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Critical Care NursingCGM-UCI23NCT07687368

Clinical Trial Protocol for Continuous Glucose Monitoring in Critical Care

A study testing Continuous Glucose Monitoring and Conventional Glucose Measurement in people with Critical Care Nursing and Critical Illness, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

High blood glucose levels (hyperglycaemia) are very common in patients admitted to intensive care units (ICUs) and are associated with worse health outcomes. Traditionally, glucose levels in critically ill patients are monitored using point-of-care blood glucose (POC-G) testing (fingerstick, arterial, or venous blood… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Continuous Glucose Monitoring and Conventional Glucose Measurement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
1 siteSpain
Study dates
14 Jun 2025to 1 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or over
  • Stay in ICU and/or intermediate care
  • Blood glucose levels >180 mg/dL (10 mmol/L).

Who cannot join

  • Pregnancy
  • Contraindications for the use of CGM (such as skin issues or allergies to adhesives)
  • End-of-life process

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Carrer de Villarroel, 170

    Barcelona, Catalonia, 08036

Other trials in Spain

About this study

Official title: Continuous Glucose Monitoring in Critically Ill Patients: a Randomized Controlled Trial in the Intensive Care Units of Hospital Clínic of Barcelona (CGM-UCI23)

High blood glucose levels (hyperglycaemia) are very common in patients admitted to intensive care units (ICUs) and are associated with worse health outcomes. Traditionally, glucose levels in critically ill patients are monitored using point-of-care blood glucose (POC-G) testing (fingerstick, arterial, or venous blood samples), which may require multiple measurements each day.

Continuous glucose monitoring (CGM) is a technology that measures glucose levels continuously throughout the day and night, providing real-time information and alerts when glucose levels are too high or too low. Previous studies have shown that CGM can be used safely in critically ill patients and may reduce the number of blood glucose tests required. However, more evidence is needed to determine whether CGM improves glucose control and patient outcomes in the ICU.

Read more

The purpose of this study is to compare CGM-based glucose management with standard point-of-care glucose testing in critically ill patients with hyperglycaemia admitted to the Hospital Clínic of Barcelona. Participants will be randomly assigned to one of two groups. In the experimental group, healthcare professionals will use real-time CGM data to make glucose management decisions. In the control group, glucose management will be based on standard point-of-care testing, while CGM data will be collected in the background for later analysis.

The study will evaluate whether CGM improves the amount of time that glucose levels remain within the target range, reduces episodes of high and low glucose, decreases the number of blood glucose tests required, and influences patient outcomes such as complications, hospital readmissions, and mortality up to 90 days after ICU discharge.

Researchers hope that the results of this study will help determine whether CGM should become part of routine ICU care, improving patient safety, reducing the burden of glucose monitoring, and supporting more efficient clinical decision-making.

Being tested
Continuous Glucose Monitoring, Conventional Glucose Measurement
Medical subject headings
Critical Illness, Hyperglycemia

What participants receive

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

  • Continuous Glucose MonitoringDevice

    Also called CGM, CGM Guided

    CGM uses a subcutaneous sensor inserted into the upper arm or abdomen to measure interstitial glucose every 5 minutes. The system provides real-time glucose values, trends, and configurable alerts for hyperglycaemia and hypoglycaemia to support glycaemic management. Point-of-care blood glucose measurements may be performed when clinically indicated for confirmation of hypoglycaemia, extreme glucose values, or according to institutional safety protocols during intravenous insulin therapy.

  • Conventional Glucose MeasurementDevice

    Also called POC-G Group, Conventional Group, Sham Group

    Conventional glucose monitoring consists of capillary blood glucose measurements as the primary method for insulin dose adjustment according to standard ICU practice, complemented by arterial or venous blood glucose measurements when clinically indicated, all know as POC-G measurements.

