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O estudo clínico NCT04620967 para Diabetes tipo 1 está desconhecido. 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. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Fast-Acting Insulin Aspart and Insulin Pump Settings Fase IV 40
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 NCT04620967 procura avaliar tratamento para Diabetes tipo 1. Este é um estudo intervencionista de Fase IV. Seu status atual é: desconhecido. O estudo começou em 1 de fevereiro de 2021 e pretende incluir 40 participantes. Coordenado por Kirsten Nørgaard e deve ser concluído em 30 de junho de 2022. Essas informações foram atualizadas no ClinicalTrials.gov em 16 de fevereiro de 2021.
Resumo
To clarify the role of fast-acting insulin aspart (Fiasp) in insulin pump-treated type 1 diabetes more research is needed.
The aim of this study is twofold:
- to compare the effects of Fiasp and Iasp in adults with type 1 diabetes who are using insulin pump and CGM and who are attending a diabetes out-patient clinic with extensive expertise in insulin pump and CGM therapy.
- to determine differences in insulin pu...
Título oficial
Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY
Condições médicas
Diabetes tipo 1Outros IDs do estudo
- 2020-001158-23
- H-20022359 (Outro identificador) (Scientific Ethical Committee of the Capital Region of Denmark)
Número NCT
Data de início (real)
2021-02-01
Última atualização postada
2021-02-16
Data de conclusão (estimada)
2022-06-30
Inscrição (estimada)
40
Tipo de estudo
Intervencionista
FASE
Fase IV
Status
Desconhecido
Palavras-chave
Insulin pump
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Estudo cruzado
Cegamento (Mascaramento)
Triplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalIasp-Fiasp First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp | Insulin aspart Insulin aspart (Iasp) in insulin pump Fast-acting insulin aspart Fast-acting insulin aspart (Fiasp) in insulin pump |
ExperimentalFiasp-Iasp First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp | Insulin aspart Insulin aspart (Iasp) in insulin pump Fast-acting insulin aspart Fast-acting insulin aspart (Fiasp) in insulin pump |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Time in range | Difference in time spent with glucose values in the range 3.9-10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Mean glucose | Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Coefficient of variation | Difference in coefficient of variation between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time below range level 1 | Difference in time spent with glucose values below 3.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time below range level 2 | Difference in time spent with glucose values below 3.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time above range level 1 | Difference in time spent with glucose values above 10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time above range level 2 | Difference in time spent with glucose values above 13.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Fructosamine | Difference in change in fructosamine between Fiasp and Iasp treatment | 16 weeks |
Total daily insulin dose | Difference between Fiasp and Iasp treatment in total daily insulin dose | Last two weeks of the 16-week interventions |
Total daily basal insulin dose | Difference between Fiasp and Iasp treatment in total daily basal insulin dose | Last two weeks of the 16-week interventions |
Total daily bolus insulin dose | Difference between Fiasp and Iasp treatment in total daily bolus insulin dose | Last two weeks of the 16-week interventions |
Severe hypoglycemia | Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events | 16 weeks |
Ketoacidosis | Difference between Fiasp and Iasp treatment in number of ketoacidosis events | 16 weeks |
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Type 1 diabetes for ≥ 5 years
- HbA1c 53-75 mmol/mol (7.0-9.0%)
- Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion)
- CGM use for ≥ 6 months (all CGM makes are eligible for inclusion)
- Carbohydrate counting for all snacks and meals
- Use of the insulin pump bolus calculator for all meals and snacks
- Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods
- Gastroparesis (clinical assessment)
- Shift work
- Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns
- Use of a hybrid closed-loop system
- Use of flash glucose monitoring
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- Chronic paracetamol use
- Alcohol or drug abuse
- Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol
- Impaired renal function (eGFR< 60 ml/min/1.73 m2)
- History of local skin reactions to Fiasp and/or Iasp
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- Lack of compliance with key study procedures at the discretion of the investigator
- Unacceptable adverse events at the discretion of the investigator
- Less than 40 weeks guarantee remaining on insulin pump
Kirsten NørgaardResponsável pelo estudo
Kirsten Nørgaard, Patrocinador-Investigador, Senior Consultant, Steno Diabetes Center Copenhagen
Contato central do estudo
Contato: Signe Schmidt, MD PhD, +45 51174785, [email protected]
1 Locais do estudo em 1 países
Steno Diabetes Center Copenhagen, Gentofte Municipality, 2820, Denmark
Signe Schmidt, MD PhD, Contato, +45 51174785, [email protected]
Ajenthen Ranjan, MD PhD, Subinvestigador
Hanne-Charlotte Andersen, RN, Subinvestigador
Signe Schmidt, MD PhD, Subinvestigador
Em recrutamento