FreeStyle Libre Flash Glucose Monitoring System Accuracy Study
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|ClinicalTrials.gov Identifier: NCT03141892|
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus||Device: FreeStyle Libre Flash Glucose Monitoring System|
Up to 60 subjects will be enrolled at up to six clinical research sites in the United States. Subjects will wear two Sensors of Three unique sensor lots. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen).
Subjects will be asked to perform at least 8 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will follow the same BG testing schedule during in-clinic visits. Subjects will be instructed to report any problems with the device.
Subjects will make seven (7) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have four (4) in-clinic visits during which intravenous blood draws and YSI reference testing will occur. Each in-clinic visit is anticipated to last approximately 10 hours.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||FreeStyle Libre Flash Glucose Monitoring System Accuracy Study|
|Actual Study Start Date :||April 13, 2017|
|Actual Primary Completion Date :||May 23, 2017|
|Actual Study Completion Date :||May 30, 2017|
Diabetes Mellitus, Type 1 and Type 2
Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
Device: FreeStyle Libre Flash Glucose Monitoring System
Blood Glucose Monitoring
- System Performance [ Time Frame: Approximately 32 hours ]System performance will be characterized with respect to YSI reference venous plasma sample measurements.
- System related adverse device effects and serious adverse effects [ Time Frame: Up to 42 days ]System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
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): NCT03141892
|United States, California|
|William Sansum Diabetes Center|
|Santa Barbara, California, United States, 93105|
|Diablo Clinical Research|
|Walnut Creek, California, United States, 94598|
|United States, Idaho|
|Rocky Mountain Diabetes & Osteoporosis Center|
|Idaho Falls, Idaho, United States, 83404|
|United States, Washington|
|Rainier Clinical Research Center|
|Renton, Washington, United States, 98057|
|Study Director:||Shridhara Karinka, PhD||Abbott Diabetes Care|