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Continuous Glucose Monitoring (CGM) After Kidney Transplantation (CGM-KTx) 54

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De klinische studie NCT06675903 (CGM-KTx) is een observationeel studie bij Hyperglycaemia, Niertransplantatie met de status rekruterend. Het doel is om 54 deelnemers te includeren vanaf 12 november 2024. De studie wordt geleid door Bo Feldt-Rasmussen en de voltooiing is gepland op 1 januari 2026. Laatste update op ClinicalTrials.gov: 13 november 2024.
Beknopte samenvatting
This study examines glucose levels measured by continuous glucose monitoring (CGM) in the immediate period following kidney transplantation among recipients with diabetes, without diabetes, and with pre-diabetes.

The primary objective is to analyse differences in mean sensor glucose between these three groups.

CGMs are applied to participants within 72 hours after kidney transplantation, with a total of 54 particip...

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Uitgebreide beschrijving
Introduction:

Hyperglycaemia is a common medical complication within the first two weeks following kidney transplantation. High doses of prednisone induce a state of insulin resistance, which can cause hyperglycaemia or disrupt glucose regulation in patients with pre-existing diabetes. Current guidelines recommend daily blood glucose monitoring (BGM), defined as four daily glucose measurements during the first four ...

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Officiële titel

Continuous Glucose Monitoring in Kidney Transplant Recipients with Diabetes, Pre-diabetes and Without Diabetes

Aandoeningen
HyperglycaemiaNiertransplantatie
Andere studie-ID's
  • CGM-KTx
  • H-24046404
NCT-ID
NCT06675903
Startdatum (Werkelijk)
2024-11-12
Laatste update geplaatst
2024-11-13
Verwachte einddatum
2026-01-01
Inschrijving (Geschat)
54
Studietype
Observationeel
Status
Rekruterend
Trefwoorden
Kidney transplantation
diabetes
prediabetes
hyperglycaemia
continuous glucose monitoring
CGM
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
Diabetes
Diabetes group defined as type 2 diabetes, type 1 diabetes, receiving glucose-lowering therapy, FPG ≥ 7 mmol/l, HbA1c ≥ 48mmol/l or non-fasting plasma glucose ≥11.1 mmol/l
N.v.t.
No diabetes
No diabetes defined as HbA1c \<42mmol/mol or FPG\<6.1 mmol/L
N.v.t.
Prediabetes
Prediabetes group defined as HbA1c 42-47 mmol/mol or FPG 6.1-6.9 mmol/L
N.v.t.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Difference in Mean Sensor Glucose
Mean sensor glucose (mmol/L) evaluated by CGM
10 days
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Time in range (%)
Time within 3.9-10.0 mmol/L as evaluated by CGM
10 days
Compliance with applicable guideline (%)
Based on capillary blood glucose (mmol/L) and daily insulin dose (IE per day)
10 days
Time in hypoglycaemia (%)
Time in level 1 (3.0-3.8 mmol/L) and level 2 (below 3.0 mmol/L\]) evaluated by CGM
10 days
Time in tight glycaemic range (%)
Time in 3.9-7.8 mmol/L evaluated by CGM
10 days
Time i hyperglycaemia (%)
Time in level 1 (10.1-13.9 mmol/L) and level 2 (above 13.9 mmol/L) evaluated by CGM
10 days
Glucose variability
Standard deviation \[mmol/L\] and coefficient of variation \[%\]) evaluated by CGM
10 days
Glucose management indicator (GMI) (mmol/mol and %)
Evaluated by CGM
10 days
Number of hyperglycaemic events (Number/days measured)
Defined as glucose ≥10.0mmol/L for more than 15 minutes measured by CGM
10 days
Number of hypoglycaemic events (Number/days measured)
Defined as glucose \<3.9mmol/L for more than 15 minutes measured by CGM
10 days
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • Written informed consent obtained before CGM application
  • Male or female; age: ≥18 years
  • Kidney transplantation

  • Unable to cooperate to CGM the first ten days after surgery
  • Allergic to plasters in CGM units
  • Combined kidney and liver or pancreatic transplantation
  • Graft loss/rejection within first 48 hours after transplantation
Bo Feldt-Rasmussen logoBo Feldt-Rasmussen
Verantwoordelijke instantie
Bo Feldt-Rasmussen, Sponsor-Onderzoeker, Professor, Rigshospitalet, Denmark
Centraal Contactpersoon
Contact: Ida S Voss, MD, +4535457063, [email protected]
1 Studielocaties in 1 landen

DK

Rigshospitalet, Copenhagen, DK, 2100, Denmark
Ida S Voss, MD, Contact, +4535457063, [email protected]
Tobias Bomholt, MD, PhD, Contact, +4535457952, [email protected]
Ida S Voss, MD, Contact
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