ABBOTT PARK, Ill., April 28, 2022 /PRNewswire/ -- Abbott (NYSE: ABT) today announced results from a new meta-analysis of 75 real-world, observational studies demonstrating that its FreeStyle® Libre system provides significant reductions in glycated hemoglobin (HbA1c) that are sustained up to 24 months in adults with both type 1 and type 2 diabetes.1 People with type 2 diabetes who use insulin are often restricted when it comes to access to continuous glucose monitoring, but both clinical trials and real-world studies demonstrate significant improvement of glycemic control. The results were presented today at the Advanced Technologies & Treatments for Diabetes (ATTD) Congress, April 27-30, 2022, in Barcelona.
After three months of using the FreeStyle Libre system, HbA1c levels were reduced by 0.53% in adults with type 1 diabetes (from 8.20% to 7.67%) and 0.45% in adults with type 2 diabetes (from 8.17% to 7.72%). These are clinically significant reductions of average glucose levels towards the internationally recommended HbA1c goal of 7% for adults with diabetes. Reductions were sustained for up to 24 months in those with type 1 diabetes and up to 12 months in those with type 2 diabetes, reflecting the duration of the studies available for analysis. Reductions in HbA1c over time followed a similar pattern for people with type 1 and type 2 diabetes, demonstrating that, in a real-world setting, people with type 2 diabetes who use insulin benefit from FreeStyle Libre system in a similar way as people with type 1 diabetes.1
"Many people with type 2 diabetes who use insulin have a very similar experience to people with type 1 diabetes in terms of the risk of complications and the need to monitor blood glucose, but access to sensing technology is rarely equal for both groups," said Mark Evans MD FRCP, University Professor of Diabetic Medicine, University of Cambridge. "Our analysis demonstrates the value of constant glucose monitoring to support glycemic control in people with advanced type 2 diabetes who use insulin as we see clinically meaningful benefits translated to a real-world setting."
Currently, in most European countries, the FreeStyle Libre system is reimbursed for all people with type 1 diabetes, but people with type 2 diabetes can only get the product reimbursed if they meet certain criteria, such as using insulin several times a day or having poorly controlled HbA1c levels.
HbA1c provides an estimate of average glucose levels over a period of time and is the standard measurement of glycemic control for people with diabetes.2 Increased HbA1c is associated with a greater risk of developing complications related to diabetes, such as cardiovascular disease.3 The new meta-analysis found that people with a higher HbA1c at baseline experienced greater reductions in HbA1c after being initiated on the FreeStyle Libre system.1
"Our FreeStyle Libre system is the most widely used wearable glucose monitor with proven clinical and real-world data from more than 1 million users," said Alexander Seibold, EMEA medical director for Abbott's diabetes care business. "It provides people real-time insights into how their glucose levels are affected by their daily routines, empowering them to make healthy adjustments and see the benefit to their health and life. It puts people with diabetes in control of their health."
The FreeStyle Libre glucose monitoring system includes a sensor, which is applied to the back of the upper arm for up to 14 days and continuously measures glucose, paired with a reader or compatible smartphone app4 that display glucose readings. It is the number one sensor-based glucose monitoring system used in Europe and worldwide.5 Abbott's FreeStyle Libre portfolio has already changed the lives of approximately 4 million people across 60 countries6 by providing breakthrough technology that is accessible and affordable.7
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Indications and Important Safety Information
FreeStyle Libre 14 day system: Failure to use FreeStyle Libre 14 day system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.
FreeStyle Libre 2 system: Failure to use FreeStyle Libre 2 system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.
1 Evans M, Welsh Z & Seibold A. Reductions in HbA1c with flash glucose monitoring are sustained for up to 24 months: a meta analysis of 75 real-world observational studies. Presented at ATTD 2022
2 World Health Organization. Use of Glycated Hemoglobin (HbA1C) in the Diagnosis of Diabetes Mellitus: Abbreviated Report of a WHO Consultation Published. 2011. p. 2, Glycated hemoglobin (HbA1c) for the diagnosis of diabetes. Available online at: https://www.who.int/diabetes/publications/report-hba1c_2011.pdf . Last accessed April 2022.
3 Sherwani SI, Khan HA, Ekhzaimy, et al. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomarker Insights 2016:11 95–104 doi: 10.4137/BMI.S38440
4 The app is only compatible with certain mobile devices and operating systems.
5 Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre portfolio compared to the number of users for other leading personal use, sensor-based glucose monitoring systems.
6 Data on file. Abbott Diabetes Care.
7 Based on a comparison of list prices of the FreeStyle Libre portfolio versus competitor CGM systems available worldwide. The actual cost to patients may or may not be lower than other CGM systems, depending on local reimbursement, if any.