Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes

NCT ID: NCT00850135

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2015-09-30

Brief Summary

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 determine which one correlates better with adverse pregnancy outcomes as well as which one more accurately identifies patients at risk for adverse pregnancy outcomes.

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 patient 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 pregnancy. The patient will be treated routinely, based on the results of the routine glucola test.

Conditions

Diabetes, Gestational

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Continuous Glucose Monitor in pregnancy

The Seven Continuous Glucose Monitoring System: 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 patient 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. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.

Group Type: OTHER

The Seven Continuous Glucose Monitoring System

Intervention Type: DEVICE

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 patient 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. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.

Interventions

The Seven Continuous Glucose Monitoring System

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 patient 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. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Pregnant patients
• Age 18-50
• Gestational age less than 28 weeks

Exclusion Criteria

• Minors less than 18 years of age
• Multiple gestation
• Known fetal anomalies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Yasser Yehia El-Sayed

Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasser Yehia El-Sayed

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Santa Clara Valley Medical Center

San Jose, California, United States

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Sung JF, Kogut EA, Lee HC, Mannan JL, Navabi K, Taslimi MM, El-Sayed YY. Correlation of continuous glucose monitoring profiles with pregnancy outcomes in nondiabetic women. Am J Perinatol. 2015 Apr;32(5):461-8. doi: 10.1055/s-0034-1390344. Epub 2014 Sep 28.

Reference Type: RESULT

PMID: 25262455 (View on PubMed)

Other Identifiers

IRB #12335

Identifier Type: OTHER

Identifier Source: secondary_id

SU-02052009-1738

Identifier Type: -

Identifier Source: org_study_id