Perceptions of Continuous Glucose Monitoring Systems in the T1D Exchange Diabetes Registry: Satisfaction, Concerns, and Areas for Future Improvement.

Manufacturers continue to improve performance and usability of continuous glucose monitoring (CGM) systems. As CGM becomes a standard of care, especially for people on insulin therapy, it is important to routinely gauge how satisfied people with diabetes are with this technology. This article describes survey feedback from a large cohort of people with diabetes using older and current CGM systems and highlights areas of current satisfaction, concern, and future system improvement.

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.

Clinical Practice Experiences Using a Professional Diabetes Management Ecosystem During COVID.

BACKGROUND: Challenges of patient care in diabetes were exacerbated by COVID, undermining the ability of patients to engage in-person with health care professionals (HCPs). To combat this, there has been accelerated adoption of telemedicine to support patient and provider connectivity. METHODS: We collated survey information regarding telemedicine from 21 European clinical institutions. Health care professionals joined virtual meetings focusing on the OneTouch Reveal (OTR) ecosystem and its utility for conducting telemedicine. Selected HCPs provided clinical case studies to explain how the OTR ecosystem supported patient care. RESULTS: Remote consultations increased by nearly 50% in 21 European clinics during the pandemic (Belgium [24%], Iberia [65%], Germany [34%], Italy [54%]). In all, 52% of people with diabetes using OTR app to connect remotely with HCPs had type 1 diabetes and 48% had type 2 diabetes. Remote connection methods included telephone (60%), email (19%), video chat (10%), text only (3%), or a mix of these methods (8%). Health care professionals usually reviewed patient data during consultations (45%) rather than before consultations (25%). Fifty-five percent of HCPs indicated digital ecosystems like OTR ecosystem would become their standard of care for diabetes management. In-depth conversations with HCPs provided a deeper understanding of how a digital ecosystem integrated into clinical practice and population management. In addition, five patient case studies using OTR ecosystem were provided by a selection of our HCPs. CONCLUSION: Diabetes management solutions, such as OTR ecosystem, supported telemedicine during the pandemic and will continue to play a valuable role in patient care beyond the pandemic.

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.

Patient and Healthcare Professional Satisfaction with the OneTouch Verio Reflect® Blood Glucose Monitoring System in the UAE.

AIMS: The goal of this study was to collect the opinions of patients and HCPs who used OneTouch Verio Reflect® in the United Arab Emirates (UAE). BACKGROUND: Blood glucose monitoring devices are essential tools that aid healthcare professionals (HCPs) in improving outcomes in people with diabetes. OBJECTIVES: To assess the satisfaction of patients and HCPs with the new functionalities of the OneTouch Verio Reflect® Blood Glucose Meter (BGM). METHODS: We conducted a multicenter cross-sectional study that recruited eight HCPs and 100 patients with diabetes who had used OneTouch Verio Reflect® with OneTouch Verio® test strips for four weeks in four hospitals in the UAE. RESULTS: Around 98% of patients and HCPs declared their satisfaction with the new features in the OneTouch Verio Reflect® BGM. Participants' responses were not associated with the duration of diabetes (p-values >0.05) except for the Results Log feature (p-value=0.016). Patients rated Blood Sugar Mentor® messages, which include mentor tips, pattern messages, and awards, as the most important features, while HCPs rated ColorSure® Dynamic Range Indicator as the most helpful feature. Patients and HCPs stated that the "pattern found (high glucose)," which was the most frequently seen message, was the most useful message. All HCPs strongly agreed that the ColorSure® Dynamic Range Indicator helped them understand results and 98% of patients agreed that automated meter messages helped them to be more confident in following HCP recommendations. CONCLUSION: Patients and HCPs indicated high levels of satisfaction with the features within the OneTouch Verio Reflect® meter.

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.

Evidence From a Long-Term, Systematic Post-Market Surveillance Program: Clinical Performance of a Hematocrit-Insensitive Blood Glucose Test Strip.

BACKGROUND: Described is a manufacturer's systematic post-market evaluation of the long-term clinical accuracy of a commercially available blood glucose monitoring (BGM) test strip product. METHODS: Production batches of test strips were routinely and regularly sampled and evaluated in a clinical setting to assess product accuracy. Evaluations were performed on capillary blood samples from a minimum of 100 subjects with diabetes, by clinical staff according to instructions for use. Readings were compared against capillary blood samples collected at the same time and measured by a standard laboratory reference method. Clinical accuracy was calculated according to EN ISO 15197:2015. RESULTS: A total of 21 115 paired results were obtained, equating to 209 production batches over the >3-year period since test strip launch. Of the results, 97.6% met the accuracy criterion (range: 97.1-98.1% by year), with 98.1% of values presenting zero risk as defined by the surveillance error grid. At the <5th (21.0-33.8%) and >95th (48.3-59.4%) percentile extremes of hematocrit distribution, 97.9% and 96.4% of values were clinically accurate. The product also demonstrated clinical accuracy across all seven glucose ranges ("bins") as defined by the standard. Under conditions of combined hematocrit and glucose (<80 mg/dL and ≥300 mg/dL) extremes, 97.7% of values were clinically accurate. CONCLUSIONS: Methodologies and results from a manufacturer's self-imposed clinical accuracy surveillance program of a BGM product is presented. Given the publication of sometimes-conflicting data presented within ad hoc BGM clinical accuracy evaluations, usually of limited size, it is advocated that BGM manufacturers adopt similarly robust and systematic surveillance programs to safeguard patients.

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.

Healthcare Professional Perceptions of Blood Glucose Meter Features That Support Achievement of Self-Management Goals Recommended by Clinical Practice Guidelines.

