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

4 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

400

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore fittizio: 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.
Dispositivo: 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.

Altri nomi:
  • Gruppo Sham
  • POC-G Group
  • Conventional Group
Sperimentale: 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.
Dispositivo: 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.
Altri nomi:
  • CGM
  • CGM Guided

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time in Range
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time Above Range (TAR)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Investigatori

  • Direttore dello studio: Eva M Guix-Comellas, PhD, University of Barcelona
  • Direttore dello studio: Alberto Villamor-Ordozgoiti, PhD, Hospital Clinic of Barcelona

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 giugno 2025

Completamento primario (Effettivo)

1 giugno 2026

Completamento dello studio (Effettivo)

1 giugno 2026

Date di iscrizione allo studio

Primo inviato

2 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 luglio 2026

Primo Inserito (Effettivo)

7 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HCB/2023/0377
  • PR678/2024 (Altro numero di sovvenzione/finanziamento: Official College of Nurses of Barcelona)
  • HOS-2023-021 (Altro numero di sovvenzione/finanziamento: Dexcom)
  • IRB00003099/CER052429 (Altro identificatore: Bioethics Committee of the University of Barcelona)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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