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| CeQur's PaQ device--Courtesy CeQur |
An improvement in blood glucose control can mean fewer and less severe complications for people with diabetes. But many diabetes patients aren't able to meet the demands of continual monitoring and medication dosing, thereby falling outside of desirable parameters. In fact, roughly half of all diabetes patients using insulin multiple times daily report that they sometimes skip doses because of the demands of daily activities.
Several companies are experimenting with long-term wearable insulin delivery systems that work via continuous subcutaneous infusion to help ease the administration of the medication, thereby making it easier for patients to remain compliant. One such system from startup CeQur recently reported data from a small pilot study.
In the single-arm study, 8 Type 2 diabetes patients transitioned from multiple insulin injections per day to wearing the three-day PaQ device. After 12 weeks, 6 of the study participants had an average reduction in HbA1c of 1.8 (+/-0.9%). Total daily insulin use as well as weight remained similar to baseline, with no hypoglycemic or other serious adverse events occurring during the study.
"Results from this study show that PaQ may free people from the burden of multiple-daily insulin injections and improve their glycemic control," Dr. Julia Mader of the Medical University of Graz, Austria, said in a statement. She presented data recently at the 8th International Conference on Advanced Technologies & Treatments for Diabetes in Paris. "It suggests we are rapidly moving toward a time when simple insulin delivery could help many people with Type 2 diabetes manage their disease more comfortably and effectively."
The PaQ device can provide constant background insulin dosing as well as a bolus of insulin at mealtime. It consists of both an infuser component, which is filled with rapid-acting insulin and attached to the abdomen via adhesive, and a messenger unit that tracks the time of use and notifies the user when to replace the device.
It's designed to continue to be effective during bathing and swimming. There are 7 preset basal doses, as well as two potential bolus units that can be used. The device can deliver up to 330 units of insulin over three days.
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| CeQur CEO Douglas Lawrence |
"The significant improvement in glycemic control that study participants experienced demonstrates that PaQ safely and effectively addresses many of the issues that make daily injection therapy a challenge for so many people with diabetes, and, importantly, can provide better clinical outcomes," CeQur CEO Douglas Lawrence said in a statement.
PaQ received a CE mark in November 2012. The company told FierceMedicalDevices in 2013 that it expected to submit the device to the FDA in early 2014 and gain 501(k) approval last year, but that has not yet come to pass. Last year, the startup brought in Lawrence as CEO; he was previously VP for the Insulin Injection business at Becton Dickenson ($BD).
The Swiss startup is backed by investors including Endeavour Vision, Shroder & Co. Bank and VI Partners. It most recently reported a cash infusion of $27 million in a Series C round from September 2013.
- here is the release
Special Report: FierceMedicalDevices' 2013 Fierce 15 - CeQur