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. METHODS: Anonymized glucose and app analytics from more than 55,000 people with diabetes (PWDs) were extracted from a server. Data from their first 14 days using OTVR Meter and OTR App was compared with 14 days prior to 90- and 180-day timepoints using paired within-subject differences. RESULTS: In people with type 1 (PwT1D) or type 2 diabetes (PwT2D), readings in-range (RIR 70-180 mg/dL) improved by 7.8 percentage points (57.9-65.7%) and 12.0 percentage points (72.8-84.8%), respectively, over 180 days and hyperglycemia (> 180 mg/dL) was reduced by - 8.4 percentage points (37.9-29.5%) and - 12.2 percentage points (26.2-14.1%). RIR improved by > 10 percentage points in 38% of PwT1D and 39% of PwT2D. PwT1D spending > 2 to 4 sessions or > 10 to 20 min per week on the app improved RIR by 7.0 and 8.2 percentage points, respectively. PwT2D spending > 2 to 4 sessions or > 10 to 20 min per week on the app improved RIR by 12.6 and 12.1 percentage points, respectively. In PwT1D or T2D, mean blood glucose reduced by - 14.3 and - 19.8 mg/dL, respectively, from baseline to 180 days, with no clinically meaningful changes in percentage of hypoglycemic readings (< 70 mg/dL). PwT1D 65 years and older performed the most app sessions (10 per week) and improved RIR by 7.9 percentage points. PwT2D 65 years and older spent more time on the app (45 min per week) than PwT2D of any other age and improved RIR by 7.6 percentage points. All glycemic changes were statistically significant (p < 0.0005). CONCLUSION: Real-world data from more than 55,000 PWDs demonstrates sustained improvements in readings in-range in PWDs using the OneTouch Verio Reflect Blood Glucose Meter and OneTouch Reveal App.

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 (Po2) within the applied sample. Limited in-clinic data exists regarding the quantitative effect of Po2 in unmanipulated capillary fingertip blood samples across physiologically representative glucose and Po2 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. The data set comprised 29 901 paired BGM-comparator readings and corresponding Po2 values from 5 428 blood samples from a panel of 975 subjects. RESULTS: A linear regression-calculated bias range of 5.22% (+0.72% [low Po2: 45 mm Hg] to -4.5% [high Po2: 105 mm Hg]); biases calculated as absolute at <100 mg/dL glucose was found. Below the nominal Po2 of 75 mm Hg, a linear regression bias of +3.14% was calculated at low Po2, while negligible impact on bias (regression slope: +0.002%) was observed at higher than nominal levels (>75 mm Hg). When evaluating BGM performance under corner conditions of low (<70 mg/dL) and high (>180 mg/dL) glucose, combined with low and high Po2, linear regression biases ranged from +1.52% to -5.32% within this small group of subjects and with no readings recorded at <70 mg/dL glucose at low and high Po2. CONCLUSIONS: Data from this large-scale clinical study, performed on unmanipulated fingertip capillary bloods from a diverse diabetes population, indicate Po2 sensitivity of the BGM to be markedly lower than published studies, which are mainly laboratory-based, requiring artificial manipulation of oxygen levels in aliquots of venous blood.

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. METHODS: Anonymized glucose and app analytics were extracted from a server from over 144 000 people with diabetes (PWDs). Data from their first 14 days using OTVF and OTR were compared with 14 days prior to 90- and 180-day timepoints using paired within-subject differences. RESULTS: In people with type 1 diabetes (PwT1D) or people with type 2 diabetes (PwT2D), readings in-range (RIR) improved by +6.1 (54.5% to 60.6%) and +11.9 percentage points (68.2% to 80.1%), respectively, over 180 days, and hyperglycemia was reduced by -6.6 (40.5% to 33.9%) and -12.0 (30.3% to 18.3%). In total, 35% of PwT1D and 40% of PwT2D improved RIR by >10 percentage points. People with type 1 diabetes spending two to four sessions or 10 to 20 minutes per week on the app improved RIR by +5.1 and 7.0, respectively. People with type 2 diabetes spending two to four sessions or 10 to 20 minutes per week on the app improved RIR by +11.6 and 12.0, respectively. In PwT1D or PwT2D, mean BG reduced by -11.4 and -19.5 mg/dL, respectively, from baseline to 180 days, with no clinically meaningful changes in percentage of hypoglycemic readings. All glycemic changes were statistically significant (P < .0005 level). CONCLUSION: Real-world data from over 144 000 PWDs demonstrated improved percentage readings in-range and reduced hyperglycemia in PWDs using the OneTouch Verio Flex blood glucose meter and OneTouch Reveal app.

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). RESULTS: Thirty-three individual test-strip batches were evaluated corresponding to 506 unique donors. Accuracy performance - FDA: 98.9% of values within ±15% of comparator; ISO: 99.0% within ±15 mg/dL or ±15% at <100 mg/dL (<5.55 mmol/L) or ≥100 mg/dL (≥5.55 mmol/L) glucose, respectively. Overall MARD was 4.19% with a MARD range of 3.54%-5.73% across all test strip batches. CONCLUSIONS: This post-market surveillance program demonstrates the new BGM system consistently meets measures of clinical accuracy specified by regulators. This program supports a growing demand by regulators for real-world evidence demonstrating consistent in-market product efficacy as opposed to the current largely passive approach that relies on assessment of reports filed by device users.

