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May 08 2017 Press release
 
- FREESTYLE® LIBRE SYSTEM ELIMINATES ROUTINE FINGER STICKS(1) FOR GLUCOSE MEASUREMENTS AND REQUIRES NO FINGER STICKS FOR CALIBRATION
 
- NOW REIMBURSED IN FRANCE, THE SECOND LARGEST MARKET(2) FOR FREESTYLE LIBRE GLOBALLY
 
- FIRST-OF-ITS-KIND LIBRE PRODUCT NOW HAS FULL OR PARTIAL REIMBURSEMENT ACROSS 13 COUNTRIES IN EUROPE, INCLUDING FRANCE, AUSTRIA, GERMANY, ITALY
 
NEWS PROVIDED BY
Abbott
08 May, 2017, 06:00 ET
 
PARIS, May 8, 2017 - Abbott today announced that the French Health Ministry has granted national reimbursement across France for FreeStyle® Libre—Abbott's glucose monitoring technology that removes the need for routine finger sticks1 for people with diabetes.
 
This reimbursement decision will mean access to the FreeStyle Libre system for hundreds of thousands of people from age four3 across France with both Type 1 and Type 2 diabetes who use insulin multiple times per day.
 
As part of the evaluation published in July 2016, the French Health Technology Assessment (HTA) body – Haute Autorité de Santé (HAS) – issued a positive opinion stating that FreeStyle Libre provides added clinical value (category of ASAIII) over the current standard of care for people with diabetes who use insulin multiple times per day. Unlike older continuous glucose monitoring (CGM) technology, FreeStyle Libre is now the first glucose sensing product to obtain the ASAIII category leading to a reimbursement agreement.
 
"Our goal is to develop breakthrough technologies that improve people's lives, and we thank the HAS and the French Health Ministry for recognizing the great benefit FreeStyle Libre has and for ensuring that people in France have wide access to this innovation," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "We share a common goal—to make the best technology available to people with diabetes so that they have access to the information that they need to live healthier lives."
 
The FreeStyle Libre system eliminates the challenges of routine finger sticking1 for people with diabetes. With the data from the device, they can have a better understanding of their glucose levels through the Ambulatory Glucose Profile (AGP), a chart generated by the software that provides a visual snapshot of glucose levels, trends and patterns over time.
 
It also provides doctors and diabetic nurses with deeper insights to make more informed treatment decisions.
"People with diabetes find finger sticking painful and cumbersome so they often don't test as frequently as they should," said Hélène Hanaire, M.D., University Hospital Center of Toulouse, Toulouse, France. "Having easier access to technology like FreeStyle Libre is going to increase freedom for individual patients on a larger scale, and ultimately change how they—and we—manage diabetes going forward."
 
Abbott's FreeStyle Libre system was introduced across Europe in 2014, and is now available in more than 30 countries and used by more than 300,0004 people with diabetes around the world.
 
Two published clinical trials5 and real-world evidence from more than 50,000 users6 with 400 million glucose data show that people who use FreeStyle Libre system test their glucose levels an average of at least 15 times per day. The studies show that people who scan more frequently spend less time in hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) while having improved average glucose levels, demonstrating improved glucose control overall.
 
About the FreeStyle Libre System
Abbott's FreeStyle Libre system is designed to change how people with diabetes measure their glucose levels and ultimately help them achieve better health outcomes. The system reads glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days, eliminating the need for routine finger sticks1. In addition, no finger stick calibration is needed—a key differentiator from current continuous glucose monitoring systems. In the U.S., the FreeStyle Libre system is currently under review by the U.S. Food and Drug Administration7.
 
