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Diabetes MellitusGLUCOSENSNCT06473480

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

A study testing Abbott FreeStyle Libre System 2 Plus and Abbott Freestyle Libre Pro in people with Diabetes Mellitus and Hypoglycemia (Diabetic), run by Odense University Hospital at 2 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 110 years
What is being tested?
Abbott FreeStyle Libre System 2 Plus and Abbott Freestyle Libre Pro
Could I receive a placebo?
No, everyone receives an active treatment
How many people
329 participants
Where
2 sitesDenmark
Study dates
26 Jun 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Helen Schultz, RN, PhD contact

+4522401513

Helen.Schultz@rsyd.dk

Karoline Schousboe, MD, PhD contact

+4524349740 ext. 0045

Karoline.Schousboe@rsyd.dk

Denmark2 sites, 2 recruiting

  • Department of Surgery, Zealand University Hospital

    Køge, Køge, 4600

    Tine Lumbye Thomsen, RN, MCN

    Recruiting

  • The Department of Surgery, Odense Univeristy Hospital

    Odense, Odense, 5000

    Helen Schultz, RN, PhD, +4522401513, Helen.Schultz@rsyd.dk

    Line Abrahamsen, RN, MCN, +4565412244, line.abrahamsen@rsyd.dk

    Recruiting

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
Abbott FreeStyle Libre System 2 Plus, Abbott Freestyle Libre Pro
Keywords
Blood glucose monitoring, point-of-care fingerstick capillary glucose monitoring, continuous glucose monitoring system, Patient satisfaction, Patient experience, Nursing staff's workload, Nursing staff's experience, accuracy
Medical subject headings
Diabetes Mellitus, Hypoglycemia, Hyperglycemia, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abbott FreeStyle Libre System 2 PlusDevice

    The sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.

  • Abbott Freestyle Libre ProDevice

    The sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.

Study groups in NCT06473480
Study groupRoleWhat they receive
PERIOD 1: Point-of-care fingerstick glucose monitoring = standard careNo interventionSubjects' 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.
PERIOD 2: Glucose monitoring system as point-of-care = study interventionActive comparatorThe 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.
Receives: Device: Abbott FreeStyle Libre System 2 Plus
PERIOD 3: Point-of care fingerstick glucose monitoring = standard care + blinded sensorExperimentalPERIOD 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.
Receives: Device: Abbott Freestyle Libre Pro

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: During hospitalization (up to 30 days)

  2. 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'

    Measured: During hospitalization (up to 30 days)

  3. 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

    Measured: During hospitalization (up to 30 days)

  4. 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

    Measured: During hospitalization (up to 30 days)

  5. Substudy 6: Differences in interstitial and plasma glucose

    Glucose levels from CGMS are compared to plasma glucose, which are co-analyzed in blood tests.

    Measured: During hospitalization (up to 30 days)

Secondary outcomes (36)

  1. Substudy 1: • Mean dose of short-acting insulin (IE)

    Unit: International units (IE)

    Measured: During hospitalization (up to 30 days)

  2. Substudy 1: Mean dose of long-acting insulin (IE)

    Unit: International units (IE)

    Measured: During hospitalization (up to 30 days)

  3. eGFR

    Estimated Glomerular Filtration Rate

    Measured: During hospitalization (up to 30 days)

  4. Substudy 1: Complication: Sepsis

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

    Measured: During hospitalization (up to 30 days)

  5. Substudy 1: Complication: Acute kidney failure

    Plasma creatinine, μmol/L

    Measured: During hospitalization (up to 30 days)

  6. 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

    Measured: During hospitalization (up to 30 days)

  7. 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

    Measured: During hospitalization (up to 30 days)

  8. Substudy 1: Complication: Infections

    CRP, leucocytes, central body temperature. Unit: Days

    Measured: During hospitalization (up to 30 days)

  9. Substudy 1: Complication: Antibiotics

    Received antibiotics Unit: Days

    Measured: During hospitalization (up to 30 days)

  10. Substudy 1: Complication: Bedsore

    Presence of bedsore during hospitalization: yes/no

    Measured: During hospitalization (up to 30 days)

  11. Substudy 1: Complication: Diabetes ketoacidosis

    Diabetes ketoacidosis, defined as: pH < 7.30 and blood ketones > 3 mmol/L. Unit: Number of occurrence.

    Measured: During hospitalization (up to 30 days)

  12. Substudy 1: Complication: Anastomotic leak

    Presence of anastomotic leak during hospitalization: yes/no

    Measured: During hospitalization (up to 30 days)

  13. Substudy 1: Readmission

    Assesment of 30-day numbers of readmissions

    Measured: 30-days after discharge from hospital

  14. Substudy 1: Mortality during hospitalization

    Yes or no

    Measured: During hospitalization (up to 30 days)

  15. Substudy 1: Mortality after discharge from hospital

    Assesment of 90-day numbers of mortality.