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. METHODS: Medication profiles were analysed for 1023 subjects (425 with type 1 (T1D) and 598 with type 2 diabetes (T2D)) attending 3 UK hospitals. Blood samples were analysed to determine clinical accuracy of the BGM test-strip against a laboratory comparator. RESULTS: 538 different medications (48 diabetes and 490 non-diabetes) were recorded across the 1023 subjects. Patients took on average 6.9 (n = 1-36) individual medications and 4.1 (n = 1-13) unique medication classes. Clinical accuracy to EN ISO 15197:2015 criteria were met irrespective of increasing average number of individual medications, categorized from 1-3, 4-6, 7-9, 10-12 and >12 taken per subject (97.7%, 97.7%, 97.8%, 97.8%, and 98.4%, respectively). Clinical accuracy criteria were met across 15 classes of medication using the combined dataset (97.9%; 29784/30433). Surveillance Error Grid (SEG) analysis showed 98.7% (29959/30368) of readings presented no clinical risk. No individual class or combination of medication classes impacted clinical accuracy of the BGM test-strip. CONCLUSIONS: Clinical performance for the test strip under assessment demonstrated no evidence of interference from over 500 prescription medications, with clinical accuracy maintained across a range of polypharmacy conditions in people with diabetes.

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 (pO2) 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 pO2 level of 75.3 mm Hg was recorded, with a standard deviation (SD) of 10.6 mm Hg and a range of 27.7 to 151.5 mm Hg. This data set, unique in terms of size, gathered more than 14 years at four separate clinical sites, provides a robust and comprehensive representation of an unmanipulated pO2 fingertip capillary sample distribution, which should be of interest for physiological reasons, but also from a medical device development perspective, in which the effect of pO2 on device performance may be an important design consideration.

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

Background: 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. Methods: 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). Data from their first 14 days were compared with the 14 days before the 90-day time point using paired within-subject differences. Results: Percentage glucose readings in range (RIR) 70-180 mg/dL improved by +8.1% (from 58% to 66.1%) in PwT1D and by +11.2% (from 72.4% to 83.6%) in PwT2D. Hyperglycemic readings (>180 mg/dL) reduced by -8.5% (from 37.1% to 28.6%) in PwT1D and by -11.3% (from 26.4% to 15.1%) in PwT2D. Mean glucose reduced on average by -14.5 mg/dL (from 174.8 to 160.2 mg/dL) in PwT1D and -18.2 mg/dL (from 157.8 to 139.6 mg/dL) in PwT2D. Glycemic improvement was strongly associated with OTR app engagement. Two to three sessions or 11 to 20 min/week in the app improved readings in range in PwT1D by +7.0% or +8.4%, respectively. Similar engagement trends for glycemic improvement were observed in PwT2D. Proportions of subjects achieving a 5% or 10% improvement in RIR were 46.9%/36.6% for PwT1D and 48.7%/37.7% for PwT2D. Conclusions: Real-world data from over 17,000 people with diabetes (PWDs) demonstrated significantly improved readings in range and reduced the burden of hyperglycemia in PWDs using the OTVR meter and OTR app.

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 (n = 81) used the meter and app for 12 weeks, while a randomized control group (n = 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. Results: Test subjects experienced a mean reduction in A1C of 1.0% after 12 weeks (P <0.001), a statistically significant greater reduction than in control subjects (P = 0.045). The improvement in A1C in test subjects was sustained over the next 12 weeks. Crossed-over subjects also demonstrated significant improvements in A1C (P <0.001). Mean blood glucose was reduced significantly without an increase in hypoglycemia, and results in range increased over 12 weeks of meter and mobile app use. Results were independent of subjects' numeracy skills. Subjects using the new meter and app reacted favorably to the tools and expressed improvements in their diabetes treatment satisfaction based on Diabetes Treatment Satisfaction Questionnaire-Change scores. Conclusion: Use of the OT meter and a Spanish-language version of its diabetes management app in an underserved population helped participants achieve a sustained improvement in glycemic control. The tools were well received by the subjects and may have important utility in other low-numeracy, low-literacy populations.

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) (n = 73) or type 1 diabetes (T1D) (n = 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 P < .001). There was significantly greater willingness to act on high and low results shown with DCRI or BSM screens. Subjects also expressed a high degree of satisfaction with these features. CONCLUSIONS: Use of DCRI and BSM in this meter may help patients improve their diabetes management decisions.

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. The Insulin Mentor may simplify the difficult process of correctly calculating mealtime insulin doses for PWD.

