Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor

NCT00011622 | Completed

• 1 other identifier: NCRR-M01RR02558-0158
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal is a pilot study to describe the variations of blood sugar in pregnant women with various degrees of glucose intolerance, and how they relate to standardized meals. Blood sugar control during pregnancy is important to prevent complications for the newborn. The variation and timing of the blood sugar measurements in gestational diabetics and how this relates to the baby's outcome is controversial. We will use an FDA approved device called Minimed Glucose Continuous Monitor, which is used in clinical practice for certain diabetics. It is very small, similar to a beeper, and is connected to the patient through a small plastic catheter subcutaneously. This measures blood sugar every five minutes for a total of 288 readings a day with minimum discomfort. The hypothesis of this study is that use of the Minimed glucose monitor will provide information about variations of blood sugar in gestational diabetics that is missed by capillary glucose monitors. Our conclusions will allow us to compare blood glucose trends among the groups. After the data is analyzed in this pilot study, we plan to design a bigger study involving more subjects to study the impact of the blood sugar variations in the outcome of the newborn, and to obtain generalizable results for the population in general.

Conditions

Pregnancy

Interventions

Continuous ambulatory subcutaneous glucose monitor DEVICE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women, between 28 and 36 weeks of gestation. Gestational age will be determined by a combination of the date of the last menstrual period and ultrasound, done during the first or second trimester of pregnancy.
• Previous glucose challenge test and if abnormal, an oral glucose tolerance test.
• Body mass index (BMI) between 25 and 30 Kg/m2.
• Gestational diabetes in a previous pregnancy, if glucose between pregnancies was normal.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead

Study Sites (1)

University of Texas Medical School

Houston, Texas, 40202, United States

Location

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 22, 2001
• First Posted: February 26, 2001
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)