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Clinical Test of Blood Glucose Test Strips

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ClinicalTrials.gov Identifier: NCT00976924
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : September 15, 2009
Sponsor:
Information provided by:
Andon Medical Co.,Ltd

Brief Summary:
Blood glucose test strips are tested with the test meters to test the accuracy of the blood pressure monitoring function.

Condition or disease Intervention/treatment Phase
Diabetes Device: blood glucose monitor Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Test of Blood Glucose Test Strips
Study Start Date : July 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Andon
Andon blood glucose test strips with test meter
Device: blood glucose monitor
Blood glucose monitor is used to monitor the blood glucose level of the human-being.
Other Name: Andon or lifescan blood glucose monitor
Active Comparator: Lifescan
Lifescan blood glucose test strips with test meter
Device: blood glucose monitor
Blood glucose monitor is used to monitor the blood glucose level of the human-being.
Other Name: Andon or lifescan blood glucose monitor



Primary Outcome Measures :
  1. blood glucose value [ Time Frame: 5 seconds ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The patients with blood glucose within the range of ISO15197

Exclusion Criteria:

  • The patients with blood glucose out of the range of ISO15197

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): NCT00976924


Locations
China, Tianjin
Tianjin Medical University general hospital
Tianjin, Tianjin, China, 300070
Sponsors and Collaborators
Andon Medical Co.,Ltd

Responsible Party: Yi Liu, Andon Medical Co.,Ltd
ClinicalTrials.gov Identifier: NCT00976924     History of Changes
Other Study ID Numbers: AndonMedical1
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

Keywords provided by Andon Medical Co.,Ltd:
blood glucose