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Clinical trial of Blood glucose test strips (glucose dehydrogenase method)

Clinical trial of Blood glucose test strips (glucose dehydrogenase method) - Clinical trial of Blood glucose test strips

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069964
Enrollment
Unknown
Registered
2023-03-30
Start date
2023-02-16
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

diabetes

Interventions

Gold Standard:the reference measurement procedure EKF
Index test:Blood glucose concentration

Sponsors

The Second Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adult, regardless of gender 2. Stable vital signs 3. Outpatients or ward patients, or other patients with diabetes, health examination population 4. Age: 18-80 years old 5. 10% <= hematocrit <= 70% 6. Good compliance, willing to participate in this clinical trial and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Hematocrit70% 2. The patient can't cooperate because of serious mental illness 3. Functions of people without reading ability 4. The researcher believes that it is not suitable to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
the system accuracy of the blood glucose test strips;—

Secondary

MeasureTime frame
User Performance Evaluation;Product performance evaluation;—

Countries

China

Contacts

Public ContactYibing Lu

the Second Affiliated Hospital of Nanjing Medical University

yibing.lu@163.com+86 18951762690

Outcome results

None listed

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