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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
History of Changes
  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:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Birthweight centile [ Time Frame: Delivery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Journal of Diabetes Science and Technology. 2008 May;2(3):456-460  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186004     History of Changes
Other Study ID Numbers: 78694
Study First Received: September 13, 2005
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013