Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring (GLUCOSENS)

Continuous GLUCOse Monitoring System With a SENSor Compared to Fingerstick Glucose Monitoring in Surgical Wards (GLUCOSENS)

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Diabetes Mellitus; Hypoglycemia (Diabetic); Hypoglycemia Night
• Intervention / Treatment: Device: Abbott FreeStyle Libre System 2 Plus; Device: Abbott Freestyle Libre Pro

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.

• Study Type: Interventional
• Enrollment (Estimated): 329
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karoline Schousboe, MD, PhD; Phone Number: 0045 +4524349740; Email: Karoline.Schousboe@rsyd.dk
• Study Contact Backup: Name: Helen Schultz, RN, PhD; Phone Number: +4522401513; Email: Helen.Schultz@rsyd.dk

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Recruiting
    • Department of Surgery, Zealand University Hospital
    • Contact: Tine Lumbye Thomsen, RN, MCN
  • Odense, Denmark, 5000
    • Recruiting
    • The Department of Surgery, Odense Univeristy Hospital
    • Contact: Line Abrahamsen, RN, MCN; Phone Number: +4565412244; Email: line.abrahamsen@rsyd.dk
    • Contact: Helen Schultz, RN, PhD; Phone Number: +4522401513; Email: Helen.Schultz@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.	Device: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substudy 1: Mean daytime and nocturnal point-of-care glucose levels	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/L	During hospitalization (up to 30 days)
Substudy 2: Patient-reported outcome on 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 30 days)
Substudy 3: Mean minutes surgical nursing staff spent on bedside glucose monitoring	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 measurement	During hospitalization (up to 30 days)
Substudy 5: Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay	Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay	During hospitalization (up to 30 days)
Substudy 6: Differences in interstitial and plasma glucose	Glucose levels from CGMS are compared to plasma glucose, which are co-analyzed in blood tests.	During hospitalization (up to 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: HbA1c three months after discharge	mmol/mol	90-days after discharge from hospital
Substudy 1: • Mean dose of short-acting insulin (IE)	Unit: International units (IE)	During hospitalization (up to 30 days)
Substudy 1: Mean dose of long-acting insulin (IE)	Unit: International units (IE)	During hospitalization (up to 30 days)
eGFR	Estimated Glomerular Filtration Rate	During hospitalization (up to 30 days)
Substudy 1: Complication: Sepsis	Defined as suspected or confirmed infection, as well as organ damage	During hospitalization (up to 30 days)
Substudy 1: Complication: Acute kidney failure	Plasma creatinine, μmol/L	During hospitalization (up to 30 days)
Substudy 1: Complication: First acute transfer to intensive care unit	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: Days	During hospitalization (up to 30 days)
Substudy 1: Complication: Second acute transfer to intensive care unit	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: Days	During hospitalization (up to 30 days)
Substudy 1: Complication: Infections	CRP, leucocytes, central body temperature. Unit: Days	During hospitalization (up to 30 days)
Substudy 1: Complication: Antibiotics	Received antibiotics Unit: Days	During hospitalization (up to 30 days)
Substudy 1: Complication: Bedsore	Presence of bedsore during hospitalization: yes/no	During hospitalization (up to 30 days)
Substudy 1: Complication: Diabetes ketoacidosis	Diabetes ketoacidosis, defined as: pH < 7.30 and blood ketones > 3 mmol/L. Unit: Number of occurrence.	During hospitalization (up to 30 days)
Substudy 1: Complication: Anastomotic leak	Presence of anastomotic leak during hospitalization: yes/no	During hospitalization (up to 30 days)
Substudy 1: Mortality during hospitalization	Yes or no	During hospitalization (up to 30 days)
Substudy 1: TIR and other established outcome derived from CGM	Percentage	90-days after discharge from hospital
Substudy 2: DTSQ-IP, treatment satisfaction (item 1)	Ranging from 0 - 6 0 represents 'At no time' 6 represents 'Very satisfied'	During hospitalization (up to 30 days)
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 30 days)
Substudy 2: DTSQ-IP, treatment surveillance and flexibility (items 5+9),	Ranging from 0 - 6 0 represents 'very unsatisfied"/"very inflexible' 6 represents ''very satisfied"very flexible"	During hospitalization (up to 30 days)
Substudy 2: DTSQ-IP, treatment information, knowledge, and communication (items 15-18)	Ranging from 0 - 6 0 represents 'very unsatisfied' 6 represents 'very satisfied'	During hospitalization (up to 30 days)
Substudy 2: DTSQ-IP, contact with specialized diabetes nurses (items 20-21)	Ranging from 0 - 6 0 represents 'very unsatisfied' 6 represents 'very satisfied'	During hospitalization (up to 30 days)
Substudy 3: Mean minutes surgical nursing staff spent on reporting glucose levels and management to diabetes nurses	Measurement: Mean minutes	During hospitalization (up to 30 days)
Substudy 3: Mean minutes the diabetes nurse spent in relation to the surgical patients	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 30 days)
Substudy 5: CGMS, time above range (TAR) 10,1-13.9 mmol/l	Percentage of time above range (TAR) 10,1-13.9 mmol/l	During hospitalization (up to 30 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 30 days)
Substudy 5: CGMS, time below range 3.0-3.9 mmol/l	Percentage of time below range 3.0-3.9 mmol/l	During hospitalization (up to 30 days)
Substudy 5: CGMS, time below range <3.0	Percentage of time below range <3.0 mmol/l	During hospitalization (up to 30 days)
Substudy 5: CGMS, standard deviation (SD)	mmol/l	During hospitalization (up to 30 days)
Substudy 5: CGMS, coefficient of variation (CV)	SD divided by mean glucose level	During hospitalization (up to 30 days)
Substudy 5: CGMS, mean glucose level daytime	mmol/l	During hospitalization (up to 30 days)
Substudy 5: CGMS, mean glucose level night-time	mmol/l	During hospitalization (up to 30 days)
Substudy 5: CGMS, Hypoglycemia level 1 (3.0-3.9 mmol/l)	Duration more than 15 consecutive minutes	During hospitalization (up to 30 days)
Substudy 5: CGMS, hypoglycemia level 2 (<3.0 mmol/l)	Duration more than 15 consecutive minutes	During hospitalization (up to 30 days)
Substudy 5: CGMS, number of hypoglycemic events in level 1 and 2, respectively	Number	During hospitalization (up to 30 days)
Substudy 6: Differences in interstitial and capillary glucose	Glucose levels from CGMS are compared to FSGM data, which are co-analyzed in blood tests.	During hospitalization (up to 30 days)

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Zealand University Hospital
• Investigators: Study Chair: Karoline Schousboe, MD, PhD, Steno Diabetes Center Odense, Odense University Hospital; Study Chair: Helen Schultz, RN, PhD, The Department of Surgery, Odense University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: JAMA Surg. 2017 Aug 1;152(8):803. doi: 10.1001/jamasurg.2017.1943.
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• 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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Helpful Links

• Prevalence of patients with diagnosed diabetes in Denmark in 2022
• Incidence of diabetes worldwide
• User's guide for Abbotts' freestyle libre devices

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Patient satisfaction; accuracy; Blood glucose monitoring; continuous glucose monitoring system; Patient experience; point-of-care fingerstick capillary glucose monitoring; Nursing staff's workload; Nursing staff's experience
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hypoglycemia; Hyperglycemia
• Other Study ID Numbers: GLUCOSENS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes