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MARLBOROUGH, Mass. /PRNewswire/ -- CeQur SA, a leader in simple infusion for people with diabetes, announced that results from a clinical study evaluating the company's PaQ® Insulin Delivery Device appear in this month's Journal of Diabetes Science and Technology. The data demonstrate that switching to the PaQ device from multiple-daily insulin injections (MDI) can help people with type 2 diabetes overcome barriers to insulin therapy and negative appraisal of insulin treatment without increasing diabetes-related distress.
The paper titled, "Novel Simple Insulin Delivery Device Reduces Barriers to Insulin Therapy in Type 2 Diabetes: Results from a Pilot Study" summarizes patient-reported outcomes from a six-week, prospective, single-arm study evaluating feasibility of PaQ use, as well as the safety and efficacy of transitioning study participants from MDI.
"Embarrassment, fear of hypoglycemia, stigma, and pain are among the barriers that prevent many people with type 2 diabetes from adhering to their prescribed insulin regimen, despite the known clinical benefits of consistent insulin therapy," said Norbert Hermanns, PhD, director of the Research Institute at Diabetes Academy Mergentheim in Bad Mergentheim, Germany, and the lead study author. "Results from this study suggest that use of the PaQ device can greatly reduce these barriers, potentially supporting improved adherence to insulin therapy."
Eighteen participants in the PaQ study completed validated questionnaires (three each) assessing patient-reported outcomes, including barriers to insulin therapy (BIT), diabetes-related distress and negative attitudes toward insulin. After just two weeks of PaQ device use, patients reported a strong and clinically significant reduction in overall BIT (difference = -5.4 +0.77, p= 0.01, effect size = 0.70). Most patients perceived less hardship from insulin therapy, less stigmatization by insulin injection and less fear about hypoglycemia. Negative attitudes toward insulin treatment and patients' diabetes-related distress were also slightly reduced.
"It is possible that this reduction of insulin-therapy barriers may have contributed to the trend toward improved glycemic control that was also observed in this study and previously reported in the journal Diabetes Care," said Doug Lawrence, CEO of CeQur.
Data from a questionnaire evaluating satisfaction with PaQ, including time required to maintain the device, administer an insulin dose, and learn how to use the device revealed a high level of PaQ satisfaction and acceptance. All but one device satisfaction and acceptance measure scored above 4 (on a scale of 1 to 5, with 5 representing maximum satisfaction), indicating high and very-high satisfaction with PaQ.
"The data published today demonstrate that PaQ does exactly what we envisioned it would do - simplify insulin therapy to make it easier and more comfortable for people with type 2 diabetes to adhere to their treatment and, we hope, live healthier, happier lives as a result," said Lawrence.
The Need for Simple Insulin Infusion
Every day more than 11 million people with type 2 diabetes in the United States and Europe inject insulin to manage their disease. The majority of these people are not achieving target glycemic control. Studies suggest that simple CSII regimens may improve glycemic control and quality of life among these individuals, however, current CSII has not been widely used in this population to date due to its complexity and cost.
PaQ Insulin Delivery Device is a simple and cost effective three-day insulin delivery device that enables patients to experience the benefits of CSII without the complexity 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.
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 three-day, wearable device that provides freedom from multiple daily injections. More information can be found at www.cequrcorp.com.
Forward Health Communications, Inc.
SOURCE CeQur SA
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