Phase 2 N=57 Diagnostic

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

Diabetes, Gestational

Bottom Line

View on ClinicalTrials.gov: NCT00850135 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Correlation Between Glucose AUC and Birth Weight. — 0.2902; 0.2935; 0.2915; 0.2859 correlation coefficient — p=0.035

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: The Seven Continuous Glucose Monitoring System (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Stanford University
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Correlation Between Glucose AUC and Birth Weight.	0.2902; 0.2935; 0.2915; 0.2859; 0.2499; -0.0234	0.035 sig
SECONDARY Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000	31; 5; 7; 0; 4; 1	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00850135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.