NCT00186004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 15, 2011

Status Verified

June 1, 2011

Enrollment Period

3.8 years

First QC Date

September 13, 2005

Last Update Submit

June 13, 2011

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Birthweight centile

    Delivery

Interventions

Continuous Glucose MonitorDEVICE

Subjects are fitted with a CGM system and perform self blood glucose measures three or more times per day for 3 days.

Also known as: Paradigm CGM and FreeStyle Navigator blood glucose monitor.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant patients 18 years or older, less than 28 weeks gestation without pregestational diabetes.

You may qualify if:

  • \- Pregnant patients under 28 weeks gestation

You may not qualify if:

  • \- Pre-gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yasser Yehia El-Sayed

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

December 1, 2002

Primary Completion

September 1, 2006

Study Completion

May 1, 2008

Last Updated

June 15, 2011

Record last verified: 2011-06

Locations

US(1)