The Food and Drug Administration (FDA) has approved the FreeStyle® Libre 2 integrated continuous glucose monitoring system (Abbott) for adults and children ≥4 years of age with diabetes.
The FreeStyle Libre 2 includes a self-applied sensor that is worn on the back of the upper arm for up to 14 days; the sensor is inserted just under the skin and continuously measures glucose every minute. Using a handheld reader to scan the sensor, users can view real-time glucose readings and monitor glucose trends with 8 hours of logged history.
Additionally, using Bluetooth technology, the device automatically alerts users when their glucose levels are high or low without the need for scanning the sensor. These customizable real-time alarms can be turned on or off by the user.
“Using this technology can improve time in optimal glucose range and lower HbA1c because we can get a full picture of what a child’s glucose levels are doing without having to disrupt their play or sleep with painful fingersticks,” said Larry Kurt Midyett, MD, pediatric endocrinologist, Midwest Women’s and Children’s Specialty Group. “The alarms are a bonus because they provide parents a level of reassurance.”
The FreeStyle Libre 2 system is expected to be available in the coming weeks and will be offered at the same price as the currently available FreeStyle Libre 14 day system.
Recent data presented at the American Diabetes Association (ADA) 80th Virtual Scientific Sessions showed that use of the FreeStyle Libre system was associated with significant reductions in HbA1c levels in patients with type 2 diabetes on either long-acting insulin or noninsulin therapy. Specifically, an overall reduction of 0.8% (from 8.5% to 7.7%) and 0.6% (from 8.5% to 7.9%) was observed following 6 months and 1 year of FreeStyle Libre system use, respectively.
Commenting on the study results, one of the lead investigators, Dr Eden Miller, DO said, “”These data highlight how use of Abbott’s continuous glucose monitor could be game-changing for people beyond intensive insulin users, translating to broader use of the technology to benefit all those living with diabetes, no matter where they are in the spectrum of care.”
Additionally, use of the sensor-based glucose monitoring system was found to reduce the rates of diabetic ketoacidosis (DKA), according to a retrospective French study also presented at the ADA virtual sessions. Results showed that overall, yearly DKA rates were reduced by 52% in patients with type 1 diabetes and 47% in patients with type 2 diabetes following FreeStyle Libre system initiation.
“It is plausible that the use of the FreeStyle Libre system allowed people to detect and limit persistent hyperglycemia, and subsequently ketoacidosis,” said lead study author Ronan Roussel, MD, PhD, chief of the endocrinology, diabetes, and nutrition department at Hôpital Bichat, Fédération de Diabétologie, AP-HP, Paris, France. “The positive results of this study demonstrate that intermittently scanned continuous glucose monitoring may have significant implications for patient-centered clinical care and, given the increased burden of ketoacidosis on healthcare utilization and expenditure, it may have a positive impact on long-term economic health outcomes.”
For more information visit abbott.com.