Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor

This study has been completed.
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00011622
First received: February 22, 2001
Last updated: June 23, 2005
Last verified: December 2003

February 22, 2001
June 23, 2005
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Complete list of historical versions of study NCT00011622 on ClinicalTrials.gov Archive Site
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Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor

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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Cross-Sectional
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Pregnancy
Device: Continuous ambulatory subcutaneous glucose monitor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00011622
NCRR-M01RR02558-0158
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National Center for Research Resources (NCRR)
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National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP