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ClinicalTrials.gov Identifier: NCT01268345
Recruitment Status : Completed
First Posted : December 30, 2010
Last Update Posted : December 30, 2010
Sponsor:
Information provided by:
Andon Medical Co.,Ltd

Brief Summary:
Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : October 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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 blood glucose monitor
Active Comparator: Lifescan Device: blood glucose monitor
Blood glucose monitor is used to monitor the blood glucose level of the human-being.
Other Name: Lifescan blood glucose monitor



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


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Ages Eligible for Study:   21 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • people ( disbetes people)with at least 8 hours of limosis

Exclusion Criteria:

  • After meal(when doing the test)
  • take Hypoglycemic Drugs(when doing the test)
  • with insulin(when doing the test)
  • after strenuous exercise(when doing the test)
  • Pregnant women
  • neonates
  • patients in a hyperglycemic-hyperosmolur state, with or without ketosis.
  • patients who are dehydrated, hypertensive, hypotensive or in shock.

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): NCT01268345


Locations
China, Tianjin
Tianjin Hexi Ruijing metabolism hospital
Tianjin, Tianjin, China
Sponsors and Collaborators
Andon Medical Co.,Ltd

Responsible Party: Yi Liu, Andon Medical Co.,Ltd
ClinicalTrials.gov Identifier: NCT01268345     History of Changes
Other Study ID Numbers: AndonMedical2
First Posted: December 30, 2010    Key Record Dates
Last Update Posted: December 30, 2010
Last Verified: December 2010

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