The GRADE Capillary Blood Collection Pilot Study

GRADE Study Group

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Procedure: Capillary HbA1c collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02388100

GRADE_CAP

1U01DK098246-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This pilot study is planned to validate the comparability of HbA1c results obtained from whole blood collection via venous phlebotomy versus a capillary collection of whole blood. The participant will self-collect capillary blood into HbA1c prep vials containing a buffer; these prep vials will be sent to the CBL at ambient temperature via US Postal System (USPS) mail. The feasibility of self-collection of these capillary samples by GRADE participants will also be evaluated.

Enrollment: 70 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current GRADE participant with a scheduled follow-up visit

Exclusion criteria

• GRADE participants attending first quarterly (Month 3) visit or an annual visit