AST Clinical Investigation

This study has been completed.
Sponsor:
Information provided by:
Andon Medical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01268345
First received: December 29, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

December 29, 2010
December 29, 2010
October 2010
December 2010   (final data collection date for primary outcome measure)
blood glucose value [ Time Frame: 5 seconds ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
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AST Clinical Investigation
Not Provided

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes
  • 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
  • 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
  • Experimental: Andon
    Andon blood glucose test strips with test meter
    Intervention: Device: blood glucose monitor
  • Active Comparator: Lifescan
    Intervention: Device: blood glucose monitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
21 Years to 78 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01268345
AndonMedical2
No
Yi Liu, Andon Medical Co.,Ltd
Andon Medical Co.,Ltd
Not Provided
Not Provided
Andon Medical Co.,Ltd
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP