Clinical trial NCT00850135: Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
Official title: Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes, Gestational
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2009-02-24
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Correlation Between Glucose AUC and Birth Weight.
timeFrame: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery
Secondary outcomes:
measure: Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000
timeFrame: CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Yasser Yehia El-Sayed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.