Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose

Gestational Diabetes Clinical Trial

Official title:

Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose Values in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502359
• Other study ID #: keinen
• 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
• 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

• Diabetes, Gestational
• Gestational Diabetes

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,