patient satisfaction and experience with glucose management during hospitalization and up to three months after discharge. Additionally, the study will investigate the nursing staff's workload and experience in the surgical ward, and the accuracy of CGMS throughout hospitalization, including during surgical procedures and medical imaging.
Seven substudies will be conducted:
Substudy 1 - Glucose levels and management for surgical patients in relation to hospitalization: Compares point-of-care 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 staff's glucose monitoring and management workload in the surgical ward: Compares the nursing staff's 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 one compares the patient experience of FSGM with CGM one month after discharge.
Substudy 5 - Continuous glucose level for surgical patients in relation to 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 in the surgical ward. Further, it compares continuous glucose levels using point-of-care FSGM and CGM after discharge.
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 staff's experience with fingerstick monitoring and CGSM for surgical patients: Compares the nursing staff's experience with point-of-care FSGM to point-of-care CGMS and glucose management for surgical patients.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 329
- Hospitalized patients (≥ 18 years old) in surgical wards
- Glucose measurements at least 4 times (OUH) and 3 times (SUH) daily for at least three days, prescribed by surgeon
- Expected hospitalization for at least three days
- Communicates in Danish
- Signed a declaration of consent to study participation
- At risk of hypo- and hyperglycemia (with or without a diabetes diagnosis)
- Specific for substudy 4 inclusion criteria as above with the following add on: Patients being treated with insulin at discharge and patients residing within the OUH admission area.
- Cognitively impaired patients
- Indication for glucose monitoring solely because of parenteral nutrition treatment
- Patients admitted with a CGMS
- Patients from the point-of-care fingerstick capillary glucose monitoring group cannot be included in the continuous glucose monitoring system group
Eligibility criteria solely for substudy 7
Inclusion Criteria:
- Nursing staff with at least one month of experience with both point-of-care fingerstick capillary glucose monitoring and continuous glucose monitoring system and are registered nurses or certified nursing assistants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PERIOD 2: Fingerstick glucose monitoring = standard care + blinded sensor Abott Freestyle Libre Pro Same as for period 1, but with a blinded sensor (FreeStyle Libre Pro). The data from the blinded sensors are concealed from both participants and nurses and will be used for comparison with the experimental arm. PERIOD 3: Continuous glucose monitoring system = study Intervention Abott FreeStyle Libre System 2 PERIOD 3: Continuous glucose monitoring system = study intervention, involving 140 participants. The sensor from the continuous glucose monitoring system is scanned by surgical nurses as point-of-care according to the predefined schedule, as in standard care. Monitoring is conducted by surgical ward nurses. Diabetes treatment management is overseen by specific in-house diabetes nurses. Diabetes nurses' treatment decisions are based on the continuous glucose monitoring system values
- Primary Outcome Measures
Name Time Method Substudy 1: Mean daytime and nocturnal point-of-care glucose levels During hospitalization (up to 30 days) Point-of-care glucose levels measured by point-of-care continuous glucose monitoring system (CGMS) or point-of-care fingerstick capillary glucose monitoring (FSGM)
Arm allocation:
Period 1: FSGM Period 2: CGMS Number of measurements: minimum four times daily, hourly if fasting. Blood glucose measurement: mmol/LSubstudy 2: Patient-reported outcome on the convenience of glucose monitoring During hospitalization (up to 30 days) 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'Substudy 3: Mean minutes surgical nursing staff spent on bedside glucose monitoring During hospitalization (up to 30 days) Mean time: minutes.
Data include:
* Profession
* Preparation (gathering materials, handwashing, disinfecting hands, putting on gloves, etc.)
* Time for fingerstick or scanning of the continuous glucose monitor sensor
* Display time of glucose level on device
* Glucose level (mmol/L)
* Actions taken after measurement (insulin injection, handwashing, documentation, disinfection, etc.)
* Time for leaving the room
* Time for completed procedure including documentation
* Other observations made during the measurementSubstudy 5: Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay During hospitalization (up to 30 days) Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay
Substudy 6: Differences in interstitial and plasma glucose During hospitalization (up to 30 days) Glucose levels from CGMS are compared to plasma glucose, which are co-analyzed in blood tests.
- Secondary Outcome Measures
Name Time Method Substudy 1: Mean dose of long-acting insulin (IE) During hospitalization (up to 30 days) Unit: International units (IE)
Substudy 1: Complication: Sepsis During hospitalization (up to 30 days) Defined as suspected or confirmed infection, as well as organ damage
Substudy 1: Complication: Second acute transfer to intensive care unit During hospitalization (up to 30 days) The date for the second acute transfer to the intensive care unit and back to the surgical ward The number of days at the intensive care unit
Unit: DaysSubstudy 1: Complication: Infections During hospitalization (up to 30 days) CRP, leucocytes, central body temperature. Unit: Days
Substudy 1: TIR and other established outcome derived from CGM 90-days after discharge from hospital Percentage
Substudy 2: DTSQ-IP, treatment satisfaction (item 1) During hospitalization (up to 30 days) Ranging from 0 - 6
0 represents 'At no time' 6 represents 'Very satisfied'eGFR During hospitalization (up to 30 days) Estimated Glomerular Filtration Rate
Substudy 1: Complication: Antibiotics During hospitalization (up to 30 days) Received antibiotics Unit: Days
Substudy 1: Complication: Bedsore During hospitalization (up to 30 days) Presence of bedsore during hospitalization: yes/no
Substudy 1: Complication: Diabetes ketoacidosis During hospitalization (up to 30 days) Diabetes ketoacidosis, defined as: pH \< 7.30 and blood ketones \> 3 mmol/L. Unit: Number of occurrence.
