New real-world evidence shows that patients with type 2 diabetes (T2D) on insulin therapy significantly reduced their glycated hemoglobin (A1C) after 3 to 6 months of using the FreeStyle Libre Flash glucose monitoring system. The findings were presented Saturday at the 79th Scientific Sessions of the American Diabetes Association (ADA) meeting in San Francisco, California.
The meta-analysis covers 3 chart review studies involving 363 patient records from Austria, France, and Germany; the patients had an average A1C of 8.9% (±0.9%) and had been on a basal-bolus insulin regimen at least 1 year before starting the FreeStyle Libre system. Their average age was 63.5 years (±11.0 years) and the average time using insulin was 8.3 years (±5.8 years). Of the group, 56.4% were male. Several had comorbidities, including cardiovascular disease (36.4%), renal complications (33.9%), and retinopathy (19.6%).
Besides insulin, 67.8% of the patients were taking oral medications, including metformin, sulfonylureas, sodium glucose cotransporter 2 inhibitors, dipeptidyl peptidase 4 inhibitors, and thiazolidinediones.
For the study, A1C was recorded between 90 and 194 days from the start of using FreeStyle Libre between January 2015 and August 2018. The FreeStyle Libre system, which is factory calibrated and does not require finger sticks to confirm accuracy, was used in Europe before it received FDA approval
in September 2017. The system is made by Abbott.
Results showed the following:
- The overall mean change in A1C after at least 3 months of use was reduced by 0.9% ± 0.05% (P <.0001), with no differences between countries.
- No significant differences in A1C lowering were seen by age, gender, body mass index, or duration of insulin use.
The FreeStyle Libre uses a sensor wire that is inserted below the skin surface to constantly monitor glucose levels. Patients who use the product can wave a mobile reader over the device to determine if their blood glucose levels are in range, too high, or too low, and what the status has looked like for the past 8 hours.
Because the product is less expensive than competing glucose monitoring systems, some experts believe it will be the system that will penetrate the T2D market
in the United States, where comparatively few of the estimated 29 million who have this type of diabetes use continuous glucose monitoring (CGM) systems. This occurs despite the growing consensus that time-in-range is a more important measure for long-term health in diabetes care. A consensus statement on time-in-range targets
when using CGM was released at the ADA sessions.
“Doctors tell us that FreeStyle Libre is changing the course of care for people with diabetes, and the combination of these real-world data and clinical research is further proof that our technology delivers significant reductions in [A1C] in people with type 2 diabetes,” Mahmood Kazemi, MD, divisional vice president, global and scientific affairs for Abbott Diabetes Care, said in a statement
Abbott officials said that the FreeStyle Libre system is now used by 1.5 million people in 46 countries. The statement said that full or partial reimbursement is available in 33 countries, including France, Ireland, Japan, and the United Kingdom. Medicare covers FreeStyle Libre and a few other glucose monitoring systems for those with type 1 and for patients with T2D who can demonstrate intensive insulin use, typically at least 4 injections per day. Historically, Medicaid has had limited coverage for CGM, but this is changing, Abbott officials said in an email.
In the email, Abbott said most US commercial payers cover the system for both type 1 and T2D patients who use intensive insulin. Besides covering CGM through their medical policy under durable medical equipment, the statement said, "more and more, commercial payers are now placing CGM on their formularies, allowing patients to obtain CGM at their retail pharmacy."
Kroeger J, Fasching P, Hanaire H. Meta-analysis of three real-world, chart review studies to determine the effectiveness of FreeStyle Libre Flash glucose monitoring system on HbA1c in adults with type 2 diabetes. Presented at: 79th Scientific Sessions of the American Diabetes Association; San Francisco, California; June 7-12, 2019. Abstract 99-LB.