The GRADE Capillary Blood Collection Pilot Study

November 13, 2024 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

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

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

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

GRADE Study Group

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Study Chair: David Nathan, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

March 13, 2015

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

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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