NCT00876590

Brief Summary

According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of fingertips as samples to evaluate the accuracy of portable BGM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
319

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
Last Updated

April 8, 2009

Status Verified

April 1, 2009

Enrollment Period

6 months

First QC Date

April 6, 2009

Last Update Submit

April 7, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • glucose

    10 min

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The glucose concentrations of volunteer shall be distributed as specified in ISO15197 Table 3

You may qualify if:

  • volunteers with diabetes and non-diabets

You may not qualify if:

  • hypertension,fever,AIDS,hemophilia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

  • Feng-Huei Lin, PhD

    Biomedical Engineering Department of National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

April 1, 2006

Primary Completion

October 1, 2006

Study Completion

December 1, 2006

Last Updated

April 8, 2009

Record last verified: 2009-04

Locations

TW(1)