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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00186004
• Collaborator: Santa Clara Valley Health & Hospital System (Other)
• Enrollment: 21
• Location: 1
• Duration (Months): 65
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Insulin Resistance	Device: Continuous 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 21 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes
• Study Start Date: Dec 1, 2002
• Actual Primary Completion Date: Sep 1, 2006
• Actual Study Completion Date: May 1, 2008

Outcome Measures

Primary Outcome Measures

1. Birthweight centile [Delivery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pregnant patients under 28 weeks gestation

Exclusion Criteria:

• Pre-gestational diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00186004
• Other Study ID Numbers: 78694
• First Posted: Sep 16, 2005
• Last Update Posted: Jun 15, 2011
• Last Verified: Jun 1, 2011

• Additional relevant MeSH terms: Insulin Resistance

Study Results

No Results Posted as of Jun 15, 2011