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Abbott FreeStyle Libre (Flash)

Device Name:FreeStyle Libre / Libre Flash
Manufacturer:Sole: Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm or Abdomen
Measurement Occurrence:Single and continuous measurements
Availability:Available Currently
Description: The Abbott FreeStyle Libre (Flash) is a clinically validated blood glucose meter. Measurements are taken from the upper arm or abdomen and it is intended for self-measurement and home use.
Assessment:

The technology used in the Abbott FreeStyle Libre (Flash), to measure blood glucose, has been assessed, in general populations, according to a non-standard protocols. It has also been assessed in a study, the results of which have not been published and cannot be verified.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhen an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
TÜV Rheinland NederlandGeneral useUnpublished internal data
MDR CriteriaAdultsValidation with amended protocol - may require further study

Validation Publications

Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technol Ther. 2015 Nov;17(11):787-94. Epub: 2015 Jul 14. doi: 10.1089/dia.2014.0378. PMID: 26171659. Available from: PMC4649725.

Ad Hoc protocol General population

Fokkert MJ, van Dijk PR, Edens MA, Abbes S, de Jong D, Slingerland RJ, Bilo HJ. Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2017 Feb 17;5(1):e000320. doi: 10.1136/bmjdrc-2016-000320. PMID: 28243449. Available from: PMC5316912.

Ad Hoc protocol General population

Ji L, Guo X, Guo L, Ren Q, Yu N, Zhang J. A Multicenter Evaluation of the Performance and Usability of a Novel Glucose Monitoring System in Chinese Adults With Diabetes. J Diabetes Sci Technol. 2017 Mar;11(2):290-5. Epub: 2016 Sep 25. doi: 10.1177/1932296816662884. PMID: 27559031.

Ad Hoc protocol General population

Edge J, Acerini C, Campbell F, Hamilton-Shield J, Moudiotis C, Rahman S, Randell T, Smith A, Trevelyan N. An alternative sensor-based method for glucose monitoring in children and young people with diabetes. Arch Dis Child. 2017 Jun;102(6):543-9. Epub: 2017 Jan 30. doi: 10.1136/archdischild-2016-311530. PMID: 28137708. Available from: PMC5466923.

Ad Hoc protocol Children and adolescents

Ancona P, Eastwood GM, Lucchetta L, Ekinci EI, Bellomo R, Mårtensson J The performance of flash glucose monitoring in critically ill patients with diabetes. Crit Care Resusc. 2018 jun;19(2):167-174. PMID: 28651513.

15197:2013 Critically Ill (Note: Based on the abstract, 64.3% of readings within criteria were deemed acceptable.)

CLSI:2013 Critically Ill (Note: Based on the abstract, 56.8% of readings within criteria were deemed acceptable.)

Alsaffar H, Turner L, Yung Z, Didi M, Senniappan S. Continuous Flash Glucose Monitoring in children with Congenital Hyperinsulinism; first report on accuracy and patient experience. Int J Pediatr Endocrinol. 2018;2018:3. Epub: 2018 Mar 27. doi: 101186/s13633-018-0057-2. PMID: 29599801. Available from: PMC5870486.

Ad Hoc protocol Children, aged 0.5-11 years, with congenital hyperinsulinism (n=11)

The Abbott Freestyle Optimum Neo was used as a reference device. Noticeable variability between the two methods of measuring the glucose was noted. Despite the ease of using the FSL system, concerns related to accuracy, especially at low glucose values do remain although parents find the glucose trend to be very useful. Further larger trials are needed in CHI patients before FSL is recommended as a routine alternative method for measuring glucose levels.

Cao B, Wang R, Gong C, Wu D, Su C, Chen J, Yi Y, Liu M, Liang X, Li W. An Evaluation of the Accuracy of a Flash Glucose Monitoring System in Children with Diabetes in comparison with Venous Blood Glucose. J Diabetes Res. 2019 Sep 9;2019:4845729. doi: 101155/2019/4845729. PMID: 31583249. Available from: PMC6754897.

Ad Hoc protocol Hospitalised children, aged 0-14 years, with newly diagnosed type 1 diabetes (n=13) (Note: Recommended for use in paediatric population with higher HbA1c but not recommended for use in detecting hypoglycaemia.)

Relevant Publications

Freckmann G, Pleus S, Schlüter S, Heinemann L. Comment on "The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System" by Bailey et al. Diabetes Technol Ther. 2016 May;18(5):334-5. Epub: 2016 Feb 22. doi: 10.1089/dia.2016.0008. PMID: 26900898.

The publication is a letter or correspondence in which the Abbott FreeStyle Libre (Flash) is referenced.

Bonora B, Maran A, Ciciliot S, Avogaro A, Fadini GP. Head-to-head comparison between flash and continuous glucose monitoring systems in outpatients with type 1 diabetes. J Endocrinol Invest. 2016 Dec;39(12):1391-9. Epub: 2016 Jun 10. doi: 10.1007/s40618-016-0495-8. PMID: 27287421.

Measurements from the Abbott FreeStyle Libre (Flash) are compared to those from the Dexcom G4 Platinum, though not in a formal validation.

Pariente Rodrigo E, Deib-Morgan K, García de Diego O, García-Velasco P, Sgaramella GA García González I Accuracy and reliability between glucose meters: A study under normal clinical practice conditions Semergen. 2017 Jan;43(1):20-27. Epub: 2016. doi: 10.1016/j.semerg.2016.01.011. PMID: 26968861.

Measurements from the Abbott FreeStyle Libre (Flash) are compared to those from the Dexcom G4 Platinum, though not in a formal validation.

The authors concluded that there was good agreement between the devices.

