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Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study 60 Observacional

Ativo, não recrutando
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O estudo clínico NCT06297850 é um estudo observacional para Diabetes mellitus, Disglicemia, Complicação perioperatória, Circulatory; Complications. Seu status atual é: ativo, não recrutando. O estudo começou em 1 de abril de 2024 e pretende incluir 60 participantes. Coordenado por University Hospital Bispebjerg and Frederiksberg e deve ser concluído em 1 de dezembro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 3 de dezembro de 2025.
Resumo
The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment.

The main questions it aims to answer are:

• Do CGM measurements have a decreased accuracy compared to standard blood glucose m...

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Descrição detalhada
This is a prospective observational study on patients living with diabetes who a) undergo surgery at the Department of Vascular Surgery, Rigshospitalet, Denmark and the Surgical Department and Department of Orthopedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital, Denmark, or b) are admitted to the intensive care unit (ICU) at Bispebjerg and Frederiksberg Hospital with circulatory impairment.

The s...

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Título oficial

Validation of the Accuracy of Continuous Glucose Monitoring Using the Dexcom G7 in Patients With Diabetes in Situations With Circulatory Impairment. A Prospective Observational Study

Condições médicas
Diabetes mellitusDisglicemiaComplicação perioperatóriaCirculatory; Complications
Outros IDs do estudo
  • WARD-Glucose Validation v.2.2
Número NCT
NCT06297850
Data de início (real)
2024-04-01
Última atualização postada
2025-12-03
Data de conclusão (estimada)
2025-12-01
Inscrição (estimada)
60
Tipo de estudo
Observacional
Status
Ativo, não recrutando
Palavras-chave
Diabetes Mellitus
Continuous glucose monitoring
Medical devices
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
N/A
Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)
A CGM device placed on the posterior aspect of the upper arm in which a sensor placed in the skin registers glucose values. Via Bluetooth, these readings are sent to a receiver near the patient every 5 minutes. The CGM system can alert when deviating glucose levels, but will for this observational study be blinding to patients and clinical staff. Thus, the patients' diabetic care will rely on standard practice.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Agreement between glucose
Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements (matched pairs within 5 minutes) in the perioperative setting
Perioperatively
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Agreement between glucose readings when at low glucose levels
Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at low glucose levels (\<3.9 mmol/l in the POC blood glucose measurement)
Perioperatively
Agreement between glucose readings when at normal glucose levels
Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at normal glucose levels (\>3.9-10.0 mmol/l in the POC blood glucose measurement)
Perioperatively
Agreement between glucose readings when at high glucose levels
Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at high glucose levels (\>10.0 mmol/l in the POC blood glucose measurement)
Perioperatively
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  • Medical history with diabetes mellitus requiring antidiabetic drugs
  • Age ≥18 years
  • Surgery with estimated surgery time ≥45 minutes with expected stay for at least one night in hospital postoperatively OR
  • Admission to the ICU with Circulatory impairment defined as need of vasopressors to maintain a mean arterial pressure (MAP) ≥65 mmHg and peripheral perfusion index <1.5

  • Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area
  • Contraindications to skin puncture (arteriovenous fistula for dialysis, post-mastectomy lymphoedema etc)
  • Known allergy to plaster used in the CGM device
University Hospital Bispebjerg and Frederiksberg logoUniversity Hospital Bispebjerg and Frederiksberg
  • 🏥Rigshosp...
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Responsável pelo estudo
Casper Pedersen, Investigador principal, MD, principal investigator, University Hospital Bispebjerg and Frederiksberg
Sem dados de contato.
4 Locais do estudo em 1 países

The Capital Region of Denmark

Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, Copenhagen, The Capital Region of Denmark, 2100, Denmark
Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital, Copenhagen, The Capital Region of Denmark, 2400, Denmark
Department of Orthopaedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital, Copenhagen, The Capital Region of Denmark, 2400, Denmark
Surgical department, Bispebjerg and Frederiksberg Hospital,, Copenhagen, The Capital Region of Denmark, 2400, Denmark