- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01930097
Closed-loop Control of Glucose Levels After Meal Intake in Adults With Type 1 Diabetes
An Open-label, Randomized, Three-way, Cross-over Study to Compare the Efficacy of Closed-loop Operation Combined With Meal-and-carbohydrate-announcement Closed-loop Operation Combined With Meal-announcement, and Conventional Pump Therapy in Regulating Glucose Levels in 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 dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The objective of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control.
Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than conventional pump treatment in regulation of glucose levels in adults with T1D.
Visão geral do estudo
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.
Each patient will be admitted three times to a clinical research facility. In the meal-and-carbohydrate-announcement visit, patients will eat 3 meals accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the meal-announcement visit, patients will eat the 3 same meals but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. In the control visit, patients will use conventional pump therapy to regulate glucose levels.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
Quebec
-
Montreal, Quebec, Canadá, H2W1R7
- Institut de Recherches Cliniques de Montreal
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Medication likely to affect with the interpretation of the results because of their well known impact on gastric emptying: Motilium®, Prandase®, Victoza®, Byetta® and Symlin®.
- Known or suspected allergy to the trial products, meal contents including nuts, peanuts, dairy products or eggs.
- Unusual nutritional habits (e.g. vegetarians)
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
- Unreliable carbohydrate counting or lack of insulin to carbohydrate ratios
- Problems with venous access
Plano de estudo
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 |
---|---|
Comparador Ativo: CHO-dependant bolus
An insulin bolus dependant of carbohydrate content will be given after each meal. Each subject insulin-to-carbohydrate ratio (U per 10g CHO) will be used to calculate the insulin bolus to be given. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings. |
Subjects will be admitted at the IRCM at 6:30.
Subjects will be asked to fast from midnight.
At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served.
At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served.
At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served.
Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
|
Comparador Ativo: CHO-independent bolus
An insulin bolus independent of carbohydrate content will be given after each meal.
The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.
|
Subjects will be admitted at the IRCM at 6:30.
Subjects will be asked to fast from midnight.
At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served.
At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served.
At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served.
Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
|
Comparador Ativo: Conventional treatment
Patients will use conventional pump therapy to regulate glucose levels
|
Subjects will be admitted at the IRCM at 6:30.
Subjects will be asked to fast from midnight.
At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served.
At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served.
At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served.
Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The positive incremental area under the curve of postprandial glucose excursions
Prazo: 4 hours after meal intake
|
The positive incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals.
|
4 hours after meal intake
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Mean plasma glucose
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Incremental two hours postprandial glucose
Prazo: 2 hours after meal intake
|
2 hours after meal intake
|
Incremental postprandial peak-glucose values
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Percentage of time of plasma glucose levels spent above 10.0 mmol/L
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Percentage of time of plasma glucose levels spent below 4.0 mmol/L
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Total insulin delivery
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Total glucagon delivery
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Standard deviation of glucose levels
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Percentage of time of plasma glucose concentrations below 3.5 mmol/L
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Percentage of time of plasma glucose concentrations above 14 mmol/L
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Mean plasma insulin concentration
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Mean plasma glucagon concentration
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Number of patients experiencing hypoglycemia requiring oral treatment
Prazo: 8h00 to 21h00
|
8h00 to 21h00
|
Incremental area under the curve of the 4-hr postprandial glucose excursions but the reference glucose is set to 5.0 mmol/L if premeal glucose is less than 5.0 mmol/L.
Prazo: 4 hours after meal intake
|
4 hours after meal intake
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CLASS-05
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Diabetes tipo 1
-
Oxford Brookes UniversityUniversity of OxfordConcluídoAtividade física | Saúde Mental Bem-estar 1 | Função Cognitiva 1, Social | Academic Attainment | Fitness TestingReino Unido
-
Merck Sharp & Dohme LLCRecrutamentoCâncer de Pulmão de Células Não Pequenas | Tumores Sólidos | Morte Celular Programada-1 (PD1, PD-1) | Ligante 1 de morte celular programada 1 (PDL1, PD-L1) | Ligante 2 de morte celular programada 1 (PDL2, PD-L2)Japão
-
Rambam Health Care CampusIsrael Science FoundationConcluído
-
Alvotech Swiss AGConcluído
-
PfizerConcluído
-
SanionaConcluído
-
Calliditas Therapeutics ABEurofins Optimed; York Bioanalytical SolutionConcluído
-
Calliditas Therapeutics ABConcluído
-
Reproductive Medicine Associates of New JerseyConcluídoCada paciente é tanto caso quanto controle | 1 embrião será biopsiado e 1 embrião não seráEstados Unidos
-
JKT Biopharma Co., Ltd.Recrutamento
Ensaios clínicos em 14 hours intervention
-
University of TurkuDesconhecidoSaudável | Comportamento de saúdeFinlândia
-
Henry Ford Health SystemBlue Cross Blue Shield of Michigan FoundationConcluído
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconhecidoInfarto CerebralAlemanha
-
Northwestern UniversityEmory UniversityConcluídoAfasia Progressiva Primária | Esgotamento do cuidadorEstados Unidos
-
Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...ConcluídoCyberbullyingEstados Unidos
-
University of VirginiaConcluídoLesão da medula espinal | Úlceras de pressãoEstados Unidos
-
Charles G. ProberStanford University; Heidelberg University; University of Stellenbosch; University...ConcluídoAleitamento Materno Exclusivo | Práticas de alimentação infantilÁfrica do Sul
-
University of Alabama, TuscaloosaNational Institute of Nursing Research (NINR)ConcluídoDor | Cuidado paliativo | Distúrbios da Retenção Cognitiva | Outra doença crônicaEstados Unidos
-
Brigham and Women's HospitalUniversity of Colorado, DenverConcluídoDiabetes Mellitus GestacionalEstados Unidos
-
LuciLabCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal; Sojecci...ConcluídoComportamento de risco | Declínio CognitivoCanadá