Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00011622|
Recruitment Status : Completed
First Posted : February 26, 2001
Last Update Posted : June 24, 2005
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 or disease||Intervention/treatment|
|Pregnancy||Device: Continuous ambulatory subcutaneous glucose monitor|
|Study Type :||Observational|
|Observational Model:||Defined Population|
|Official Title:||Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011622
|United States, Texas|
|University of Texas Medical School|
|Houston, Texas, United States, 40202|