    Glucose is typically measured approximately six times daily, with frequency adjusted according to clinical condition and insulin requirements. During the study, a CGM device is worn only for glucose data collection; CGM values remain blinded to healthcare professionals and are not used for clinical decision-making. All therapeutic decisions are based exclusively on conventional blood glucose measurements.

Study groups in NCT07687368
Study groupRoleWhat they receive
Conventional Glucose MeasurementSham comparatorParticipants receive standard glycemic management according to ICU standard practice. Capillary blood glucose is the primary method used for insulin dose adjustment and is complemented, when clinically indicated, by arterial or venous blood glucose measurements. On average, approximately six blood glucose measurements are performed per day; however, the frequency may be increased or decreased according to the prescribed treatment regimen, insulin requirements, and the patient's clinical condition during ICU admission. CGM is used throughout the study period to collect glucose data. In this control arm, CGM data are blinded to healthcare professionals and are not used for clinical decision-making, serving as a sham intervention for study comparison purposes. All therapeutic decisions, including insulin dose adjustments, are based exclusively on conventional blood glucose measurements according to standard ICU practice.
Receives: Device: Conventional Glucose Measurement
Continuous Glucose Monitoring GroupExperimentalParticipants randomized to the experimental group will receive glucose management guided by a CGM system. A CGM sensor will be inserted on the upper arm or abdomen and will provide real-time glucose measurements every 5 minutes. Glucose values, trends, and alerts for hyperglycaemia and hypoglycaemia will be available to the clinical team and used to support glycaemic management decisions during the ICU stay. The CGM system will be configured with predefined glucose alerts and predictive hypoglycaemia alarms. Healthcare professionals may perform additional point-of-care glucose measurements when clinically indicated, including confirmation of hypoglycaemia, extreme glucose values, or during intravenous insulin therapy according to safety criteria.
Receives: Device: Continuous Glucose Monitoring

What is being measured

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

  1. Time in Range

    Percentage of time that glucose values remain within the target range of 70-180 mg/dL (3.9-10.0 mmol/L), measured by continuous glucose monitoring.

    Measured: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).

Secondary outcomes (7)
  1. Time Above Range (TAR)

    Percentage of time that glucose values are above 180 mg/dL (10.0 mmol/L), measured by continuous glucose monitoring.

    Measured: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).

  2. Time Below Range (TBR)

    Percentage of time that glucose values are below 70 mg/dL (3.9 mmol/L), measured by continuous glucose monitoring.

    Measured: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).

  3. Number of Point-of-Care Glucose Measurements

    Total number of point-of-care glucose measurements performed during ICU admission.

    Measured: During ICU stay (up ICU discharge or death)

  4. Hospital Readmissions

    Number of participants readmitted to the hospital following discharge from the ICU.

    Measured: Up to 90 days after ICU discharge.

  5. Morbidity at 90 Days

    Presence of illness, disease, or complications affecting health status, quality of life, or functional ability that occur during hospitalization or within 90 days following ICU discharge.

    Measured: Up to 90 days after ICU discharge.

  6. Mean Absolute Relative Difference (MARD)

    Accuracy of continuous glucose monitoring assessed by the Mean Absolute Relative Difference (MARD) between continuous glucose monitoring values and paired point-of-care glucose measurements. MARD will be calculated as the mean of the absolute relative differences between paired glucose values and expressed as a percentage.

    Measured: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).

  7. Diabetes Technology Society (DTS) Error Grid Analysis

    Clinical risk associated with continuous glucose monitoring accuracy assessed using the Diabetes Technology Society (DTS) Error Grid. Paired continuous glucose monitoring and point-of-care glucose values will be classified according to risk categories, and the proportion of values within the no-risk and slight-risk zones will be reported.

    Measured: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).

