Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose

NCT ID: NCT00502359

Last Updated: 2007-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2005 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-12-31

Brief Summary

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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)

Detailed Description

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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

Conditions

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Gestational Diabetes

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

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capillary blood glucose measurement

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Principal Investigators

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01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

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Clinic of obstetrics, University Hospital of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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keinen

Identifier Type: -

Identifier Source: org_study_id