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

4 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

400

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur factice: 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.
Dispositif: 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.

Autres noms:
  • Groupe Sham
  • POC-G Group
  • Conventional Group
Expérimental: 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.
Dispositif: 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.
Autres noms:
  • CGM
  • CGM Guided

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Time in Range
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time Above Range (TAR)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Les enquêteurs

  • Directeur d'études: Eva M Guix-Comellas, PhD, University of Barcelona
  • Directeur d'études: Alberto Villamor-Ordozgoiti, PhD, Hospital Clinic of Barcelona

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 juin 2025

Achèvement primaire (Réel)

1 juin 2026

Achèvement de l'étude (Réel)

1 juin 2026

Dates d'inscription aux études

Première soumission

2 juin 2026

Première soumission répondant aux critères de contrôle qualité

4 juillet 2026

Première publication (Réel)

7 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HCB/2023/0377
  • PR678/2024 (Autre subvention/numéro de financement: Official College of Nurses of Barcelona)
  • HOS-2023-021 (Autre subvention/numéro de financement: Dexcom)
  • IRB00003099/CER052429 (Autre identifiant: Bioethics Committee of the University of Barcelona)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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