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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 22, 2001
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00011622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
Official Title ^ICMJE	Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
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.
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Defined Population Time Perspective: Cross-Sectional Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition ^ICMJE	Pregnancy
Intervention ^ICMJE	Device: Continuous ambulatory subcutaneous glucose monitor
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00011622
Other Study ID Numbers ^ICMJE	NCRR-M01RR02558-0158
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Center for Research Resources (NCRR)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	December 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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