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Milpitas, CA, United States

Ginsberg B.H.,Diabetes Technology Consultants | Shemain A.,Facet Technologies | Pynes M.K.,Facet Technologies | Wallace D.A.,LifeScan Inc. | And 2 more authors.
Postgraduate Medicine | Year: 2011

The pain associated with lancing can be a significant barrier to self-monitoring of blood glucose (SMBG). The OneTouch® Delica™ lancing device contains features to reduce lancing pain, including improved lancet control and stability, reduced vibration, and a thinner, 33-gauge lancet. This 2-visit, randomized controlled trial assessed perceived pain of lancing with the OneTouch® Delica™ compared with 4 other common lancing devices: OneTouch® Comfort™, ACCU-CHEK® Softclix, ACCU-CHEK® Multiclix, and Ascensia® Microlet™2. Two hundred patients with type 1 or type 2 diabetes mellitus were assigned to the OneTouch® Delica™ and also randomized to 1 of the 4 comparator devices (n = 50 per device pair). At visit 1, we determined the minimum depth settings required to produce ≥ 1 μL of fingertip blood for each patient with each device. At visit 2, patients lanced their fingertips with the devices at the predetermined depths and used a 150-mm visual analog scale (VAS) to rate lancing pain relative to their "usual pain" associated with SMBG. The VAS ranged from "much less painful" (0 mm) to "much more painful" (150 mm), with the midpoint (75 mm) labeled as "usual pain." Fingertip pain scores from patients using OneTouch® Delica™ were significantly lower than those obtained using OneTouch® Comfort™, ACCU-CHEK® Multiclix, and Ascensia® Microlet ™2. Pain scores for OneTouch® Delica™ and ACCU-CHEK® Softclix were not significantly different. In conclusion, OneTouch® Delica™ was either less painful or no different than the comparator devices when used for fingertip lancing. Innovative lancing devices that cause less pain may improve compliance and persistence with prescribed SMBG. © Postgraduate Medicine. Source

Tanaka Y.,Eli Lilly and Company | Li G.,LifeScan Inc. | Wang Y.,Johnson and Johnson | Chen J.,Merck And Co.
Journal of Biopharmaceutical Statistics | Year: 2012

Consistency of treatment effects across different regions in multiregional clinical trials (MRCTs) has been an important question for the regulatory authorities. Many consistency definitions are proposed in literature. One of the definitions of consistency is expressed as qualitative consistency, whereas inconsistency is defined as qualitative treatment by region interaction. This article focuses on the qualitative consistency and extends Gail-Simon and Sasabuchi's one-sided multivariate likelihood ratio tests. Simulations are used to evaluate operating characteristics of these qualitative consistency assessment approaches. For a given number of regions, the guideline for setting significance level, and consistency cut-off are explored. © 2012 Taylor and Francis Group, LLC. Source

Bergman E.,LifeScan Inc.
Journal of Diabetes Science and Technology | Year: 2012

This paper provides an introduction to "human factors engineering," an applied science that seeks to optimize usability and safety of systems. Human factors engineering pursues this goal by aligning system design with the perceptual, cognitive, and physical capabilities of users. Human factors issues loom large in the diabetes management domain because patients and health care professionals interact with a complex variety of systems, including medical device hardware and software, which are themselves embedded within larger systems of institutions, people, and processes. Usability considerations must be addressed in these systems and devices to ensure safe and efective diabetes management. © Diabetes Technology Society. Source

Katz L.B.,LifeScan Inc. | Grady M.,LifeScan | Stewart L.,LifeScan | Cameron H.,LifeScan
Expert Review of Medical Devices | Year: 2016

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. In a separate study, healthcare professionals used an on-line simulator of the BGMS and answered questions about its potential utility to their patients. OTVF was accurate over a wide glucose range and met lay user and system accuracy blood glucose standards described in ISO15197:2013 as well as the accuracy requirements to fulfill US FDA expectations for 510(k) clearance of BGMS. Patients and healthcare professionals felt the features of OTVF, which has the capability to connect wirelessly to mobile devices and interact wirelessly with diabetes management software, could provide significant benefits to them or their patients. © 2016 Informa UK Limited, trading as Taylor & Francis Group. Source

Tunis S.L.,IMS Health | Willis W.D.,LifeScan Inc. | Foos V.,IMS Health
Current Medical Research and Opinion | Year: 2010

Objective: Stakeholders in Europe remain interested in assessments of country-specific value of self-monitoring of blood glucose (SMBG) for patients with type 2 diabetes treated with oral anti-diabetes drugs (OADs). This study used the IMS-CORE Diabetes Model to project the long-term (40-year) cost-effectiveness of SMBG at once, twice, or three times per day (vs. no SMBG) for this population from national reimbursement system perspectives in France, Germany, Italy, and Spain. Methods: SMBG input costs (strips, lancets, meters, nurse training) were supplied by LifeScan in E2007 values and applied as appropriate for each country's reimbursement policy. Cohort characteristics and assumed HbA1c effects came from a US Kaiser Permanente longitudinal analysis of new SMBG users. Country-specific estimations for use of screening programs and several concomitant medications, as well as mortality rates were used. Country-specific complication costs from published sources were inflated to E2007. Base case outcomes were discounted at 3% per annum for France, Germany, and Italy; 6% for Spain. Sensitivity analyses varied time horizon and discount rates for each country. They also included a 0.036 dis-utility for SMBG in year 1. Main outcome measures: Primary outcomes included total direct costs, gains in quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over 40 years. Results: ICERs were largest in France (with meter costs included), and in Italy (with highest reimbursed costs for strips/lancets). ICERs for SMBG once, twice, and three times per day were E12 114, E6282, and E7958 (respectively) in France; and E12 694, E11 934, and E15 368 in Italy. ICERs for SMBG once or twice per day were5E2000 in Germany and5E4000 in Spain. ICERs for SMBG three times per day were5E6000/ QALY in both countries. Results were most sensitive to the 5-year time horizon, although ICERs for SMBG once per day were below E50 000/QALY in all countries but Italy (ICER = E77 064). Five-year ICERs for SMBG twice per day were below E40 000/QALY for all four countries, and those for SMBG three times per day were below E45 000/QALY. With the SMBG dis-utility, ICERs increased modestly (E321- E2264/ QALY) in all scenarios except SMBG once per day in France (E9578 increase) and Italy (E5979 increase). Study limitations include the use of relatively short-term data from a single US observational study for SMBG clinical effects, unknown levels of patient adherence, and assumptions regarding the duration of clinical effects. Conclusions: With cost assumptions reflecting current reimbursement levels in France, Germany, Italy, and Spain, SMBG was found to be cost-effective across a 40-year time horizon, with all base case ICERs 516 000/QALY. This study adds to the literature on the country-specific, long-term value of SMBG for type 2 diabetes patients treated with OADs. Under current model assumptions, variations in cost-effectiveness results stemmed primarily from payer reimbursement practices for SMBG within each country. © 2010 Informa UK Ltd. Source

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