Accuracy Characterization Study (ACS)
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.
Subjects With Type 1 or Type 2 Diabetes Requiring Multiple Daily Insulin Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII).
Device: No treatment
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System Compared to Venous and Capillary Glucose|
- Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System compared to venous and capillary glucose [ Time Frame: 14 days ] [ Designated as safety issue: No ]To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against venous glucose reference (YSI) using the Consensus Error Grid.
|Study Start Date:||August 2013|
|Study Completion Date:||March 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01932944
|United States, California|
|Diablo Clinical Research|
|Walnut Creek, California, United States, 94598|
|United States, Washington|
|Rainier Clinical Research Center|
|Rainier, Washington, United States, 98057|
|Principal Investigator:||Mark Christiansen, M.D.||Diablo Clinical Research|
|Principal Investigator:||Leslie Klaff, M.D.||Rainier Clinical Research Center|