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
2 other identifiers
observational
70
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2015
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 6, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedNovember 15, 2024
November 1, 2024
1.4 years
March 6, 2015
November 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c obtained from venous versus capillary measurements at one point in time for each participant.
Cross sectional
Interventions
Eligibility Criteria
All GRADE study participants scheduled for a follow-up visit at selected GRADE clinical sites.
You may qualify if:
- Current GRADE participant with a scheduled follow-up visit
You may not qualify if:
- GRADE participants attending first quarterly (Month 3) visit or an annual visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Southwestern American Indian Center
Phoenix, Arizona, United States
University of Colorado
Denver, Colorado, United States
Pacific Health Research and Education Institute (VA Pacific Islands)
Honolulu, Hawaii, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Related Publications (1)
Nathan DM, Krause-Steinrauf H, Braffett BH, Arends VL, Younes N, McGee P, Lund C, Johnson M, Lorenzi G, Gao X, Steffes MW, Lachin JM; GRADE Research Group; DCCT/EDIC Research Group. Comparison of central laboratory HbA1c measurements obtained from a capillary collection versus a standard venous whole blood collection in the GRADE and EDIC studies. PLoS One. 2021 Nov 15;16(11):e0257154. doi: 10.1371/journal.pone.0257154. eCollection 2021.
PMID: 34780485BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Nathan, MD
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2015
First Posted
March 13, 2015
Study Start
March 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
November 15, 2024
Record last verified: 2024-11