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A new test strip technology platform for self-monitoring of blood glucose.

ABSTRACT: In the management of diabetes, accuracy of devices used for self-monitoring of blood glucose (SMBG) is critical because SMBG results can affect patient diabetes-related health outcomes. A new blood glucose monitoring system (BGMS) platform has been developed that is based on the new CONTOUR® NEXT (CN) test strip. This BGMS platform uses a proprietary electron mediator and algorithm to minimize errors at different steps in the testing process, thus minimizing outliers and significantly improving accuracy from prior-generation blood glucose meter systems. As demonstrated by questionnaire results from clinical studies with the new BGMS platform, accuracy and ease of use are important considerations for people with diabetes and their health care professionals when selecting an SMBG device. This article provides an overview of laboratory studies and clinical trials in the hands of lay users involving the performance of the portfolio of blood glucose meters that uses the new test strip. Each BGMS in the platform, which includes the CONTOUR XT (CONTOUR NEXT EZ in the United States), CONTOUR NEXT LINK, CONTOUR NEXT USB, and CN systems, demonstrated advanced accuracy both in the laboratory and in the hands of subjects (people with diabetes) and trained health care professionals. All systems met and exceeded International Organization for Standardization accuracy criteria (both ISO 15197:2003 and ISO 15197:2013). Each system in the new BGMS platform delivers advanced accuracy, which is essential to people who utilize SMBG for improved management.

SUBMITTER: Bernstein R

PROVIDER: S-EPMC3876385 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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A new test strip technology platform for self-monitoring of blood glucose.

Bernstein Robert R Parkes Joan Lee JL Goldy Amy A Brown Daniel D Harrison Bern B Chu Amy A Pflug Brian K BK Simmons David A DA Pardo Scott S Bailey Timothy S TS

Journal of diabetes science and technology 20130901 5

In the management of diabetes, accuracy of devices used for self-monitoring of blood glucose (SMBG) is critical because SMBG results can affect patient diabetes-related health outcomes. A new blood glucose monitoring system (BGMS) platform has been developed that is based on the new CONTOUR® NEXT (CN) test strip. This BGMS platform uses a proprietary electron mediator and algorithm to minimize errors at different steps in the testing process, thus minimizing outliers and significantly improving ...[more]

PMID: 24124968

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Project description:BackgroundSelf-monitoring of blood glucose (SMBG) has been shown to reduce hemoglobin A1C (HbA1C). Accordingly, guidelines recommend SMBG up to 4-10 times daily for adults with type 2 diabetes (T2DM) on insulin. For persons not on insulin, recommendations are equivocal. Newer technology-enabled blood glucose monitoring (BGM) devices can facilitate remote monitoring of glycemic data. New evidence generated by remote BGM may help to guide best practices for frequency and timing of finger-stick blood glucose (FSBG) monitoring in uncontrolled T2DM patients managed in primary care settings. This study aims to evaluate the impact of SMBG utility and frequency on glycemic outcomes using a novel BGM system which auto-transfers near real-time FSBG data to a cloud-based dashboard using cellular networks.MethodsSecondary analysis of the intervention arm of a comparative non-randomized trial with propensity-matched chart controls. Adults with T2DM and HbA1C > 9% receiving care in five primary care practices in a healthcare system participated in a 3-month diabetes boot camp (DBC) using telemedicine and a novel BGM to support comprehensive diabetes care management. The primary independent variable was frequency of FSBG. Secondary outcomes included frequency of FSBG by insulin status, distribution of FSBG checks by time of day, and hypoglycemia rates.Results48,111 FSBGs were transmitted by 359 DBC completers. Participants performed 1.5 FSBG checks/day; with 1.6 checks/day for those on basal/bolus insulin. Higher FSBG frequency was associated with greater improvement in HbA1C independent of insulin treatment status (p = 0.0003). FSBG frequency was higher in patients treated with insulin (p = 0.003). FSBG checks were most common pre-breakfast and post-dinner. Hypoglycemia was rare (1.2% < 70 mg/dL).ConclusionsAdults with uncontrolled T2DM achieved significant HbA1C improvement performing just 1.5 FSBGs daily during a technology-enabled diabetes care intervention. Among the 40% taking insulin, this improvement was achieved with a lower FSBG frequency than guidelines recommend. For those not on insulin, despite a lower frequency of FSBG, they achieved a greater reduction in A1C compared to patients on insulin. Low frequency FSBG monitoring pre-breakfast and post-dinner can potentially support optimization of glycemic control regardless of insulin status in the primary care setting.Trial registrationTrial registration number: NCT02925312 (10/19/2016).

Dataset Information

A new test strip technology platform for self-monitoring of blood glucose.

Publications

A new test strip technology platform for self-monitoring of blood glucose.

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