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Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform

22 de junho de 2017 atualizado por: Mark DeBoer, MD, University of Virginia
The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.

Visão geral do estudo

Status

Concluído

Descrição detalhada

Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population with clear needs but unique challenges regarding the application of artificial pancreas (AP) technologies. Young children are likely to benefit from an AP system, with current deficits in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels; however, they have undeveloped abilities to control and interact with the AP system, posing potential safety issues. During the hours that these children are away from their parents at school and elsewhere, they lack the sophistication to operate the currently-available tools in an AP system--and may induce harm if they are allowed to do so, causing parental resistance to AP use. Commercially-available insulin pumps have mechanisms to lock access to children to prevent inappropriate insulin-delivery. However, the AP is more complex than an insulin pump, both in requiring more detailed setting information (that a child could adversely alter) and in providing alerts for impending low- and high-blood glucose (BG) levels (that one wouldn't want to lock out to child use). These functions are all run via a platform on a smart phone-a device with which young children may already feel a high degree of familiarity and thus be more likely to attempt to explore and potentially change settings. It is likely that young children will benefit the most from a system that gives them access to some AP features but provides access to other features only for their parents. In this sense, young children require a device that is not user-centered as much as family-centered. A redesign of the system to provide appropriate access to AP tools-in which certain users can obtain access to certain functionalities-is direly needed before children in this age range can benefit from the improvements in blood glucose (BG) control that the AP has to offer.

Tipo de estudo

Intervencional

Inscrição (Real)

12

Estágio

  • Não aplicável

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

    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • University of Virginia Center for Diabetes Technology

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

5 anos a 9 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes,

    • The diagnosis of type 1 diabetes is based on the investigator's judgment
    • C peptide levels and antibody determinations are not required
  • Daily insulin therapy for ≥ 12 months
  • Insulin pump therapy for ≥ 3 months
  • Age ≥5 - ≤8 years old
  • Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
  • Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study

Exclusion Criteria:

The presence of any of the following is an exclusion for the study:

  • Diabetic ketoacidosis in the past month
  • Hypoglycemic seizure or loss of consciousness in the past 3 months
  • History of seizure disorder (except for hypoglycemic seizure)
  • History of any heart disease including coronary artery disease, heart failure, or arrhythmias
  • Cystic fibrosis
  • Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
  • History of ongoing renal disease (other than microalbuminuria).
  • Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
  • Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
  • Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met.
  • Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:

    • Inpatient psychiatric treatment in the past 6 months
    • Uncontrolled adrenal insufficiency

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 Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Group A
In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.
All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
Experimental: Group B
Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.
All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percent of Sensor Glucose Readings Between 70-180 mg/dL
Prazo: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percent of Time Sensor Glucose Readings Are <70 mg/dL
Prazo: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Percent of Time Sensor Glucose Readings Are >150 mg/dL
Prazo: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Percent of Time Sensor Glucose Readings Are >180 mg/dL
Prazo: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Percent of Time Sensor Glucose Readings Are >250 mg/dL
Prazo: 68 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Percent of Time Sensor Glucose Readings Are >400 mg/dL
Prazo: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)
Prazo: 72 hours
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Distribution of Sensor and Meter Glucose Values (Maximum)
Prazo: 72 hours
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Distribution of Sensor and Meter Glucose Values (Minimum)
Prazo: 72 hours
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)
Prazo: 72 hours
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Mean BG (as Measured by CGM)
Prazo: 68 hours
All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
68 hours
Hypoglycemia Area Under the Curve <60
Prazo: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Hypoglycemia Area Under the Curve <70 mg/dL
Prazo: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Hyperglycemia Area Under the Curve >180
Prazo: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Hyperglycemia Area Under the Curve >250 mg/dL
Prazo: 72 hours
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
72 hours
Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
Prazo: 68 hours
All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.
68 hours
End of Night Blood Glucose
Prazo: 72 hours
All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.
72 hours

Colaboradores e Investigadores

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

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Mark D. DeBoer, MD, University of Virginia, Pediatrics, Endocrinology/Diabetes

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 maio de 2016

Conclusão Primária (Real)

1 de maio de 2016

Conclusão do estudo (Real)

1 de maio de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

15 de abril de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de abril de 2016

Primeira postagem (Estimativa)

25 de abril de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de julho de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de junho de 2017

Última verificação

1 de junho de 2017

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Not yet determined

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