NCT00850135|CompletedPhase 1/2Results
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Sponsor study identifier
Secondary identifiers
OTHER · Stanford University Medical Center IRB
interventional
57
1 country
2
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
September 2015
Actual (reported)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 monitoring to the one-hour glucola test, and determine which one correlates better with adverse pregnancy outcomes as well as which one more accurately identifies patients at risk for adverse pregnancy outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
February 20, 2009
Actual (reported)February 24, 2009
Actual (reported)July 2014
Actual (reported)September 2015
Actual (reported)May 19, 2016
Actual (reported)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
Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000
CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Sung JF, Kogut EA, Lee HC, Mannan JL, Navabi K, Taslimi MM, El-Sayed YY. Correlation of continuous glucose monitoring profiles with pregnancy outcomes in nondiabetic women. Am J Perinatol. 2015 Apr;32(5):461-8. doi: 10.1055/s-0034-1390344. Epub 2014 Sep 28.
Limited monitoring period between 24 and 28 weeks' gestation. Sample size was under powered to detect differences in secondary outcomes of interest.
Yasser Yehia El-Sayed
Stanford University
57 participants (actual enrollment reported by the registry).
First Submitted
February 20, 2009
First Posted
February 24, 2009
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2014
Actual (reported)Study Completion
September 2015
Actual (reported)Last Updated
May 19, 2016
Results First Posted
May 19, 2016
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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