Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes

This study has been completed.
Sponsor:
Collaborator:
Santa Clara Valley Health & Hospital System
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186004
First received: September 13, 2005
Last updated: June 13, 2011
Last verified: June 2011

September 13, 2005
June 13, 2011
December 2002
September 2006   (final data collection date for primary outcome measure)
Birthweight centile [ Time Frame: Delivery ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00186004 on ClinicalTrials.gov Archive Site
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Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes
Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes

We wish to find out if in non-diabetic pregnancies, as well as diabetic pregnancies, additional data obtained by Continuous Glucose Monitoring improves perinatal risk prediction.

Patients are recruited for 3 day continuous glucose monitoring (CGM) plus self-blood glucose monitoring followed by routine diabetes screening at 26-28 weeks gestation to determine if maternal blood glucose excursions correlate with deviation from optimized birth weight.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Pregnant patients 18 years or older, less than 28 weeks gestation without pregestational diabetes.

Insulin Resistance
Device: Continuous Glucose Monitor
Subjects are fitted with a CGM system and perform self blood glucose measures three or more times per day for 3 days.
Other Name: Paradigm CGM and FreeStyle Navigator blood glucose monitor.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
May 2008
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

- Pregnant patients under 28 weeks gestation

Exclusion Criteria:

- Pre-gestational diabetes

Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00186004
78694
No
Yasser Yehia El-Sayed, Stanford University School of Medicine
Stanford University
Santa Clara Valley Health & Hospital System
Principal Investigator: Yasser Yehia El-Sayed Stanford University
Stanford University
June 2011

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