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Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
This study is currently recruiting participants.
Study NCT00850135   Information provided by Stanford University
First Received: February 20, 2009   No Changes Posted
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February 20, 2009
February 20, 2009
February 2009
Birth weight centile
Same as current
No Changes Posted
Unplanned operative deliveries
Same as current
 
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes

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 detremine which one correlates better with adverse pregnancy outcomes as well as which one more accurately identifies patients at risk for adverse pregnancy outcomes.

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 aptient 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. She will perform the routine glucola test sometime between days 2 to 7 . Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS. Results of CGMS will not be available to the patient or her physician until after completion of the paregnancy. The patient will be treated routinely, based on the results of the routine glucola test.

Phase I, Phase II
Interventional
Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Diabetes, Gestational
Device: The Seven Continuous Glucose Monitoring System
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
230
 
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:-Pregnant patients with no diagnosis of pre-existing diabetes

  • Age 18-50
  • Gestational age less than 28 weeks

Exclusion Criteria:-Minors less than 18 years of age

  • Multiple gestation
  • Known fetal anomalies
  • Pre-existing diabetes
  • Prior cesarean section
  • Planned cesarean section for delivery in current pregnancy
Female
18 Years to 50 Years
No
Contact: Sung Joyce, M.D. (650) 804-5956 joycefu@stanford.edu
United States
 
 
NCT00850135
Sung Joyce, M.D.
IRB #12335
Stanford University
DexCom, Inc.
Principal Investigator: Yasser Yehia El-Sayed Stanford University
Stanford University
February 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.