NCT01932944

Accuracy Characterization Study

Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System Compared to Venous and Capillary Glucose

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring System (System) interstitial glucose results against venous glucose reference and capillary fingerstick using the Consensus Error Grid over the wear duration. During the course of the wear duration, the subject is required to be testing fingerstick glucose measurement at least 8 times a day for capillary reference glucose measurements and three in-clinic visits of maximum 10 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.

Conditions

• Type2 Diabetes
• Type1diabetes
• Insulin Dependent Diabetes

Interventions

Type	Name	Description
DEVICE	No treatment

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-10-01
• Completion: 2014-03-01
• First posted: 2013-08-30
• Last updated: 2017-01-24

Locations

2 sites across 1 country: United States