- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Michal Fishel Bartal, MD
- Numéro de téléphone: 713-500-6421
- E-mail: Michal.F.Bartal@uth.tmc.edu
Sauvegarde des contacts de l'étude
- Nom: Sarah Nazeer
- Numéro de téléphone: 713-500-6412
- E-mail: Sarah.A.Nazeer@uth.tmc.edu
Lieux d'étude
-
-
Texas
-
Houston, Texas, États-Unis, 77030
- The University of Texas Health Science Center at Houston
-
Contact:
- Sarah Nazeer
- Numéro de téléphone: 713-500-6412
- E-mail: Sarah.A.Nazeer@uth.tmc.edu
-
Contact:
- Michal F Bartal, MD
- Numéro de téléphone: 713-500-6421
- E-mail: Michal.F.Bartal@uth.tmc.edu
-
Sous-enquêteur:
- Sean Blackwell
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
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
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:
|
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
Collaborateurs
Les enquêteurs
- Chercheur principal: Michal Fishel Bartal, MD, The University of Texas Health Science Center, Houston
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HSC-MS-22-0153
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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
-
University of Illinois at ChicagoRésiliéDiabète gestationnelÉtats-Unis
-
City of Hope Medical CenterNational Cancer Institute (NCI)Actif, ne recrute pasPetit lymphome lymphocytaire récurrent | Leucémie lymphoïde chronique réfractaire | Leucémie lymphoïde chronique récurrente | Petit lymphome lymphocytaire réfractaireÉtats-Unis
-
University of PecsMedical University of PecsComplété
-
LabrhaStatitecRecrutementArthrose du genouFrance, Monaco
-
City of Hope Medical CenterNational Cancer Institute (NCI)RetiréLymphome folliculaire récurrent | Lymphome folliculaire réfractaireÉtats-Unis
-
HRH Pharmaceuticals LimitedGALZU INSTITUTE OF RESEARCH, TEACHING, SCIENCE AND APPLIED TECHNOLOGY, Brazil et autres collaborateursComplété
-
HRH Pharmaceuticals LimitedGALZU INSTITUTE OF RESEARCH, TEACHING, SCIENCE AND APPLIED TECHNOLOGY, Brazil et autres collaborateursComplété
-
Tehran University of Medical SciencesInconnueObésitéIran (République islamique d
-
Nobias Therapeutics, Inc.ComplétéSyndrome de délétion 22q11États-Unis, Canada
-
Narendranath EpperlaRetiréLymphome récurrent de la zone marginale | Lymphome folliculaire récurrent | Lymphome folliculaire réfractaire | Lymphome réfractaire de la zone marginale | Lymphome de la zone marginale nodale réfractaire | Lymphome nodal récurrent de la zone marginale | Lymphome récurrent de la zone marginale... et d'autres conditions