Diabetes research — alongside the plethora of innovative technologies it's spawned — has taken what we once thought about life with diabetes and turned it completely upside down. But the true test of any new diabetes technology is its real-world impact: How it's used, and how it's changing the lives of users.
Real-World Data Continues to Show that the FreeStyle Libre System Delivers Positive Health Outcomes
Recent scientific studies presented at Advanced Technologies and Treatments for Diabetes (ATTD) add to a growing body of real-world evidence compiled from FreeStyle Libre users around the world. This new data show reinforces that users of the FreeStyle Libre system have improved glucose control,1 increased time in target glucose range,1 and decreased time in hyperglycemia2 (high glucose levels) and hypoglycemia2 (low glucose levels), as well as reduced HbA1Ci3 (average glucose levels over a three month period).
"As the world leader in sensor-based glucose monitoring with more than two million users, Abbott's FreeStyle Libre system has an unmatched body of real-world evidence supporting its clinical benefits," said Mahmood Kazemi, M.D., divisional vice president, global medical and scientific affairs, and chief medical officer, Diabetes Care, Abbott. "Time and time again, we've seen meaningful data that reaffirm our technology's direct impact in achieving better health outcomes for people with diabetes — and the findings at ATTD underscore how we're continuing to transform people's lives."
More Information Means Better Control
One study presented showed that people living in Germany with Type 1 or Type 2 diabetes on insulin showed a sustained reduction in HbA1c over 12 months following use of the FreeStyle Libre system,3 indicating that FreeStyle Libre users had an improved HbA1c that was maintained over a substantial period of time.
People with Type 1 diabetes using the FreeStyle Libre system with a baseline HbA1c greater than 7.5% showed an average reduction of 1.4%, and people with Type 2 diabetes showed an average reduction of 1.2%. These are important figures, as an HbA1c level that is reduced by almost 1% is linked to an overwhelming reduction in long-term complications of diabetes by 30% according to studies.6
Another study11 showed people with Type 1 and Type 2 diabetes significantly reduced their HbA1c when they used the FreeStyle Libre system for three to nine months. A reduction of HbA1c of 0.44% for people with Type 1 and 0.67% for people with Type 2 were observed with first-time users of FreeStyle Libre system.
Still more real-world data1 from Canada demonstrates that higher frequency of scanning is associated with increased time in target glucose range (hours per day spent in between 70-180 mg/dL)5 and decreased hypoglycemia. Not surprisingly, spending more time in that target range has been linked to more stable glucose control, which could lead to fewer complications.
As with many aspects of monitoring and treatment of diabetes, increased control often leads to better results. FreeStyle Libre users who scanned at the lowest frequency12 (3.3 scans per day) spent 54.6% time in range, and users with the highest scanning frequency (29.3 scans per day) spent 66.7% time in range.
This analysis, in addition to previous real-world findings,(FN6) consistently show a strong association between FreeStyle Libre users who scan more frequently and overall improved glucose control.
Additional data also showed the benefits of continuous glucose monitoring (CGM). More than 12,000 people with diabetes using a CGM for the first time, including the FreeStyle Libre system, experienced a substantial reduction in acute diabetes complications4 — even in people with diabetes that have a history of self-monitoring of blood glucose (SMBG) using less than four test strips per day.7 People with Type 1 diabetes experienced a significant reduction in acute diabetes complications of 44% after CGM usage.2 For people with Type 2 diabetes, there was a reduction of 51%.2
The Future of Diabetes Management
More than 2 million people around the world are using the FreeStyle Libre system as a means to manage their diabetes.8 And when used in tandem with its apps, FreeStyle LibreLink9 and LibreLinkUp, users can share their glucose data with loved ones and caregivers — information gained through simply scanning their sensor with a compatible smartphone.
References
1Canadian real-world analysis of flash glucose monitoring and glycemic control; Lori Berard, Laura Brandner.
2Acute diabetes complications defined by hypoglycemia, hypoglycemic coma, hyperglycemia, ketoacidosis, or hyperosmolarity ICD-10 codes as primary diagnosis for inpatient or as any position in the outpatient emergency claim; Matthew Kerr, Gregory Roberts, Diana Souto, Yelena Nabutovsky.
3Improving HbA1c control in people with Type 1 or Type 2 diabetes using flash glucose monitoring: a retrospective observational analysis in two German centers; Gerhard Klausmann, Ludger Rose, Alexander Seibold.
4The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus, The New England Journal of Medicine, September 30, 1993, Volume 329, Number 14.
5ADA, International Consensus on Time-In-Range. The group recommends a target range of 70-180 mg/dL [3.9-10.0 mmol/L] for individuals with Type 1 diabetes and Type 2 diabetes, and 63-140 mg/dL [3.5-7.8 mmol/L] during pregnancy, along with a set of targets for the time per day
6Expanded real-world use confirms strong association between frequency of flash glucose monitoring and glucose control. Presented at the 12th Advanced Technologies & Treatments for Diabetes (ATTD) in Berlin, Germany; Lang, SR Jangam.
7Compared outcomes before and after purchase of continuous glucose monitoring.
8Data on file, Abbott Diabetes Care.
9The FreeStyle LibreLink app is compatible with NFC-enabled smartphones running Android OS 5.0 or higher and iPhone 7 or later running iOS 11 or later. Use of the FreeStyle LibreLink app requires registration with LibreView, a service provided by Abbott and Newyu, Inc.
10The LibreLinkUp app is compatible with iPhones running iOS 10 and later. Use of the LibreLinkUp app requires registration with LibreView, a service provided by Abbott and Newyu, Inc.
11Real-world study of FreeStyle Libre system among adults with Type 1 and Type 2 diabetes within the Swedish National Diabetes Register; Katarina Eeg-Olofsson, Ann-Marie Svensson, Stefan Franzén, Hodan Ahmed Ismail, Michael Törnblom, Fleur Levrat-Guillen.
12Canadian real-world analysis of flash glucose monitoring and glycemic control; Lori Berard, Laura Brandner.
Indications and Important Safety Information
The FreeStyle Libre Flash Glucose Monitoring system is a continuous glucose monitoring (CGM) device indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription.
CONTRAINDICATIONS: Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The FreeStyle Libre system does not have alarms unless the sensor is scanned, and the system contains small parts that may be dangerous if swallowed. The FreeStyle Libre system is not approved for pregnant women, persons on dialysis, or critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. Review all product information before use or contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information.
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