New data suggest PaQ device can reduce known barriers to insulin therapy among people with type 2 diabetes

Jun 24 2013

CeQur^® SA, a company focused on the development and commercialization of simple insulin delivery devices, announced that comprehensive data from a study of the company's PaQ^® Insulin Delivery Device will be presented today and tomorrow at the American Diabetes Association 73^rd Scientific Sessions in Chicago, IL. The data suggest that PaQ can reduce known barriers to insulin therapy among people with type 2 diabetes, potentially improving their glycemic control.

Dr. Julia Mader of the University Hospital in Graz, Austria, will present the findings from a 20-patient study that evaluated the ability of people with type 2 diabetes who were on a stable multiple daily insulin injection (MDI) regimen to use PaQ in replacing the insulin injections required to control their blood sugar (Posters #812-P and #990-P). Study endpoints included glycemic control, patient satisfaction and safety.

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, and CGM revealed no episodes of severe hypoglycemia.

Previous research suggests that approximately 50 percent of insulin-requiring individuals do not achieve appropriate glycemic control.[1] Poor glycemic control is associated with additional health-care costs and high risk of disabling complications, including diabetic retinopathy, chronic kidney disease and cardiovascular disease.[2] Half of all patients requiring MDIs report that they intentionally skip doses because they consider the injections embarrassing, inconvenient, painful, and/or disruptive to their daily activities.

"There is increasing evidence that simple insulin infusion devices such as PaQ may have a positive impact on glycemic control as well as attitudes toward insulin therapy among people with type 2 diabetes who need multiple daily injections," said Dr. Mader.

Nineteen patients in the PaQ study completed validated questionnaires assessing patient-reported outcomes, including Barriers to Insulin Treatment (BIT). There was a strong and clinically significant effect of PaQ on the mean BIT total score. Patients perceived less hardship from insulin therapy, less stigmatization by insulin injection and less fear of hypoglycemia. Diabetes-related distress was also slightly reduced.

"The reduction in perceived 'hardship of insulin treatment' and 'feeling of stigmatization' might be at least partly explained by the fact that PaQ use replaced - on average - 5.2 daily insulin injections," said Dr. Mader. "That equates to a meaningful reduction in the amount of time, as well as inconvenience and discomfort, associated with insulin injections for these patients."

Data on PaQ feasibility of use, efficacy and safety were previously presented at the 6^th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Paris, France. These data demonstrated that – in the Graz study - PaQ safely and effectively delivered patients' insulin requirements with a high level of patient satisfaction and acceptance. No severe hypoglycemic events occurred during the study baseline period or while participants were on PaQ, and all patients were able to correctly assemble and use PaQ with just one hour of training.

The Need for Simple Insulin Infusion

There are currently more than 11 million people in the United States and European Union who are taking insulin injections to manage their type 2 diabetes. Studies suggest that simple continuous, subcutaneous insulin-infusion (CSII) regimens may improve glycemic control and quality of life among these individuals. However, current CSII has not been widely used in T2D to date due to its complexity and cost.

"We have been extremely gratified by the ability of simple insulin therapy to free people with type 2 diabetes from the burden of multiple daily injections so that they can maintain target glycemic values and potentially improve their long-term health," said James Peterson, founder and CEO, CeQur.