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

Katz, Laurence B.; Stewart, Lorna; Guthrie, Brian; Cameron, Hilary

doi:10.1177/1932296819867396

Cited by 21 publications

(17 citation statements)

References 17 publications

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“…In a previous clinical evaluation, the OneTouch Verio Reflect BGM met ISO15197 accuracy criteria. 6 The accuracy criteria specified in the ISO15197 guideline are used for regulatory clearance in most countries in the European Union and Canada. In the United States, however, the FDA does not recognize ISO15197 as the standard for BGM accuracy, and in 2016, the agency issued guidelines for SMBG test systems for over-the-counter use.…”

Section: Discussionmentioning

confidence: 99%

“…Although we have no clinical data from patients in this study, in a previous study, patients using this meter felt strongly that these features would be of potential benefit to them. 6 In summary, a BGM previously tested under conditions described in ISO15197 passed different accuracy criteria described in the FDA guidelines for SMBG systems.…”

Section: Discussionmentioning

confidence: 99%

“…Although we have no clinical data from patients in this study, in a previous study, patients using this meter felt strongly that these features would be of potential benefit to them. 6…”

Section: Discussionmentioning

confidence: 99%

“…The meter has a ColorSure® Dynamic Range Indicator that points to low, high, or one of the five in-range segments that lets patients know where their result lies according to their customizable glucose range (Figure 1(a)). 6 The meter has a Blood Sugar Mentor™ which provides personalized guidance (Figure 1(b)), insight (Figure 1(c)), and encouragement (Figure 1(d)) based on individual results. 6 When used in conjunction with the OneTouch Reveal® mobile app, readings from the meter will automatically sync with the app via Bluetooth low energy connectivity.…”

Section: Methodsmentioning

confidence: 99%

“…6 The meter has a Blood Sugar Mentor™ which provides personalized guidance (Figure 1(b)), insight (Figure 1(c)), and encouragement (Figure 1(d)) based on individual results. 6 When used in conjunction with the OneTouch Reveal® mobile app, readings from the meter will automatically sync with the app via Bluetooth low energy connectivity.…”

Section: Methodsmentioning

confidence: 99%

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

Katz¹,

Stewart

King

et al. 2020

J Diabetes Sci Technol

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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

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…Although we have no clinical data from patients in this study, in a previous study, patients using this meter felt strongly that these features would be of potential benefit to them. 6…”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 3 more Smart Citations

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

Katz¹,

Stewart

King

et al. 2020

J Diabetes Sci Technol

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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

Grady

Cameron

Holt³

2023

Diabetes Ther

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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. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-023-01415-3.

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

Greenwood

Grady

2020

J Diabetes Sci Technol

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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.

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

Cited by 21 publications

References 17 publications

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

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

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

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

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