Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor - Full Text View

Sponsor:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00011622

Purpose

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.

Condition	Intervention
Pregnancy	Device: Continuous ambulatory subcutaneous glucose monitor

Study Type:	Observational
Study Design:	Cross-Sectional, Defined Population, Prospective Study
Official Title:	Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor

Resource links provided by NLM:

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Detailed Description:

We will coordinate the study through the CRC. The women will have to come in only twice, to have the monitor placed and then taken off three days later. A blood sample will be collected at each visit. Meals and snacks will be provided for each day of the study, specially packaged, to supply an equivalent amount of calories for each subject. These will meet the nutritional requirements for both the mother and the fetus. Women will do separate fingerstick blood sugar measurements using a capillary glucometer four times a day, to ensure the accuracy of the sensor's readings.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

1. Inclusion Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011622

Locations

United States, Texas
University of Texas Medical School
Houston, Texas, United States, 40202

Sponsors and Collaborators

National Center for Research Resources (NCRR)

More Information

No publications provided

Study ID Numbers:	NCRR-M01RR02558-0158
Study First Received:	February 22, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00011622 History of Changes
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on November 30, 2009