BACKGROUND: Blood glucose meters remain an effective tool for blood glucose monitoring (BGM) but not all meters provide the same level of insight beyond the numerical glucose result. OBJECTIVE: To investigate healthcare professional (HCP) perceptions of four meters and how these meters support the achievement of self-management goals recommended by diabetes clinical practice guidelines. METHODS: Three hundred and fifty-three HCPs from five countries reviewed the features and benefits of four meters using interactive webpages and then responded to statements about the utility of each meter and ranked each meter in terms of clinical value. RESULTS: Meter D ranked significantly higher in terms of clinical utility for all 13 guideline questions (70%-84%, P < .05) compared to other meters. Endocrinologists (69%-85%), primary care physicians (PCP; 63%-80%), and diabetes nurses (DN; 80%-89%) consistently ranked meter D highest for all guideline questions. DNs ranked selected questions significantly higher compared to PCPs (8 of 13) or endocrinologists (3 of 13; P < .05). Meter D achieved strong endorsement from HCPs in France and Germany, followed by the United States and Canada, with comparatively lower responses from Italian HCPs (P < 0.05). With respect to self-management, 80% of HCPs selected meter D as their first choice for patients with type 1 diabetes to help patients improve diabetes management or understand their numbers to help them stay in range. CONCLUSIONS: HCPs had strong preference for a meter providing additional insights, messages, and guidance direct to the patient to support achievement of self-management goals recommended by diabetes clinical practice guidelines.

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.

Health Care Professionals' Clinical Perspectives and Acceptance of a Blood Glucose Meter and Mobile App Featuring a Dynamic Color Range Indicator and Blood Sugar Mentor: Online Evaluation in Seven Countries.

BACKGROUND: Despite many new therapies and technologies becoming available in the last decade, people with diabetes continue to struggle to achieve good glycemic control. Innovative and affordable solutions are needed to support health care professionals (HCPs) to improve patient outcomes. OBJECTIVE: To gather current self-management perceptions of HCPs in seven countries and investigate HCP satisfaction with a new glucose meter and mobile app featuring a dynamic color range indicator and a blood sugar mentor. METHODS: A total of 355 HCPs, including 142 endocrinologists (40.0%), 108 primary care physicians (30.4%), and 105 diabetes nurses (29.6%), were recruited from the United Kingdom (n=50), France (n=50), Germany (n=50), India (n=54), Algeria (50), Canada (n=51), and the United States (n=50). HCPs experienced the OneTouch Verio Reflect glucose meter and the OneTouch Reveal mobile app online from their own office computers using interactive demonstrations via webpages and multiple animations. After providing demographic and clinical practice insights, HCPs responded to statements about the utility of the system. RESULTS: Concerning current practice, 83.1% (295/355) of HCPs agreed that poor numeracy or health literacy was a barrier for their patients. A total of 85.9% (305/355) and 92.1% (327/355) of HCPs responded that type 2 diabetes (T2D) and type 1 diabetes (T1D) patients were aware of what represented a low, in-range, or high blood glucose result. Only 62.0% (220/355) felt current glucose meters made it easy for patients to understand if results were in range. A total of 50.1% (178/355) and 78.0% (277/355) of HCPs were confident that T1D and T2D patients took action for low or high results. A total of 87.0% (309/355) agreed that the ColorSure Dynamic Range Indicator could help them teach patients how to interpret results and 88.7% (315/355) agreed it made them more aware of hyper- and hypoglycemic results so they could take action. A total of 83.7% (297/355) of HCPs agreed that the Blood Sugar Mentor feature gave personalized guidance, insight, and encouragement so patients could take action. A total of 82.8% (294/355) of HCPs also agreed that the Blood Sugar Mentor provided real-time guidance to reinforce the goals HCPs had set so patients could take steps to manage their diabetes between office visits. After experiencing the full system, 85.9% (305/355) of HCPs agreed it was beneficial for patients with lower numeracy or health literacy; 96.1% (341/355) agreed that it helped patients understand when results were low, in range, or high; and 91.0% (323/355) agreed that the way it displayed diabetes information would make patients more inclined to act upon results. A total of 89.0% (316/355) of HCPs agreed that it would be helpful for agreeing upon appropriate in-range goals for their patients for their next clinic visit. CONCLUSIONS: This multi-country online study provides evidence that HCPs were highly satisfied with the OneTouch Verio Reflect meter and the OneTouch Reveal mobile app. Each of these use color-coded information and the Blood Sugar Mentor feature to assist patients with interpreting, analyzing, and acting upon their blood glucose results, which is particularly beneficial to keep patients on track between scheduled office visits.

Measures of Accuracy for Continuous Glucose Monitoring and Blood Glucose Monitoring Devices.

Currently, patients with diabetes may choose between two major types of system for glucose measurement: blood glucose monitoring (BGM) systems measuring glucose within capillary blood and continuous glucose monitoring (CGM) systems measuring glucose within interstitial fluid. Although BGM and CGM systems offer different functionality, both types of system are intended to help users achieve improved glucose control. Another area in which BGM and CGM systems differ is measurement accuracy. In the literature, BGM system accuracy is assessed mainly according to ISO 15197:2013 accuracy requirements, whereas CGM accuracy has hitherto mainly been assessed by MARD, although often results from additional analyses such as bias analysis or error grid analysis are provided. The intention of this review is to provide a comparison of different approaches used to determine the accuracy of BGM and CGM systems and factors that should be considered when using these different measures of accuracy to make comparisons between the analytical performance (ie, accuracy) of BGM and CGM systems. In addition, real-world implications of accuracy and its relevance are discussed.