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.

Site-specific cancer risk following cobalt exposure via orthopedic implants or in occupational settings: A systematic review and meta-analysis.

In 2020, the European Commission up-classified metal cobalt as Class 1B Carcinogen (presumed to have carcinogenic potential) based primarily on data from rodent inhalation carcinogenicity studies. This up-classification requires an assessment under the Medical Device Regulations of cobalt cancer risk from medical devices. We performed a systematic review and meta-analysis to evaluate site-specific cancer risks with cobalt exposure from either total joint replacement (TJR) or occupational exposure (OC).

An integrated benefit-risk assessment of cobalt-containing alloys used in medical devices: Implications for regulatory requirements in the European Union.

In 2017, the European Union (EU) Committee for Risk Assessment (RAC) recommended the classification of metallic cobalt (Co) as Category 1B with respect to its carcinogenic and reproductive hazard potential and Category 2 for mutagenicity but did not evaluate the relevance of these classifications for patients exposed to Co-containing alloys (CoCA) used in medical devices. CoCA are inherently different materials from Co metal from a toxicological perspective and thus require a separate assessment. CoCA are biocompatible materials with a unique combination of properties including strength, durability, and a long history of safe use that make them uniquely suited for use in a wide-range of medical devices.

Carcinogenic assessment of cobalt-containing alloys in medical devices or cobalt in occupational settings: A systematic review and meta-analysis of overall cancer risk from published epidemiologic studies.

In 2020, the European Commission up-classified pure cobalt metal to a Category 1B hazard, based primarily on data from rodent inhalation carcinogenicity studies of metallic cobalt. The European Commission review did not evaluate cobalt-containing alloys in medical devices, which have very different properties vs. pure cobalt metal and did not include a systematic epidemiologic review.

A hazard evaluation of the reproductive/developmental toxicity of cobalt in medical devices.

Cobalt (Co) is an essential element with human exposure occurring from the diet, supplement ingestion, occupational sources, and medical devices. The European Chemical Agency (ECHA) recently voted to classify Co metal as a Reproductive Hazard Category 1B; presumed human reproductive toxicant due to adverse testicular effects in male rodents. A weight of evidence evaluation of the preclinical reproductive and developmental toxicity studies and available clinical data was performed to critically evaluate the relevance of this proposed classification for Co in medical devices.

Carcinogenic hazard assessment of cobalt-containing alloys in medical devices: Review of in vivo studies.

Cobalt (Co) alloys have been used for over seven decades in a wide range of medical devices, including, but not limited to, hip and knee implants, surgical tools, and vascular stents, due to their favorable biocompatibility, durability, and mechanical properties. A recent regulatory hazard classification review by the European Chemicals Agency (ECHA) resulted in the classification of metallic Co as a Class 1B Carcinogen (presumed to have carcinogenic potential for humans), primarily based on inhalation rodent carcinogenicity studies with pure metallic Co. The ECHA review did not specifically consider the carcinogenicity hazard potential of forms or routes of Co that are relevant for medical devices.

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.

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.

Health Care Professionals' Clinical Perspectives on Glycemic Control and Satisfaction With a New Blood Glucose Meter With a Color Range Indicator: Online Evaluation in India, Russia, China, and the United States.

Background: We previously demonstrated in patients with diabetes that displaying blood glucose results in association with color improved their ability to interpret glucose results.

Objective: The objective of this study was to investigate the perceptions of health care professionals (HCPs) in specific countries about the value of color on a new glucose meter and to determine if HCP perspectives among countries differ on the value of this approach in clinical practice.

Methods: A total of 180 HCPs, including 105 endocrinologists, 34 primary care physicians, 25 diabetes educators, and 16 pharmacists, were recruited from India (n=50), Russia (n=50), China (n=50), and the United States (n=30).

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.

Use of Blood Glucose Meters Featuring Color Range Indicators Improves Glycemic Control in Patients With Diabetes in Comparison to Blood Glucose Meters Without Color (ACCENTS Study).

Background: The ability of patients to improve glycemic control depends partly on their ability to interpret and act on blood glucose results. We investigated whether switching people with diabetes to blood glucose meters (BGMs) featuring a color range indicator (CRI) could improve glycemic control compared to remaining on their current BGM without color.

Methods: 163 adults with type 1 (T1D) or type 2 diabetes (T2D) and a hemoglobin A1c (A1c) of 7.

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.

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.

A comprehensive evaluation of strip performance in multiple blood glucose monitoring systems.

Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. Accurate self-monitoring of blood glucose results are required for optimal insulin dosing and detection of hypoglycemia. However, blood glucose monitoring systems may be susceptible to error from test strip, user, environmental and pharmacological factors.

Interactive Exposure With a Blood Glucose Monitor With a Novel Glucose Color Range Indicator Is Associated With Improved Glucose Range Interpretation and Awareness in Patients With Type 2 Diabetes.

Aims: The ability of patients to achieve glycemic control depends in part on their ability to interpret and act on blood glucose (BG) results. This clinical study was conducted to determine if a simple on-meter color range indicator (CRI) could improve the ability of patients to categorize BG values into low, in-range, and high glycemic ranges.

Methods: The clinical study was conducted in 59 subjects with type 2 diabetes (T2DM).

A clinical evaluation of routine blood sampling practices in patients with diabetes: impact on fingerstick blood volume and pain.

Background: There is a perception that patients with diabetes struggle to produce sufficient blood to fill glucose test strips, including strips with 1-µL fill requirements. The purpose of this study was to determine the volume of blood expressed when these patients perform routine fingersticks using their own lancing device and sampling technique and to evaluate the relationship between blood volume and pain.

Methods: Sixty-four patients (type 1 or type 2 diabetes) performed 8 fingersticks using their own lancing device and preferred depth setting and lancing technique.

Automated glycemic pattern analysis can improve health care professional efficiency and accuracy.

Background: Health care professionals (HCPs) routinely review handwritten blood glucose (BG) logbooks during office visits of patients with diabetes.

Method: In this study, 64 HCPs were asked to assess glycemic patterns and estimate BG averages in six simulated handwritten logbooks. The HCPs then reviewed the pattern logs and averages in six OneTouch® Verio™IQ meters containing corresponding data sets.