NCT00985257

Performance of a New Glucose Meter System in Children and Young Adults

Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 4 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-09-28
• Last updated: 2016-02-29
• Results posted: 2010-11-02

Locations

2 sites across 1 country: United States