Fundamental Importance of Reference Glucose Analyzer Accuracy for Evaluating the Performance of Blood Glucose Monitoring Systems (BGMSs).

Background: As blood glucose monitoring system (BGMS) accuracy is based on comparison of BGMS and laboratory reference glucose analyzer results, reference instrument accuracy is important to discriminate small differences between BGMS and reference glucose analyzer results. Here, we demonstrate the important role of reference glucose analyzer accuracy in BGMS accuracy evaluations.

Methods: Two clinical studies assessed the performance of a new BGMS, using different reference instrument procedures.

The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System.

Introduction: The purpose of the study was to evaluate the performance and usability of the FreeStyle(®) Libre™ Flash glucose monitoring system (Abbott Diabetes Care, Alameda, CA) for interstitial glucose results compared with capillary blood glucose results.

Materials And Methods: Seventy-two study participants with type 1 or type 2 diabetes were enrolled by four U.S.

Accuracy and user performance evaluation of the Contour(®) Next Link 2.4 blood glucose monitoring system.

Background: The Contour(®) Next Link 2.4 blood glucose monitoring system (BGMS), which communicates wirelessly exclusively with a Medtronic insulin pump, was assessed in 2 separate studies.

Methods: In the laboratory study (N=100), subject capillary fingertip samples were tested in duplicate using 3 test strip lots; accuracy was assessed based on ISO 15197:2013 section 6.

Clinical performance and safety of adapters for intradermal delivery with conventional and autodisable syringes.

Although the number of vaccines and diagnostic tests currently delivered intradermally is limited, this route of administration offers potential advantages due to the high concentration of antigen-presenting cells in the skin. One factor which may in part be limiting development and use of intradermal (ID) administration is concern about the ease and reliability of the needle and syringe-based Mantoux technique. A phase I clinical study was conducted to evaluate two ID adapters that have been developed as injection-delivery aids to increase the safety, simplicity, and reliability of ID injection: a prototype autodisable, intradermal (ADID) adapter for autodisable (AD) syringes, and a marketed side-merge adapter (SMA).

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.

Background: This study evaluated the accuracy of Contour(®) Next (CN; Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) compared with five blood glucose monitoring systems (BGMSs) across a wide range of clinically occurring blood glucose levels.

Subjects And Methods: Subjects (n=146) were ≥ 18 years and had type 1 or type 2 diabetes. Subjects' glucose levels were safely lowered or raised to provide a wide range of glucose values.

Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Patients with Type 2 Diabetes (Begin: Compare).

Objective: The purpose of the present study was to provide clinical data on the efficacy and safety of insulin degludec (IDeg) 200 U/mL compared with IDeg 100 U/mL in patients with type 2 diabetes mellitus (T2DM) currently treated with basal insulin in combination with oral antidiabetic drugs.

Methods: In this 22-week, treat-to-target trial, eligible adult patients with T2DM were randomized 1:1 to IDeg 200 or IDeg 100 U/mL once daily (OD) (n = 186 and 187, respectively). The starting insulin dose was based on a 1:1 transfer of the total prerandomization basal insulin dose.

Clinical evaluation of the FreeStyle Precision Pro system.

Background: A new version of international standard (ISO 15197) and CLSI Guideline (POCT12) with more stringent accuracy criteria are near publication. We evaluated the glucose test performance of the FreeStyle Precision Pro system, a new blood glucose monitoring system (BGMS) designed to enhance accuracy for point-of-care testing (POCT).

Methods: Precision, interference and system accuracy with 503 blood samples from capillary, venous and arterial sources were evaluated in a multicenter study.

Performance variability of seven commonly used self-monitoring of blood glucose systems: clinical considerations for patients and providers.

Background: Blood glucose data are frequently used in clinical decision making, thus it is critical that self-monitoring of blood glucose (SMBG) systems consistently provide accurate results. Concerns about SMBG accuracy have prompted the development of newly proposed International Organization for Standardization (ISO) standards: ≥ 95% of individual glucose results shall fall within ± 15 mg/dl of the results of the manufacturer's reference procedure at glucose concentrations <100 mg/dl and within ± 15% for values ≥ 100 mg/dl. We evaluated seven marketed systems against the current and proposed ISO criteria (criterion A).

Performance of a glucose meter with a built-in automated bolus calculator versus manual bolus calculation in insulin-using subjects.

Background: Patients consider multiple parameters in adjusting prandial insulin doses for optimal glycemic control. Difficulties in calculations can lead to incorrect doses or induce patients to administer fixed doses, rely on empirical estimates, or skip boluses.

Method: A multicenter study was conducted with 205 diabetes subjects who were on multiple daily injections of rapid/ short-acting insulin.

Effect of adding sitagliptin, a dipeptidyl peptidase-4 inhibitor, to metformin on 24-h glycaemic control and beta-cell function in patients with type 2 diabetes.

Aim: The aim of this study was to assess the effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on 24-h glucose control when added to the regimen of patients with type 2 diabetes who had inadequate glycaemic control on metformin therapy.

Methods: In a double-blind, randomized, placebo-controlled, two-period crossover study, patients with type 2 diabetes with inadequate glycaemic control on metformin monotherapy (i.e.