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Assessment of Stability of Mail-in Capillary Hemoglobin A1c Test Kit

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511030
First Posted: August 3, 2007
Last Update Posted: January 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Mercy Hospital Kansas City
  Purpose
The purpose of this study is to determine the stability of capillary HBA1c blood samples collected by the participant with this kit and mailed to the laboratory at Children's Mercy Hospital.

Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Stability and Ease of Use of a Mail-in Capillary Blood Hemoglobin A!c Sample Kit

Further study details as provided by Children's Mercy Hospital Kansas City:

Biospecimen Retention:   None Retained
Capillary blood

Enrollment: 23
Study Start Date: July 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:
Participants are given home lab kit for obtaining HbA1c by capillary blood and shipping it to Children's Mercy Hospital and Clinics. They will mail in sample before their next visit and this result will be compared to the HbA1c performed during this visit.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and females, age 1-17, receiving care in the Endocrine clinic at Children's Mercy Hospital who require HbA1c for standard of care.
Criteria

Inclusion Criteria:

  • Male or female diabetic patients ages 1-17 years who have an A1c test drawn within 24 hours
  • Participants receiving medical care in the Endocrine Clinic at Children's Mercy Hospital

Exclusion Criteria:

  • Not meeting above inclusion criteria
  Contacts and Locations
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): NCT00511030


Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Uttam Garg, PhD Children's Mercy Hospital
  More Information

Responsible Party: Uttam Garg, PhD, Children's Mercy Hospital and Clinics
ClinicalTrials.gov Identifier: NCT00511030     History of Changes
Other Study ID Numbers: 07 06-084E
First Submitted: August 1, 2007
First Posted: August 3, 2007
Last Update Posted: January 23, 2008
Last Verified: July 2007

Keywords provided by Children's Mercy Hospital Kansas City:
Diabetes