Sustained Improvements in Readings in-Range Using an Advanced Bluetooth Connected Blood Glucose Meter and a Mobile Diabetes App: Real-World Evidence from more than 55,000 People with Diabetes.

Introduction: The OneTouch Verio Reflect (OTVR) Blood Glucose Meter features a color range indicator and provides on-meter guidance, insights, and encouragement. Diabetes management is enhanced by the OneTouch Reveal (OTR) Mobile App. We sought to provide real-world evidence (RWE) that combining devices improves glycemia.

Clinical Accuracy of a Glucose Oxidase-Based Blood Glucose Test-Strip Across Extremes of Oxygen Partial Pressure.

Background: Glucose oxidase (GOx)-based blood glucose monitors (BGMs) are influenced by the partial pressure of oxygen (Po) within the applied sample. Limited in-clinic data exists regarding the quantitative effect of Po in unmanipulated capillary fingertip blood samples across physiologically representative glucose and Po ranges.

Method: Clinical accuracy data were collected as part of a BGM manufacturer's ongoing post-market surveillance program for a commercially available GOx-based BGM test-strip.

Improved Glycemic Control Using a Bluetooth®-Connected Blood Glucose Meter and a Mobile Diabetes App: Real-World Evidence From Over 144 000 People With Diabetes.

Background: The OneTouch Verio Flex® (OTVF) blood glucose (BG) meter features a ColorSure® Range Indicator. Diabetes management is enhanced by connecting the meter to the OneTouch Reveal® (OTR) mobile app. We sought to provide real-world evidence (RWE) that combining both devices improves glycemic control.

Real-World Evidence of Improved Glycemic Control in People with Diabetes Using a Bluetooth-Connected Blood Glucose Meter with a Mobile Diabetes Management App.

The OneTouch Verio Reflect (OTVR) meter provides ColorSure Dynamic Range Indicator (DCRI) and Blood Sugar Mentor (BSM) features that are complemented by the OneTouch Reveal (OTR) mobile app. We sought to provide real-world evidence that these products support improved glycemic control. Anonymised glucose and app analytics were extracted from the LifeScan server for 4154 people with type 1 diabetes (PwT1D) and 13,623 people with type 2 diabetes (PwT2D).

Distribution of Oxygen Partial Pressures in Native Capillary Fingertip Blood Samples From a Large Diabetes Patient Population.

A data set comprising 28 533 oxygen partial pressure (pO) values gathered from nonarterialized fingertip capillary blood samples of a large diabetes population is reported. Data were gathered routinely as part of the ongoing clinical surveillance activities of a blood glucose monitoring (BGM) system manufacturer. Overall, a mean pO level of 75.

Use of a Meter With Color-Range Indicators and a Mobile Diabetes Management App Improved Glycemic Control and Patient Satisfaction in an Underserved Hispanic Population: "Tu Salud"-A Randomized Controlled Partial Cross-Over Clinical Study.

Objective: To demonstrate the clinical value of OneTouch (OT) Verio Flex glucose meter used in combination with a Spanish-language version of the OT Reveal mobile application (app) to support diabetes care and improve glycemic control in an underserved Hispanic population with type 2 diabetes.

Research Design And Methods: Test subjects ( = 81) used the meter and app for 12 weeks, while a randomized control group ( = 39) used their own glucose meters without connection to an app. Thereafter, test subjects continued the same regimen for an additional 12 weeks to determine the durability of effect, and control subjects crossed over to use the new meter and app.

Post-Market Surveillance of a Blood Glucose Test Strip Demonstrates No Evidence of Interference on Clinical Accuracy in a Large Cohort of People with Type 1 or Type 2 Diabetes.

Background: Regulations and industry guidance relating to testing for interference in blood glucose monitoring (BGM) systems continue to focus on in vitro laboratory bench tests. Post-market surveillance (PMS) in a clinical setting allows for BGM accuracy assessments to evaluate the impact of real-world exposure to polypharmacy in people with diabetes. This study evaluated the OneTouch Select Plus® BGM test-strip accuracy with respect to polypharmacy using a clinical registry dataset.

Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance.

Background: On-going manufacturer-led post-market surveillance (PMS), assessing the clinical accuracy of blood glucose monitoring (BGM) systems, is critical to substantiate the performance of such products for people with diabetes.