References
1 A fingerstick test using a glucometer is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels; or if hypoglycemia or impending hypoglycemia is reported by the system; or when symptoms do not match the system readings
2 Data on file, Abbott Diabetes Care, Inc.
3 A caregiver at least 18 years old is responsible for supervising, managing, and assisting the child or young person ages 4-17 years old in using the FreeStyle Libre system and interpreting its readings
4 Data on file, Abbott Diabetes Care, Inc.
5 Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial [published online September 12, 2016]. Lancet. 2016
6 Data on file. Dunn T, Xu Y, Hayter G;  Evidence of a Strong Association Between Frequency of Flash Glucose Monitoring and Glucose Control Measures During Real-World Usage
7 Pending FDA approval. Not available for sale in the United States
 
Nyhetsinfo 170624
www red DiabetologNytt
 
 
FreeStyle Libre-published clinical trials, manuscripts and abstracts. February 2017
 
Trial title
First author
Trial ID
 
Randomised controlled study to evaluate the impact of novel glucose-sensing technology on hypoglycaemia in type 1 diabetes. ( IMPACT)
J Bolinder
The Lancet, Published online September 12, 2016 http://dx.doi.org/10.1016/S0140-6736(16)31535-5
NCT02232698
 
Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes ( REPLACE)
Thomas Haak
Diabetes Therapy
November 9, 2016
DOI 10.1007/s13300-016-0223-6
NCT02082184
 
Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System - Paediatric Label Extension Study (CE) (BEAGLE)
Julie Edge
http://adc.bmj.com/ on January 31, 2017 - Published by group.bmj.com
http://dx.doi.org/10.1136/
archdischild-2016-311530).
NCT02388815
 
Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System
T Bailey
Diabetes Technology and Therapeutics, 17(11), 1-8. doi: 10.1089/dia.2014.0378
NCT02073058
 
An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People   ( SELFY)
Recruitment ceased December 2016. Results pending second half of 2017
NCT02821117
 
Accuracy evaluation of FreeStyle Libre flash glucose monitoring system when used by pregnant women with diabetes ( FLIPS)
E Scott
Abstract presented ATTD February 2017
 
Novel flash glucose sensing technology reduces hypoglycaemia in individuals with Type 1 diabetes using multiple daily injections ( MDI)
( IMPACT)
J Bolinder
Abstract presented ATTD February 2017
 
Evidence of a strong association between frequency of flash glucose monitoring and glucose control measures during real world usage
T Dunn
http://cmoffice.kenes.com/ATTD17/CM.NET.WebUI/CM.NET.WEBUI.scpr/SCPRfunctiondetail.aspx?confID=05000000-0000-0000-0000-000000000209&sesID=05000000-0000-0000-0000-000000045451&absID=07000000-0000-0000-0000-000000560959
 
Flash Glucose Monitoring improves outcomes in a type 1 diabetes clinic.
Prospective assessment
Anna Dover
Journal of Diabetes Science and Technology,
doi: 10.1177/1932296816661560
 
Available at a flash: a new way to check glucose
H Thabit,
The Lancet, Published online September 12, 2016 http://dx.doi.org/10.1016/S0140-6736(16)31582-3
Cost effectiveness analysis of a Flash Glucose Monitoring System for type 1 diabetes (T1DM) patients receiving intensive insulin treatment in Europe and Australia *
H Li
Presented November 8, 2014, ISPOR-EU International Society for Pharmacoeconomics and Outcomes Research - 17th Annual European Congress, Amsterdam, Netherlands
 
Cost effectiveness analysis of flash glucose monitoring for type 2 diabetes patients receiving  intensive insulin treatment in Europe
H Li
Presented November 8, 2014, ISPOR-EU International Society for Pharmacoeconomics and Outcomes Research - 17th Annual European Congress, Amsterdam, Netherlands.
Health State Utilities Associated with Glucose Monitoring Devices
LS Matza
Value in Health
journal homepage: www.elsevier.com/locate/jval
 
Additional External Studies
Sweden,
Eeg-Olofsson (2015)
Clinical Experience with Freestyle Libre
To report the clinical experience with the FreeStyle Libre system
HbA1c improved 15 mmol/mol (1.4% units DCCT) over 3–9 months of follow-up
 
Israel,
Ish-Shalom (2016)
Improvement in Glucose Control in Difficult-to-Control Patients With Diabetes Using a Novel Flash Glucose
Monitoring Device
10.1177/1932296816653412
 
