System accuracy assessments with a blood glucose meter with combined glucose and ß-hydroxybutyrate measurement capabilities

ABSTRACT

Background: We evaluated the Wellion Galileo GLU/KET blood and ketone (ß-Hydroxybutyrate, ß-OHB) meter to demonstrate that it meets ISO15107:2015 regulatory approval criteria.

Research Design and Methods: A total of 100 subjects (52 female, age: 30 to 84 years, diabetes: 10 type 1/90 type 2) with blood glucose levels distributed over the entire measurement range as required by the ISO15197 protocol were tested (double determinations with 3 strip lots and two devices). A similar test protocol was followed to test ß-OHB strip performance (reference devices: YSI 2300plus for glucose and STANBIO ß-HOB LiquiColor TestKit for ß-OHB). Precision was tested for glucose with 3 blood glucose concentrations (ß-OHB: 2 control solutions).

Results: All glucose test-strip lots met the strict ISO acceptance criteria. Mean absolute relative difference (MARD) was 4.9% and all data pairs were in zone A of the consensus error grid. The ß-OHB test-strips also met the pre-defined acceptance criteria. Within-run and between-run precision was calculated to be 2.3% and 0.7% for the glucose strips (3.7%/0.8% for the ketone strips).

Conclusions: When tested according to the ISO15197:2015 guideline, the device showed very accurate measurement performance for glucose and ß-OHB testing and fully met regulatory accuracy approval criteria.

KEYWORDS:

• Blood glucose meter
• accuracy
• precision
• ß-hydroxybutyrate
• ß-OHB

Article highlights

• Accurate blood glucose meters for self-testing are mandatory for efficient and safe diabetes care.

• The Galileo GLU/KET meter has successfully passed the evaluation criteria set forth by ISO15,197

• The meter measures both glucose and ketones with high accuracy

Declaration of interest

Sylvia Weißenbacher is an employee of MED TRUST, the manufacturer of the device. Chen-Yu Yang and Tang-Chin Kuan are employed by the strip manufacturer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewers Disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This study was funded by a general research grant from MedTrust.