ABBOTT PARK, Ill., Sep 20, 2022 – Abbott today announced new data from the Real World Evidence of FreeStyle Libre (RELIEF) study showing the use of FreeStyle Libre, a continuous glucose monitoring system (CGM) significantly reduced the rate of hospitalizations due to acute diabetes events (ADEs) for people living with Type 2 diabetes on once-daily (basal) insulin therapy.1 These findings were published in the Journal of Diabetes Technology & Therapeutics and presented at the 58th Annual European Association for the Study of Diabetes (EASD) meeting.
The retrospective study of the French national health claims database shows that the 5,933 people with Type 2 diabetes who were following a basal-only regimen and using the FreeStyle Libre system had 67% fewer ADE-related hospitalizations one year after initiating the FreeStyle Libre treatment. The data also show a 75% reduction in hospitalizations for diabetic ketoacidosis (DKA), a potentially life-threatening condition when glucose levels are too high for too long and ketone levels rise to dangerous levels in the blood, and a 44% reduction in admissions for severe hypoglycemia (low glucose levels). Further, the study showed sustained reductions in hospitalizations over a two-year period of FreeStyle Libre system use, regardless of whether the patients were under the care of a diabetes specialist or a general healthcare practitioner.1
"The results of the RELIEF study highlight the value of FreeStyle Libre system in reducing serious diabetes-related events and hospitalizations among patients with Type 2 diabetes on basal-only therapy," says Professor Jean-Pierre Riveline, Centre Universitaire du Diabète et de ses Complications, Hôpital Lariboisière. "The reductions are similar to the results seen among the larger cohort of people with Type 2 diabetes who were receiving multiple daily injections, suggesting that FreeStyle Libre technology therapy should be proposed as part of individualized care for patients with Type 2 diabetes on basal-only insulin, not just people on intensive insulin therapy."
When oral medications are no longer sufficient to regulate glucose levels, a doctor might change diabetes treatment, starting with once-a-day (basal) insulin therapy. However, studies show that people with Type 2 diabetes who start basal insulin therapy are three times more likely to experience severe hypoglycemia. 2
The fear of hypoglycemia affects both people with Type 2 diabetes and their doctors. This fear is a barrier to intensifying treatment and impacts a patient’s willingness to follow the basal insulin therapy as prescribed by their doctor.3,4,5 The RELIEF study suggests that reducing the incidence of hypoglycemia and DKA may improve adherence and help people with diabetes achieve their glycemic targets. This is especially relevant for older people, where hypoglycemia is associated with a significantly increased risk of falls, fractures, dementia, and death.6
"Moving from oral medications to insulin therapy can have a big impact on people with Type 2 diabetes, both mentally and physically. Although the switch is often necessary to manage glucose levels, it can be stressful to inject insulin, which comes with associated risks," said Dr. Alexander Seibold, senior medical director in Abbott’s diabetes care division. "Our goal is to make diabetes care easier, which is why we offer solutions where people can check their actual glucose values and trends anytime on their smartphone or reader. This will help them catch rapidly changing glucose levels and allow them to make adjustments to their lifestyle or medications with much more confidence."
The results from this latest study add to a growing body of evidence that has shown the effectiveness of the FreeStyle Libre system in reducing hospitalizations in people with Type 1 and Type 2 diabetes on multiple daily injections of insulin.9 Currently, in most European countries, the FreeStyle Libre system is reimbursed for all people with Type 1 diabetes. 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 glucose levels.
About FreeStyle Libre:
The FreeStyle Libre system includes a sensor, which is applied to the back of the upper arm for up to 14 days, paired with a reader or compatible smartphone app7 that displays glucose readings. The Freestyle Libre system is the most widely used CGM system worldwide helping more than four million people living across more than 60 countries easily monitor their glucose levels.8
The RELIEF study (Real world Evidence of FreeStyle Libre: analysis of the SNDS database in France)9 funded by Abbott, was conducted using the French national health claims database (SNDS), which covers the entire French population (approximately 66 million people), making it one of the world’s largest continuous homogeneous claim database. The database includes extensive information on all healthcare resource use, including outpatient visits, dispensed medication, procedures, chronic conditions, as well as hospital admission diagnoses and procedures, and date of death, on an individual level. The goal of the RELIEF study was to understand the impact of using the Freestyle Libre system on acute diabetes events in standard practice in France following its approval for reimbursement by the National Sickness Fund in June 2017.
This retrospective sub-study was conducted on all French people with Type 2 diabetes on basal insulin therapy receiving a first reimbursement of FreeStyle Libre between Aug. 1, 2017, and Dec. 31, 2018, a total number of 5,933 people. The analysis looked at claims data for the 12 months before, and up to 24 months after FreeStyle Libre initiation. Hospitalizations for the following diabetes-related acute events were identified: severe hypoglycemia events, DKA events, comas and hyperglycemia related stays.
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1 Gerci 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, 20-22 September 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 app is only compatible with certain mobile devices and operating systems
8 Data on file. Abbott Diabetes Care.
9 Roussel R, Riveline J-P, 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.