To report experience using the FreeStyle Libre system in patients with difficult-to-control diabetes
Follow-up of 12 weeks. HbA1c reduced by 1.33% at 8 weeks and plateaued thereafter. No major hypoglycemia events. All patients were highly satisfied
 
UK,
McKnight and Gibb  (2017)
Flash Glucose Monitoring is associated with improved glycaemic control but use is largely limited to more affluent people in a UK diabetes centre
10.1111/dme.13315
 
To determine the prevalence of FreeStyle Libre system use among adults (age ≥ 18 years) with T1DM  who attended the Edinburgh Centre for Endocrinology & Diabetes clinics & the demographic characteristics of these adults
Patients using FreeStyle Libre system achieved a median 0.2% reduction in HbA1c compared with a 0.1% increase for non-users.  Of patients above HbA1c target of ≥ 58 mmol/mol, 32.2% of FreeStyle Libre patients and 9.8% of non-FreeStyle Libre users (p < 0.001) had reached their target at last clinic visit
 
Italy,
Bonora  (2016)
Head‑to‑head comparison between flash and continuous glucose monitoring systems in outpatients with type 1 diabetes
10.1007/s40618-016-0495-8
To determine the agreement between the factory-calibrated FGM FreeStyle Libre system and the gold-standard CGM Dexcom G4 Platinum in the real world
Good agreement between FreeStyle Libre system and G4 readings, and no significant difference in time in glucose ranges or glucose variability as measured by two systems
 
Germany,
Schmid (2016)
Glucose monitoring with a newly developed sensor system: Step and time analysis
To analyze the amount of time and effort required to record and display a glucose value with the FreeStyle Libre system and compare it with that required for a SMBG measurement
Use of FreeStyle Libre system, due to a simplification of the measuring process, involves fewer process steps, saves time and can reduce potential sources of error
Launched countries,
Dunn (2017)
 
Evidence of a Strong Association between Frequency of Flash Glucose Monitoring and Glucose Control Measures during Real-World Usage
To evaluate association of the real-world scanning with flash glucose monitoring (FreeStyle Libre) and glucose control measures.
In real-world use of flash continuous glucose monitoring, high scan rates were found, averaging 16 times per day and higher rates of scanning to self-monitor glucose were  found to strongly associate with improved glycemic metrics
 
Sweden,
Löndahl  (2017)
Effect of flash glucose monitoring on metabolic control and self-esteemed treatment satisfaction in people with type 1 diabetes
To evaluate the effects on HbA1c and diabetes treatment satisfaction after introduction of flash glucose monitoring in people with T1DM
Use of flash glucose monitoring adds clinically significant advantage to individuals with T1DM in terms of HbA1c reduction and improved self-estimated treatment satisfaction
 
Italy,
Scorsone (2017)
Glucose control and quality of life in type 1 diabetic subjects under flash glucose monitoring and self monitored glucose testing (SMBG)
To assess whether the FreeStyle Libre system vs SMBG, reduced exposure to high glucose levels. Quality of life was also evaluated
FreeStyle Libre system is a not inferior to SMBG, even using carbo-counting technique, in achieving good glucose control with a better quality of life
 
USA,
Toschi (2017)
Use of mobile-based technologies to improve diabetes self-management behavior and postprandial glucose control
To assess if flash glucose monitoring  together with real-time contextual prompts from a smartphone app and web-based nutrition education can improve
eating behavior in T1DM patients
The combination of continuous glucose monitoring and the interactive nutrition education prompted participants to reflect on the impact of food intake on glucose excursions
 
Multiple countries,
Rayman (2016)
Can FreeStyle Libre Sensor-based Glucose Data Support Decisions for Safe Driving?
To assess whether FreeStyle Libre sensor-based glucose data supports decisions for safe driving
Many drivers do not perform the required SMBG testing associated with driving, potentially putting themselves and other road users at risk. FreeStyle Libre system users demonstrated regular and consistent use of sensor glucose results and are thus presumably more likely to have checked their sensor glucose level before driving
Spain,
ADC white paper (2015)
 
