An observational study in Diabetes, sponsored by DexCom, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-23.
Sponsored by DexCom, Inc. · Observational
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing.
Device performance will be primarily evaluated in terms of the proportion of glucose values within a pre-specified range compared to reference values.
Safety data of the G4 System will also be collected vis-a-vis adverse event reporting characterized by the incidence and severity of Serious Adverse Device Events, and Adverse Device Events experienced by study participants.
DexCom, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects that fit the inclusion criteria will be chosen from the general population
Exclusion Criteria:
Adults that have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
Absolute Relative Difference (%) to Reference Standard
The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI. The point accuracy is measured as the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels \>80 mg/dL and ±20 mg/dL at YSI glucose levels \<80 mg/dL.
Time frame: one time measure (day 1)
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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DexCom, Inc.