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In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A 13

Interrompido
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT04650945 é um estudo intervencionista para Diabetes mellitus tipo 1, Diabetes mellitus tipo 2, Diabetes mellitus. Seu status atual é: interrompido. O estudo começou em 4 de janeiro de 2021 e pretende incluir 13 participantes. Coordenado por a Universidade de Aarhus e deve ser concluído em 16 de novembro de 2022. Essas informações foram atualizadas no ClinicalTrials.gov em 21 de novembro de 2022.
Resumo
The aim of the study is to investigate the applicability of a Flash glucose monitoring sensor (Freestyle Libre, isCGM) for in-hospital glucose monitoring in patients with diabetes requiring nutritional therapy (tube feeding or parenteral feeding).
Descrição detalhada
All patients who meet study criteria will be invited to participate in the study. All patients included in the study will be followed by a trained clinical diabetes specialist and a trained study nurse (study personnel) for glucose management during their hospitalization. All patients included in the study will receive a Freestyle Libre isCGM. The patients will be randomized to control (blinded isCGM glucose values t...Mostrar mais
Título oficial

In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A

Condições médicas
Diabetes mellitus tipo 1Diabetes mellitus tipo 2Diabetes mellitus
Outros IDs do estudo
  • 1-10-72-188-20
Número NCT
NCT04650945
Data de início (real)
2021-01-04
Última atualização postada
2022-11-21
Data de conclusão (estimada)
2022-11-16
Inscrição (estimada)
13
Tipo de estudo
Intervencionista
FASE
N/A
Status
Interrompido
Palavras-chave
Continuous glucose monitoring
Hospitalization
Nutritional therapy
Propósito principal
Outro
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Comparador ativoisCGM-arm
isCGM (intermittently scanned continuous glucose monitor) data obtained from a FreeStyle Libre Flash continuous glucose monitoring system will be viewed real-time and used to adjust diabetes treatment
isCGM group
As previously described
Nenhuma intervençãoPOC-arm
POC glucose readings are used to adjust diabetes treatment. CGM data from the Freestyle Libre monitor are blinded to all and only gathered for comparison purposes to intervention group.
N/A
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Glucose time in range (3,9-10 mmol/l) (% pr day)
Glucose time in range (3,9-10 mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) (% pr day)
2-14 days
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Mean glucose (mmol/l) isCGM versus POC PG
Mean glucose (mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Glycemic variability; coefficient of variation (CV) (in %)
CV when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Glycemic variability; standard deviation (SD)
SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Time in hypoglycemia (<3 mmol/L) (%)
Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Time in hypoglycemia (<3,9 mmol/l) (%)
Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Number of events with hypoglycemia (<3,9 mmol/l) (%)
Number of events with hypoglycemia per day (\<3,9 mmol/L for \>15 minutes) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Time in hyperglycemia (>10 mmol/l) (%)
Time in hyperglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) (%)
Glucose out of range: Time in hypoglycemia and time in hyperglycemia (\<3,9 and \>10 mmol/l) (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Daily total insulin dosage (IE)
Daily total insulin dosage (IE) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Time with active isCGM
Time with active isCGM (%) in intervention group
2-14 days
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  • Expected length of hospital stay of at least 48 hours
  • Diagnosed with diabetes
  • Literate in Danish
  • Nutritional therapy using tube feeding or parenteral nutritional therapy
  • Admission to Department of Gastrointestinal Surgery or Department of Heart-, Lung-, and Vascular surgery, both at Aarhus University Hospital, Denmark.

  • Pregnancy
  • Patient unable to provide informed consent
  • Patient unable to use mobile phone for reading isCGM sensor
  • Known allergy to adhesives
  • Anticipated MRI during the hospital admission
  • Patients using CGM prior to hospital admission
University of Aarhus logoUniversidade de Aarhus305 estudos clínicos ativos para explorar
Aarhus University Hospital logoAarhus University Hospital
Responsável pelo estudo
Julie Støy, Investigador principal, Principal investigator, University of Aarhus
Sem dados de contato.
1 Locais do estudo em 1 países
Aarhus university hospital, Aarhus, 8200, Denmark