Exploratory research on blood analytes sampled with minimally invasive blood sampling device OneDraw

JRCT ID: jRCTs052210065

Registered date:17/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetes
• Date of first enrollment: 24/09/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Blood collection

Outcome(s)

• Primary Outcome: Correlation of seven analytes (HbA1c, LDL-chol, HDL-chol, TG, creatinine, ALT, and glucose) between whole blood obtained by novel blood collecting device and matched serum.

Secondary Outcome

1) Time required for blood collection
2) Pain scale
3) Preference for two sampling methods

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: patients with diabetes

Exclude criteria

1) Patients under anticoagulant therapy
2) Patients with known interference factors in HbA1c measurement

Related Information

• Primary Sponsor: Ikeda Kaori
• Source(s) of Monetary Support: Drawbridge Health, Inc.,Kyoto University