- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00850135
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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-
California
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San Jose, California, Forenede Stater, 95128
- Santa Clara Valley Medical Center
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Stanford, California, Forenede Stater, 94305
- Stanford University School of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Pregnant patients
- Age 18-50
- Gestational age less than 28 weeks
Exclusion Criteria:
- Minors less than 18 years of age
- Multiple gestation
- Known fetal anomalies
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Continuous 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.
Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
|
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 the patient 2 times daily during the 7 days of wearing the CGMS.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Correlation Between Glucose AUC and Birth Weight.
Tidsramme: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery
|
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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000
Tidsramme: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Yasser Yehia El-Sayed, Stanford University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SU-02052009-1738
- IRB #12335 (Anden identifikator: Stanford University Medical Center IRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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