Materials And Methods: Batches of Verio test-strip product were randomly and routinely selected over the period from launch of an improved-algorithm product to reporting date and sent to 3 clinic sites for clinician-led accuracy assessment. Accuracy is reported as per recently adopted FDA guidance for BGM systems, EN ISO 15197:2015 and MARD/MAD (Mean absolute relative difference/Mean absolute difference).

Patients With Diabetes Using a New Glucose Meter With Blood Sugar Mentor and Dynamic Color Range Indicator Features Show Improved Interpretation and Willingness to Act on Blood Glucose Results (ASCEND Study).

Background: We examined whether dynamic color range indicator (DCRI) and blood sugar mentor (BSM) features in a new blood glucose meter could improve interpretation of results and encourage patient action.

Methods: One hundred and thirty three people with type 2 (T2D) ( = 73) or type 1 diabetes (T1D) ( = 60) evaluated information first without and then with DCRI or BSM guidance using interactive exercises.

Results: Subjects improved their ability to categorize results into low, in range, or high glycemic ranges by 29% (T2D) and 22% (T1D) (each  < .

Satisfaction of Healthcare Professionals and People With Diabetes With an Insulin Bolus Calculator Mobile Application.

People with diabetes (PWD) who need to take mealtime insulin to help control their blood sugar often have difficulty correctly calculating their dose due to consideration of many factors such as current blood glucose, carbohydrate consumption, active insulin duration, insulin-to-carb ratio, and insulin sensitivity. The Insulin Mentor, a bolus calculator tool in the OneTouch Reveal diabetes management app, uses an algorithm to automate many of these calculations and contains a link to a food diary to help estimate carbohydrate intake. In the current study, healthcare professionals and PWD from United States and Germany responded favorably to simulations of this calculator tool and compared it positively with other apps on the market.

Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users.

The OneTouch Verio Reflect blood glucose monitor (BGM) has market clearance in several countries based in part on fulfilling the lay user and system accuracy criteria described in ISO15197:2015. However, the Food and Drug Administration (FDA) does not recognize the accuracy criteria in ISO15197 as a basis for gaining regulatory clearance for these devices. The current study evaluates the BGM using the accuracy guidelines issued by the agency for self-monitoring blood glucose test systems for over-the-counter use.

Analysis of a Unique Postmarket Surveillance Dataset That a Glucose Test-Strip Demonstrates no Evidence of Interference and Robust Clinical Accuracy Irrespective of the Prescription Medication Status of a Large Cohort of Patients With Diabetes.

Background: Despite a marked increase in polypharmacy in patients with diabetes there have been no thorough evaluations of the impact of polypharmacy on the accuracy of any current blood glucose monitoring (BGM) system. This study evaluated the accuracy of a BGM test-strip with respect to polypharmacy using a large clinical registry dataset.

Methods: Medication profiles were analyzed for 830 subjects (334 with type 1 [T1D] and 496 with type 2 diabetes [T2D]) attending three hospitals.

Patient Satisfaction With a New, High Accuracy Blood Glucose Meter That Provides Personalized Guidance, Insight, and Encouragement.

Background: Accurate self-monitoring of blood glucose (SMBG) is a key component of effective self-management of glycemic control.

Methods: The OneTouch Verio Reflect and OneTouch Ultra Plus Reflect BG monitoring systems were evaluated for accuracy in a clinical setting. Subjects also used the meters for a one-week trial period and reported their level of satisfaction with meter features.

Clinical Evaluation of a New, Lower Pain, One Touch Lancing Device for People With Diabetes: Virtually Pain-Free Testing and Improved Comfort Compared to Current Lancing Systems.

Background: Patients worldwide use lancing devices to perform self-monitoring of blood glucose (SMBG). Continued innovation remains important to minimize pain associated with finger sticking to facilitate patient adherence to SMBG regimens. The original One Touch Delica lancer (OTD) reduced the pain of testing.

Examining the Impact of a Novel Blood Glucose Monitor With Color Range Indicator on Decision-Making in Patients With Type 1 and Type 2 Diabetes and its Association With Patient Numeracy Level.

Background: Many patients struggle to interpret and respond appropriately to the numerical blood glucose results displayed on their meter, with many regularly taking no action or self-care adjustment for out-of-range results. We recently reported that a glucose meter that provides automatic onscreen information using a color range indicator (ColorSure Technology) improved the ability of patients to categorize their blood glucose results.

