Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring
NCT ID: NCT06473480
Last Updated: 2025-04-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
329 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-06-26
Study Completion Date
2025-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Diabetes Mellitus
Hypoglycemia (Diabetic)
Hypoglycemia Night
Hyperglycemia
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SEQUENTIAL
PERIOD 1: Point-of-care fingerstick glucose monitoring = Standard care, 110 patients
* Substudy 1-3: 110 patients
* Substudy 4: 14 patients of the 110 patients
PERIOD 2: Point-of-care continuous glucose monitoring system = study Intervention 110 patients and 24 nursing staff
* Substudy 1-3: 110 patients
* Substudy 4: 20 patients of the 110 patients
* Substudy 5\*: 85 patients of the 110 patients
* Substudy 6\*: 85 patients of the 110 patients
* Substudy 7: 24 nursing staff (20 surgical nursing staff and 4 specialized diabetes nurses)
PERIOD 3\*: Point-of-care fingerstick glucose monitoring = standard care + blinded sensor, 85 patients
* Substudy 5\*: 85 patients
* Substudy 6\*: 85 patients
* Only conducted at Odense University Hospital
* Substudy 1-3: 110 patients
* Substudy 4: 14 patients of the 110 patients
PERIOD 2: Point-of-care continuous glucose monitoring system = study Intervention 110 patients and 24 nursing staff
* Substudy 1-3: 110 patients
* Substudy 4: 20 patients of the 110 patients
* Substudy 5\*: 85 patients of the 110 patients
* Substudy 6\*: 85 patients of the 110 patients
* Substudy 7: 24 nursing staff (20 surgical nursing staff and 4 specialized diabetes nurses)
PERIOD 3\*: Point-of-care fingerstick glucose monitoring = standard care + blinded sensor, 85 patients
* Substudy 5\*: 85 patients
* Substudy 6\*: 85 patients
* Only conducted at Odense University Hospital
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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PERIOD 1: Point-of-care fingerstick glucose monitoring = standard care
Subjects' blood glucose levels are monitored using point-of-care fingerstick capillary glucose monitoring (standard care), which is conducted by surgical ward nurses according to a predefined schedule. Diabetes treatment management is overseen by specific in-house diabetes nurses. Treatment decisions are based on point-of-care fingerstick capillary glucose values.
Group Type
NO_INTERVENTION
No interventions assigned to this group
PERIOD 2: Glucose monitoring system as point-of-care = study intervention
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.
Group Type
ACTIVE_COMPARATOR
Abbott FreeStyle Libre System 2 Plus
Intervention Type
DEVICE
The sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.
PERIOD 3: Point-of care fingerstick glucose monitoring = standard care + blinded sensor
PERIOD 3: 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.
This study period is only conducted at OUH.
Group Type
EXPERIMENTAL
Abbott Freestyle Libre Pro
Intervention Type
DEVICE
The sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.
Interventions
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Abbott FreeStyle Libre System 2 Plus
The sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.
Intervention Type
DEVICE
Abbott Freestyle Libre Pro
The sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
* 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)
* 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
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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
110 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Zealand University Hospital
OTHER
Sponsor Role
collaborator
Odense University Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Karoline Schousboe, MD, PhD
Role: STUDY_CHAIR
Steno Diabetes Center Odense, Odense University Hospital
Helen Schultz, RN, PhD
Role: STUDY_CHAIR
The Department of Surgery, Odense University Hospital
Locations
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Department of Surgery, Zealand University Hospital
Køge, Køge, Denmark
Site Status
RECRUITING
The Department of Surgery, Odense Univeristy Hospital
Odense, Odense, Denmark
Site Status
RECRUITING
Countries
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Denmark
Central Contacts
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Facility Contacts
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Tine Lumbye Thomsen, RN, MCN
Role: primary
References
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Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
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Kotagal M, Symons RG, Hirsch IB, Umpierrez GE, Dellinger EP, Farrokhi ET, Flum DR; SCOAP-CERTAIN Collaborative. Perioperative hyperglycemia and risk of adverse events among patients with and without diabetes. Ann Surg. 2015 Jan;261(1):97-103. doi: 10.1097/SLA.0000000000000688.
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Carstensen B, Ronn PF, Jorgensen ME. Prevalence, incidence and mortality of type 1 and type 2 diabetes in Denmark 1996-2016. BMJ Open Diabetes Res Care. 2020 May;8(1):e001071. doi: 10.1136/bmjdrc-2019-001071.
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Carstensen B, Ronn PF, Jorgensen ME. Components of diabetes prevalence in Denmark 1996-2016 and future trends until 2030. BMJ Open Diabetes Res Care. 2020 Aug;8(1):e001064. doi: 10.1136/bmjdrc-2019-001064.
