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Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor

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ClinicalTrials.gov Identifier: NCT00011622
Recruitment Status : Completed
First Posted : February 26, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)

Tracking Information
First Submitted Date February 22, 2001
First Posted Date February 26, 2001
Last Update Posted Date June 24, 2005
Study Start Date Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
Official Title 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 Observational
Study Design Observational Model: Defined Population
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Pregnancy
Intervention Device: Continuous ambulatory subcutaneous glucose monitor
Study Groups/Cohorts 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 Completed
Enrollment Not Provided
Original Enrollment Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00011622
Other Study ID Numbers NCRR-M01RR02558-0158
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Center for Research Resources (NCRR)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Center for Research Resources (NCRR)
Verification Date December 2003