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

Abgebrochen
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT04630925 (INDIGO) ist eine interventionsstudie zur Untersuchung von Typ-1-Diabetes mellitus, Typ-2-Diabetes mellitus, Diabetes mellitus und hat den Status abgebrochen. Die Studie startete am 4. Januar 2021 und soll 1 Teilnehmer aufnehmen. Durchgeführt von Universität Aarhus ist der Abschluss für 16. November 2022 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 21. November 2022 aktualisiert.
Kurzbeschreibung
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
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
Typ-1-Diabetes mellitusTyp-2-Diabetes mellitusDiabetes mellitus
Weitere Studien-IDs
  • INDIGO
  • 1-10-72-188-20, B
NCT-Nummer
NCT04630925
Studienbeginn (tatsächlich)
2021-01-04
Zuletzt aktualisiert
2022-11-21
Studienende (vorauss.)
2022-11-16
Geplante Rekrutierung
1
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Abgebrochen
Stichwörter
Hypoglycemia
Continuous glucose monitoring
Hospitalization
Primäres Ziel
Andere
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Aktives VergleichspräparatisCGM-arm
CGM data will be viewed real-time and used to adjust diabetes treatment
isCGM
As previously described
Keine InterventionPOC-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.
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • 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 logoUniversität Aarhus305 aktive klinische Studien zum Erkunden
Aarhus University Hospital logoAarhus University Hospital
Verantwortliche Partei
Julie Støy, Hauptprüfer, Clinical diabetes specialist, University of Aarhus
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
Aarhus university hospital, Aarhus, 8200, Denmark