Closing the Loop in Youth With Type 1 Diabetes in the Home Setting
22 de setembro de 2013 atualizado por: Dr Roman Hovorka, University of Cambridge
An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy, Safety and Utility of Real-time Continuous Subcutaneous Glucose Monitoring Combined With Overnight Closed-loop Glucose Control in the Home Setting in Comparison With Real-time Continuous Subcutaneous Glucose Monitoring Alone in Adolescents With Type 1 Diabetes on Subcutaneous Insulin Infusion Pump Therapy.
Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring life-long insulin therapy.
Children and adolescents with T1D need regular insulin injections or the continuous insulin delivery using an insulin pump in order to keep blood glucose levels normal.
The investigators know that keeping blood sugars in the normal range will help prevent long-term diabetes-related complications involving the eyes, kidneys and heart.
However, achieving treatment goals can be very difficult as the tighter the investigators try to control blood glucose levels, the greater the risk to develop symptoms and signs of low glucose levels (hypoglycaemia).
This is a particular problem at night and one solution is to develop a system whereby the amount of insulin injected is controlled by a computer and is very closely matched to the blood sugar levels on a continuous basis.
This can be achieved by what is known as a "closed-loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives an insulin pump.
The investigators have been testing such a system in Cambridge over the last three years in children and have found that this system is effective at preventing nocturnal hypoglycaemia.
The next stage of this research is to test the system for a longer period of time at home.
In the present study the investigators are planning to study 16 adolescents aged 12-18 years on insulin pump therapy.
During 21 nights glucose will be controlled by the computer and during the other 21 nights the subjects will make their own adjustments to the insulin therapy.
The investigators will then analyze the data to determine the effect of the computer algorithm in keeping glucose levels between 3.9 and 8 mmol/L (normal levels) and reducing the time they spent with glucose below 3.9 mmol/L (hypoglycaemia).
Subjects' response to the use of the system in terms of life-style change, daily diabetes management and fear of hypoglycaemia will be assessed.
The investigators will also test for longer term glucose control by measuring glycated haemoglobin and other blood parameters.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
17
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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Cambridgeshire
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Cambridge, Cambridgeshire, Reino Unido, CB2 0QQ
- Department of Paediatrics, Weston paediatric diabetes centre
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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 a 18 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- The subject is between 12 and 18 years of age (inclusive)
- The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
- The subject will all have been insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment as judged by the investigator
- The subject willing to perform regular finger-prick blood glucose monitoring, with at least 4 blood glucose measurements taken every day
- HbA1c ≤ 10 % based on analysis from central laboratory or equivalent
- The subject is literate in English
- Able to accommodate on site or in close proximity member(s) of study team for supervised closed-loop night(s)
Exclusion Criteria:
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Current treatment with drugs known to interfere with glucose metabolism, eg systemic corticosteroids, non-selective beta-blockers and MAO inhibitors etc
- Known or suspected allergy against insulin
- Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
- Total daily insulin dose ≥ 2 IU/kg/day
- Pregnancy, planned pregnancy, or breast feeding
- Prolonged use of any continuous glucose monitoring devices over the last 1 month prior the study
- Severe visual impairment
- Severe hearing impairment
- Subjects using implanted internal pace-maker -
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: Overnight closed-loop combined with real-time CGM
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The closed-loop system is purpose-built and comprises a hand-held computer containing the algorithm and communicating with the CGM device and the insulin pump.
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Comparador Ativo: Real-time CGM alone
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The closed-loop system is purpose-built and comprises a hand-held computer containing the algorithm and communicating with the CGM device and the insulin pump.
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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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Primary Efficacy Outcome
Prazo: At least 7 days of valid CGM nights (midnight-7:30)
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The primary objective of the study is to assess the efficacy of continuous glucose monitoring (CGM) combined with overnight automated closed-loop glucose control in maintaining CGM glucose levels within the target range from 3.9 to 8.0 mmol/L, when compared with the use of CGM alone in the home setting.
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At least 7 days of valid CGM nights (midnight-7:30)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Secondary outcomes
Prazo: At least 7 days of valid CGM nights (midnight-7:30)
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As a secondary research question, the safety of overnight automated closed-loop glucose control in terms of number of episodes of severe hypoglycaemia as well as the number of subjects experiencing severe hypoglycaemia and other adverse events. Furthermore, the frequency and duration of use of the closed-loop system will be evaluated. Subjects' perception in terms of life-style change, daily diabetes management and fear of hypoglycaemia will be assessed using questionnaires and a qualitative interview. |
At least 7 days of valid CGM nights (midnight-7:30)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Thabit H, Elleri D, Leelarathna L, Allen J, Lubina-Solomon A, Stadler M, Walkinshaw E, Iqbal A, Choudhary P, Wilinska M, Barnard K, Heller S, Amiel S, Evans M, Dunger D, Hovorka R. Unsupervised overnight closed loop insulin delivery during free living: analysis of randomised cross-over home studies in adults and adolescents with type 1 diabetes. Lancet. 2015 Feb 26;385 Suppl 1:S96. doi: 10.1016/S0140-6736(15)60411-1.
- Thabit H, Leelarathna L, Wilinska ME, Elleri D, Allen JM, Lubina-Solomon A, Walkinshaw E, Stadler M, Choudhary P, Mader JK, Dellweg S, Benesch C, Pieber TR, Arnolds S, Heller SR, Amiel SA, Dunger D, Evans ML, Hovorka R. Accuracy of Continuous Glucose Monitoring During Three Closed-Loop Home Studies Under Free-Living Conditions. Diabetes Technol Ther. 2015 Nov;17(11):801-7. doi: 10.1089/dia.2015.0062. Epub 2015 Aug 4.
- Hovorka R, Elleri D, Thabit H, Allen JM, Leelarathna L, El-Khairi R, Kumareswaran K, Caldwell K, Calhoun P, Kollman C, Murphy HR, Acerini CL, Wilinska ME, Nodale M, Dunger DB. Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial. Diabetes Care. 2014;37(5):1204-11. doi: 10.2337/dc13-2644.
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 junho de 2012
Conclusão Primária (Real)
1 de março de 2013
Conclusão do estudo (Real)
1 de março de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
14 de outubro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de outubro de 2010
Primeira postagem (Estimativa)
15 de outubro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
24 de setembro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de setembro de 2013
Última verificação
1 de setembro de 2013
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- APCam06
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