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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186004
First Posted: September 16, 2005
Last Update Posted: June 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Santa Clara Valley Health & Hospital System
Information provided by:
Stanford University
  Purpose
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.

Condition Intervention
Insulin Resistance Device: Continuous Glucose Monitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Birthweight centile [ Time Frame: Delivery ]

Enrollment: 21
Study Start Date: December 2002
Study Completion Date: May 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients 18 years or older, less than 28 weeks gestation without pregestational diabetes.
Criteria

Inclusion Criteria:

- Pregnant patients under 28 weeks gestation

Exclusion Criteria:

- Pre-gestational diabetes

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186004


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Santa Clara Valley Health & Hospital System
Investigators
Principal Investigator: Yasser Yehia El-Sayed Stanford University
  More Information

Additional Information:
Responsible Party: Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186004     History of Changes
Other Study ID Numbers: 78694
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: June 15, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases