Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

2 décembre 2022 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Interventionnel

Inscription (Anticipé)

816

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Texas
      • Houston, Texas, États-Unis, 77030
        • The University of Texas Health Science Center at Houston
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Sean Blackwell

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Expérimental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of neonates that show Composite Adverse Neonatal Outcome such as Large for gestational age(LGA)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: within 28 days of birth
within 28 days of birth

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Feasibility as assessed by the number of participants who complete the CGM diagnostic testing
Délai: 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
Délai: 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
Délai: From enrollment to delivery
From enrollment to delivery
Number of women that have preterm birth
Délai: 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
Délai: at time of birth
at time of birth
Number of women that experience pregnancy induced hypertension
Délai: 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
Délai: 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
Délai: 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
Délai: at time of birth
at time of birth
Number of women with Postpartum hemorrhage: defined as greater then 1000ml or need for blood transfusion
Délai: From enrollment to discharge( upto 6 months from birth)
From enrollment to discharge( upto 6 months from birth)
Number of women with endometritis
Délai: From enrollment to discharge( upto 6 months from birth)
From enrollment to discharge( upto 6 months from birth)
Number of women with wound complications
Délai: 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
Délai: birth to 6 weeks postpartum
birth to 6 weeks postpartum
Number of neonates with Apgar score less than 7
Délai: 5 minutes after birth
5 minutes after birth
Number of neonates that are admitted to the Neonatal intensive care unit (NICU)
Délai: birth to discharge from NICU(upto 6 months after delivery)
birth to discharge from NICU(upto 6 months after delivery)
NICU length of stay
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: upto 6 weeks postpartum
upto 6 weeks postpartum
Number of participants who formula fed their babies
Délai: upto 6 weeks postpartum
upto 6 weeks postpartum

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 janvier 2023

Achèvement primaire (Anticipé)

1 août 2025

Achèvement de l'étude (Anticipé)

1 août 2026

Dates d'inscription aux études

Première soumission

14 juin 2022

Première soumission répondant aux critères de contrôle qualité

17 juin 2022

Première publication (Réel)

24 juin 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

6 décembre 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 décembre 2022

Dernière vérification

1 décembre 2022

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Group 1: one-hour GCT

3
S'abonner