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

NCT00850135 | Completed Phase 1 Results

• 2 other identifiers: SU-02052009-1738IRB #12335
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes, Gestational

Outcome Measures

Primary Outcomes (1)

• Correlation Between Glucose AUC and Birth Weight.

  For each patient's CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values "AUC-110," "AUC-120," "AUC-130," "AUC-140," and "AUC-180," and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result.

  CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery

Secondary Outcomes (1)

• Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000

  CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery

Study Arms (1)

Continuous Glucose Monitor in pregnancy

OTHER

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.

Device: The Seven Continuous Glucose Monitoring System

Interventions

The Seven Continuous Glucose Monitoring System 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.

Continuous Glucose Monitor in pregnancy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• DexCom, Inc.: collaborator

Study Sites (2)

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 25262455 RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Limited monitoring period between 24 and 28 weeks' gestation. Sample size was under powered to detect differences in secondary outcomes of interest.

Results Point of Contact

• Title: Yasser El-Sayed, MD
• Organization: Stanford University School of Medicine

Yasser.el-sayed@stanford.edu

(650) 723-3198

Study Officials

• Yasser Yehia El-Sayed

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 24, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2015
• Last Updated: May 19, 2016
• Results First Posted: May 19, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)