Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502359
Status:
COMPLETED
Last Update Posted:
2007-07-20
First Post:
2007-07-16
Brief Title:
Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose Values in Pregnancy
Status:
COMPLETED
Status Verified Date:
2007-07
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:
Present practice Measurement of fasting glucose values in 2nd trimester of pregnancy if above 48 mmoll a Glucose Tolerance Test is performed Two-step procedure 1 Appointment for the fasting glucose measurement 2 Appointment for the Glucose Tolerance Test
Detailed Description:
Present practice Measurement of fasting glucose values in 2nd trimester of pregnancy if above 48 mmoll a Glucose Tolerance Test is performed Two-step procedure 1 Appointment for the fasting glucose measurement 2 Appointment for the Glucose Tolerance Test Study Testing of reliability and applicability of the Ascensia Contour Glucometer Bayer Comparison of 100 fasting glucose values measured in venous plasma by the hexokinase method in the Laboratory with 100 fasting glucose values measured in capillary whole blood on the Ascensia Contour Glucometer Outcome If Ascensia Contour Glucometer shows applicable accuracy narrow scatter of values the two-step procedure should be replaced by one-step procedure 1 only one appointment for the measurement of the fasting glucose value in capillary whole blood on Ascensia Contour Glucometer and if above 48 mmoll Glucose Tolerance Test on the same day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None