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Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes Fase I, Fase II 57 Gravidanza

Completato
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La sperimentazione clinica NCT00850135 è stata uno studio interventistico di Fase I Fase II condotto per esaminare la diagnostica per Diabete gestazionale, attualmente completato. Avviato il 1 febbraio 2009, ha previsto l'arruolamento di 57 partecipanti. Sotto la guida di l'Università di Stanford, si è concluso il 1 settembre 2015. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 19 maggio 2016.
Sommario breve
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...Mostra di più
Descrizione dettagliata
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...Mostra di più
Titolo ufficiale

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

Patologie
Diabete gestazionale
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • SU-02052009-1738
  • IRB #12335 (Altro identificativo) (Stanford University Medical Center IRB)
Numero NCT
Data di inizio (effettiva)
2009-02
Ultimo aggiornamento pubblicato
2016-05-19
Data di completamento (stimata)
2015-09
Arruolamento (previsto)
57
Tipo di studio
Interventistico
FASE
Fase I
Fase II
Stato
Completato
Scopo principale
Diagnostico
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
AltroContinuous 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...Mostra di più
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...Mostra di più
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Adulto
Età minima
18 Years
Sessi idonei
Femmina
  • 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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Parte responsabile dello studio
Yasser Yehia El-Sayed, Investigatore principale, Professor of Obstetrics and Gynecology, Stanford University
Nessun dato di contatto
2 Centri dello studio in 1 paesi

California

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