Objective: The objective of this study was to examine how ColorSure Technology (or color) affected patient decision making on blood glucose results and how patient numeracy levels influenced such decisions.

Capillary and Venous Blood Glucose Accuracy in Blood Glucose Meters Versus Reference Standards: The Impact of Study Design on Accuracy Evaluations.

Background: Anecdotal blood glucose assessments conducted by health care professionals (HCPs) in the field have highlighted differences in results when methodology used is not according to best practices for measuring blood glucose. This study assessed the impact on accuracy of blood glucose measurements when methodology deviates from the recommended study design and recommended reference instrument.

Methods: Adults with type 1 or type 2 diabetes provided capillary and venous blood samples for accuracy assessments using OneTouch® Verio® (Verio) and OneTouch® Ultra 2® (Ultra) blood glucose meters (BGM) and two different reference instruments.

Diabetes App-Related Text Messages From Health Care Professionals in Conjunction With a New Wireless Glucose Meter With a Color Range Indicator Improves Glycemic Control in Patients With Type 1 and Type 2 Diabetes: Randomized Controlled Trial.

Background: Mobile diabetes apps enable health care professionals (HCPs) to monitor patient progress, offer remote consultations, and allow more effective and informed treatment decisions between patients and HCPs. The OneTouch Reveal app aggregates data from a blood glucose meter and provides analytics to help patients and HCPs visualize glycemic trends and patterns, enabling more informed treatment and lifestyle decisions. The app also allows patients and HCPs to keep connected by exchanging text messages (short message service [SMS]) or progress reports via email.

Patient and Health-care Professional Satisfaction with a New, Simple, High Accuracy Blood Glucose Meter with Color Range Indicator.

Background: Accurate self-monitoring of blood glucose (BG) is a key component of effective self-management of glycemic control.

Methods: The OneTouch Select Plus Simple™ (OTSPS) BG monitoring system (BGMS) was evaluated for accuracy in a clinical setting.

Results: OTSPS was accurate over a wide glucose range and met lay user and system accuracy BG standards described in ISO 15197:2013.

Seven-Year Surveillance of the Clinical Performance of a Blood Glucose Test Strip Product.

Background: A key approach in enabling people with diabetes to better manage their condition is through self-monitoring of blood glucose (SMBG). Any functional SMBG system should demonstrate clinical accuracy across a broad glucose range and be insensitive to hematocrit. Furthermore, it should be incumbent on the manufacturer to demonstrate that their product continues to meet clinical accuracy claims during product lifetime.

A Comprehensive Evaluation of a Novel Color Range Indicator in Multiple Blood Glucose Meters Demonstrates Improved Glucose Range Interpretation and Awareness in Subjects With Type 1 and Type 2 Diabetes.

Aims: We previously demonstrated that people with type 2 diabetes (T2DM) can improve their ability to categorize blood glucose (BG) results into low, in range, or high glycemic ranges after experiencing a color range indicator (CRI or ColorSure™ Technology) in a single meter. This study examined whether a CRI was effective in people with type 1 (T1) or T2DM when used in 3 glucose meters.

Methods: A total of 179 subjects (139 T2DM and 40 T1DM) classified BG values as low, in range, or high based on individual current knowledge.

Patient and healthcare professional satisfaction with a new, high accuracy blood glucose meter with color range indicator and wireless connectivity.

Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. The OneTouch VerioFlex(™) (OTVF) blood glucose monitoring system (BGMS) was evaluated for accuracy in a clinical setting. Patients also used OTVF for a 1-wk trial period and reported their level of satisfaction with meter features.

Remote Health Consultations Supported by a Diabetes Management Web Application With a New Glucose Meter Demonstrates Improved Glycemic Control.

Background: Cloud-connected diabetes applications enable health care professionals (HCPs) to monitor patient progress and offer the potential for remote consultations. OneTouch Reveal (OTR) is a cloud-based web application that aggregates data from blood glucose (BG) meters or insulin pumps and provides analytics to help patients and HCPs make more informed treatment and lifestyle decisions. This study assessed the experience of patients using OTR and the OneTouch Verio (OTV) BG meter and determined the extent of changes in glycemic control.