Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM) (ICU-TeleCGM)
13 de agosto de 2026 atualizado por: Imperial College Healthcare NHS Trust
The aim of this observational study is to assess safety and implementation of continuous glucose monitors within the Intensive Care Unit.
The Dexcom G7 is a continuous glucose monitoring system that shows blood glucose values in real-time and includes alarms if the glucose is very low or high.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
Aim: To assess safety and implementation of networked CGM with ViewsEMR® telemetry within ICU.
The study will be conducted in a two-stage process:
- Phase 1: A single arm (non-randomised) unmasked feasibility study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry. This phase will be conducted at a single site at Imperial College Healthcare NHS Trust (ICHNT).
- Phase 2: A randomised, parallel-group pilot study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry compared to standard of care. This phase will be conducted at three hospitals within the same site: ICHNT (St Mary's Hospital, Charing Cross Hospital and Hammersmith Hospital). The study will be conducted at Imperial College Healthcare NHS Trust in people with hyperglycaemia on admission to ICU requiring insulin.
Tipo de estudo
Observacional
Inscrição (Estimado)
70
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.
Contato de estudo
- Nome: Parizad Avari, MBBS, PhD
- Número de telefone: 020 33133706
- E-mail: p.avari@nhs.net
Estude backup de contato
- Nome: Narvada Jugnee, MSc
- Número de telefone: 020 33133706
- E-mail: n.jugnee@nhs.net
Locais de estudo
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London, Reino Unido
- Imperial College Healthcare NHS Trust
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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
Método de amostragem
Amostra Não Probabilística
População do estudo
Adults admitted to the intensive care unit with hyperglycaemia
Descrição
Inclusion Criteria:
- Age >18years inclusive
- Hyperglycaemia requiring insulin therapy (subcutaneous injection or intravenous insulin) during admission on ICU
- Admission to ICU within 48hours
Exclusion Criteria:
- Known significant allergy to tape/ adhesives
- Imminent death or anticipated length of stay <24hours
- Women who are pregnant
- Imminent extracorporeal membrane oxygenation (ECMO)
- Requirement for therapeutic temperature control (i.e. cooling) post cardiac arrest
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
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)
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Continuous glucose monitoring.
ViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends
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Usual care + masked Dexcom G7
Use of continuous glucose monitoring (Dexcom G7) without telemetry (ViewsEMR/CampViews®)
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Continuous glucose monitoring.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Phase 1: Eligible participants that consent to participate.
Prazo: Throughout Phase 1 study period, up to 6 months
|
Percentage of eligible participants that consent to participate, including the percentage enrolled through participant informed consent, via personal consultee, and via nominated consultee.
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Throughout Phase 1 study period, up to 6 months
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Phase 1: Time from admission to ICU to initiation of CGM
Prazo: From admission to ICU to initiation of CGM, up to 48 hours
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Time in minutes from admission to ICU to initiation of CGM
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From admission to ICU to initiation of CGM, up to 48 hours
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Phase 1: Time from consent to initiation of CGM
Prazo: From enrollment to the end of intervention at 10 days
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Time from consent to initiation of CGM
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From enrollment to the end of intervention at 10 days
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Phase 1: Percentage of CGM data availability for each participant
Prazo: From enrollment to the end of intervention at 10 days
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Percentage of CGM data availability for each participant
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From enrollment to the end of intervention at 10 days
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Phase 1: Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
Prazo: From enrollment to the end of intervention at 10 days
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Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
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From enrollment to the end of intervention at 10 days
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Phase 1: Number of premature sensor failures per participant (defined as <70% of anticipated use)
Prazo: From enrollment to the end of intervention at 10 days
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Number of premature sensor failures per participant (defined as <70% of anticipated use)
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From enrollment to the end of intervention at 10 days
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Phase 1: Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
Prazo: From enrollment to the end of intervention at 10 days
|
Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
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From enrollment to the end of intervention at 10 days
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Phase 1: Proportion of participants completing the study
Prazo: Throughout Phase 1 study period, up to 6 months
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Proportion of participants completing the study
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Throughout Phase 1 study period, up to 6 months
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Phase 1: Proportion of nursing staff completing study survey
Prazo: Throughout Phase 1 study period, up to 6 months
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Proportion of nursing staff completing study survey
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Throughout Phase 1 study period, up to 6 months
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Phase 2: Number of episodes of hypoglycaemia per participant
Prazo: Throughout Phase 2, up to 30 days
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Number of episodes of hypoglycaemia per participant (defined as <3.9mmol/L for 15minutes)
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Throughout Phase 2, up to 30 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Phase 1: Safety Outcomes
Prazo: From enrollment to the end of intervention, up to 10 days
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- Duration of CGM signal loss (units: minutes)
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From enrollment to the end of intervention, up to 10 days
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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
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- Dhatariya KK, Umpierrez G. Gaps in our knowledge of managing inpatient dysglycaemia and diabetes in non-critically ill adults: A call for further research. Diabet Med. 2023 Mar;40(3):e14980. doi: 10.1111/dme.14980. Epub 2022 Nov 16.
- Avari P, Lumb A, Flanagan D, Rayman G, Misra S, Dhatariya K, Choudhary P. Continuous Glucose Monitoring Within Hospital: A Scoping Review and Summary of Guidelines From the Joint British Diabetes Societies for Inpatient Care. J Diabetes Sci Technol. 2023 May;17(3):611-624. doi: 10.1177/19322968221137338. Epub 2022 Nov 28.
- Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care. 2017 Jun;40(6):736-741. doi: 10.2337/dc17-0133. Epub 2017 Apr 7.
- Zelada H, Perez-Guzman MC, Chernavvsky DR, Galindo RJ. Continuous glucose monitoring for inpatient diabetes management: an update on current evidence and practice. Endocr Connect. 2023 Sep 25;12(10):e230180. doi: 10.1530/EC-23-0180. Print 2023 Oct 1.
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- 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.
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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 (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
1 de junho de 2028
Conclusão do estudo (Estimado)
1 de junho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
29 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de agosto de 2026
Primeira postagem (Real)
17 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 167867
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Ethics approval does not allow sharing of individual participant data
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
Sim
produto fabricado e exportado dos EUA
Sim
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