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NCT00186004 Clinical Trial

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

Insulin Resistance Clinical Trial

Official title:
Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00186004
Other study ID # 78694
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated June 13, 2011
Start date December 2002
Est. completion date May 2008

Study information
Verified date June 2011
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date May 2008
Est. primary completion date September 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pregnant patients under 28 weeks gestation

Exclusion Criteria:

- Pre-gestational diabetes

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (2)
Lead Sponsor Collaborator
Stanford University Santa Clara Valley Health & Hospital System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Birthweight centile Delivery No
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