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In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part B 1

Terminato
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La sperimentazione clinica NCT04630925 (INDIGO) è uno studio interventistico per Diabete mellito di tipo 1, Diabete mellito di tipo 2, Diabete mellito, attualmente terminato. Avviato il 4 gennaio 2021, prevede di arruolare 1 partecipanti. Sotto la guida di l'Università di Aarhus, dovrebbe concludersi entro il 16 novembre 2022. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 21 novembre 2022.
Sommario breve
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 and hypoglycemia (<3,9 mmol/l) during the hospitalization
Descrizione dettagliata
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...Mostra di più
Titolo ufficiale

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

Patologie
Diabete mellito di tipo 1Diabete mellito di tipo 2Diabete mellito
Altri ID dello studio
  • INDIGO
  • 1-10-72-188-20, B
Numero NCT
NCT04630925
Data di inizio (effettiva)
2021-01-04
Ultimo aggiornamento pubblicato
2022-11-21
Data di completamento (stimata)
2022-11-16
Arruolamento (previsto)
1
Tipo di studio
Interventistico
FASE
N.D.
Stato
Terminato
Parole chiave
Hypoglycemia
Continuous glucose monitoring
Hospitalization
Scopo principale
Altro
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Comparatore attivoisCGM-arm
CGM data will be viewed real-time and used to adjust diabetes treatment
isCGM
As previously described
Nessun interventoPOC-arm
POC glucose readings are used to adjust diabetes treatment. CGM data are blinded to all and only gathered for comparison purposes to intervention group.
N.D.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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) and standard deviation (SD)
CV and SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Number and duration of events with hypoglycemia (<3 mmol/L and <3,9 mmol/l) (time in hypoglycemia)
Number and duration of events with hypoglycemia 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) undetected with POC PG (use of data from blinded CGM in control group)
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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • Expected length of hospital stay of at least 48 hours
  • Diagnosed with diabetes
  • Literate in Danish
  • In-hospital hypoglycemia with at least one POC glucose < 3,9 mmol/l (current hospitalization)
  • In-hospital treatment with insulin or sulfonylurea
  • 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 logoUniversità di Aarhus305 studi clinici attivi da esplorare
Aarhus University Hospital logoAarhus University Hospital
Parte responsabile dello studio
Julie Støy, Investigatore principale, Clinical diabetes specialist, University of Aarhus
Nessun dato di contatto
1 Centri dello studio in 1 paesi
Aarhus university hospital, Aarhus, 8200, Denmark