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Clinical Trial Protocol for Continuous Glucose Monitoring in Critical Care (CGM-UCI23)

4 juli 2026 bijgewerkt door: Marc Pañero Moreno, Institut d'Investigacions Biomèdiques August Pi i Sunyer

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.

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

400

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Spanje
    • Catalonia
      • Barcelona, Catalonia, Spanje, 08036
        • Carrer de Villarroel, 170

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: Conventional Glucose Measurement
Participants 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.
Apparaat: Conventional Glucose Measurement

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.

Andere namen:
  • Sham-groep
  • POC-G Group
  • Conventional Group
Experimenteel: Continuous Glucose Monitoring Group
Participants 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.
Apparaat: Continuous Glucose Monitoring
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.
Andere namen:
  • CGM
  • CGM Guided

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time in Range
Tijdsspanne: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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.
During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time Above Range (TAR)
Tijdsspanne: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
Percentage of time that glucose values are above 180 mg/dL (10.0 mmol/L), measured by continuous glucose monitoring.
During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
Time Below Range (TBR)
Tijdsspanne: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
Percentage of time that glucose values are below 70 mg/dL (3.9 mmol/L), measured by continuous glucose monitoring.
During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
Number of Point-of-Care Glucose Measurements
Tijdsspanne: During ICU stay (up ICU discharge or death)
Total number of point-of-care glucose measurements performed during ICU admission.
During ICU stay (up ICU discharge or death)
Hospital Readmissions
Tijdsspanne: Up to 90 days after ICU discharge.
Number of participants readmitted to the hospital following discharge from the ICU.
Up to 90 days after ICU discharge.
Morbidity at 90 Days
Tijdsspanne: Up to 90 days after ICU discharge.
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.
Up to 90 days after ICU discharge.
Mean Absolute Relative Difference (MARD)
Tijdsspanne: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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.
During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
Diabetes Technology Society (DTS) Error Grid Analysis
Tijdsspanne: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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.
During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Onderzoekers

  • Studie directeur: Eva M Guix-Comellas, PhD, University of Barcelona
  • Studie directeur: Alberto Villamor-Ordozgoiti, PhD, Hospital Clinic of Barcelona

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 juni 2025

Primaire voltooiing (Werkelijk)

1 juni 2026

Studie voltooiing (Werkelijk)

1 juni 2026

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 juli 2026

Eerst geplaatst (Werkelijk)

7 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

4 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HCB/2023/0377
  • PR678/2024 (Ander subsidie-/financieringsnummer: Official College of Nurses of Barcelona)
  • HOS-2023-021 (Ander subsidie-/financieringsnummer: Dexcom)
  • IRB00003099/CER052429 (Andere identificatie: Bioethics Committee of the University of Barcelona)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

Beginning 12 months after publication of the study results and ending 5 years after publication.

IPD-toegangscriteria voor delen

Anonymized IPD underlying the published results to researchers upon reasonable request. Requests will be reviewed by the principal investigator and may require approval from the relevant ethics committee and the sponsoring institution. Data will be provided for scientifically sound research purposes and in accordance with applicable data protection regulations. Access will be granted through a secure data-sharing process following the execution of an appropriate data access agreement.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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