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American Diabetes Association Professional Practice Committee. 16. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S244-S253. doi: 10.2337/dc22-S016.
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Mianowska B, Mlynarski W, Szadkowska I, Szadkowska A. Evaluation of Three Lancing Devices: What Do Blood Volume and Lancing Pain Depend On? J Diabetes Sci Technol. 2021 Sep;15(5):1076-1083. doi: 10.1177/1932296820949930. Epub 2020 Aug 17.
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Kocher S, Tshiananga JK, Koubek R. Comparison of lancing devices for self-monitoring of blood glucose regarding lancing pain. J Diabetes Sci Technol. 2009 Sep 1;3(5):1136-43. doi: 10.1177/193229680900300517.
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Gothong C, Singh LG, Satyarengga M, Spanakis EK. Continuous glucose monitoring in the hospital: an update in the era of COVID-19. Curr Opin Endocrinol Diabetes Obes. 2022 Feb 1;29(1):1-9. doi: 10.1097/MED.0000000000000693.
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Lin R, Brown F, James S, Jones J, Ekinci E. Continuous glucose monitoring: A review of the evidence in type 1 and 2 diabetes mellitus. Diabet Med. 2021 May;38(5):e14528. doi: 10.1111/dme.14528. Epub 2021 Mar 6.
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Carlsson CJ, Norgaard K, Oxboll AB, Sogaard MIV, Achiam MP, Jorgensen LN, Eiberg JP, Palm H, Sorensen HBD, Meyhof CS, Aasvang EK. Continuous Glucose Monitoring Reveals Perioperative Hypoglycemia in Most Patients With Diabetes Undergoing Major Surgery: A Prospective Cohort Study. Ann Surg. 2023 Apr 1;277(4):603-611. doi: 10.1097/SLA.0000000000005246. Epub 2021 Oct 8.
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BACKGROUND
Cavalcante Lima Chagas G, Teixeira L, R C Clemente M, Cavalcante Lima Chagas R, Santinelli Pestana DV, Rodrigues Silva Sombra L, B Lima B, J Galindo R, Abreu M. Use of continuous glucose monitoring and point-of-care glucose testing in hospitalized patients with diabetes mellitus in non-intensive care unit settings: A systematic review and meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2025 Feb;220:111986. doi: 10.1016/j.diabres.2024.111986. Epub 2025 Jan 9.
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Olsen MT, Klarskov CK, Jensen SH, Rasmussen LM, Lindegaard B, Andersen JA, Gottlieb H, Lunding S, Pedersen-Bjergaard U, Hansen KB, Kristensen PL. In-Hospital Diabetes Management by a Diabetes Team and Insulin Titration Algorithms Based on Continuous Glucose Monitoring or Point-of-Care Glucose Testing in Patients With Type 2 Diabetes (DIATEC): A Randomized Controlled Trial. Diabetes Care. 2025 Apr 1;48(4):569-578. doi: 10.2337/dc24-2222.
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Verissimo D, Vinhais J, Ivo C, Martins AC, Nunes E Silva J, Passos D, Lopes L, Jacome de Castro J, Marcelino M. Continuous Glucose Monitoring vs. Capillary Blood Glucose in Hospitalized Type 2 Diabetes Patients. Cureus. 2023 Aug 21;15(8):e43832. doi: 10.7759/cureus.43832. eCollection 2023 Aug.
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BACKGROUND
Schultz H, Petersen MC, Nielsen KB, Abrahamsen L, Nielsen TD, Joergensen UL, Thomsen TL, Schousboe K. GLUCOSENS study protocol: a continuous glucose monitoring system compared to fingerstick glucose monitoring in surgical wards - a two-centre before-after clinical trial. BMJ Open. 2025 Apr 2;15(4):e095503. doi: 10.1136/bmjopen-2024-095503.
Reference Type
DERIVED
Related Links
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https://diabetes.dk/forskning/viden-om-diabetes/diabetes-i-danmark
Prevalence of patients with diagnosed diabetes in Denmark in 2022
https://www.who.int/health-topics/diabetes?gad_source=1&gclid=EAIaIQobChMIv8fij6DnhQMVS0CRBR3--Q_yEAAYASAAEgLq_vD_BwE#tab=tab_1
Incidence of diabetes worldwide
https://www.diabetescare.abbott/support/manuals/dk.html
User's guide for Abbotts' freestyle libre devices
Other Identifiers
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GLUCOSENS
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
NA
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NA
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UNKNOWN
NA
Develop Novel Methods to Display, Report and Analyze CGM Data for Clinical Decision-Making in People With Diabetes
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NA
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