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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00502359
Other study ID # keinen
Secondary ID
Status Completed
Phase Phase 4
First received July 16, 2007
Last updated July 19, 2007
Start date April 2005
Est. completion date December 2006

Study information

Verified date July 2007
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

Present practice: Measurement of fasting glucose values in 2nd trimester of pregnancy, if above 4.8 mmol/l, a Glucose Tolerance Test is performed. (Two-step procedure: 1. Appointment for the fasting glucose measurement, 2. Appointment for the Glucose Tolerance Test)


Description:

Present practice: Measurement of fasting glucose values in 2nd trimester of pregnancy, if above 4.8 mmol/l, 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 4.8 mmol/l Glucose Tolerance Test on the same day


Recruitment information / eligibility

Status Completed
Enrollment 2005
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion criteria:

- Healthy pregnant women in 2nd Trimester of pregnancy scheduled for the measurement of fasting glucose value

Exclusion criteria:

- Pregnant women with pre-existent (Type 1 or 2) diabetes or already diagnosed diabetes of pregnancy

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Device:
capillary blood glucose measurement


Locations

Country Name City State
Switzerland Clinic of obstetrics, University Hospital of Zurich Zurich

Sponsors (2)

Lead Sponsor Collaborator
University of Zurich Bayer

Country where clinical trial is conducted

Switzerland, 

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