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Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00502359
First received: July 16, 2007
Last updated: July 19, 2007
Last verified: July 2007
History of Changes
  Purpose

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)


Condition Intervention Phase
Gestational Diabetes
 Device: capillary blood glucose measurement
 Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose Values in Pregnancy

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Zurich:

Enrollment: 2005
Study Start Date: April 2005
Study Completion Date: December 2006
Detailed 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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502359

Locations
Switzerland
Clinic of obstetrics, University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Bayer
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00502359     History of Changes
Other Study ID Numbers: keinen
Study First Received: July 16, 2007
Last Updated: July 19, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Gestational diabetes, screening, glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013