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Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

2 de dezembro de 2022 atualizado por: Michal Fishel Bartal, The University of Texas Health Science Center, Houston

Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy:A Comparative Effectiveness Randomized Control Trial (PRECISE)

The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Tipo de estudo

Intervencional

Inscrição (Antecipado)

816

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.

Contato de estudo

Estude backup de contato

Locais de estudo

    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • The University of Texas Health Science Center at Houston
        • Contato:
        • Contato:
        • Subinvestigador:
          • Sean Blackwell

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

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

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: 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)
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.
Experimental: CGM screening

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:

  • Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or
  • Average glucose≥130 mg/dL or
  • Any glucose value ≥200 mg/dL

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
LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)
at time of birth
Number of neonates that show Composite Adverse Neonatal Outcome such as shoulder dystocia
Prazo: at time of birth
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
at time of birth
Number of neonates that show Composite Adverse Neonatal Outcome such as birth injury
Prazo: at time of birth
Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury
at time of birth
Number of neonates that show Composite Adverse Neonatal Outcome such as Neonatal hypoglycemia
Prazo: from birth to discharge( upto 6 months from birth)
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
from birth to discharge( upto 6 months from birth)
Number of neonates that show Composite Adverse Neonatal Outcome such as respiratory distress
Prazo: from birth to discharge( upto 6 months from birth)
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
from birth to discharge( upto 6 months from birth)
Number of fetal or neonatal deaths
Prazo: within 28 days of birth
within 28 days of birth

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)
From enrollment to discharge( upto 6 months from birth)
Number of women that use diabetic medication during pregnancy
Prazo: From enrollment to delivery
diabetic medication is described as any glycemic control agent
From enrollment to delivery
Number of women that show Polyhydramnios during pregnancy not related to known fetal anomaly
Prazo: From enrollment to delivery
From enrollment to delivery
Number of women that have preterm birth
Prazo: at time of birth
Pre term birth id described as delivery less than 37 weeks of gestation
at time of birth
Number of women that undergo induced labor
Prazo: at time of birth
at time of birth
Number of women that experience pregnancy induced hypertension
Prazo: From enrollment to discharge( upto 6 months from birth)
From enrollment to discharge( upto 6 months from birth)
Number of women that experience Eclampsia: seizures
Prazo: From enrollment to discharge( upto 6 months from birth)
From enrollment to discharge( upto 6 months from birth)
Number of women admitted due to poor glucose control
Prazo: From enrollment to discharge( upto 6 months from birth)
From enrollment to discharge( upto 6 months from birth)
Number of women with Primary cesarean section
Prazo: at time of birth
at time of birth
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)
From enrollment to discharge( upto 6 months from birth)
Number of women with endometritis
Prazo: From enrollment to discharge( upto 6 months from birth)
From enrollment to discharge( upto 6 months from birth)
Number of women with wound complications
Prazo: From enrollment to discharge( upto 6 months from birth)
From enrollment to discharge( upto 6 months from birth)
Number of women with diagnosis of type 2 diabetes during postpartum
Prazo: birth to 6 weeks postpartum
birth to 6 weeks postpartum
Number of neonates with Apgar score less than 7
Prazo: 5 minutes after birth
5 minutes after birth
Number of neonates that are admitted to the Neonatal intensive care unit (NICU)
Prazo: birth to discharge from NICU(upto 6 months after delivery)
birth to discharge from NICU(upto 6 months after delivery)
NICU length of stay
Prazo: day of NICU discharge(upto 6 months after delivery)
day of NICU discharge(upto 6 months after delivery)
Number of neonates with hyperbilirubinemia requiring phototherapy
Prazo: birth to discharge( upto 6 months from birth)
birth to discharge( upto 6 months from birth)
Number of neonates with need for intravenous glucose therapy
Prazo: birth to discharge( upto 6 months from birth)
birth to discharge( upto 6 months from birth)
Number of neonates that are Small for gestational age
Prazo: at time of birth
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)
at time of birth
Number of participants who breastfed their babies
Prazo: upto 6 weeks postpartum
upto 6 weeks postpartum
Number of participants who formula fed their babies
Prazo: upto 6 weeks postpartum
upto 6 weeks postpartum

Colaboradores e Investigadores

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

Colaboradores

Investigadores

  • Investigador principal: Michal Fishel Bartal, MD, The University of Texas Health Science Center, Houston

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 (Antecipado)

1 de janeiro de 2023

Conclusão Primária (Antecipado)

1 de agosto de 2025

Conclusão do estudo (Antecipado)

1 de agosto de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

14 de junho de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de junho de 2022

Primeira postagem (Real)

24 de junho de 2022

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

6 de dezembro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de dezembro de 2022

Última verificação

1 de dezembro de 2022

Mais Informações

Termos relacionados a este estudo

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Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

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Ensaios clínicos em Group 1: one-hour GCT

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