Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
8 de fevereiro de 2019 atualizado por: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes
Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas 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 artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
37
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Quebec
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Montreal, Quebec, Canadá, H2W 1R7
- Institut de recherches cliniques de Montreal
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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:
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Use of medication with an effect on heart rate (e.g. beta-blockers).
- Abnormal blood panel and/or anemia.
- Ongoing or planned pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
- 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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Unannounced exercise
The target blood glucose of the algorithm will be as usual.
A pre-meal full insulin bolus will be given.
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Será usado o análogo de insulina de ação rápida usual do paciente.
O sensor de glicose Dexcom G4 Platinum será usado para medir os níveis de glicose.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
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Comparador Ativo: Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
|
Será usado o análogo de insulina de ação rápida usual do paciente.
O sensor de glicose Dexcom G4 Platinum será usado para medir os níveis de glicose.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
|
Comparador Ativo: Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
|
Será usado o análogo de insulina de ação rápida usual do paciente.
O sensor de glicose Dexcom G4 Platinum será usado para medir os níveis de glicose.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Prazo: From 9:30 to 11:30 (120 minutes)
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From 9:30 to 11:30 (120 minutes)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Relative decrease in glucose levels during exercise compared to pre-breakfast levels
Prazo: From 8:00 to 10:50 (170 minutes)
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Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
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From 8:00 to 10:50 (170 minutes)
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Number of patients experiencing exercise-induced hypoglycemia requiring treatment
Prazo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Decremental area under the curve from the start of the exercise
Prazo: From 9:30 to 11:00 (90 minutes)
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From 9:30 to 11:00 (90 minutes)
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Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Prazo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent below 3.3 mmol/L
Prazo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent below 2.8 mmol/L
Prazo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
Prazo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent above 10 mmol/L
Prazo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent above 13.9 mmol/L
Prazo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent above 16.7 mmol/L
Prazo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Mean plasma glucose levels
Prazo: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
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Standard deviation of glucose levels
Prazo: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
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Coefficient of variation of glucose levels
Prazo: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
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Mean time (minutes) to the first hypoglycemic event
Prazo: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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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
1 de setembro de 2016
Conclusão Primária (Real)
1 de dezembro de 2018
Conclusão do estudo (Real)
1 de dezembro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
1 de agosto de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de agosto de 2016
Primeira postagem (Estimativa)
4 de agosto de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de fevereiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de fevereiro de 2019
Última verificação
1 de fevereiro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Doenças do sistema imunológico
- Doenças autoimunes
- Doenças do Sistema Endócrino
- Diabetes Mellitus
- Diabetes Mellitus, Tipo 1
- Hipoglicemiantes
- Efeitos Fisiológicos das Drogas
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Insulina
- Insulina, Globina Zinco
- Hormônios
Outros números de identificação do estudo
- CLASS-16
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
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