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O estudo clínico NCT06641765 para Diabetes mellitus, tipo 2, Diabetes mellitus tipo 1, Monitorização contínua da glicose, Hemodiálise, Diálise peritoneal está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Continuous Glucose Monitoring in Dialysis Patients With Diabetes 96 Randomizado Duplo-cego
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O estudo clínico NCT06641765 é um estudo intervencionista para Diabetes mellitus, tipo 2, Diabetes mellitus tipo 1, Monitorização contínua da glicose, Hemodiálise, Diálise peritoneal. Seu status atual é: ativo, não recrutando. O estudo começou em 1 de novembro de 2024 e pretende incluir 96 participantes. Coordenado por Bo Feldt-Rasmussen e deve ser concluído em 30 de outubro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 27 de fevereiro de 2026.
Resumo
The primary objective of this multicenter, randomized controlled trial is to assess whether the intermittent or continuous use of continous glucose monitoring can enhance glycaemic control among dialysis patients with type 1 or type 2 diabetes, in comparison to the standard monitoring involving finger-prick glucose and HbA1c.
Participants will be monitored for 9 months and randomly assigned to one of three groups:
...
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INTRODUCTION
Dialysis patients with diabetes have a very short life expectancy likely caused by a high incidence of co-morbidities combined with an increased risk of hypoglycaemia and poor glycaemic control. Glycaemic monitoring is a challenge in dialysis patients, and the number of available glucose-lowering agents are reduced often necessitating the use of insulin. Overall, this means that dialysis patients do not...
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Continuous Glucose Monitoring in Haemodialysis and Peritoneal Dialysis Patients With Type 1 and Type 2 Diabetes
Condições médicas
Diabetes mellitus, tipo 2Diabetes mellitus tipo 1Monitorização contínua da glicoseHemodiáliseDiálise peritonealOutros IDs do estudo
- CGM-Dialysis study
Número NCT
Data de início (real)
2024-11-01
Última atualização postada
2026-02-27
Data de conclusão (estimada)
2026-10-30
Inscrição (estimada)
96
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ativo, não recrutando
Palavras-chave
Hypoglycaemia
Quality of life
Time-in-range
HbA1c
Diabetes
Dialysis
Quality of life
Time-in-range
HbA1c
Diabetes
Dialysis
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Nenhuma intervençãoControl group (Group 1) Will undergo standard glycaemic monitoring (HbA1c and finger-prick glucose) along with 10 days double-blinded CGM sessions scheduled at months 0, 3, 6, and 9.
Glucose-lowering treatment is adjusted by an endocrinologist or a diabetes nurse at months 0, 3, and 6.
CGM data will be double-blinded, and treatment adjustments will be based on usual monitoring of HbA1c and finger-prick glucose. | N/A |
Comparador ativoIntermittent CGM (Group 2) Will have intermittent access to 10 days of open CGM scheduled at months 0, 3, 6 along with double-blinded CGM at month 9.
Glucose-lowering treatment is adjusted by an endocrinologist or a diabetes nurse at months 0, 3, and 6.
The objective is to adjust their glucose-lowering treatment to ensure patients spend less than 1% of their time with glucose levels below 3.9 mmol/L and more than 60% of the time within the t...Mostrar mais | Continous Glucose Monitoring 10 days of real time open access to Continous Glucose Monitoring - either at defined time intervals (Group 2) or continuously for 9 months (Group 3). |
Comparador ativoContinuous CGM (Group 3) Will have continuous access to open CGM throughout the entire duration of the study from month 0-9.
Glucose-lowering treatment is adjusted by an endocrinologist or a diabetes nurse at months 0, 3, and 6.
The objective is to adjust their glucose-lowering treatment to ensure patients spend less than 1% of their time with glucose levels below 3.9 mmol/L and more than 60% of the time within the target range (3.9 to 10....Mostrar mais | Continous Glucose Monitoring 10 days of real time open access to Continous Glucose Monitoring - either at defined time intervals (Group 2) or continuously for 9 months (Group 3). |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change in time-in-target-range (3.9-10 mmol/L) from baseline through to study end between the three groups. | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Difference in percentage of participants reaching the goal of minimum of 60% of time-in-target-range (3.9-10 mmol/L) between the three groups. | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Change in time-in-range < 3 mmol/L from baseline through to study end between the three groups. | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Change in time-in-range < 3.9 mmol/L from baseline through to study end between the three groups. | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Change in time-in-range 3.9-7.8 mmol/L from baseline through to study end between the three groups. | Evaluated by 10 days of CGM obtained at baseline ,months 0, 3, 6, and 9. | 9 Months |
Change in time-in-range > 10 mmol/L from baseline through to study end between the three groups. | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Change in time-in-range > 13.9 mmol/L from baseline through to study end between the three groups. | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Change in Mean Sensor Glucose (mmol/L) from baseline through to study end between the three groups. | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Change in Glucose Variability (SD (mmol/L) and coefficient of variation (%)) from baseline through to study end between the three groups. | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Change in HbA1c (%, mmol/mol) from baseline through to study end between the three groups. | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Change in Glucose Management Indicator (%, mmol/mol) from baseline through to study end between the three groups. | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Difference in length of time-period with active CGM between the three groups | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Difference in incidence of CGM time in <3.0mmol/L range lasting >15 minutes between the three groups | Evaluated by 10 days of CGM obtained at baseline, months 0, 3, 6, and 9. | 9 Months |
Difference in incidence of severe hypoglycaemia (Requiring third party assistance) between the three groups | Evaluated by medical records and patient interview at months 0, 3, 6, and 9. | 9 Months |
Difference in incidence of Adverse Events (AE) and Adverse Device Events between the three groups | Evaluated by medical records and patient interview at months 0, 3, 6, and 9. | 9 Months |
Difference in incidence of Serious Adverse Events (SAE) and Serious Adverse Device Events between the three groups | Evaluated by medical records and patient interview at months 0, 3, 6, and 9. | 9 Months |
Difference in incidence of Suspected Unexpected Serious Adverse Reactions (SUSAR) between the three groups | Evaluated by medical records and patient interview at months 0, 3, 6, and 9. | 9 Months |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Written informed consent obtained before any trial-related procedures are performed
- Diabetes, one of the following groups: Type 1 diabetes OR Type 2 diabetes receiving glucose-lowering therapy OR Type 2 diabetes managed with lifestyle changes with an HbA1c ≥ 50 mmol/mol
- Maintenance haemodialysis or peritoneal dialysis (minimum of two weeks)
- Subject must be willing and able to comply with trial protocol and be fluent in Danish or English
- Major allergy to tape/adhesives
- Women who are pregnant or planning pregnancy
- Ongoing use of CGM
- Ongoing use of insulin pump
Bo Feldt-RasmussenSteno Diabetes Center CopenhagenResponsável pelo estudo
Bo Feldt-Rasmussen, Patrocinador-Investigador, MD, DMSc, Professor, Rigshospitalet, Denmark
Sem dados de contato.
5 Locais do estudo em 1 países
Rigshospitalet, Copenhagen, 2100, Denmark
Herlev Hospital, Herlev, 2730, Denmark
North Zealand Hospital, Hillerød, Hillerød, 3400, Denmark
Holbæk Sygehus, Holbæk, 4300, Denmark
Zealand University Hospital, Roskilde, 4000, Denmark