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

Diabetes, Gestational Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00850135
• Other study ID #: SU-02052009-1738
• Secondary ID: IRB #12335
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 20, 2009
• Last updated: March 30, 2015
• Start date: February 2009
• Est. completion date: July 2015

Study information

• Verified date: March 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes, Gestational

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Santa Clara Valley Medical Center	San Jose	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth weight centile		At time of delivery	No
Secondary	Unplanned operative deliveries		t time of delivery	No