An Accuracy Trial of Abbott’s Flash Glucose Monitoring System, Now Enrolling in the US!
Clinical Trial Identifier: NCT02283411
This 14-day study is testing the safety and accuracy of the “Abbott sensor based glucose monitoring system,” which we already know by the name Abbott FreeStyle Libre in Europe (where it launched last October; see our test drive in this issue). As a reminder, Abbott's FreeStyle Libre system involves a 14-day sensor inserted on their upper arm and a separate touchscreen reader device. When the reader device is swiped close to the sensor, the sensor transmits both an instantaneous glucose reading, trend, and an eight-hour history. The FreeStyle Libre system does not require fingerstick calibration, so users can dose insulin based on its readings (except for when glucose levels are in hypoglycemia range, are rapidly changing, or when symptoms don’t match the system’s readings). The two primary outcomes of the trial will be the system's accuracy and safety, as determined by adverse and serious adverse effects experienced by study participants. We believe this is the accuracy study that could support FDA approval of this transformative technology, so it is a very big deal indeed.
The trial aims to enroll up to 164 participants with type 1 or type 2 diabetes. To participate, volunteers must be 18 years or older, be on intensive or non-intensive insulin therapy, and be willing to perform a minimum of eight fingersticks per day during the study (to compare the sensor’s accuracy to a reference). Exclusion criteria include having allergies to medical grade adhesive or isopropyl alcohol, being pregnant, having a history of hypoglycemia unawareness, being on dialysis, and anyone who has experienced a diabetes-related complication requiring assistance from another person in the last six months (i.e., severe hypoglycemia), among others. There are six sites actively recruiting participants right now in five states: CA, GA, ID, TX, WA. Boy would we be excited to be in this trial. Specifically, for more information, contact Shridhara Karinka at 510-749-6393 or [email protected]. -AJW