Performance of a New Glucose Meter System in Children and Young Adults
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|ClinicalTrials.gov Identifier: NCT00985257|
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : November 2, 2010
Last Update Posted : February 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Device: DIDGET (Investigational Blood Glucose Monitoring System)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Subjects with diabetes
Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
Device: DIDGET (Investigational Blood Glucose Monitoring System)
Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.
- Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method [ Time Frame: 1-2 hours ]Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG values >/=75mg/dL) of the reference method results.
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): NCT00985257
|United States, California|
|Escondido, California, United States, 92026|
|United States, Florida|
|Larry C. Deeb, MD PA|
|Tallahassee, Florida, United States, 32308|
|Principal Investigator:||Timothy Bailey, MD||AMCR Institute|
|Principal Investigator:||Larry C Deeb, MD PA||Larry C. Deeb, MD PA|