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

NCT ID: NCT00186004

Last Updated: 2011-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-12-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Insulin Resistance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Paradigm CGM and FreeStyle Navigator blood glucose monitor.

Eligibility Criteria

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Inclusion Criteria

\- Pregnant patients under 28 weeks gestation

Exclusion Criteria

\- Pre-gestational diabetes
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Santa Clara Valley Health & Hospital System

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Stanford University School of Medicine

Principal Investigators

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Yasser Yehia El-Sayed

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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78694

Identifier Type: -

Identifier Source: org_study_id

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