Abbott FreeStyle Lite
Device Name:
FreeStyle Lite
Manufacturer:
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:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Device Manual:
Click here to download the Device Manual
Description:
The Abbott FreeStyle Lite is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Abbott FreeStyle Lite, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in nine clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
BG TÜV Rheinland Nederland General use Unpublished internal data
BG Institute of Health Economics (CA) General use No evidence provided
BG MDR Criteria Self-measurement Published evidence
Consumer BodyYear(s)LevelComment
BG Consumer Reports (US) Latest: 2019-2022 Excellent
Validation Publications:

Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.

15197:2003 - Pass General population

Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, Pfützner A. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012 Apr;14(4):330-7. Epub: 2011 Dec 16. doi: 10.1089/dia.2011.0170. PMID: 22176154.

15197:2003 - Pass General population

15197:2013 - Pass General population

Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1076-86. doi: 10.1177/193229681200600511. PMID: 23063033. Available from: PMC3570841.

15197:2003 - Pass General population (Note: 4 test-strip lots; all 4 within requirements)

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Pass General population

15197:2013 - Pass General population

Zueger T, Schuler V, Stettler C, Diem P, Christ ER. Assessment of three frequently used blood glucose monitoring devices in clinical routine. Swiss Med Wkly. 2012 Jul 12;142:w13631. doi: 10.4414/smw.2012.13631. PMID: 22791566. eCollection 2012.

15197:2003 - Pass General population (Note: Reference device: HemoCue Glucose 201+)

Parwaiz M, Lunt H, Florkowski CM, Logan FJ, Irons L, Perwick C, Frampton CM, Moore MP. Assessment of glucose meter performance at the antenatal diabetes clinic: exploration of patient-related and pre-analytical factors. Ann Clin Biochem. 2014 Jan 5;51(Pt 1):47-53. Epub: 2013 Sep 3. doi: 10.1177/0004563213487893. PMID: 24003257.

15197:2013 - Pass General population

Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014 May;8(3):466-72. Epub: 2014 Feb 18. doi: 10.1177/1932296814522804. PMID: 24876607. Available from: PMC4455429.

15197:2013 - Pass General population

Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

FDA:2016H - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Pass General population (Note: Subject-recorded measurements)

FDA:2016H - Pass General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population

SKUP Evaluations 2007/64, 2010/89

Sutheran HL, Reynolds T. Technical and clinical accuracy of three blood glucose meters: clinical impact assessment using error grid analysis and insulin sliding scales. J Clin Pathol. 2016 Oct;69(10):899-905. Epub: 2016 Feb 5. doi: 10.1136/jclinpath-2015-203339. PMID: 26850631.

15197:2003 General population

From the absract, it appears that an evaluation of the Abbott FreeStyle Lite, the Roche Accu-Chek Aviva and an unnamed third device was performed. Neither the protocol used nor the results are clear from the abstract.

Baumstark A, Jendrike N, Pleus S, Haug C, Freckmann G. Evaluation of Accuracy of Six Blood Glucose Monitoring Systems and Modeling of Possibly Related Insulin Dosing Errors. Diabetes Technol Ther. 2017 Oct;19(10):580-8. Epub: 2017 Jul 13. doi: 10.1089/dia.2016.0408. PMID: 28704063.

15197:2013 General population

Six devices were validated in the study (the Roche Accu-Chek Aviva Nano, the Roche Accu-Chek Mobile, the Roche Accu-Chek Performa Nano, the Ascensia Contour Next Link 2.4, the Abbott FreeStyle Lite and the J&J LifeScan OneTouch Verio IQ). According to the abstract, one of them failed but it does not state which one.

Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018 Aug;41(8):1681-8. Epub: 2018 Jun 13. doi: 10.2337/dc17-1960. PMID: 29898901. Available from: www.diabetestechnology.org.

DTS:2016 - Pass General population

SKUP. Report from the evaluation SKUP/2007/64: Freestyle Lite (Abbott Diabetes Care), a system for blood glucose measurement. Bergen, Norway: SKUP; 2007. 44 p. Available from: skup.org.

15197:2003 - Pass General population

Results counted in Sølvik et al. 2015.

SKUP. Report from the evaluation SKUP/2010/89: FreeStyle Lite (Abbott Diabetes Care), a system for blood glucose measurement. Bergen, Norway: SKUP; 2010. 44 p. Available from: skup.org.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

Results counted in Sølvik et al. 2015.

Relevant Publications:

Hoss U, Budiman ES, Liu H, Christiansen MP. Feasibility of Factory Calibration for Subcutaneous Glucose Sensors in Subjects With Diabetes. J Diabetes Sci Technol. 2014 Jan;8(1):89-94. Epub: 2014 Jan 1. doi: 10.1177/1932296813511747. PMID: 24876543. Available from: PMC4454101.

Measurements from the Abbott FreeStyle Lite are compared to those from the Abbott FreeStyle Navigator, though not in a formal validation.

Fingerstick and wired-enzyme technologies are compared.

Klaff LJ, Brazg R, Hughes K, Tideman AM, Schachner HC, Stenger P, Pardo S, Dunne N, Parkes JL. Accuracy evaluation of contour next compared with five blood glucose monitoring systems across a wide range of blood glucose concentrations occurring in a clinical research setting. Diabetes Technol Ther. 2015 Jan;17(1):8-15. doi: 10.1089/dia.2014.0069. PMID: 25260047.

Measurements from the Abbott FreeStyle Lite are compared to those from the Ascensia (Bayer) Contour Next and, indirectly, the Roche Accu-Chek Aviva Nano, the J&J LifeScan OneTouch Ultra 2, the J&J LifeScan OneTouch Verio Pro and the Nipro Truetrack, though not in a formal validation.

McGrath RT, Donnelly VC, Glastras SJ, Preda VA, Sheriff N, Ward P, Hocking SL, Fulcher GR. Evaluation of Blood Glucose Meter Efficacy in an Antenatal Diabetes Clinic. Diabetes Technol Ther. 2016 Feb;18(2):68-74. Epub: 2015 Oct 6. doi: 10.1089/dia.2015.0104. PMID: 26440810. Available from: PMC5519155. Retraction in: Diabetes Technol Ther. 2017 Jun;19(6):382.

Retraction of: RT McGrath, et al; Evaluation of Blood Glucose Meter Efficacy in an Antenatal Diabetes Clinic. Diabetes Technol Ther. 2016;18(2):68–74. DOI: 10.1089/dia.2015.0104 Diabetes Technol Ther. 2017 Jun. 382 p. doi: 10.1089/dia.2015.0104.retract. PMID: 28541796. Available from: PMC5519155.

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