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Testing Ascensia Contour Glucometer for the Measurement of Blood Glucose

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502359
First Posted: July 17, 2007
Last Update Posted: July 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by:
University of Zurich
  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:


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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00502359     History of Changes
Other Study ID Numbers: keinen
First Submitted: July 16, 2007
First Posted: July 17, 2007
Last Update Posted: July 20, 2007
Last Verified: July 2007

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

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