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O estudo clínico NCT02530450 para Diabetes mellitus tipo 1 está concluído. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Continuous Glucose Monitor in Children With Poorly Controlled Diabetes 30
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O estudo clínico NCT02530450 foi um estudo observacional para Diabetes mellitus tipo 1. Seu status atual é: concluído. O estudo começou em 1 de maio de 2011 e incluiu 30 participantes. Coordenado por The University of Texas Health Science Center at San Antonio e foi concluído em 1 de março de 2013. Essas informações foram atualizadas no ClinicalTrials.gov em 6 de outubro de 2017.
Resumo
The purpose of this study is to determine if the use of continuous glucose monitoring in a practical outpatient clinic setting in children with poorly controlled diabetes will lead to improved blood sugar control.
Descrição detalhada
The trial was designed as a six month, randomized, prospective, interventional pilot study of children with uncontrolled (HgbA1c > 8.5%) diabetes who were between the ages of 7-17 years of age. The purpose of the study was to determine the effect in glycemic control as measured by HgbA1c with use of iPro™ CGM at regularly scheduled clinic appointments. Recruitment for this study was limited to patients at the Univer...Mostrar mais
Título oficial
iPro Continuous Glucose Monitor in Children With Poorly Controlled Diabetes: A 6-Month, Randomized, Interventional Pilot Study
Condições médicas
Diabetes mellitus tipo 1Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- HSC20110049H
Número NCT
Data de início (real)
2011-05
Última atualização postada
2017-10-06
Data de conclusão (estimada)
2013-03
Inscrição (estimada)
30
Tipo de estudo
Observacional
Status
Concluído
Palavras-chave
children
poor adherence
continuous glucose monitoring
poor adherence
continuous glucose monitoring
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Group 1 Initially blinded to continuous glucose monitoring (CGM) data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use | continuous glucose monitoring (CGM) All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points. |
Group 2 Never blinded to continuous glucose monitoring (CGM) data | continuous glucose monitoring (CGM) All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
The Primary Outcome Measure Was Change in HgbA1c | 0 months, 3 months and 6 months |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia | 3 months and 6 months |
Critérios de elegibilidade
Idades elegíveis
Criança
Idade mínima
7 Years
Sexos elegíveis
Todos
- Clinical diagnosis of diabetes for at least 6 months, type 1 or type 2 diabetes.
- Treated at UT Health Science Center pediatric diabetes clinic for at least the previous 3 months.
- HgbA1c >8.5% (equivalent to average BG of >205 mg/dL for past three months).
- Supportive family with willingness to self monitoring blood glucose values at least 4 times per day during study.
- Supportive family with willingness to participate in continuous glucose monitoring (CGM) for at least 48 hours including self monitoring blood glucose values at least 4 times per day, documenting meals, carbohydrates eaten, insulin dose given, exercise, and hypoglycemic symptoms.
- Attend proposed clinic, nutritional, and CGM follow up visits.
- Pump or multiple daily injection (MDI) insulin therapy (3-4 injections minimum daily). If on pump, on pump for at least the past 3 months. Current insulin regimen involves basal/ bolus therapy with no plans to switch the modality of insulin administration during the study (e.g., injection user switching to a pump, pump user switching to injections).
- Hypoglycemic unawareness.
- English or Spanish primary language.
- Medications known to affect glycemic control (oral steroids, growth hormone, psychotropics).
- Documented concomitant chronic disease known to affect glycemic control.
- 3 or more incidents in the last 12 months of severe hypoglycemia with documented blood glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalization or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
- 3 or more incidents in the last 12 months of diabetic ketoacidosis (DKA).
- Reported alcohol or drug abuse.
- Documented cutaneous allergy to latex products.
- Documented eating disorders or morbid obesity as assessed by the investigator.
- Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
- Home use of CGM in the past 6 months.
The University of Texas Health Science Center at San AntonioMedtronic DiabetesSem dados de contato.
Sem dados de locais.