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Comparison of an Artificial Pancreas Versus Threshold Low Glucose Suspend in Type 1 Diabetic Children (SHAN)

12 de junho de 2018 atualizado por: University Hospital, Montpellier

Assessment of the Efficacy on the Reduction of Nocturnal Hypoglycemia in Children With Type 1 Diabetes of a Closed-loop Insulin Therapy (Artificial Pancreas) Compared to Insulin Pump Therapy Combined With Continuous Glucose Monitoring With Threshold Low Glucose Suspend of Infusion in Home-like Conditions

The objective of this study is to assess the efficacy of an Artificial Pancreas system which includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical centres. After a 2 week run-in period, they will attend two investigational sessions of 65 hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will be activated, depending on the randomization. The main endpoint is the time spent below 70mg/dL between 22:00 and 07:00.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The study is an open randomized control trial preceded by a run-in period and follows a cross-over design.After inclusion, the therapy will be moved to sensor augmented pump therapy with a dedicated training to continuous glucose monitoring using study system (study CGM). During 2 to 3 weeks, the patient will use his/her usual insulin pump and the study CGM (run-in period). At the end of this period, the patient and the relative will be admitted in a parents'house or hotel/resort nearby the hospital for 65 hours to undergo the first interventional session. Admission will be at 17:00 Day 1. The investigator will connect wirelessly the study pump and CGM to the study platform DiAs and remote monitoring will be activated. Until 08:00 Day 2, insulin delivery will be managed in open-loop mode, i.e. insulin doses will be decided according to capillary glucose measurements. From 08:00 Day 2, one algorithm will be activated according to the randomization order, i.e. either the threshold low glucose suspend (TLGS) algorithm (threshold will be set at 70 mg/dl) or the closed-loop algorithm. Insulin delivery will then be managed in open-loop mode with activated TLGS or by the closed-loop algorithm until 08:00 Day 4. In both cases, meals will be of free content and taken around 09:00, 13:00, 17:00 and 20:00. Meal insulin doses will be managed according to pre-meal glucose level and CHO meal content in open-loop mode with TLGS, or according to DiAs bolus calculator suggestion in closed-loop mode. Patient and relative will be encouraged to move in parents'house or hotel/resort and surroundings between meals. The algorithm will be inactivated at 08:00 Day 4. The study pump will be removed and replaced by patient's usual pump. The patient and the relative will be released at 10:00 after breakfast. Study CGM will still be used at home for 2 to 4 weeks until the second interventional session. This session will be similar to the first one but the alternative algorithm will be activated. Patient will come back to pre-study insulin therapy from 08:00 Day 4 and be released at 10:00 when second session is completed.

Tipo de estudo

Intervencional

Inscrição (Real)

24

Estágio

  • Fase 2

Contactos e Locais

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Locais de estudo

  • França
      • Angers, França, 49000
        • CHU d'Angers
      • Montpellier, França, 34985
        • CHU Montpellier - Hôpital Lapeyronie
      • Paris, França, 75019
        • AP-HP, Hôpital Robert Debré
      • Tours, França, 37000
        • CHU de Tours, Hôpital Clocheville

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

7 anos a 12 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Age from 7 to 12
  2. Puberty status at Prader 1
  3. Diabetes diagnosed according to WHO criteria since more than 1 year
  4. Fasting plasma C-peptide level <0.2 ng/ml for a fasting blood glucose level < 180 mg/dl
  5. At least one positiveness for plasma antibodies against pancreatic islets: IAA, IA2, GAD, ICA or ZnT8, since diagnosis of diabetes
  6. Treatment of diabetes by insulin pump since more than 6 months
  7. HbA1c level below 8.5%
  8. Trained in carbohydrate counting
  9. Lack of any associated disease or therapy (except insulin) affecting glucose metabolism
  10. Willingness to follow all study procedures
  11. Informed consent signed by patient and parent or legally responsible party
  12. Patient must be affiliated or beneficiary of a social medical insurance

Exclusion Criteria:

  1. Unwillingness of one parent or the legally responsible party to be present during all study procedures
  2. Expected use of acetaminophen-containing drugs
  3. Any disease or therapy (except insulin) affecting glucose metabolism during previous month
  4. Impaired cognitive or psychological abilities which may result in defective adherence to study procedures
  5. Active enrollment in another clinical trial or participation in a study within 30 days or participation in previous studies resulting in a cumulated annual income which would exceed 4500 €

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
Experimental: Control-to-Range algorithm and Threshold Low Glucose Suspend

On this arm, patients will realize two investigational sessions:

  • the first with Control-to-Range algorithm (CTR),
  • the second with Threshold Low Glucose Suspend (TLGS).
Dispositivo: Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm
The insuline used is usual patient insuline. There is no specific insulin for this protocol
Dispositivo: Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
The insuline used is usual patient insuline. There is no specific insulin for this protocol
Experimental: Threshold Low Glucose Suspend and Control-to-Range algorithm

On this arm, patients will realize two investigational sessions:

  • the first with Threshold Low Glucose Suspend (TLGS),
  • the second with Control-to-Range algorithm (CTR).
Dispositivo: Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm
The insuline used is usual patient insuline. There is no specific insulin for this protocol
Dispositivo: Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
The insuline used is usual patient insuline. There is no specific insulin for this protocol

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Time spent with blood glucose <70 mg/dl
Prazo: from 22:00 to 08:00, over two consecutive nights
from 22:00 to 08:00, over two consecutive nights

Medidas de resultados secundários

Medida de resultado
Prazo
Percent time spent with blood glucose <70mg/dl
Prazo: over two consecutive days (48h)
over two consecutive days (48h)
Percent time spent with blood glucose level in 70-180 mg/dl range
Prazo: from 22:00 to 08:00 over two consecutive nights
from 22:00 to 08:00 over two consecutive nights
Percent time spent with blood glucose level in 80-150 mg/dl range
Prazo: from 22:00 to 08:00 over two consecutive nights
from 22:00 to 08:00 over two consecutive nights
Percent time spent with blood glucose level in 70-180 mg/dl range
Prazo: over two consecutive days (48h)
over two consecutive days (48h)
Mean blood glucose level
Prazo: from 22:00 to 08:00, over two consecutive nights
from 22:00 to 08:00, over two consecutive nights
Mean blood glucose level
Prazo: over two consecutive days (48h)
over two consecutive days (48h)
Number of needed interventions by the patients, the parents, and by the investigational team, to treat hypoglycemia
Prazo: during 65 hours of each investigational session
during 65 hours of each investigational session
Number of needed interventions by the patients, the parents, and by the investigational team, to fix issues related to the functioning of the insulin delivery system
Prazo: during 65 hours of each investigational session
during 65 hours of each investigational session
Score of the Artificial Pancreas Acceptance Questionnaire
Prazo: at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
Score of the Hypo Fear Survey
Prazo: at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)
at time of inclusion (at Visit 2) and 5 to 6 weeks after inclusion (i.e at Visit 4)

Colaboradores e Investigadores

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

Patrocinador

University Hospital, Montpellier

Publicações e links úteis

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Publicações Gerais

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 (Real)

16 de junho de 2015

Conclusão Primária (Real)

1 de dezembro de 2016

Conclusão do estudo (Real)

1 de dezembro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

8 de julho de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de julho de 2015

Primeira postagem (Estimativa)

28 de julho de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de junho de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de junho de 2018

Última verificação

1 de julho de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 9525 (Outro identificador: CTEP)

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