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
  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:


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
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, see Learn About Clinical Studies.

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 August 26, 2014