New Data Show On-Demand, Mealtime Insulin Delivery System Enabled More than 50 Percent of Patients to Report Improved Dose Compliance
Innovative, In-Development Patch Allows Simple and Discreet Dosing and Greater Patient Satisfaction
CHESTERBROOK, Pennsylvania, June 13, 2016 - People with type 1 and type 2 diabetes who used the new OneTouch Via™ mealtime, on-demand insulin delivery system reported they missed fewer doses and felt less stress about dosing compared to multiple daily injections, according to research presented by Calibra Medical, Inc., one of the Johnson & Johnson Diabetes Care Companies, at the annual American Diabetes Association (ADA) conference. Results of the Market Acceptance Evaluation (MAE) study also demonstrated that physicians were more likely to recommend the innovative insulin delivery device to patients who are not at A1C goals or who are new to rapid-acting insulin (RAI) therapy.
The new OneTouch Via™ is a wearable, on-demand insulin delivery system in development that allows patients to discreetly deliver rapid-acting, or bolus, insulin at mealtimes by simply pressing two buttons on the device, accessible even through clothing. The thin, water-resistant patch can be worn continuously for up to three days, providing injection-free delivery of insulin when needed.
"People with diabetes can often feel embarrassment or discomfort when they need to inject insulin at mealtimes or when snacking. In a social situation, they may choose to miss a dose so they don't have to take themselves out of the moment, but avoiding needed insulin doses may lead to serious health complications over time," said Dr. Brian Levy, Chief Medical Officer, Lifescan, Inc. "Because patients in the study were empowered to dose discreetly with the OneTouch Via™, they felt encouraged to dose more often - and ultimately, they reported missing fewer doses and better adherence to their treatment regimen."
The MAE study followed 44 patients with a median age of 57 years, who used the OneTouch Via™ patch for 60 days, instead of their bolus injection device (75 percent pen users and 25 percent syringe and vial users). Patients responded to insulin usage questionnaires at baseline, then after 1, 4 and 8 weeks. By weeks 4 to 8, more than half (58 percent and 52 percent, respectively) of study participants acknowledged dosing more often than they would with a pen or syringe - with satisfaction rates increasing the longer they used OneTouch Via™. Furthermore, 98 percent of patients said the patch let them dose discreetly in public, with 88 percent noting they worried less about forgetting insulin - creating a less stressful disease management experience.
The healthcare professionals who assisted with the study noted that they preferred the OneTouch Via™ over both insulin pens and syringes (75 percent and 100 percent, respectively) and would be likely to recommend it to their patients. The doctors also reported that they would start patients on mealtime insulin earlier because of the ease of use of the OneTouch Via™ patch.1
"We understand the physical and emotional challenges people with diabetes face every day, and are constantly driving to create innovative solutions that help people with diabetes manage their condition and live the life they want," said John Wilson, Worldwide Vice President of Insulin Delivery, Animas Corporation. "As an injection-free insulin delivery patch, OneTouch Via™ will help people stay on top of their treatment and also allow them to stay in those vital moments in life - a dinner party, a grandchild's birthday, a work event. It is our hope that once commercially available, it will eliminate the barriers many people living with diabetes face surrounding mealtime insulin and ultimately improve health outcomes."
The U.S. Food and Drug Administration (FDA) approved the insulin delivery patch on April 10, 2012, for use by adults over 21 years of age with type 1 and type 2 diabetes. An additional Clinical Outcomes Study, being conducted across 60 trial sites in the U.S. and Europe, will measure the change in A1C levels, glycemic variability and patient reported quality of life seen in patients using OneTouch Via™ compared to insulin pens over the course of 24 and 44 weeks.
Calibra Medical, Inc., plans to make the OneTouch Via™ commercially available in limited markets outside the U.S. in late 2016, with U.S. availability to follow shortly thereafter.
About Calibra Medical, Inc.
Calibra Medical, Inc. is one of the Johnson & Johnson Diabetes Care Companies. With a shared vision of creating a world without limits for people with diabetes, the Johnson & Johnson Diabetes Care Companies are a collaboration of Johnson & Johnson companies dedicated to diabetes and includes LifeScan, Inc., a world leader in blood glucose monitoring; Animas Corporation, maker of innovative insulin delivery systems; Calibra Medical, Inc. developer of OneTouch Via™ on-demand insulin delivery; and the Johnson & Johnson Diabetes Institute, LLC, a global initiative to improve care and better outcomes worldwide through education and training programs.
1 Patient User Experience Evaluation of Bolus Patch Insulin Delivery System, Patient User Experience, American Diabetes Association 76th Scientific Sessions, June 11, 2016; V.Zraick, D.Dreon, R.Naik , D.Shearer, S.Crawford, J.Bradford, B.Levy; Calibra Medical, Inc., Redwood City, Ca., and LifeScan, Inc., Wayne, Pa.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the OneTouch Via™ insulin patch. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Calibra Medical, Inc., any of the Johnson & Johnson Diabetes Care Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.