- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00891995
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Visão geral do estudo
Status
Condições
Descrição detalhada
The specific aim of this study is to determine if early restoration of metabolic control will improve C-peptide production compared to children receiving routine diabetes management and the secondary aim is to determine if allowing the islet cells to be less metabolically active will have an impact on the underlying autoimmune process.
Following completion of the baseline procedures (Mixed Meal Tolerance Test and blood sample collection), participants are randomized to either the Standard Treatment Group or the Intensive Treatment Group which includes 4-6 days of inpatient closed loop therapy followed by outpatient use of an insulin pump and continuous glucose monitor for diabetes management.
All subjects will be seen 7 times in the first year and 4 times in the second year for follow-up testing. Subjects who are still producing insulin after 2 years may be asked to return every 6 months for an additional 2 years.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
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California
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Stanford, California, Estados Unidos, 94305
- Stanford University
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Colorado
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Aurora, Colorado, Estados Unidos, 80010
- Barbara Davis Center for Childhood Diabetes
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06519
- Yale University
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 6.0 to <46.0 years
- Diagnosis of type 1 diabetes with initiation of insulin therapy within past 7 days (day 1 being the first day of insulin therapy)
- If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative.
- Willing to accept randomization to either the intensive diabetes management group or the standard care group.
- Willing to complete the planned 2 years of follow-up.
- Able to electronically transmit data monthly.
- Investigator believes that the participant (and parent/guardian for children) understands and agrees to comply with the study protocol and is capable of undertaking all necessary testing.
Exclusion Criteria:
- Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
- Currently anemic (hematocrit level will be obtained at the screening visit).
- Chronic use of systemic steroids or other noninsulin pharmaceuticals that might affect glycemic control or the presence of a disease that is likely to be treated with such medications during the first two years of the study.
- Complicating medical issues that might interfere with study conduct.
- Inpatient psychiatric treatment in the past 6 months (if the participant is a minor, for either the participant or the participant's primary care giver).
- Currently participating in another type 1 diabetes treatment study, including an intervention trial for treatment of diabetic ketoacidosis.
Plano de estudo
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: Intensive Treatment
closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)
|
Closed loop therapy for up to 4 to 6 days
Standard diabetes management using a home glucose meter.
Insulin pump use for 2 years
Continuous glucose monitor use for 2 years
|
Comparador Ativo: Standard Treatment
home glucose monitoring (2 years)
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Standard diabetes management using a home glucose meter.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.
Prazo: At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal
|
In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).
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At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
HbA1c
Prazo: 1 ano
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1 ano
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Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment
Prazo: 0 to 240 min post meal at 1 year MMTT
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0 to 240 min post meal at 1 year MMTT
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Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT
Prazo: 0 to 240 min post meal at 1 year MMTT
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Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2
pmol/ml.
Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.
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0 to 240 min post meal at 1 year MMTT
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Adverse Events (Severe Hypoglycemia)
Prazo: 1 year
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1 year
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CGM Mean Glucose
Prazo: 1 year
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1 year
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CGM Measured Glucose Outcomes
Prazo: 1 year
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Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation.
These indices were calculated by giving equal weight to each of the 24 h of the day.
At least 24 h of CGM data were required for calculating these indices.
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1 year
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Daily Insulin Dose
Prazo: 1 year
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1 year
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BMI Percentile
Prazo: 1 year
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jay S. Skyler, M.D., M.A.C.P., University of Miami
Publicações e links úteis
Publicações Gerais
- Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group. Effectiveness of early intensive therapy on beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15.
- Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group; Buckingham BA, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Cantwell M. The effects of inpatient hybrid closed-loop therapy initiated within 1 week of type 1 diabetes diagnosis. Diabetes Technol Ther. 2013 May;15(5):401-8. doi: 10.1089/dia.2013.0002. Epub 2013 Apr 9.
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
- DirecNet 012
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 .
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