New Tu Salud Study Shows LifeScan’s OneTouch^® Blood Glucose Meter and Spanish-Language Diabetes Management App Significantly Improved Diabetes Management for People with Diabetes in an Underserved Hispanic Population

MALVERN, Pa., September 28, 2021 -- LifeScan, a world leader in blood glucose monitoring, today announced findings from its Tu Salud (Your Health) clinical trial showing that using its OneTouch Verio Flex^® meter with a Spanish-language version of its OneTouch Reveal^® mobile application (app) led to significant and sustained improvement in diabetes management in people with diabetes and low numeracy and low literacy in an underserved Hispanic population. The study, conducted with LCH Health and Community Services, a Federally Qualified Health Center in Chester County, Pennsylvania, was published today in Diabetes Spectrum, a peer-reviewed journal of the American Diabetes Association.

According to the US Centers for Disease Control and Prevention (CDC), literacy, numeracy, and technology skills are important in today’s information-rich environments. What people know, and what they do with what they know can impact their lives. Conversely, people with lower literacy proficiency are more likely to report poor health than those with better literacy skills¹.

To help address this, LifeScan partnered with LCH Health and Community Services to evaluate the clinical value of the Bluetooth-enabled OneTouch Verio Flex blood glucose meter in combination with a Spanish-language version of the OneTouch Reveal mobile app on its ability to support overall diabetes care, glycemic management and patient reported outcomes in people with diabetes in a low numeracy, low literacy population. Of the 120 people enrolled in the trial, approximately half were male, 95% were of Hispanic or Latino ethnicity, nearly all (98%) had type 2 diabetes, and more than half had either no formal education (16%) or only primary school education (50%). At baseline, 67% of participants reported feeling “overwhelmed” by their diabetes care, more than twice the number reported in similar studies conducted in predominantly White subjects from urban and suburban areas of the United Kingdom.

"There is an urgent need to address the disparities in diabetes outcomes experienced by communities in the US that are socioeconomically disadvantaged. In particular, African Americans and Hispanics with diabetes generally exhibit worse glycemic measures and poorer outcomes relative to non-Hispanic whites^2,3,” said Dr. Elizabeth Holt, Head of Global Medical, Clinical, and Safety, LifeScan. “The Tu Salud study findings reinforce the importance of providing people with diabetes with relevant tools that give meaning to their glucose numbers and foster greater understanding of how to manage the condition. The findings show that with the right tools and support, people can build their skills and achieve better results."

“The Tu Salud study gave LCH a data driven format to demonstrate our ability to efficiently recruit study patients and conduct clinical trials that are meaningful to our patients in our community,” said Ronan Gannon, CEO of LCH Health and Community Services. “We look forward to working alongside innovative companies like LifeScan to explore new approaches to caring for patients,” Gannon added.

Study Results

Study Design
In the study, test group participants used the OneTouch Verio Flex meter with color range indicators and Spanish-language OneTouch Reveal mobile app for 12 weeks, and those in the control group used their own glucose meters without connection to an app. Test group participants continued the same regimen for an additional 12 weeks to determine the durability of effect, and control group participants crossed over to use the OneTouch meter and app after week 12.

Blood Glucose Changes

• 11% decrease in mean blood glucose (p<0.05)
• 13% increase in in-range blood glucose values (p<0.05)
• 14% decrease in above-range blood glucose values (p<0.05)
• No change in number of hypoglycemic events or below-range blood glucose values

Patients using the new meter and app said that it helped them better understand their blood glucose results (compared to their previous meter)⁴ and expressed improvements in their diabetes treatment satisfaction based on a Diabetes Treatment Satisfaction Questionnaire.

Diabetes in Hispanic and Latino American Adults
It’s estimated that over their lifetimes, US adults overall have a 40% chance of developing type 2 diabetes. For Hispanic/Latino adults in the US, the chance of developing type 2 diabetes is more than 50%, they are likely to develop it at a younger age and they experience more severe diabetes complications⁵. The prevalence and incidence of type 2 diabetes, as well as rates of hospital admissions and diabetes-related complications within the Hispanic/Latino population in the US, are higher than the national average likely influenced by a variety of cultural and social factors, including low numeracy and low literacy^6,7,8.

About the OneTouch^® brand made by LifeScan
LifeScan is a global leader in blood glucose monitoring innovation and digital health technology and has a vision to create a world without limits for people with diabetes and related conditions. More than 20 million people and their caregivers around the world count on LifeScan’s OneTouch brand products to manage their diabetes. Together, LifeScan and OneTouch improve the quality of life for people with diabetes with products and digital platforms defined by simplicity, accuracy, and trust. www.LifeScan.com and www.OneTouch.com

¹ https://www.cdc.gov/healthliteracy/learn/UnderstandingLiteracy.html
² Saydah S et al Race and ethnic differences in glycemic control among adults with diagnosed diabetes in the US. Ethn Dis 2007;17:529–535
³ Karter AJ et al. Ethnic disparities in diabetic complications in an insured population. JAMA 2002;287:2519–2527
⁴ Tu Salud Study Supplemental Table S1. Subject Acceptance Survey Results – All Subjects using OT Verio Flex meter and OT Reveal mobile app
⁵ https://www.cdc.gov/diabetes/library/features/hispanic-diabetes.html
⁶ Agency for Healthcare Research and Quality. National Healthcare Quality Report, 2013 (AHRQ Publication No. 14-0005). Rockville, MD, U.S. Department of Health and Human Services, 2014
⁷ Testerman J, Chase D. Influences on diabetes self-management education participation in a low-income, Spanish-speaking,Latino population. Diabetes Spectr 2018;31:47–57
⁸ Aguayo-Mazzucato C, Diaque P, Hernandez S, Rosas S, Kostic, A, Caballero AE. Understanding the growing epidemic of type 2 diabetes in the Hispanic population living in the United States.Diabetes Metab Res Rev 2019;35:e3097

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