Timeline

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

  1. First posted7 Jul 2026
  2. Study start14 Jun 2025
  3. Primary completion1 Jun 2026
  4. Study completion1 Jun 2026

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups.
Masking
Single blind
Who is masked
Participant
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07687368
Sponsor's protocol ID
HCB/2023/0377
Other IDs
PR678/2024, HOS-2023-021, IRB00003099/CER052429
Acronym
CGM-UCI23
Status last verified
Jul 2026
First submitted
2 Jun 2026
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD that underlie the results reported in publications, after anonymization, will be available to qualified researchers upon reasonable request. Data sharing will require approval from the principal investigator and the relevant ethics committee and will comply with applicable data protection regulations.

Publications

  • Panero-Moreno M, Muxella-Roson M, Dube-Llobet G, Cabrerizo-Jimenez M, Guix-Comellas EM, Villamor-Ordozgoiti A, Marsa-Perez N. The use of continuous glucose monitoring: A scoping review of accuracy, feasibility and nursing workload reduction in intensive care setting. Enferm Intensiva (Engl Ed). 2025 Jul-Sep;36(3):500534. doi: 10.1016/j.enfie.2025.500534.

    PubMed 40883056
  • Faulds ER, Boutsicaris A, Sumner L, Jones L, McNett M, Smetana KS, May CC, Buschur E, Exline MC, Ringel MD, Dungan K. Use of Continuous Glucose Monitor in Critically Ill COVID-19 Patients Requiring Insulin Infusion: An Observational Study. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4007-e4016. doi: 10.1210/clinem/dgab409.

    PubMed 34100545
  • Agarwal S, Mathew J, Davis GM, Shephardson A, Levine A, Louard R, Urrutia A, Perez-Guzman C, Umpierrez GE, Peng L, Pasquel FJ. Continuous Glucose Monitoring in the Intensive Care Unit During the COVID-19 Pandemic. Diabetes Care. 2021 Mar;44(3):847-849. doi: 10.2337/dc20-2219. Epub 2020 Dec 23.

    PubMed 33361145
  • Rijkenberg S, van Steen SC, DeVries JH, van der Voort PHJ. Accuracy and reliability of a subcutaneous continuous glucose monitoring device in critically ill patients. J Clin Monit Comput. 2018 Oct;32(5):953-964. doi: 10.1007/s10877-017-0086-z. Epub 2017 Dec 7.

    PubMed 29218549
  • Ammar MA, Ammar AA, Wee T, Deshpande R, Band M, Akhtar S. Relationship Between Glucose Time in Range in Diabetic and Non-Diabetic Patients and Mortality in Critically Ill Patients. J Intensive Care Med. 2022 Dec;37(12):1625-1633. doi: 10.1177/08850666221098383. Epub 2022 May 2.

    PubMed 35491687
  • American Diabetes Association Professional Practice Committee for Diabetes*. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2026. Diabetes Care. 2026 Jan 1;49(Suppl 1):S183-S215. doi: 10.2337/dc26-S009.

    PubMed 41358900
  • Panero-Moreno M, Carbonell-Sabate C, Conesa-Gonzalez R, Risco-Patino L, Guix-Comellas EM, Villamor-Ordozgoiti A, Cordon-Arnau T. Continuous glucose monitoring in a critically ill patient with extracorporeal membrane oxygenation (ECMO), intra-aortic balloon pump, and continuous renal replacement therapy: Case report. Enferm Intensiva (Engl Ed). 2026 Apr-Jun;37(2):500589. doi: 10.1016/j.enfie.2026.500589. Epub 2026 Apr 11.

    PubMed 41967195
  • Panero-Moreno M, Guix-Comellas EM, Villamor-Ordozgoiti A. Clinical trial protocol for continuous glucose monitoring in critical care at Hospital Clinic of Barcelona (CGM-UCI23). Nurs Crit Care. 2025 May;30(3):e13198. doi: 10.1111/nicc.13198. Epub 2024 Oct 28.

    PubMed 39467825

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Glucose Monitoring and Conventional Glucose Measurement in people with Critical Care Nursing and Critical Illness, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer at 1 site in Spain.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in Range (time frame: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).). 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 NCT07687368, which also lists 8 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 7 Jul 2026.

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