Aberer F, Hajnsek M, Rumpler M, Zenz S, Baumann PM, Elsayed H, Puffing A, Treiber G, Pieber TR, Sourij H, Mader J. Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes. Diabetes Obes Metab. 2017 Jul;19(7):1051-5. Epub: 2017 Mar 16. doi: 10.1111/dom.12907. PMID: 28205324. Available from: onlinelibrary.wiley.com.

Assessment in patients with T1DM over 12 hours in standardised conditions.

Schierenbeck F, Franco-Cereceda A, Liska J. Accuracy of 2 Different Continuous Glucose Monitoring Systems in Patients Undergoing Cardiac Surgery. J Diabetes Sci Technol. 2017 Jan;11(1):108-16. Epub: 2016 Jul 9. doi: 10.1177/1932296816651632. PMID: 27257168. Available from: PMC5375060.

Measurements from the Abbott FreeStyle Libre (Flash) are compared to those from the Maquet Eirus, though not in a formal validation.

Boscari F, Galasso S, Facchinetti A, Marescotti MC, Vallone V, Amato AML, Avogaro A, Bruttomesso D. FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):180-6. Epub: 2017 Nov 11. doi: 10.1016/j.numecd.2017.10.023. PMID: 29258716.

Measurements from the Abbott FreeStyle Libre (Flash) are compared to those from the Dexcom G4 Platinum, though not in a formal validation.

The authors concluded that both devices performed similarly for 2 weeks (manufacturer-specified lifetime for the Libre; double that lifetime for the G4) but that both performed less well during hypoglycaemia with the Libre beings more accurate during glucose swings.

Al Hayek AA, Robert AA, Al Dawish MA. Evaluation of FreeStyle Libre Flash Glucose Monitoring System on Glycemic Control, Health-Related Quality of Life, and Fear of Hypoglycemia in Patients with Type 1 Diabetes. Clin Med Insights Endocrinol Diabetes. 2017 Dec 10;10:1179551417746957. doi: 101177/1179551417746957. PMID: 29270042. Available from: PMC5731614.

The frequent use of FGM scanning reduced the frequency of hypoglycemia, HbA1c level, and worry and increased the behavior and QoL. As compared with self-testing by the conventional finger-pricking method, the use of FGM increased the frequency of self-testing and thus diabetes control.

Massa GG, Gys I, Op't Eyndt A, Bevilacqua E, Wijnands A, Declercq P, Zeevaert R. Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Horm Res Paediatr. 2018;89(3):189-99. Epub: 2018 Mar 27. doi: 10.1159/000487361. PMID: 29587254.

Comparisons in children and adolescents with T1DM (aged 4 to 18 years) to the Roche Accu-Chek Mobile (n=24), the Bayer Contour Next Link (n=26) and the JnJ LifeScan OneTouch Verio IQ (n=17). Authors conclude reasonable agreement but with large interindividual variability and that further studies in children are imperative.

Freckmann G, Link M, Pleus S, Westhoff A, Kamecke U, Haug C. Measurement Performance of Two Continuous Tissue Glucose Monitoring Systems Intended for Replacement of Blood Glucose Monitoring. J Diabetes Sci Technol. 2018 Aug;20(8):541-549. doi: 10.1089/dia.2018.0105. PMID: 30067410. Available from: PMC6080122.

The publication evaluates the performance of the Abbott FreeStyle Libre (Flash), though not in a formal validation.

Approximately 25% of results showed differences from reference results exceeding 15 mg/dL, at glucose concentration below 100 mg/dL, or exceeding 15%, at glucose concentration above 100 mg/dL, at times of therapeutic decisions.

Al Hayek AA, Robert AA, Al Dawish MA. Differences of FreeStyle Libre Flash Glucose Monitoring System and Finger Pricks on Clinical Characteristics and Glucose Monitoring Satisfactions in Type 1 Diabetes Using Insulin Pump. Clin Med Insights Endocrinol Diabetes. 2019 Jul 1;12:1179551419861102. doi: 101177/1179551419861102. PMID: 31308786. Available from: PMC6604122.

The frequency of hypoglycemia, HbA1c level, capillary glucose, daily carbohydrates intake decreased, while the total daily insulin dose, daily bolus insulin and total GMS score increased with the use of FGM scanning for 12 weeks.

Ontario Health (Quality). Flash Glucose Monitoring System for People with Type 1 or Type 2 Diabetes: A Health Technology Assessment. Ont Health Technol Assess Ser. 2019 Dec 12;19(8):1-108. PMID: 31942227. Available from: PMC6939983.

Flash glucose monitoring improves diabetes management among adults with well-controlled type 1 diabetes and adults with type 2 diabetes requiring intensive insulin therapy.

Al Hayek AA, Robert AA, Al Dawish MA. Effectiveness of the Freestyle Libre Flash Glucose Monitoring System on Diabetes Distress Among Individuals with Type 1 Diabetes: A Prospective Study. Diabetes Ther. 2020 Apr;11(4):927-937. Epub: 2020 Mar 7. doi: 101007/s13300-020-00793-2. PMID: 32146691. Available from: PMC7136360.

Once patients had been switched from the fingerprick method to FGMS, the DRD and related clinical parameters showed remarkable improvement. However, further studies are necessary to determine whether the continued and consistent use of the FGMS will achieve better results.

Al Hayek AA, Robert AA, Al Dawish MA. Acceptability of the FreeStyle Libre Flash Glucose Monitoring System: The Experience of Young Patients With Type 1 Diabetes. Clin Med Insights Endocrinol Diabetes. 2020 Mar 16;13:1179551420910122. doi: 101177/1179551420910122. PMID: 32206014. Available from: PMC7076574.

The findings of this study showed that the study population had a high level of acceptability of the FGM.