The GRADE Capillary Blood Collection Pilot Study

The Glycemia Reduction Approaches in Diabetes: a Comparative Effectiveness Study (GRADE Study) Capillary Blood Collection: a Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02388100

Enrollment

Registered

2015-03-13

Start date

2015-03-31

Completion date

2016-08-31

Last updated

2024-11-15

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

Conditions

Type 2 Diabetes

Brief summary

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.

Interventions

PROCEDURECapillary HbA1c collection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
HbA1c obtained from venous versus capillary measurements at one point in time for each participant.	Cross sectional

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026