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Clinical Test of Blood Glucose Test Strips

This study has been completed.
Sponsor:
Information provided by:
Andon Medical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT00976924
First received: September 8, 2009
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Test of Blood Glucose Test Strips

Resource links provided by NLM:

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

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

Primary Outcome Measures:
  • blood glucose value [ Time Frame: 5 seconds ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   22 Years to 78 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976924

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

No publications provided

Responsible Party: Yi Liu, Andon Medical Co.,Ltd
ClinicalTrials.gov Identifier: NCT00976924     History of Changes
Other Study ID Numbers: AndonMedical1
Study First Received: September 8, 2009
Last Updated: September 14, 2009
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013