Clinical trial NCT06473480: Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring
Official title: Continuous GLUCOse Monitoring System With a SENSor Compared to Fingerstick Glucose Monitoring in Surgical Wards (GLUCOSENS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Hypoglycemia (Diabetic)
Hypoglycemia Night
Hyperglycemia
Keywords: Blood glucose monitoring
point-of-care fingerstick capillary glucose monitoring
continuous glucose monitoring system
Patient satisfaction
Patient experience
Nursing staff&#39;s workload
Nursing staff&#39;s experience
accuracy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2024-06-25
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)
* 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.

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 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

Primary outcomes:
measure: Substudy 1: Mean daytime and nocturnal point-of-care glucose levels
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 2: Patient-reported outcome on the convenience of glucose monitoring
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 3: Mean minutes surgical nursing staff spent on bedside glucose monitoring
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 6: Differences in interstitial and plasma glucose
timeFrame: During hospitalization (up to 30 days)
Secondary outcomes:
measure: Substudy 1: • Mean dose of short-acting insulin (IE)
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Mean dose of long-acting insulin (IE)
timeFrame: During hospitalization (up to 30 days)
measure: eGFR
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Complication: Sepsis
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Complication: Acute kidney failure
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Complication: First acute transfer to intensive care unit
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Complication: Second acute transfer to intensive care unit
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Complication: Infections
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Complication: Antibiotics
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Complication: Bedsore
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Complication: Diabetes ketoacidosis
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Complication: Anastomotic leak
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Readmission
timeFrame: 30-days after discharge from hospital
measure: Substudy 1: Mortality during hospitalization
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 1: Mortality after discharge from hospital
timeFrame: 90-days after discharge from hospital
measure: Substudy 1: HbA1c three months after discharge
timeFrame: 90-days after discharge from hospital
measure: Substudy 1: TIR and other established outcome derived from CGM
timeFrame: 90-days after discharge from hospital
measure: Substudy 2: DTSQ-IP, treatment satisfaction (item 1)
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 2: DTSQ-IP, experience with hyper- and hypoglycemia (items 2-3)
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 2: DTSQ-IP, treatment surveillance and flexibility (items 5+9),
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 2: DTSQ-IP, treatment information, knowledge, and communication (items 15-18)
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 2: DTSQ-IP, contact with specialized diabetes nurses (items 20-21)
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 3: Mean minutes surgical nursing staff spent on reporting glucose levels and management to diabetes nurses
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 3: Mean minutes the diabetes nurse spent in relation to the surgical patients
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, time above range (TAR) 10,1-13.9 mmol/l
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, time above range (TAR) >13.9 mmol/l
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, time below range 3.0-3.9 mmol/l
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, time below range <3.0
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, standard deviation (SD)
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, coefficient of variation (CV)
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, mean glucose level daytime
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, mean glucose level night-time
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, Hypoglycemia level 1 (3.0-3.9 mmol/l)
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, hypoglycemia level 2 (<3.0 mmol/l)
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 5: CGMS, number of hypoglycemic events in level 1 and 2, respectively
timeFrame: During hospitalization (up to 30 days)
measure: Substudy 6: Differences in interstitial and capillary glucose
timeFrame: During hospitalization (up to 30 days)
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Department of Surgery, Zealand University Hospital
city: Odense
country: Denmark
facility: The Department of Surgery, Odense Univeristy Hospital
Study officials:
affiliation: Steno Diabetes Center Odense, Odense University Hospital
name: Karoline Schousboe, MD, PhD
role: STUDY_CHAIR
affiliation: The Department of Surgery, Odense University Hospital
name: Helen Schultz, RN, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Stahl-Pehe A, Kamrath C, Prinz N, Kapellen T, Menzel U, Kordonouri O, Schwab KO, Bechtold-Dalla Pozza S, Rosenbauer J, Holl RW. Prevalence of type 1 and type 2 diabetes in children and adolescents in Germany from 2002 to 2020: A study based on electronic health record data from the DPV registry. J Diabetes. 2022 Dec;14(12):840-850. doi: 10.1111/1753-0407.13339. Epub 2022 Dec 14.
citation: Galindo RJ, Migdal AL, Davis GM, Urrutia MA, Albury B, Zambrano C, Vellanki P, Pasquel FJ, Fayfman M, Peng L, Umpierrez GE. Comparison of the FreeStyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System and Point-of-Care Capillary Glucose Testing in Hospitalized Patients With Type 2 Diabetes Treated With Basal-Bolus Insulin Regimen. Diabetes Care. 2020 Nov;43(11):2730-2735. doi: 10.2337/dc19-2073. Epub 2020 Jul 8.
citation: 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.
citation: 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.
citation: 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.
citation: Aragon D. Evaluation of nursing work effort and perceptions about blood glucose testing in tight glycemic control. Am J Crit Care. 2006 Jul;15(4):370-7.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Natale P, Chen S, Chow CK, Cheung NW, Martinez-Martin D, Caillaud C, Scholes-Robertson N, Kelly A, Craig JC, Strippoli G, Jaure A. Patient experiences of continuous glucose monitoring and sensor-augmented insulin pump therapy for diabetes: A systematic review of qualitative studies. J Diabetes. 2023 Dec;15(12):1048-1069. doi: 10.1111/1753-0407.13454. Epub 2023 Aug 8.
citation: Taylor PJ, Thompson CH, Brinkworth GD. Effectiveness and acceptability of continuous glucose monitoring for type 2 diabetes management: A narrative review. J Diabetes Investig. 2018 Jul;9(4):713-725. doi: 10.1111/jdi.12807. Epub 2018 Mar 1.
citation: Chiu CJ, Chou YH, Chen YJ, Du YF. Impact of New Technologies for Middle-Aged and Older Patients: In-Depth Interviews With Type 2 Diabetes Patients Using Continuous Glucose Monitoring. JMIR Diabetes. 2019 Feb 21;4(1):e10992. doi: 10.2196/10992.
citation: Wang M, Singh LG, Spanakis EK. Advancing the Use of CGM Devices in a Non-ICU Setting. J Diabetes Sci Technol. 2019 Jul;13(4):674-681. doi: 10.1177/1932296818821094. Epub 2019 Jan 13.
citation: Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
citation: Spanakis EK, Cook CB, Kulasa K, Aloi JA, Bally L, Davis G, Dungan KM, Galindo RJ, Mendez CE, Pasquel FJ, Shah VN, Umpierrez GE, Aaron RE, Tian T, Yeung AM, Huang J, Klonoff DC. A Consensus Statement for Continuous Glucose Monitoring Metrics for Inpatient Clinical Trials. J Diabetes Sci Technol. 2023 Nov;17(6):1527-1552. doi: 10.1177/19322968231191104. Epub 2023 Aug 17.
citation: Rutter CL, Jones C, Dhatariya KK, James J, Irvine L, Wilson EC, Singh H, Walden E, Holland R, Harvey I, Bradley C, Sampson MJ. Determining in-patient diabetes treatment satisfaction in the UK--the DIPSat study. Diabet Med. 2013 Jun;30(6):731-8. doi: 10.1111/dme.12095. Epub 2013 Mar 6.
citation: Sampson MJ, Singh H, Dhatariya KK, Jones C, Walden E, Bradley C. Psychometric validation and use of a novel diabetes in-patient treatment satisfaction questionnaire. Diabet Med. 2009 Jul;26(7):729-35. doi: 10.1111/j.1464-5491.2009.02754.x.
citation: 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.
citation: World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.