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Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM) 23 Offene Studie

Abgeschlossen
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 NCT05678712 untersuchte Hämodialyse, Typ-1-Diabetes, Typ-2-Diabetes als interventionsstudie und hat den Status abgeschlossen. Die Studie begann am 9. März 2022 mit 23 Teilnehmern. Sie wurde durchgeführt von Universität Aalborg und am 18. Dezember 2023 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 31. Januar 2024 aktualisiert.
Kurzbeschreibung
The 16-week trial is an open-label cross-over trial which includes heamodialysis patients with T2D and T1D on insulin therapy. During one period, patients carry a non-blinded CGM. In the other period they follow standard procedures (the last two weeks with a blinded CGM). The patients and the dialysis staff can use the CGM measures to regulate insulin and food intake during the non-blinded weeks. The research group w...Mehr anzeigen
Ausführliche Beschreibung
Background: Managing diabetes is often problematic in haemodialysis (HD) patients. Low blood glucose is especially common during treatment. Typically, the patient's blood sugar is only measured during treatment if considered relevant. Otherwise, HbA1c is used to control diabetes - a method associated with uncertain in HD patients. An alternative or supplement to the current management of diabetes could be CGM which e...Mehr anzeigen
Offizieller Titel

Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM)

Erkrankungen
HämodialyseTyp-1-DiabetesTyp-2-Diabetes
Weitere Studien-IDs
  • N-20210070
NCT-Nummer
NCT05678712
Studienbeginn (tatsächlich)
2022-03-09
Zuletzt aktualisiert
2024-01-31
Studienende (vorauss.)
2023-12-18
Geplante Rekrutierung
23
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Abgeschlossen
Stichwörter
Diabetes
Heamodialysis
CGM
Glycemic control
Algorithm
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Crossover-Design
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Keine InterventionStandard treatment
After a two weeks "run-in" baseline period (blinded CGM) some of the participants (1:1) were randomly assigned to six weeks of standard treatment, i.e. self monitoring of blood glucose (the last two weeks with blinded CGM → 2 weeks "wash-out" (baseline for next period) (blinded CGM) → six weeks with non-blinded CGM with data available for the patient himself/herself and dialysis staff
Nicht zutreffend
ExperimentellIntervention (access to CGM data)
After a two weeks "run-in" baseline period (blinded CGM) some of the participants (1:1) were randomly assigned to six weeks with non-blinded CGM with data available for the patient himself/herself and dialysis staff → 2 weeks "wash-out" (baseline for next period) (blinded CGM) → Six weeks of standard treatment, i.e. self monitoring of blood glucose (the last two weeks with blinded CGM
Access to CGM data (Dexcom G6)
Acces to CGM data (not blinded CGM)
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
time below range (CGM)
Change in time below range (CGM) (\< 3.0 mmol/L)
6 weeks of treatment in each of the two treatment periods
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Time in range (CGM)
Change in time in range (CGM) (3,9-10,0 mmol/L)
6 weeks of treatment in each of the two treatment periods
Time in borderline low range (CGM)
Change in CGM time in low range(3.0 mmol/L ≤ glucose \< 3.9 mmol/L)
6 weeks of treatment in each of the two treatment periods
Time above range (CGM)
Change in CGM time above range (\>10 mmol/L)
6 weeks of treatment in each of the two treatment periods
Time above range (CGM) (high)
Change in CGM time above range (\>13,9 mmol/L)
6 weeks of treatment in each of the two treatment periods
Concentration of HbA1c
Change in HbA1c
6 weeks of treatment in each of the two treatment periods
Glucose variability
Glucose variability (variation coefficient or SD)
6 weeks of treatment in each of the two treatment periods
Sensitivity and specificity of algorithm
Sensitivity and specificity of algorithm to predict hypoglycemias
Through study completion, an average of one year
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • ≥ 18 years
  • Chronically ill heamodialysis patients (heamodialysis or heamodiafiltration - treatment)der modtager HD- eller hæmodiafiltrationsbehandling på dialyseafsnit,--
  • Patients at dialysis wards in Aalborg and Hjørring, Aalborg University Hospital (center and home patients)
  • T1D or T2D and in treatment with insulin
  • Being able to use CGM equipment
  • Signed consent

  • Pregnancy or breastfeeding,
  • Terms that, in the opinion of the investigator or subinvestigators, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate
  • Patients undergoing peritoneal dialysis (PD) or heamofiltration dialysis (HF)
  • Acute HD treatment
  • Gestational diabetes
Aalborg University Hospital logoUniversität Aalborg198 aktive klinische Studien zum Erkunden
Verantwortliche Partei
Peter Vestergaard, Hauptprüfer, MD, professor, Aalborg University Hospital
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
Department of nephrology (dialysis), Aalborg, 9000, Denmark