New data on Abbott's FreeStyle Libre system
21.09.2022 17:40
Abbott announced new data from the Real World Evidence of FreeStyle Libre (RELIEF) study on September 20, 2022. These show that use of the FreeStyle Libre continuous glucose monitoring (CGM) system in people with type 2 diabetes and once-daily (basal) insulin therapy was associated with a significant decrease in diabetes-related hospitalization rates.[1 ] The results were published in the Journal of Diabetes Technology & Therapeutics and presented at the 58th Annual Conference of the European Association for the Study of Diabetes (EASD).
The retrospective study of the French health services database shows that among the 5,933 people with type 2 diabetes who received pure basal therapy, the number of hospitalizations related to acute diabetes events (ADEs) fell after one year of using the FreeStyle Libre system decreased by 67 percent. Hospitalizations for diabetic ketoacidosis (DKA), a potentially life-threatening condition in which glucose levels are too high for too long, causing a dangerous rise in blood ketone levels and acidification, fell by 75 percent. The number of admissions for severe hypoglycemia (low blood sugar) fell by 44 percent. The study also demonstrated a sustained reduction in hospital stays over two years of use of the FreeStyle Libre system, regardless of whether patients were cared for by a diabetologist or a general practitioner.[1]
“The results of the RELIEF study underline the importance of the FreeStyle Libre system in reducing diabetes-related events and hospitalizations in patients with type 2 diabetes on basal insulin-only therapy,” said Professor Jean-Pierre Riveline from the University Center for Diabetes and diabetes complications at the Hôpital Lariboisière in Paris. “These declines are comparable to those observed in the larger cohort of people with type 2 diabetes who receive multiple injections per day. This suggests that therapy based on FreeStyle Libre technology should also be recommended to patients using only basal insulin as part of their individualized care and not just to those requiring intensive insulin therapy.”
When oral medications are no longer sufficient to regulate glucose concentrations, diabetes therapy is often changed, with most doctors initially prescribing once-daily (basal) insulin administration. However, studies show that starting basal insulin therapy increases the incidence of severe hypoglycemia three-fold in people with type 2 diabetes.[2]
Hypoglycemia is feared by patients with type 2 diabetes and their doctors alike. This fear creates a barrier to intensifying treatment and affects patients' willingness to adhere to physician-prescribed basal insulin therapy.[3],[4],[5] The RELIEF trial suggests that lowering Incidence of hypoglycemia and DKA may improve patient adherence and thus facilitate achievement of glucose target values. This is particularly important in older people, as hypoglycemia is associated with a significantly increased risk of falls, fractures, dementia and death.[6]
“Transitioning from oral medications to insulin therapy can be stressful, both mentally and physically, for people with type 2 diabetes. Although this change is often necessary to bring glucose levels under control, injecting insulin is a stressor for those affected due to the associated risk factors,” said Dr. Alexander Seibold, Senior Medical Director, Diabetes Care Division at Abbott. “Our goal is to make diabetes management easier. That's why we offer solutions that enable people to check their current glucose levels and trends at any time using their smartphone or reader. This allows them to identify rapidly changing glucose levels and make appropriate lifestyle or medication adjustments with more confidence.”
The results of this latest study add to the growing body of evidence demonstrating the effectiveness of the FreeStyle Libre system in reducing hospitalization rates in people with type 1 and type 2 diabetes who require multiple daily doses of insulin.[9] “This confirms for the first time what we have already observed individually in practice and derived from our experience and will hopefully also help the group of patients with basal insulin therapy to have access to the advanced CGM technology as part of individualized care,” comments Professor Thomas Haak, chief physician the Bad Mergentheim Diabetes Clinic.
Currently, the cost of the FreeStyle Libre system is covered in most countries in Europe for people with type 1 diabetes. For people with type 2 diabetes, certain criteria must be met; The costs are reimbursed, for example, if several insulin injections per day are required or if the glucose concentration is very difficult to control.
