Skip to content

Clinical trial of Premier Hb9210 HbA1c Analytical Column

Clinical trial of Premier Hb9210 HbA1c Analytical Column

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015292
Enrollment
Unknown
Registered
2018-03-21
Start date
2018-04-09
Completion date
Unknown
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes

Interventions

Gold Standard:parallel controled trial with listed product
Index test:Premier&#32
Hb9210&#32
HbA1c&#32
Column&#32
is&#32
column,&#32
ingredients&#32
hydrophilic&#32
polymer,&#32
column&#32
and&#32
sealing&#32
plug,&#32

Sponsors

Shanghai 6th People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. medical/physical examination post-test remaining, traceable of the venous blood samples (EDTA anticoagulant).The sample storage condition and shelf life should conform to the requirements of the product specifications; (2) to obtain informed consent, donors should be able to meet and comply with relevant ethical requirements; (3) after the acquisition, should be able to timely detection or save, save condition and save time conform to the requirements of the assessment of products and control product manuals; (4) sample volume can meet the demand of solution; (5) other can be included in the test of other samples.

Exclusion criteria

Exclusion criteria: (1) samples of anticoagulant deficiency or contaminated, broken, (2) samples were exposed to high temperature environment; (3) samples failed to timely treatment or saved; (4) sample source cases have income.

Design outcomes

Primary

MeasureTime frame
content of HbA1c;

Countries

China

Contacts

Public ContactWang Yufei

Shanghai Diabetes Institute, Shanghai 6th People's Hospital

wang1fei@126.com13386259806

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026