Closed-loop Control of Overnight Glucose Levels in Adults and Adolescents With Type 1 Diabetes
18 de outubro de 2014 atualizado por: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
An Open-label, Randomized, Three-way, Multicenter Study to Compare the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Insulin Pump Therapy in Regulating Overnight Glucose Levels at Home in Adolescents and 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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in a out-patient study in adults and adolescents with type 1 diabetes.
The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
We aim to conduct a multicenter study to compare the efficacy of conventional pump therapy, single-hormone closed-loop strategy and dual-hormone closed-loop strategy to regulate overnight glucose levels, at home, in adolescents and adults with type 1 diabetes. Each intervention will be tested on two nights: 1) After a carbohydrate-rich dinner meal (to exaggerate hyperglycemic risk and; 2) After an evening exercise (to exaggerate hypoglycemic risk).
Tipo de estudo
Intervencional
Inscrição (Real)
28
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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Ontario
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Toronto, Ontario, Canadá
- Mount Sinai Hospital
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Quebec
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Montreal, Quebec, Canadá
- Institut de recherches cliniques de Montréal
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Montreal, Quebec, Canadá
- Montreal Children Hospital
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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
12 anos e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Males and females aged ≥ 12 years of old.
- Body mass index < 35
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 4 months.
- HbA1c < 12%.
- At least two visits with an endocrinology team in the past 1 year.
Exclusion Criteria:
- Clinically significant nephropathy, neuropathy (peripheral or autonomic e.g. significant gastroparesis) or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled therapy).
- Known or suspected allergy to the insulin aspart, glucagon, Medtronic sensors, or Medtronic infusion sets..
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Anticipating a significant change in treatment regimen between admissions (such as a major change in an exercise routine, significant change in dietary routine or in insulin therapy.
- Failure to comply with team's recommendations.
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Conventional insulin pump therapry
Subjects will use conventional pump therapy to regulate their glucose levels.
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At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females).
Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve.
The workout will be on a treadmill and/or a stationary bicycle.
Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
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Comparador Ativo: Single-hormone closed-loop system
Variable subcutaneous insulin infusion rate will be used to regulate glucose levels.
Insulin Aspart (Novorapid) will be infused using a subcutaneous infusion pump.
The glucose level as measured by the real time sensor 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 recommendations of infusion rates.
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At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females).
Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve.
The workout will be on a treadmill and/or a stationary bicycle.
Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
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Comparador Ativo: Dual-hormone closed-loop system
Insulin Aspart (Novorapid) and glucagon (Paladin) will be infused using two separate subcutaneous infusion pumps.
The glucose levels as measured by the real time sensor will be entered manually into the computer every 10 minutes.
The pumps' infusion rate will then be changed manually based on the computer generated-recommendation delivery levels.
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At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females).
Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve.
The workout will be on a treadmill and/or a stationary bicycle.
Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of time in target range
Prazo: 8 hours
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Percentage of time for which glucose levels (as measured by the glucose sensor) are in target range.
Target range is defined to be between 4.0 to 8.0 mmol/L
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8 hours
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of time in target range for each night separately
Prazo: 8 hours
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Percentage of time for which glucose levels are in target range for each night separately.
Target range is defined to be between 4.0 and 8.0 mmol/L.
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8 hours
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Percentage of time in target range for the pooled data
Prazo: 8 hours
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Percentage of time for which glucose levels are in target range for the pooled data.
Target range is defined to be between 4.0 to 8.0 mmol/L.
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8 hours
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Percentage of time spent below 4.0 mmol/L
Prazo: 8 hours
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Percentage of time for which glucose levels are below 4.0 mmol/L.
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8 hours
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Percentage of time spent below 3.3 mmol/L
Prazo: 8 hours
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Percentage of time for which glucose levels are spent below 3.3 mmol/L.
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8 hours
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Area under the curve for glucose levels below 4.0 mmol/L
Prazo: 8 hours
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8 hours
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Area under the curve for glucose levels below 3.3 mmol/L
Prazo: 8 hours
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8 hours
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Percentage of time spent above 8.0 mmol/L
Prazo: 8 hours
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Percentage of time for which glucose levels are above 8.0 mmol/L
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8 hours
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Percentage of time spent above 10.0 mmol/L
Prazo: 8 hours
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Percentage of time for which glucose levels are above 10.0 mmol/L.
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8 hours
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Area under the curve for glucose levels spent above 8.0 mmol/L
Prazo: 8 hours
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8 hours
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Area under the curve for glucose levels spent above 10.0 mmol/L
Prazo: 8 hours
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8 hours
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Mean glucose levels
Prazo: 8 hours
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8 hours
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Standard deviation of glucose levels
Prazo: 8 hours
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Standard deviation of glucose levels as a measure of glucose variability.
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8 hours
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Total insulin delivery
Prazo: 8 hours
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8 hours
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Number of subjects experiencing at least one hypoglycemic event requiring treatment
Prazo: 8 hours
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8 hours
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Number of hypoglycemic events requiring treatment
Prazo: 8 hours
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8 hours
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bruce Perkins, Mount Sinai Hospital
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 julho de 2013
Conclusão Primária (Real)
1 de setembro de 2014
Conclusão do estudo (Real)
1 de setembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
12 de julho de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de julho de 2013
Primeira postagem (Estimativa)
22 de julho de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
21 de outubro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de outubro de 2014
Última verificação
1 de outubro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CLASS-04
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