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Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring

Not Applicable
Recruiting
Conditions
Diabetes Mellitus
Interventions
Device: Abott Freestyle Libre Pro
Device: Abott FreeStyle Libre System 2
Registration Number
NCT06473480
Lead Sponsor
Odense University Hospital
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 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.

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 6.2%. 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 9.4 to 12.9, 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 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 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 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
235
Inclusion Criteria
  • Hospitalized patients (≥ 18 years old) in surgical wards
  • Glucose measurements at least 5 times 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
  • Either have diabetes, are getting secondary diabetes by undergoing total/partial pancreatectomy or Whipple operation or are getting diabetes secondary to pancreatitis
  • Specific for substudy 4 inclusion criteria as above with the following add on: Patients with pancreatitis or who have undergone surgery on the pancreas during admission, patients still being treated with insulin at discharge, and a minimum of three days stay in the surgical ward
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Exclusion Criteria
  • 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 more than two months of experience with both point-of-care fingerstick capillary glucose monitoring and continuous glucose monitoring system
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
PERIOD 2: Fingerstick glucose monitoring = standard care + blinded sensorAbott Freestyle Libre ProSame 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 InterventionAbott FreeStyle Libre System 2PERIOD 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
NameTimeMethod
Substudy 3: The mean minutes spent on bedside glucose monitoringDuring hospitalization (up to 28 days)

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

Substudy 5: CGMS, time in range daytime (TIRd) 3.9-10.0 mmol/lDuring hospitalization (up to 28 days)

Percentage of time in range during daytime

Substudy 1: Mean daytime and nocturnal glucose levelsDuring hospitalization (up to 28 days)

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

Substudy 2: DTSQ-IP, Patient experience of the convenience of glucose monitoringDuring hospitalization (up to 28 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 5: Time in range night-time (TIRn) 3.9-10 mmol/lDuring hospitalization (up to 28 days)

Percentage of time in range during night-time

Substudy 6: Accuracy of CGMS measurementsDuring hospitalization (up to 28 days)

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

Secondary Outcome Measures
NameTimeMethod
Substudy 1: Mean dose of short-acting insulinDuring hospitalization (up to 28 days)

Unit: International units (IE)

Substudy 1: Presence of acute kidney injury during hospitalizationDuring hospitalization (up to 28 days)

Plasma creatinine, μmol/L

Substudy 1: Mortality after discharge from hospital90-days after discharge from hospital

Assesment of 90-day numbers of mortality.

Substudy 3: Nursing staff glucose managementThrough study completion, an average of one and a half year

Measurement: Mean minutes

Substudy 3: Nursing staff reporting glucose levels and management to diabetes nursesThrough study completion, an average of one and a half year

Measurement: Mean minutes

Substudy 5: CGMS, time below range <3.9During hospitalization (up to 28 days)

Percentage of time below range \<3.9 mmol/l

Substudy 1: Mean dose of long-acting insulinDuring hospitalization (up to 28 days)

Unit: International units (IE)

Substudy 1: Complications related to hospitality - diabetes ketoacidosisDuring hospitalization (up to 28 days)

Presence of bedsore during hospitalization: yes/no Diabetes ketoacidosis, defined as: pH \< 7.30 and blood ketones \> 3 mmol/L

Substudy 1: Readmission30-days after discharge from hospital

Assesment of 30-day numbers of readmissions

Substudy 2: DTSQ-IP, experience with hyper- and hypoglycemia (items 2-3)During hospitalization (up to 28 days)

Ranging from 0 - 6

0 represents 'At no time' 6 represents 'At most of the time'

Substudy 2: DTSQ-IP, treatment information, knowledge, and communication (items 15-18)During hospitalization (up to 28 days)

Ranging from 0 - 6

0 represents 'At no time' 6 represents 'At most of the time'

Substudy 1: Presence of sepsis during hospitalizationDuring hospitalization (up to 28 days)

Defined as suspected or confirmed infection, as well as organ damage

Substudy 1: Complications related to hospitality - anastomotic leakDuring hospitalization (up to 28 days)

Presence of anastomotic leak during hospitalization: yes/no

Substudy 1: Mortality during hospitalizationDuring hospitalization (up to 28 days)

Yes or no

Substudy 1: Second transfer to intensive care unitDuring hospitalization (up to 28 days)

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

Substudy 1: Complications related to hospitality - bedsoreDuring hospitalization (up to 28 days)

Presence of bedsore during hospitalization: yes/no

Substudy 1: HbA1c three months after discharge90-days after discharge from hospital

mmol/mol

Substudy 2: DTSQ-IP, treatment surveillance and flexibility (items 5+9),During hospitalization (up to 28 days)

Ranging from 0 - 6

0 represents 'At no time' 6 represents 'At most of the time'

Substudy 5: CGMS, time below range <3.0During hospitalization (up to 28 days)

Percentage of time below range \<3.0 mmol/l

Substudy 5: CGMS, mean glucose level daytimeDuring hospitalization (up to 28 days)

mmol/l

Substudy 5: CGMS, hypoglycemia level 1 <3.9 mmol/lDuring hospitalization (up to 28 days)

Duration more than 15 consecutive minutes

Substudy 1: First transfer to intensive care unitDuring hospitalization (up to 28 days)

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

Substudy 2: DTSQ-IP, contact with specialized diabetes nurses (items 20-21)During hospitalization (up to 28 days)

Ranging from 0 - 6

0 represents 'At no time' 6 represents 'At most of the time'

Substudy 5: CGMS, mean glucose level night-timeDuring hospitalization (up to 28 days)

mmol/l

Substudy 5: CGMS, hypoglycemia level 2 <3.0 mmol/lDuring hospitalization (up to 28 days)

Duration more than 15 consecutive minutes

Substudy 3: Daily mean minutes the diabetes nurse spendsDuring hospitalization (up to 28 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 rang (TAR) >10 mmol/lDuring hospitalization (up to 28 days)

Percentage of time above range \>10 mmol/l

Substudy 5: CGMS, time above range (TAR) >13.9 mmol/lDuring hospitalization (up to 28 days)

Percentage of time above range \>13.9 mmol/l

Substudy 5: CGMS, coefficient of variation (CV)During hospitalization (up to 28 days)

SD divided by mean glucose level

Substudy 5: CGMS, number of hypoglycemic eventsDuring hospitalization (up to 28 days)

Number

Substudy 5: CGMS, standard deviation (SD)During hospitalization (up to 28 days)

mmol/l

Trial Locations

Locations (2)

The Department of Surgery, Odense Univeristy Hospital

🇩🇰

Odense, Denmark

Department of Surgery, Zealand University Hospital

🇩🇰

Køge, Denmark

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