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NCT02388100 Clinical Trial

The GRADE Capillary Blood Collection Pilot Study

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02388100
Other study ID # GRADE_CAP
Secondary ID 1U01DK098246-01
Status Completed
Phase N/A
First received March 6, 2015
Last updated December 19, 2016
Start date March 2015
Est. completion date August 2016

Study information
Verified date December 2016
Source GRADE Study Group
Contact n/a
Is FDA regulated No
Health authority United States: Data and Safety Monitoring Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 30 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Capillary HbA1c collection

Locations
Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana
United States University of Colorado Denver Colorado
United States Pacific Health Research and Education Institute (VA Pacific Islands) Honolulu Hawaii
United States International Diabetes Center Minneapolis Minnesota
United States Southwestern American Indian Center Phoenix Arizona

Sponsors (2)
Lead Sponsor Collaborator
GRADE Study Group National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c obtained from venous versus capillary measurements at one point in time for each participant. Cross sectional No
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