- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02388100
The GRADE Capillary Blood Collection Pilot Study
December 19, 2016 updated by: GRADE Study Group
The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE Study) Capillary Blood Collection: A Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States
- Southwestern American Indian Center
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Colorado
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Denver, Colorado, United States
- University of Colorado
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Hawaii
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Honolulu, Hawaii, United States
- Pacific Health Research and Education Institute (VA Pacific Islands)
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Louisiana
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Baton Rouge, Louisiana, United States
- Pennington Biomedical Research Center
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Minnesota
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Minneapolis, Minnesota, United States
- International Diabetes Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All GRADE study participants scheduled for a follow-up visit at selected GRADE clinical sites.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c obtained from venous versus capillary measurements at one point in time for each participant.
Time Frame: Cross sectional
|
Cross sectional
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: David Nathan, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
March 6, 2015
First Submitted That Met QC Criteria
March 9, 2015
First Posted (Estimate)
March 13, 2015
Study Record Updates
Last Update Posted (Estimate)
December 20, 2016
Last Update Submitted That Met QC Criteria
December 19, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- GRADE_CAP
- 1U01DK098246-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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