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Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels

25 de abril de 2018 atualizado por: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels in Adults With Type 1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings.

The objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.

Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.

Visão geral do estudo

Status

Retirado

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Estágio

  • Fase 2

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Males and females ≥ 18 years of old.
  2. Clinical diagnosis of type 1 diabetes for at least one year.
  3. The subject will have been on insulin pump therapy for at least 6 months.
  4. HbA1c ≤ 12%.

Exclusion Criteria:

  1. Using a patch-pump (e.g. Omnipod)
  2. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
  3. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  4. Ongoing or planned pregnancy.
  5. Breastfeeding.
  6. Severe hypoglycemic episode within two weeks of screening.
  7. Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
  8. Known or suspected allergy to the trial products or meal contents.
  9. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  10. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
  11. Problems with venous access.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
Dispositivo: Insulin pump
The participant's insulin pump will be used to infuse insulin
Dispositivo: Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels
Outro: 11-hour intervention with the single-hormone artificial pancreas

Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations.

At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits.

Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes.
Comparador Ativo: Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
Dispositivo: Insulin pump
The participant's insulin pump will be used to infuse insulin
Dispositivo: Continuous glucose monitoring system
The Dexcom G4 Platinum will be used to measure glucose levels
Outro: 11-hour intervention with the single-hormone artificial pancreas

Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations.

At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits.

Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Change in plasma glucose levels 1 hour after the meal
Prazo: 1 hour
1 hour

Medidas de resultados secundários

Medida de resultado
Prazo
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
Prazo: 1 hour
1 hour
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
Prazo: 2 hours
2 hours
Plasma glucose level 1 hour after the meal.
Prazo: 1 hour
1 hour
Plasma glucose level 2 hours after the meal.
Prazo: 2 hours
2 hours
Glycemic peak in the 3 hours following the meal.
Prazo: 3 hours
3 hours
Change in plasma glucose levels 2 hours after the meal.
Prazo: 2 hours
2 hours
Peak time of glucose levels over the 4 hours following the meal.
Prazo: 4 hours
4 hours
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
Prazo: 4 hours
4 hours
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of plasma glucose levels below 3.9 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of sensor glucose levels below 3.9 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of plasma glucose levels below 3.3 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of sensor glucose levels below 3.3 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of plasma glucose levels below 2.8 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of sensor glucose levels below 2.8 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of plasma glucose levels above 10 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of sensor glucose levels above 10 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of plasma glucose levels above 13.9 mmol/L
Prazo: 11 hours
11 hours
Percentage of time of sensor glucose levels above 13.9 mmol/L
Prazo: 11 hours
11 hours
Percentage of time of plasma glucose levels above 16.7 mmol/L.
Prazo: 11 hours
11 hours
Percentage of time of sensor glucose levels above 16.7 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of plasma glucose levels below 3.9 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of sensor glucose levels below 3.9 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of plasma glucose levels below 3.3 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of sensor glucose levels below 3.3 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of plasma glucose levels below 2.8 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of sensor glucose levels below 2.8 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of plasma glucose levels above 10.0 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of sensor glucose levels above 10.0 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of plasma glucose levels above 13.9 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of sensor glucose levels above 13.9 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of plasma glucose levels above 16.7 mmol/L.
Prazo: 11 hours
11 hours
Area under the curve of sensor glucose levels above 16.7 mmol/L.
Prazo: 11 hours
11 hours
Standard deviation of plasma glucose levels.
Prazo: 11 hours
11 hours
Standard deviation of sensor glucose levels.
Prazo: 11 hours
11 hours
Coefficient of variance of plasma glucose levels.
Prazo: 11 hours
11 hours
Coefficient of variance of sensor glucose levels.
Prazo: 11 hours
11 hours
Total insulin delivery.
Prazo: 11 hours
11 hours
Mean plasma glucose level.
Prazo: 11 hours
11 hours
Mean sensor glucose level.
Prazo: 11 hours
11 hours
Mean plasma insulin concentration.
Prazo: 11 hours
11 hours
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
Prazo: 11 hours
11 hours

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Institut de Recherches Cliniques de Montreal

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

1 de abril de 2018

Conclusão Primária (Antecipado)

31 de dezembro de 2018

Conclusão do estudo (Antecipado)

31 de dezembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

3 de novembro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de novembro de 2017

Primeira postagem (Real)

7 de novembro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de abril de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de abril de 2018

Última verificação

1 de abril de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CLASS-FiAsp

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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