Substudy 1: Complication: Anastomotic leak During hospitalization (up to 30 days) Presence of anastomotic leak during hospitalization: yes/no
Substudy 1: Readmission 30-days after discharge from hospital Assesment of 30-day numbers of readmissions
Substudy 1: Mortality during hospitalization During hospitalization (up to 30 days) Yes or no
Substudy 1: • Mean dose of short-acting insulin (IE) During hospitalization (up to 30 days) Unit: International units (IE)
Substudy 1: Complication: Acute kidney failure During hospitalization (up to 30 days) Plasma creatinine, μmol/L
Substudy 1: Complication: First acute transfer to intensive care unit During hospitalization (up to 30 days) The date for the first acute transfer to the intensive care unit and back to the surgical ward The number of days at the intensive care unit
Unit: DaysSubstudy 1: Mortality after discharge from hospital 90-days after discharge from hospital Assesment of 90-day numbers of mortality.
Substudy 1: HbA1c three months after discharge 90-days after discharge from hospital mmol/mol
Substudy 2: DTSQ-IP, experience with hyper- and hypoglycemia (items 2-3) During hospitalization (up to 30 days) Ranging from 0 - 6
0 represents 'At no time' 6 represents 'At most of the time'Substudy 2: DTSQ-IP, treatment surveillance and flexibility (items 5+9), During hospitalization (up to 30 days) Ranging from 0 - 6
0 represents 'very unsatisfied"/"very inflexible' 6 represents ''very satisfied"very flexible"Substudy 2: DTSQ-IP, treatment information, knowledge, and communication (items 15-18) During hospitalization (up to 30 days) Ranging from 0 - 6
0 represents 'very unsatisfied' 6 represents 'very satisfied'Substudy 2: DTSQ-IP, contact with specialized diabetes nurses (items 20-21) During hospitalization (up to 30 days) Ranging from 0 - 6
0 represents 'very unsatisfied' 6 represents 'very satisfied'Substudy 3: Mean minutes surgical nursing staff spent on reporting glucose levels and management to diabetes nurses During hospitalization (up to 30 days) Measurement: Mean minutes
Substudy 3: Mean minutes the diabetes nurse spent in relation to the surgical patients During hospitalization (up to 30 days) The mean minutes diabetes nurses spent collecting information about glucose levels and management, supervising patients and surgical professionals, and being supervised by endocrinologists.
Substudy 5: CGMS, time above range (TAR) 10,1-13.9 mmol/l During hospitalization (up to 30 days) Percentage of time above range (TAR) 10,1-13.9 mmol/l
Substudy 5: CGMS, time above range (TAR) >13.9 mmol/l During hospitalization (up to 30 days) Percentage of time above range \>13.9 mmol/l
Substudy 5: CGMS, time below range 3.0-3.9 mmol/l During hospitalization (up to 30 days) Percentage of time below range 3.0-3.9 mmol/l
Substudy 5: CGMS, time below range <3.0 During hospitalization (up to 30 days) Percentage of time below range \<3.0 mmol/l
Substudy 5: CGMS, standard deviation (SD) During hospitalization (up to 30 days) mmol/l
Substudy 5: CGMS, coefficient of variation (CV) During hospitalization (up to 30 days) SD divided by mean glucose level
Substudy 5: CGMS, mean glucose level daytime During hospitalization (up to 30 days) mmol/l
Substudy 5: CGMS, mean glucose level night-time During hospitalization (up to 30 days) mmol/l
Substudy 5: CGMS, Hypoglycemia level 1 (3.0-3.9 mmol/l) During hospitalization (up to 30 days) Duration more than 15 consecutive minutes
Substudy 5: CGMS, hypoglycemia level 2 (<3.0 mmol/l) During hospitalization (up to 30 days) Duration more than 15 consecutive minutes
Substudy 5: CGMS, number of hypoglycemic events in level 1 and 2, respectively During hospitalization (up to 30 days) Number
Substudy 6: Differences in interstitial and capillary glucose During hospitalization (up to 30 days) Glucose levels from CGMS are compared to FSGM data, which are co-analyzed in blood tests.
Trial Locations
- Locations (2)
The Department of Surgery, Odense Univeristy Hospital
🇩🇰Odense, Denmark
Department of Surgery, Zealand University Hospital
🇩🇰Køge, Denmark