Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011622
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-02-22
Brief Title:
Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 babys 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
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 sensors readings
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: