INDIANAPOLIS — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Roche’s ACCU-CHEK Aviva Expert system, the first and only blood glucose meter system with a built-in insulin calculator to be approved by the U.S. Food and Drug Administration (FDA), is now available by prescription. The device represents a significant advancement in blood glucose meter technology for people with diabetes who take multiple daily insulin injections. The meter’s integrated bolus calculator provides easy-to-use and reliable dose recommendations based on automated calculations, eliminating the need for manual dosing calculations and estimations. A survey of ACCU-CHEK Aviva Expert users found that 79 percent reported increased confidence with insulin dose calculation, and 52 percent reported a reduced fear of hypoglycemia.1
In the United States, approximately 6 million people take insulin to help manage their diabetes.2 Many people also take multiple daily injections of insulin to help manage their disease, which requires them to calculate proper insulin dosage amounts based on their food intake and blood glucose readings. These calculations are complex, and constant precision is critical to determine the proper insulin dose. A multicenter study found that 63 percent of manually calculated insulin doses were incorrect.3 As an incorrect insulin dose can lead to serious health complications, including hypoglycemia, accurate calculations are required. Researchers from the U.S. Centers for Disease Control and Prevention (CDC) reported that there were nearly 100,000 emergency room (ER) visits each year between 2007 and 2011 that were attributed to insulin-related hypoglycemia and other errors, and that these visits accounted for roughly 9 percent of all ER visits due to drug reactions during this timeframe.4
"The availability of the ACCU-CHEK Aviva Expert system marks an important, game-changing milestone in diabetes self-management by making the process of calculating insulin dosage easier and less susceptible to error," said Dr. Bruce W. Bode, a clinical associate professor in the Department of Medicine at Emory University and a diabetes specialist with Atlanta Diabetes Associates in Atlanta, Georgia. "One of the biggest barriers to optimal self-management is the ability to calculate bolus doses. My hope is that the device will become the standard of care for patients on multiple daily insulin injection therapy due to the simplicity of the built-in bolus calculator."
Diabetes affects 29.1 million children and adults in the U.S., approximately 9.3 percent of the population.2 Regular and accurate monitoring of blood glucose levels through self-testing is essential to managing the disease and can reduce the risk of diabetes-related complications, such as heart disease, stroke, kidney failure, nerve damage, and blindness.2
"We are excited to provide the diabetes community with this innovative solution that will allow users to accurately calculate their insulin dose," said Marc Gibeley, Head of Roche Diabetes Care North America. "The ACCU-CHEK Aviva Expert system is the first and only system of its kind that provides meal and correction insulin bolus recommendations, which can help patients on insulin therapy have the confidence they need to better manage their diabetes."
The ACCU-CHEK Aviva Expert meter system is available by prescription only for people with diabetes who are trained in multiple daily injection therapy and are under the supervision of healthcare professionals experienced in managing insulin-treated patients.
ACCU-CHEK Aviva Expert Indications:
The ACCU-CHEK Aviva Expert system is indicated as an aid in the treatment of insulin-requiring diabetes. The ACCU-CHEK Aviva Expert system consists of the ACCU-CHEK Aviva Expert meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor feature. The ACCU-CHEK Aviva Expert system is intended to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin-treated patients.
The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert system is intended for prescription home use only.
The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a pre-planned treatment program from a healthcare professional. Before patient use, a healthcare professional must prescribe the ACCU-CHEK Aviva Expert system and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with the healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.
For more information and to get access to the ACCU-CHEK Aviva Expert, visit accu-chek.com/getexpert
About Roche Diabetes Care Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 30 years, Roche has been committed to helping people with diabetes live lives that are as normal and active as possible and has been helping healthcare professionals manage their patients’ condition in an optimal way. Today, the ACCU-CHEK portfolio offers people with diabetes and healthcare professionals innovative products, services, and comprehensive solutions for convenient, efficient, and effective diabetes management – from blood glucose monitoring through information management to insulin delivery. The ACCU-CHEK brand encompasses blood glucose meters, insulin infusion pumps, lancing, and data management systems. For more information, please visit accu-chek.com.
About Roche Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism, and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life, and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
1. Barnard K, Parkin C, Young A, Ashraf M. Use of an automated bolus calculator reduces fear of hypoglycemia and improves confidence in dosage accuracy in patients with type 1 diabetes mellitus treated with multiple daily insulin injections. J Diabetes Sci Technol. 2012;6(1):144-149.
2. Centers for Disease Control and Prevention. National diabetes statistics report: estimates of diabetes and its burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services; 2014. Available at:http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed August 18, 2014.
3. Sussman A, et al. Performance of a glucose meter with a built-in automated bolus calculator versus manual bolus calculation in insulin-using subjects. J Diabetes Sci Technol. 2012;6(2):339–344. Available at:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3380776. Accessed September 3, 2014.
4. Geller AI, et al. National estimates of insulin-related hypoglycemia and errors leading to emergency department visits and hospitalizations. JAMA Internal Medicine. 2014;174(5):678-686. Available at: http://archinte.jamanetwork.com/article.aspx?articleid=1835360. Accessed August 18, 2014.
Press release via MarketWatch.