Overview

This trial is active, not recruiting.

Condition diabetes, gestational
Treatment the seven continuous glucose monitoring system
Phase phase 1/phase 2
Sponsor Stanford University
Collaborator DexCom, Inc.
Start date February 2009
End date July 2014
Trial size 230 participants
Trial identifier NCT00850135, IRB #12335, SU-02052009-1738

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
the seven continuous glucose monitoring system 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.

Primary Outcomes

Measure
Birth weight centile
time frame: At time of delivery

Secondary Outcomes

Measure
Unplanned operative deliveries
time frame: t time of delivery

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

Official title Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
Principal investigator Yasser Yehia El-Sayed
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Stanford University.