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. Blood samples were analyzed to determine clinical accuracy of the BGM test-strip compared to a laboratory comparator. RESULTS: Across the 830 subjects, 473 different medications (41 diabetes and 432 nondiabetes) were recorded. Patients took on average 6.5 (n = 1-23) individual medications and 4 (n = 1-11) unique classes of medication. Clinical accuracy to EN ISO 15197:2015 criteria was met irrespective of increasing average number of individual medication, categorized from 1 to 4, 5 to 8, 9 to 12, and >12 taken per subject (97.7%, 98.4%, 98.1%, and 98.5%, respectively). Clinical accuracy to EN ISO 15197:2015 criteria was also met across 15 classes of medication using the combined dataset (98.1%; 13 003/13 253). Surveillance error grid analysis showed 98.8% (13 079/13 232) of readings presented no clinical risk. No individual class or combination of medication classes impacted clinical accuracy of the BGM test-strip. CONCLUSIONS: This comprehensive analysis for this specific test-strip platform demonstrated no evidence of interference and robust clinical accuracy of this test strip, irrespective of the prescription medication status of patients with diabetes.

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. This study investigated a completely re-engineered lancing system, called One Touch Delica Plus (OTDP), intended to further minimize pain while improving the patient experience. METHODS: One hundred and three subjects (type 1 or 2 diabetes) experienced finger sticks with both lancing systems. Device depth and blood volume (BV) generation were determined during visit 1. These parameters were used during pain assessments in visit 2. Patient feedback was also recorded using surveys. RESULTS: Finger-stick testing was less painful using OTDP compared to original OTD irrespective of whether 30 (-48.2 mm, -30.4 mm, P < 0.0001) or 33 gauge (-42.6 mm, 30.5 mm, P = 0.0004) lancets were used. All 103 subjects generated the required BV (≥0.4 µL) per protocol. At equivalent depth penetration, OTDP generated higher average BVs than OTD using 30 (1.58 µL, 1.10 µL) or 33 gauge lancets (1.39 µL, 0.98 µL). Subjects responded that testing with OTDP was virtually pain free (78%) and that testing with OTDP was less painful than using their current lancing systems (79%) or original OTD (67%). CONCLUSION: OTDP demonstrated lower pain than the original OTD lancing system and participants agreed that testing with OTDP was virtually pain free and less painful than using their current lancing systems.

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. Glucose results were accurate vs comparator over a wide glucose range and met lay user and glucose accuracy criteria at extreme glucose values as described in the FDA guidance.Clinicaltrials.gov NCT03851549.

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. RESULTS: Both systems were accurate over a wide glucose range and met lay user and system accuracy BG standards described in ISO15197:2015. Subjects felt that the features of a meter with a dynamic color range indicator and personalized guidance, insight, and encouragement could provide significant benefits to them in the management of their diabetes. CONCLUSIONS: Both meter systems were accurate over a wide glucose range and the features of the meter and messages were well received by patients in a short take-home trial. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT0351542.

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. RESULTS: Increases in mean bias were observed when comparing capillary to venous samples tested on the BGMs and the recommended reference instrument. Mean bias was even greater when a hospital blood glucose analyzer was used to measure venous plasma glucose. Increases in mean bias observed for Ultra BGM when testing venous blood on the meter compared to the recommended reference instrument was likely due to the interfering effects of low oxygen levels in the venous blood sample. Conversely, Verio meters, which are insensitive to low oxygen levels, showed little difference from baseline when testing venous blood on the meter compared to results from the same venous sample measured on a reference instrument. CONCLUSIONS: Deviations from the best practice study design of comparing capillary blood glucose results tested on the blood glucose meter with the manufacturer's stated reference instrument will affect accuracy of blood glucose measurements.

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. Patients also used OTSPS for a 1-week trial period and reported their level of satisfaction with meter features. In a separate study, health-care professionals (HCPs) in India naïve to OTSPS experienced OTSPS online using a variety of interactive demonstrations of the BGMS and answered questions about its potential utility to their patients. SUMMARY: Patients and HCPs felt the features of OTSPS, including a color range indicator, could provide significant benefits to them and their patients.

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. METHODS: Test strips from a globally distributed SMBG product were sampled from randomly selected production batches as part of the manufacturer's routine product evaluation process. Clinical accuracy was assessed within diabetes patients at 3 clinic sites against a standard reference method and evaluated against system accuracy in accordance with the ISO 15197:2015 standard (unchanged from ISO 15197:2013 in terms of performance specifications). Data were collected over 7 years (2010-2016) and comprised 73,600 individual glucose results. Overall clinic performance was assessed, as was accuracy at low and high glucose levels and extremes of hematocrit. RESULTS: Across the 7-year surveillance period, overall test strip clinical accuracy was 97.8% versus the 95% ISO-defined minimum criterion with by-year values of 97.0-98.6%. Accuracy at the lowest (≤50 mg/dL) and highest (>400 mg/dL) ranges of glucose was 97.0% and 98.3% respectively. Within these low/high blood glucose subpopulations, accuracy at the lower and upper first percentile hematocrit ranges, was 98.9%, and 97.1% respectively. CONCLUSIONS: This 7-year surveillance program showed the test strips to have excellent clinical accuracy at the outer ranges of subject blood glucose and hematocrit, based on assessment against the ISO 15197:2015 clinical accuracy criterion.