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

Tracking Information
First Received Date ^ICMJE	December 29, 2010
Last Updated Date	December 29, 2010
Start Date ^ICMJE	October 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 29, 2010)	blood glucose value [ Time Frame: 5 seconds ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	AST Clinical Investigation
Official Title ^ICMJE	Not Provided
Brief Summary	Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Diabetes
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Andon Andon blood glucose test strips with test meter Intervention: Device: blood glucose monitor Active Comparator: Lifescan Intervention: Device: blood glucose monitor
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	63
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	21 Years to 78 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01268345
Other Study ID Numbers ^ICMJE	AndonMedical2
Has Data Monitoring Committee	No
Responsible Party	Yi Liu, Andon Medical Co.,Ltd
Study Sponsor ^ICMJE	Andon Medical Co.,Ltd
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Andon Medical Co.,Ltd
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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