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Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes Phase 1, Phase 2 57 Schwangerschaft

Abgeschlossen
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Die klinische Studie NCT00850135 untersuchte Diagnostik im Zusammenhang mit Gestationsdiabetes. Diese interventionsstudie der Phase 1 Phase 2 hat den Status abgeschlossen. Die Studie begann am 1. Februar 2009 mit 57 Teilnehmern. Sie wurde durchgeführt von Stanford-Universität und am 1. September 2015 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. Mai 2016 aktualisiert.
Kurzbeschreibung
Diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels. the one-hour glucola test is currently used to screen pregnant patients for gestational diabetes. This involves ingesting a 50-gram glucose load, followed by a blood test one hour later. We wish to compare 7-day continuous glucose monit...Mehr anzeigen
Ausführliche Beschreibung
All pregnant patients without pre-existing diabetes will be eligible for the study. Interest in participation will be determined at their initial prenatal visit. Those that are interested will be consented. Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instruc...Mehr anzeigen
Offizieller Titel

Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes

Erkrankungen
Gestationsdiabetes
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • SU-02052009-1738
  • IRB #12335 (Andere Kennung) (Stanford University Medical Center IRB)
NCT-Nummer
Studienbeginn (tatsächlich)
2009-02
Zuletzt aktualisiert
2016-05-19
Studienende (vorauss.)
2015-09
Geplante Rekrutierung
57
Studientyp
Interventionsstudie
PHASE
Phase 1
Phase 2
Status
Abgeschlossen
Primäres Ziel
Diagnostisch
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
AndereContinuous Glucose Monitor in pregnancy
The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data...Mehr anzeigen
The Seven Continuous Glucose Monitoring System
Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by...Mehr anzeigen
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Correlation Between Glucose AUC and Birth Weight.
For each patient's CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values "AUC-110," "AUC-120," "AUC-130," "AUC-140," and "AUC-180," and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result.
CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000
For our secondary outcome analyses,we chose to focus on AUC-130 because 130 mg/dL is a common threshold used when treating gestational diabetics. In addition, 130 mg/dL was the threshold used in an earlier pilot study performed at our institution because it had the best correlation with birth weight percentile. Secondary outcomes were compared between these two groups using the chi-square test. Data were analyzed using Stata 11.2. AUC-130 values were divided into "high" and "low" at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
  • Pregnant patients
  • Age 18-50
  • Gestational age less than 28 weeks

  • Minors less than 18 years of age
  • Multiple gestation
  • Known fetal anomalies
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Verantwortliche Partei
Yasser Yehia El-Sayed, Hauptprüfer, Professor of Obstetrics and Gynecology, Stanford University
Keine Kontaktdaten vorhanden
2 Studienstandorte in 1 Ländern

California

Santa Clara Valley Medical Center, San Jose, California, 95128, United States
Stanford University School of Medicine, Stanford, California, 94305, United States