At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults
In Brief
A clinical study evaluating DIDGET (Investigational Blood Glucose Monitoring System) for Diabetes. Completed, enrolled 123 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.
Study Details
Timeline
Interventions
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.