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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier:
NCT00850135
First received: February 20, 2009
Last updated: November 17, 2014
Last verified: November 2014

February 20, 2009
November 17, 2014
February 2009
July 2014   (final data collection date for primary outcome measure)
Birth weight centile [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
Birth weight centile
Complete list of historical versions of study NCT00850135 on ClinicalTrials.gov Archive Site
Unplanned operative deliveries [ Time Frame: t time of delivery ] [ Designated as safety issue: No ]
Unplanned operative deliveries
Not Provided
Not Provided
 
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 determine 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 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. 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 pregnancy. The patient will be treated routinely, based on the results of the routine glucola test.

Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes, Gestational
Device: 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.
Other Name: The Seven Continuous Glucose Monitoring System
Continuous Glucose Monitor for diabetes in pregnancy screening
Intervention: Device: The Seven Continuous Glucose Monitoring System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
230
July 2015
July 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00850135
SU-02052009-1738, IRB #12335
No
Yasser Yehia El-Sayed, Stanford University
Stanford University
DexCom, Inc.
Principal Investigator: Yasser Yehia El-Sayed Stanford University
Stanford University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP