User Performance and System Accuracy Evaluations Using Glucose Adjustment
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|ClinicalTrials.gov Identifier: NCT02374879|
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : August 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: Blood Glucose Monitoring Systems.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||User Performance and System Accuracy Evaluations Using Glucose Adjustment|
|Actual Study Start Date :||February 1, 2015|
|Actual Primary Completion Date :||February 1, 2015|
|Actual Study Completion Date :||February 1, 2015|
Experimental: Blood Glucose monitoring System (BGMS)
Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)
Device: Blood Glucose Monitoring Systems.
In vitro diagnostic medical device.
- User Performance (UP) evaluation. [ Time Frame: Up to 6 hours ]UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP
- System Accuracy (SA) evaluation [ Time Frame: Up to 6 hours ]UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374879
|BioKinetic Europe Ltd|
|Belfast, Antrim, United Kingdom, BT2 7BA|
|Principal Investigator:||David J Bell||BioKinetic Europe Ltd|