AST Clinical Investigation | NCT01268345

Studies
AST Clinical Investigation

NCT01268345

Sponsor

Andon Medical Co.,Ltd

Status

Completed

Last Update Posted

Dec 30, 2010Estimated

Enrollment

63Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

blood glucose monitor
blood glucose monitor

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 29, 2010

First Submission Date that Met QC Criteria

Dec 29, 2010

First Posted Date

Dec 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2010

Last Update Posted Date

Dec 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Andon	Experimental	Andon blood glucose test strips with test meter	Device: blood glucose monitor
Lifescan	Active Comparator		Device: blood glucose monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood glucose monitor	Device	Blood glucose monitor is used to monitor the blood glucose level of the human-being	Andon

Measure	Description	Time Frame
blood glucose value		5 seconds

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Hexi Ruijing metabolism hospital		Tianjin	Tianjin Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided