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

4. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

400

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-komparator: 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.
Enhet: 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.

Andre navn:
  • Sham Group
  • POC-G Group
  • Conventional Group
Eksperimentell: 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.
Enhet: 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.
Andre navn:
  • CGM
  • CGM Guided

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time in Range
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time Above Range (TAR)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. juni 2025

Primær fullføring (Faktiske)

1. juni 2026

Studiet fullført (Faktiske)

1. juni 2026

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

4. juli 2026

Først lagt ut (Faktiske)

7. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HCB/2023/0377
  • PR678/2024 (Annet stipend/finansieringsnummer: Official College of Nurses of Barcelona)
  • HOS-2023-021 (Annet stipend/finansieringsnummer: Dexcom)
  • IRB00003099/CER052429 (Annen identifikator: Bioethics Committee of the University of Barcelona)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

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Nei

produkt produsert i og eksportert fra USA

Nei

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