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Improved Glycemic Control in Diabetic Patients in Hemodialysis Using Continuous Glucose Monitoring (CGM) 23 Estudo aberto

Concluído
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O estudo clínico NCT05678712 foi um estudo intervencionista para Hemodiálise, Diabetes tipo 1, Diabetes tipo 2. Seu status atual é: concluído. O estudo começou em 9 de março de 2022 e incluiu 23 participantes. Coordenado por a Universidade de Aalborg e foi concluído em 18 de dezembro de 2023. Essas informações foram atualizadas no ClinicalTrials.gov em 31 de janeiro de 2024.
Resumo
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...Mostrar mais
Descrição detalhada
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...Mostrar mais
Título oficial

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

Condições médicas
HemodiáliseDiabetes tipo 1Diabetes tipo 2
Outros IDs do estudo
  • N-20210070
Número NCT
NCT05678712
Data de início (real)
2022-03-09
Última atualização postada
2024-01-31
Data de conclusão (estimada)
2023-12-18
Inscrição (estimada)
23
Tipo de estudo
Intervencionista
FASE
N/A
Status
Concluído
Palavras-chave
Diabetes
Heamodialysis
CGM
Glycemic control
Algorithm
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Estudo cruzado
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Nenhuma intervençãoStandard 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
N/A
ExperimentalIntervention (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)
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  • ≥ 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 logoUniversidade de Aalborg198 estudos clínicos ativos para explorar
Responsável pelo estudo
Peter Vestergaard, Investigador principal, MD, professor, Aalborg University Hospital
Sem dados de contato.
1 Locais do estudo em 1 países
Department of nephrology (dialysis), Aalborg, 9000, Denmark