Clinical Trial Protocol for Continuous Glucose Monitoring in Critical Care (CGM-UCI23)
4 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
400
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Catalonia
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Barcelona, Catalonia, Espanha, 08036
- Carrer de Villarroel, 170
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Falso: 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.
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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.
Outros nomes:
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Experimental: 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.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Time in Range
Prazo: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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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.
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During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Time Above Range (TAR)
Prazo: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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Percentage of time that glucose values are above 180 mg/dL (10.0 mmol/L), measured by continuous glucose monitoring.
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During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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Time Below Range (TBR)
Prazo: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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Percentage of time that glucose values are below 70 mg/dL (3.9 mmol/L), measured by continuous glucose monitoring.
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During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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Number of Point-of-Care Glucose Measurements
Prazo: During ICU stay (up ICU discharge or death)
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Total number of point-of-care glucose measurements performed during ICU admission.
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During ICU stay (up ICU discharge or death)
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Hospital Readmissions
Prazo: Up to 90 days after ICU discharge.
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Number of participants readmitted to the hospital following discharge from the ICU.
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Up to 90 days after ICU discharge.
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Morbidity at 90 Days
Prazo: Up to 90 days after ICU discharge.
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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.
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Up to 90 days after ICU discharge.
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Mean Absolute Relative Difference (MARD)
Prazo: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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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.
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During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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Diabetes Technology Society (DTS) Error Grid Analysis
Prazo: During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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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.
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During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Diretor de estudo: Eva M Guix-Comellas, PhD, University of Barcelona
- Diretor de estudo: Alberto Villamor-Ordozgoiti, PhD, Hospital Clinic of Barcelona
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
14 de junho de 2025
Conclusão Primária (Real)
1 de junho de 2026
Conclusão do estudo (Real)
1 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
2 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de julho de 2026
Primeira postagem (Real)
7 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Processos Patológicos
- Atributos da doença
- Doenças Metabólicas
- Distúrbios do Metabolismo da Glicose
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Doença grave
- Hiperglicemia
- Técnicas de investigação
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Análise química do sangue
- Testes de química clínica
- Técnicas de diagnóstico, endócrino
- Monitoramento, fisiológico
- Monitoramento contínuo de glicose
Outros números de identificação do estudo
- HCB/2023/0377
- PR678/2024 (Número de outro subsídio/financiamento: Official College of Nurses of Barcelona)
- HOS-2023-021 (Número de outro subsídio/financiamento: Dexcom)
- IRB00003099/CER052429 (Outro identificador: Bioethics Committee of the University of Barcelona)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Beginning 12 months after publication of the study results and ending 5 years after publication.
Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .