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- Ensaio Clínico NCT05430204
Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy
Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy:A Comparative Effectiveness Randomized Control Trial (PRECISE)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Michal Fishel Bartal, MD
- Número de telefone: 713-500-6421
- E-mail: Michal.F.Bartal@uth.tmc.edu
Estude backup de contato
- Nome: Sarah Nazeer
- Número de telefone: 713-500-6412
- E-mail: Sarah.A.Nazeer@uth.tmc.edu
Locais de estudo
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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas Health Science Center at Houston
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Contato:
- Sarah Nazeer
- Número de telefone: 713-500-6412
- E-mail: Sarah.A.Nazeer@uth.tmc.edu
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Contato:
- Michal F Bartal, MD
- Número de telefone: 713-500-6421
- E-mail: Michal.F.Bartal@uth.tmc.edu
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Subinvestigador:
- Sean Blackwell
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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:
- 24-30 weeks gestation undergoing GDM screening
Exclusion Criteria:
- Known diagnosis of Type I and II DM
- History of bariatric surgery
- Major fetal anomalies
- Unwilling to use CGM for GDM screening
- Incarcerated subjects
- History of allergic reaction to any of CGM metals or adhesives in contact with the skin
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: one-hour Glucose tolerance test (GCT)
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Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test.
1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test.
If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care.
This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider.
Participants will return transmitter at follow up visit after completion of 7 days.Group
I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.
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Experimental: CGM screening
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CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of neonates that show Composite Adverse Neonatal Outcome such as Large for gestational age(LGA)
Prazo: at time of birth
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LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)
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at time of birth
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Number of neonates that show Composite Adverse Neonatal Outcome such as shoulder dystocia
Prazo: at time of birth
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Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered
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at time of birth
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Number of neonates that show Composite Adverse Neonatal Outcome such as birth injury
Prazo: at time of birth
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Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury
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at time of birth
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Number of neonates that show Composite Adverse Neonatal Outcome such as Neonatal hypoglycemia
Prazo: from birth to discharge( upto 6 months from birth)
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Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy
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from birth to discharge( upto 6 months from birth)
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Number of neonates that show Composite Adverse Neonatal Outcome such as respiratory distress
Prazo: from birth to discharge( upto 6 months from birth)
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Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life
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from birth to discharge( upto 6 months from birth)
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Number of fetal or neonatal deaths
Prazo: within 28 days of birth
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within 28 days of birth
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Feasibility as assessed by the number of participants who complete the CGM diagnostic testing
Prazo: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
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Number of women that use diabetic medication during pregnancy
Prazo: From enrollment to delivery
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diabetic medication is described as any glycemic control agent
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From enrollment to delivery
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Number of women that show Polyhydramnios during pregnancy not related to known fetal anomaly
Prazo: From enrollment to delivery
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From enrollment to delivery
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Number of women that have preterm birth
Prazo: at time of birth
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Pre term birth id described as delivery less than 37 weeks of gestation
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at time of birth
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Number of women that undergo induced labor
Prazo: at time of birth
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at time of birth
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Number of women that experience pregnancy induced hypertension
Prazo: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
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Number of women that experience Eclampsia: seizures
Prazo: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
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Number of women admitted due to poor glucose control
Prazo: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
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Number of women with Primary cesarean section
Prazo: at time of birth
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at time of birth
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Number of women with Postpartum hemorrhage: defined as greater then 1000ml or need for blood transfusion
Prazo: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
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Number of women with endometritis
Prazo: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
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Number of women with wound complications
Prazo: From enrollment to discharge( upto 6 months from birth)
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From enrollment to discharge( upto 6 months from birth)
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Number of women with diagnosis of type 2 diabetes during postpartum
Prazo: birth to 6 weeks postpartum
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birth to 6 weeks postpartum
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Number of neonates with Apgar score less than 7
Prazo: 5 minutes after birth
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5 minutes after birth
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Number of neonates that are admitted to the Neonatal intensive care unit (NICU)
Prazo: birth to discharge from NICU(upto 6 months after delivery)
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birth to discharge from NICU(upto 6 months after delivery)
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NICU length of stay
Prazo: day of NICU discharge(upto 6 months after delivery)
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day of NICU discharge(upto 6 months after delivery)
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Number of neonates with hyperbilirubinemia requiring phototherapy
Prazo: birth to discharge( upto 6 months from birth)
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birth to discharge( upto 6 months from birth)
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Number of neonates with need for intravenous glucose therapy
Prazo: birth to discharge( upto 6 months from birth)
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birth to discharge( upto 6 months from birth)
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Number of neonates that are Small for gestational age
Prazo: at time of birth
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Small for gestational age, defined as a weight below 10th percentile of the expected value according to gestational age (using the nomogram published by Duryea EL et al)
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at time of birth
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Number of participants who breastfed their babies
Prazo: upto 6 weeks postpartum
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upto 6 weeks postpartum
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Number of participants who formula fed their babies
Prazo: upto 6 weeks postpartum
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upto 6 weeks postpartum
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Michal Fishel Bartal, MD, The University of Texas Health Science Center, Houston
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HSC-MS-22-0153
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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