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Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter.

ABSTRACT: BACKGROUND:In recent clinical trials, use of the MyGlucoHealth blood glucose meter (BGM) and electronic diary was associated with an unusual reporting pattern of glycemic data and hypoglycemic events. Therefore, the performance of representative BGMs used by the patients was investigated to assess repeatability, linearity, and hematocrit interference in accordance with regulatory guidelines. METHOD:Ten devices and 6 strip lots were selected using standard randomization and repeatability procedures. Venous heparinized blood was drawn from healthy subjects, immediately aliquoted and adjusted to 5 target blood glucose (BG) ranges for the repeatability and 11 BG concentrations for the linearity tests. For the hematocrit interference test, each sample within 5 target BG ranges was split into 5 aliquots and adjusted to hematocrit levels across the acceptance range. YSI 2300 STAT Plus was used as the laboratory reference method in all experiments. RESULTS:Measurement repeatability or precision was acceptable across the target BG ranges for all devices and strip lots with coefficient of variation (CV) between 3.4-9.7% (mean: 5.7%). Linearity was shown by a correlation coefficient of .991; however, a positive bias was seen for BG <100 mg/dL (86% measurements did not meet ISO15197:2015 acceptance criteria). Significant hematocrit interference (up to 20%) was observed for BG >100 mg/dL (ISO15197:2015 acceptance criteria: ±10%), while the results were acceptable for BG <100 mg/dL. CONCLUSIONS:The BGM met repeatability requirements but demonstrated a significant measurement bias in the low BG range. In addition, it failed the ISO15197:2015 criteria for hematocrit interference.

SUBMITTER: Demircik F

PROVIDER: S-EPMC6501519 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter.

Demircik Filiz F Kirsch Valeria V Ramljak Sanja S Vogg Mario M Pfützner Anke H AH Pfützner Andreas A

Journal of diabetes science and technology 20190411 3

<h4>Background</h4>In recent clinical trials, use of the MyGlucoHealth blood glucose meter (BGM) and electronic diary was associated with an unusual reporting pattern of glycemic data and hypoglycemic events. Therefore, the performance of representative BGMs used by the patients was investigated to assess repeatability, linearity, and hematocrit interference in accordance with regulatory guidelines.<h4>Method</h4>Ten devices and 6 strip lots were selected using standard randomization and repeata ...[more]

PMID: 30974988

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Project description:BackgroundDiabetes is a global epidemic affecting approximately 30 million people in the United States. The World Health Organization recommends using technology and telecommunications to improve health care delivery and disease management. The Livongo for Diabetes Program offers a remote monitoring technology with Certified Diabetes Educator outreach.ObjectiveThe purpose of this study was to examine health outcomes measured by changes in HbA1c, in time in target blood glucose range, and in depression symptoms for patients enrolled in a remote digital diabetes management program in a Diabetes Center of Excellence setting.MethodsThe impact of the Livongo for Diabetes program on hemoglobin A1c (HbA1c), blood glucose ranges, and depression screening survey results (Patient Health Questionnaire-2 [PHQ-2]) were assessed over 12 months in a prospective cohort recruited from the University of South Florida Health Diabetes Home for Healthy Living. Any patient ≥18 years old with a diagnosis of diabetes was approached for voluntary inclusion into the program. The analysis was a pre-post design for those members enrolled in the study. Data was collected at outpatient clinic visits and remotely through the Livongo glucose meter.ResultsA total of 86 adults were enrolled into the Livongo for Diabetes program, with 49% (42/86) female, an average age of 50 (SD 15) years, 56% (48/86) with type 2 diabetes mellitus, and 69% (59/86) with insulin use. The mean HbA1c drop amongst the group was 0.66% (P=.17), with all participants showing a decline in HbA1c at 12 months. A 17% decrease of blood glucose checks <70 mg/dL occurred concurrently. Participants with type 2 diabetes not using insulin had blood glucose values within target range (70-180 mg/dL) 89% of the time. Participants with type 2 diabetes using insulin were in target range 68% of the time, and type 1 diabetes 58% of the time. Average PHQ-2 scores decreased by 0.56 points during the study period.ConclusionsParticipants provided with a cellular-enabled blood glucose meter with real-time feedback and access to coaching from a certified diabetes educator in an outpatient clinical setting experienced improved mean glucose values and fewer episodes of hypoglycemia relative to the start of the program.

Dataset Information

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter.

Publications

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter.

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