CeQur SA Release: Diabetes Care Publishes Data Demonstrating PaQ® Insulin Delivery Device Could Help People With Type 2 Diabetes Overcome Barriers To Insulin Adherence And Improve Clinical Outcomes
3/5/2014 10:08:44 AM
HORW, Switzerland, March 5, 2014 – CeQur® SA, a company focused on the development and commercialization of simple insulin delivery devices, announced that comprehensive results from a clinical study of the company’s PaQ® Insulin Delivery Device were published online today in Diabetes Care, a peer-reviewed journal produced by the American Diabetes Association.
The paper titled, “A Feasibility Study of a Three-Day Basal-Bolus Insulin Delivery Device in Individuals with Type 2 Diabetes” summarizes results from a study that evaluated the feasibility of transitioning people with type 2 diabetes from multiple daily insulin injections (MDI) to PaQ. Study endpoints included glycemic control, patient satisfaction and safety. Final data suggest that the discreet, wearable PaQ is safe and easy to use, can potentially improve glycemic control among people with type 2 diabetes, and is associated with both high patient acceptance and satisfaction.
“The findings from this study are important because ease-of-use and improved patient satisfaction are known to result in improved clinical outcomes among this population of patients,” said Professor Thomas Pieber of the University Hospital in Graz, Austria, who led the study and authored the Diabetes Care paper. “PaQ is a unique device with the potential to provide tangible clinical and quality-of-life benefits to people with type 2 diabetes.”
Previous research suggests that approximately 50 percent of insulin-requiring individuals do not achieve appropriate glycemic control. Half of all patients requiring multiple daily insulin injections report they intentionally skip doses because they consider the injections embarrassing, inconvenient, painful, and/or disruptive to their daily activities. Continuous, subcutaneous insulin infusion (CSII) is an alternative to insulin injections, but adoption has been limited by the complexity and cost of existing, approved CSII devices.
“PaQ is a simple CSII device with demonstrated ability to safely and effectively address many of the issues that make daily injection therapy a challenge for so many people with diabetes,” said James Peterson, founder and CEO, CeQur. “The data published today demonstrate PaQ has the potential to reduce the daily insulin injection burden and thereby to improve clinical outcomes for a growing number of people worldwide.”
In the six-week, prospective study, 19 participants transitioned from multiple daily injections to PaQ treatment; all demonstrated competency in assembling, placing and using the device following just one hour of training.
Changes in self-monitored blood glucose values during PaQ therapy showed a trend toward better glycemic control compared to baseline at multiple points throughout the day. Blinded continuous glucose monitoring (CGM) data during PaQ therapy also revealed a trend toward improved glycemic control. The reduction in glucose exposure occurred overnight and during the day.
Patient-reported data from the device-use questionnaire revealed a high level of PaQ satisfaction and acceptance. All but one scored above 4.00, indicating high and very-high device satisfaction.
No severe hypoglycemic events occurred during the study baseline period or while participants were on PaQ.
PaQ® Insulin Delivery Device is a simple and affordable device that enables patients to experience the benefits of CSII without the burden of daily insulin injections. PaQ provides three days of consistent, basal insulin along with easy, on-demand bolus insulin. PaQ can reduce known barriers to insulin therapy and has proven effective in clinical trials and usability studies.
PaQ has CE Mark approval and will address the emerging $3 billion market for simple insulin infusion.
About CeQur® SA
CeQur is dedicated to developing and commercializing advanced insulin delivery devices that make it easier for people living with type 2 diabetes to adhere to therapy and stay in control of their disease. The company is headquartered in Horw, Switzerland, with operations in Nordborg, Denmark and Marlborough, Massachusetts.
CeQur was established in January 2008. The company’s lead product candidate is the PaQ Insulin Delivery Device, a novel, wearable device that provides freedom from multiple daily injections. More information can be found at www.cequrcorp.com.
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