Sources
[1] Guerci B, Roussel R, Riveline JP, et al. Important decrease in hospitalizations for acute diabetes events following FreeStyle Libre®system initiation in people with type 2 diabetes on basal insulin therapy in France. Presented at EADV, September 20-22, 2022, Stockholm, Sweden.
[2] Rados DV, Falcetta MRR, Pinto LC, et al. All-Cause Mortality and Cardiovascular Safety of Basal Insulin Treatment in Patients with Type 2 Diabetes Mellitus: A Systematic Review with Meta-Analysis and Trial Sequential Analysis. Diabetes Res Clin Pract. 2021;173:108688; doi: 10.1016/j.diabres.2021.108688.
[3] Peyrot M, Barnett AH, Meneghini LF, et al. Factors Associated with Injection Omission/Non-adherence in the Global Attitudes of Patients and Physicians in Insulin Therapy Study. Diabetes Obes Metabolism 2012;14(12):1081-1087; doi: 10.1111/j.1463-1326.2012.01636.x.
[4] Polonsky WH, Fisher L, Guzman S, et al. Psychological Insulin Resistance in Patients With Type 2 Diabetes. Diabetes Care 2005;28(10):2543-2545; doi: 10.2337/diacare.28.10.2543.
[5] Walz L, Pettersson B, Rosenqvist U, et al. Impact of Symptomatic Hypoglycemia on Medication Adherence, Patient Satisfaction with Treatment, and Glycemic Control in Patients with Type 2 Diabetes. Patient Prefer Adher. 2014;8:593-601; doi: 10.2147/ppa.s58781.
[6] Mattishent K and Loke YK. Meta-Analysis: Association Between Hypoglycemia and Serious Adverse Events in Older Patients Treated With Glucose-Lowering Agents. Front Endocrinol. 2021;12:571568; doi: 10.3389/fendo.2021.571568.
[7] The FreeStyle Libre 3 App/FreeStyle LibreLink is only compatible with certain mobile devices and operating systems. Before you want to use the app, please visit the website www.FreeStyleLibre.de for more information about device compatibility.
[8] FreeStyle Libre 3 sensors can be used with either the FreeStyle Libre 3 reader or
can be read out with the FreeStyle Libre 3 app. Both devices cannot be used in parallel.
[9] The statement is based on the number of users of the FreeStyle Libre measurement system worldwide compared to the number of users of other leading sensor-based personal glucose monitoring systems. Data is available. Abbott Diabetes Care.
[10] Roussel R, Riveline JP, Vicaut E, et al. Important Drop Rate of Acute Diabetes Complications in People With Type 1 or Type 2 Diabetes After Initiation of Flash Glucose Monitoring in France: The RELIEF Study. Diabetes Care 2021;dc201690; doi: 10.2337/dc20-1690.
About the RELIEF study:
The Abbott-funded RELIEF (Real-world Evidence from FreeStyle Libre: Analysis of the SNDS database in France) study[10] was based on service records in the French National Health Insurance Fund (SNDS) database covering the entire population of approximately 66 million Cover France. This makes it one of the world's largest databases with continuous, homogeneous performance data. This database contains extensive information about the use of medical services such as outpatient doctor visits, prescribed medications, therapeutic procedures used, chronic illnesses as well as diagnoses and medical measures during hospital admissions as well as death dates by individual. The aim of the RELIEF study was to investigate the impact of the use of the FreeStyle Libre system on acute diabetes events in standard medical practice in France, after the system was approved for reimbursement by the national health insurance fund in June 2017.
This retrospective substudy included all French patients with type 2 diabetes on basal insulin therapy who received initial reimbursement for the FreeStyle Libre system between August 1, 2017 and December 31, 2018, a total of 5,933 people. The analysis examined performance data for the 12 months before and up to 24 months after initial use of the FreeStyle Libre system. Hospitalizations were identified for the following diabetes-related acute events: severe hypoglycemia, DKA, coma, and hyperglycemia.