    Measured: 90-days after discharge from hospital

  16. Substudy 1: HbA1c three months after discharge

    mmol/mol

    Measured: 90-days after discharge from hospital

  17. Substudy 1: TIR and other established outcome derived from CGM

    Percentage

    Measured: 90-days after discharge from hospital

  18. Substudy 2: DTSQ-IP, treatment satisfaction (item 1)

    Ranging from 0 - 6

    0 represents 'At no time' 6 represents 'Very satisfied'

    Measured: During hospitalization (up to 30 days)

  19. 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'

    Measured: During hospitalization (up to 30 days)

  20. 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"

    Measured: During hospitalization (up to 30 days)

  21. Substudy 2: DTSQ-IP, treatment information, knowledge, and communication (items 15-18)

    Ranging from 0 - 6

    0 represents 'very unsatisfied' 6 represents 'very satisfied'

    Measured: During hospitalization (up to 30 days)

  22. Substudy 2: DTSQ-IP, contact with specialized diabetes nurses (items 20-21)

    Ranging from 0 - 6

    0 represents 'very unsatisfied' 6 represents 'very satisfied'

    Measured: During hospitalization (up to 30 days)

  23. Substudy 3: Mean minutes surgical nursing staff spent on reporting glucose levels and management to diabetes nurses

    Measurement: Mean minutes

    Measured: During hospitalization (up to 30 days)

  24. 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.

    Measured: During hospitalization (up to 30 days)

  25. 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

    Measured: During hospitalization (up to 30 days)

  26. Substudy 5: CGMS, time above range (TAR) >13.9 mmol/l

    Percentage of time above range >13.9 mmol/l

    Measured: During hospitalization (up to 30 days)

  27. Substudy 5: CGMS, time below range 3.0-3.9 mmol/l

    Percentage of time below range 3.0-3.9 mmol/l

    Measured: During hospitalization (up to 30 days)

  28. Substudy 5: CGMS, time below range <3.0

    Percentage of time below range <3.0 mmol/l

    Measured: During hospitalization (up to 30 days)

  29. Substudy 5: CGMS, standard deviation (SD)

    mmol/l

    Measured: During hospitalization (up to 30 days)

  30. Substudy 5: CGMS, coefficient of variation (CV)

    SD divided by mean glucose level

    Measured: During hospitalization (up to 30 days)

  31. Substudy 5: CGMS, mean glucose level daytime

    mmol/l

    Measured: During hospitalization (up to 30 days)

  32. Substudy 5: CGMS, mean glucose level night-time

    mmol/l

    Measured: During hospitalization (up to 30 days)

  33. Substudy 5: CGMS, Hypoglycemia level 1 (3.0-3.9 mmol/l)

    Duration more than 15 consecutive minutes

    Measured: During hospitalization (up to 30 days)

  34. Substudy 5: CGMS, hypoglycemia level 2 (<3.0 mmol/l)

    Duration more than 15 consecutive minutes

    Measured: During hospitalization (up to 30 days)

  35. Substudy 5: CGMS, number of hypoglycemic events in level 1 and 2, respectively

    Number

    Measured: During hospitalization (up to 30 days)

  36. Substudy 6: Differences in interstitial and capillary glucose

    Glucose levels from CGMS are compared to FSGM data, which are co-analyzed in blood tests.

    Measured: During hospitalization (up to 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2024
  2. Study start26 Jun 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
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
Masking
None (open label)
Enrolment
329 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06473480
Sponsor's protocol ID
GLUCOSENS
Acronym
GLUCOSENS
Status last verified
Mar 2025
First submitted
14 May 2024
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 28467526

  • 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.

    PubMed 25133932

  • 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.

    PubMed 32475839

  • 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.

    PubMed 32784246

  • 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.

    PubMed 36515004

  • 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.

    PubMed 32641372

  • 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.

    PubMed 34964884

  • 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.

    PubMed 32856497

  • 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.

    PubMed 20144427

  • 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.

    PubMed 16823014

  • 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.

    PubMed 34845159

  • 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.

    PubMed 33496979

  • 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.

    PubMed 35129526

  • 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.

    PubMed 39798897

  • 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.

    PubMed 39887698

Questions about this trial

What is this clinical trial studying?

A study testing Abbott FreeStyle Libre System 2 Plus and Abbott Freestyle Libre Pro in people with Diabetes Mellitus and Hypoglycemia (Diabetic), run by Odense University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Helen Schultz, RN, PhD (+4522401513, Helen.Schultz@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Substudy 1: Mean daytime and nocturnal point-of-care glucose levels (time frame: During hospitalization (up to 30 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06473480, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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