Identification of Nighttime Hypoglycaemia Utilising a Diabetes Patient Education Tool and the Freestyle Libre Flash Glucose Monitoring System: A Pilot Survey
To assess the utility of an educational Patient Diary for identifying nighttime hypoglycaemic events in combination with the system in patients with T1DM or T2DM treated with MDIs of insulin
The use of FreeStyle Libre flash glucose monitoring system and the Patient Diary helps patients increase their awareness and identification of nocturnal hypoglycaemia, and helps to inform their HCPs about previously undetected hypoglycaemia events, thus supporting better clinical decision-making
 
Nyhetsinfo 170624
Nyhetsinfo www red DiabetologNytt
 
___________
 
TLV har diskvalificerat sig själv som hälsoekonomisk utredare. Debattinlägg, Jan Bolinder, prof, Karolinska
 
Det bidde inte ens en tumme.
 
Efter att under lång tid ha förhalat en önskvärd nationell samordning för användning av FGM kastar nu TLV in handduken.
 
Ett minst sagt märkligt och uppseendeväckande agerande, som nu riskerar att bidra till fortsatt ojämlik subvention och förskrivning i landet med stora regionala olikheter.
 
Detta trots att flera länder i Europa – senast i raden Frankrike – beslutat om obegränsad subvention för alla med typ 1 diabetes och typ 2 diabetes med multipel insulin-behandling.
 
Man frågar sig om inte TLV nu diskvalificerat sig själv i sin självpåtagna roll som hälsoekonomisk utredare; i den uppgiften borde väl rimligen ingå att i egen regi ta fram nödvändiga underlag, och samverka med motsvarande organ inom EU.
 
Jan Bolinder. Professor/överläkare
Kliniken för Endokrinologi, Metabolism och Diabetes
Karolinska Universitetssjukhuset Huddinge
 
Nyhetsinfo 17619
www red DiabetologNytt
________
 
TLV tar semester utan att leverera hälsoekonomiskt dokument för FGM. Ett års arbete
Publicerad 13 juni 2017
 
Ingen utvärdering av FreeStyle Libre
 
Nedan är utlagt på TLVs www
 
"TLV har inte möjlighet att publicera en hälsoekonomisk utvärdering av den kontinuerliga glukosmätaren FreeStyle Libre, eftersom företaget som marknadsför produkten valt att inte bidra med nödvändigt underlag.
 
I dag använder minst 27.000 patienter i Sverige FreeStyle Libre och merkostnaden för den användningen är minst en kvarts miljard kronor per år. FreeStyle Libre har introducerats utan ordnat införande vilket lett till ojämlik tillgång beroende på var i landet patienten bor.
 
– Det är viktigt att rätt patienter får FreeStyle Libre så det är olyckligt att vi nu inte har möjlighet att publicera en hälsoekonomisk utvärdering, säger Malin Blixt, enhetschef.
 
TLV:s utvärdering inom medicinteknikuppdraget skulle legat till grund för en nationell rekommendation från landstingens NT-råd. Syftet med rekommendationen var att ge förutsättningar för en jämlik tillgång till FreeStyle Libre.
 
Bakgrund
TLV påbörjade en hälsoekonomisk utvärdering av FreeStyle Libre sommaren 2016. På hösten samma år ansökte företaget som marknadsför produkten om att den skulle ingå i läkemedelsförmånerna och utvärderingen till NT-rådet avbröts.
 
I mars 2017 återkallade företaget sin ansökan och TLV återupptog då utvärderingen som skulle ligga till grund för NT-rådets rekommendation. Företaget har nu valt att inte bidra med materialet från ansökan och TLV kan därför inte publicera den utvärdering som gjorts.
 
För att TLV ska kunna återuppta arbetet krävs att företaget bidrar till en utvärdering."
 
Publicerad 13 juni 2017
 
Nyhetsinfo
www red DiabetologNytt
 
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