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Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

2. desember 2022 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Studietype

Intervensjonell

Registrering (Forventet)

816

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Texas
      • Houston, Texas, Forente stater, 77030
        • The University of Texas Health Science Center at Houston
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Sean Blackwell

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of neonates that show Composite Adverse Neonatal Outcome such as Large for gestational age(LGA)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: within 28 days of birth
within 28 days of birth

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. januar 2023

Primær fullføring (Forventet)

1. august 2025

Studiet fullført (Forventet)

1. august 2026

Datoer for studieregistrering

Først innsendt

14. juni 2022

Først innsendt som oppfylte QC-kriteriene

17. juni 2022

Først lagt ut (Faktiske)

24. juni 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. desember 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. desember 2022

Sist bekreftet

1. desember 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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