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The GRADE Capillary Blood Collection Pilot Study

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ClinicalTrials.gov Identifier: NCT02388100
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : December 20, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
GRADE Study Group

Study Description
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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.

Condition or disease Intervention/treatment
Type 2 Diabetes Procedure: Capillary HbA1c collection

Study Design
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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE Study) Capillary Blood Collection: A Pilot Study
Study Start Date : March 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. HbA1c obtained from venous versus capillary measurements at one point in time for each participant. [ Time Frame: Cross sectional ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All GRADE study participants scheduled for a follow-up visit at selected GRADE clinical sites.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388100


Locations
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United States, Arizona
Southwestern American Indian Center
Phoenix, Arizona, United States
United States, Colorado
University of Colorado
Denver, Colorado, United States
United States, Hawaii
Pacific Health Research and Education Institute (VA Pacific Islands)
Honolulu, Hawaii, United States
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States
Sponsors and Collaborators
GRADE Study Group
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Chair: David Nathan, MD Massachusetts General Hospital
More Information
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Responsible Party: GRADE Study Group
ClinicalTrials.gov Identifier: NCT02388100     History of Changes
Other Study ID Numbers: GRADE_CAP
1U01DK098246-01 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016