Assessment of Stability of Mail-in Capillary Hemoglobin A1c Test Kit
This study has been completed.
Sponsor:
Children's Mercy Hospital Kansas City
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 1, 2007 | ||||
| Last Updated Date | January 21, 2008 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00511030 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of Stability of Mail-in Capillary Hemoglobin A1c Test Kit | ||||
| Official Title ICMJE | Assessment of Stability and Ease of Use of a Mail-in Capillary Blood Hemoglobin A!c Sample Kit | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: None Retained Description: Capillary blood |
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| 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. |
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| Condition ICMJE | Diabetes | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 23 | ||||
| Completion Date | January 2008 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Year to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00511030 | ||||
| Other Study ID Numbers ICMJE | 07 06-084E | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Uttam Garg, PhD, Children's Mercy Hospital and Clinics | ||||
| Study Sponsor ICMJE | Children's Mercy Hospital Kansas City | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Mercy Hospital Kansas City | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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