In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System
NCT ID: NCT00803777
Last Updated: 2016-02-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
147 participants
INTERVENTIONAL
2008-12-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intended Users of the Monitoring System
Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
Investigational Blood Glucose Monitoring System
Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.
Interventions
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Investigational Blood Glucose Monitoring System
Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.
Eligibility Criteria
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Inclusion Criteria
* Age 4 to 24 years
* Routinely performs blood glucose testing at home, at least 2 times per day, for one month or more before enrollment
* Has used a handheld game system to play video games within a year of enrollment
* If above age 18, subject is able to speak, read, and understand English. If below age 18, subject's parent/guardian is able to speak, read, and understand English, and is able to provide appropriate supervision.
* Is willing to complete all study procedures, with appropriate parent/guardian supervision
Exclusion Criteria
* Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
* Infection with a blood borne pathogen (e.g., HIV, hepatitis)
* Subject or parent/guardian is employee of competitive medical device company
* Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
4 Years
24 Years
ALL
No
Sponsors
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Ascensia Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Javier Aisenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Georgeanna Klingensmith, MD
Role: PRINCIPAL_INVESTIGATOR
Barbara Davis Center
Francine Kaufman, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
Timothy Bailey, MD
Role: PRINCIPAL_INVESTIGATOR
AMCR Institute
Locations
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AMCR Institute
Escondido, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Countries
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References
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Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000 Aug;23(8):1143-8. doi: 10.2337/diacare.23.8.1143.
Other Identifiers
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CTD-2008-23
Identifier Type: -
Identifier Source: org_study_id
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