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

Em recrutamento
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 NCT06675903 (CGM-KTx) é um estudo observacional para Hyperglycaemia, Transplante renal. Seu status atual é: em recrutamento. O estudo começou em 12 de novembro de 2024 e pretende incluir 54 participantes. Coordenado por Bo Feldt-Rasmussen e deve ser concluído em 1 de janeiro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 13 de novembro de 2024.
Resumo
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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Descrição detalhada
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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Título oficial

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

Condições médicas
HyperglycaemiaTransplante renal
Outros IDs do estudo
  • CGM-KTx
  • H-24046404
Número NCT
NCT06675903
Data de início (real)
2024-11-12
Última atualização postada
2024-11-13
Data de conclusão (estimada)
2026-01-01
Inscrição (estimada)
54
Tipo de estudo
Observacional
Status
Em recrutamento
Palavras-chave
Kidney transplantation
diabetes
prediabetes
hyperglycaemia
continuous glucose monitoring
CGM
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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/A
No diabetes
No diabetes defined as HbA1c \<42mmol/mol or FPG\<6.1 mmol/L
N/A
Prediabetes
Prediabetes group defined as HbA1c 42-47 mmol/mol or FPG 6.1-6.9 mmol/L
N/A
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Difference in Mean Sensor Glucose
Mean sensor glucose (mmol/L) evaluated by CGM
10 days
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  • 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
Responsável pelo estudo
Bo Feldt-Rasmussen, Patrocinador-Investigador, Professor, Rigshospitalet, Denmark
Contato central do estudo
Contato: Ida S Voss, MD, +4535457063, [email protected]
1 Locais do estudo em 1 países

DK

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