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Clinical Test of Blood Glucose Test Strips

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976924
First Posted: September 15, 2009
Last Update Posted: September 16, 2009
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.
Information provided by:
Andon Medical Co.,Ltd
  Purpose
Blood glucose test strips are tested with the test meters to test the accuracy of the blood pressure monitoring function.

Condition Intervention
Diabetes Device: blood glucose monitor

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Test of Blood Glucose Test Strips

Resource links provided by NLM:


Further study details as provided by Andon Medical Co.,Ltd:

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

Enrollment: 200
Study Start Date: July 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  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): NCT00976924


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

Responsible Party: Yi Liu, Andon Medical Co.,Ltd
ClinicalTrials.gov Identifier: NCT00976924     History of Changes
Other Study ID Numbers: AndonMedical1
First Submitted: September 8, 2009
First Posted: September 15, 2009
Last Update Posted: September 16, 2009
Last Verified: September 2009

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