Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes - Full Text View

Sponsors and Collaborators:	Stanford University DexCom, Inc.
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00850135

Purpose

Diabetic pregnant patients are at risk for adverse pregnancy outcomes, including larger than expected fetuses and unplanned operative deliveries, due to elevated blood glucose levels. the one-hour glucola test is currently used to screen pregnant patients for gestational diabetes. This involves ingesting a 50-gram glucose load, followed by a blood test one hour later. We wish to compare 7-day continuous glucose monitoring to the one-hour glucola test, and detremine which one correlates better with adverse pregnancy outcomes as well as which one more accurately identifies patients at risk for adverse pregnancy outcomes.

Condition	Intervention	Phase
Diabetes, Gestational	Device: The Seven Continuous Glucose Monitoring System	Phase I Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Birth weight centile

Secondary Outcome Measures:

Unplanned operative deliveries

Estimated Enrollment:	230
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Detailed Description:

All pregnant patients without pre-existing diabetes will be eligible for the study. Interest in participation will be determined at their initial prenatal visit. Those that are interested will be consented. Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The aptient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. She will perform the routine glucola test sometime between days 2 to 7 . Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS. Results of CGMS will not be available to the patient or her physician until after completion of the paregnancy. The patient will be treated routinely, based on the results of the routine glucola test.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:-Pregnant patients with no diagnosis of pre-existing diabetes

Age 18-50
Gestational age less than 28 weeks

Exclusion Criteria:-Minors less than 18 years of age

Multiple gestation
Known fetal anomalies
Pre-existing diabetes
Prior cesarean section
Planned cesarean section for delivery in current pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850135

Contacts

Contact: Sung Joyce, M.D.

(650) 804-5956

joycefu@stanford.edu

Locations

United States, California
Santa Clara Valley Medical Center	Recruiting
San Jose, California, United States
Contact: Jana Mannan 408-885-5550 Jana.Mannan@hhs.sccgov.org
Principal Investigator: Jana Mannan
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Sung Joyce, M.D. 650-804-5956 joycefu@stanford.edu
Contact: Betsy Kogut, R.N. (650) 724-6372 ekogut@lpch.org
Principal Investigator: Yasser Yehia El-Sayed
Sub-Investigator: Joyce Fu Sung
Sub-Investigator: Masoud Mark Taslimi

Sponsors and Collaborators

Stanford University

DexCom, Inc.

Investigators

Principal Investigator:

Yasser Yehia El-Sayed

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University School of Medicine ( Yasser Yehia El-Sayed, Principal Investigator )
Study ID Numbers:	SU-02052009-1738, IRB #12335
Study First Received:	February 20, 2009
Last Updated:	August 28, 2009
ClinicalTrials.gov Identifier:	NCT00850135 History of Changes
Health Authority:	USA:IRB

Study placed in the following topic categories:

Metabolic Diseases
Pregnancy Complications
Diabetes Mellitus
Endocrine System Diseases

Diabetes, Gestational
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Pregnancy Complications
Diabetes Mellitus

Endocrine System Diseases
Diabetes, Gestational
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009