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

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00511030
First received: August 1, 2007
Last updated: January 21, 2008
Last verified: July 2007
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

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

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 1, 2007
Last Updated: January 21, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013