Lowering Barriers to Help Improve ComplianceFriday, September 12, 2014
CeQur has developed its PaQ simple insulin delivery device in order to help type 2 patients follow their medication regimen and achieve optimal outcomes.
By: John Parkinson, Clinical Content Coordinator, DiabetesCare.net
The CDC’s recent statistics that there are millions more people with type 2 diabetes in the U.S. from just the last national accounting done a few years ago suggest the incidence rate of the disease has not yet reached a tipping point. As the incidence rate of type 2 continues to grow, it is likely more people will also begin a regimen of insulin as their diabetes progresses.
One of the more frequent issues for type 2 patients is that they fit into a category where their introduction to diabetes is not usually met with the immediate need for insulin. Often, people with type 2 can have the disease for years before the insulin conversation with their provider arises.
And when the insulin conversation does come up, there are many barriers encountered in initiating and optimally following a daily insulin injection treatment plan. One of the more common fears patients have is giving themselves injections. Needle fear is a well-documented obstacle that patients maintain and can be a real barrier to medication adherence.
Beyond needle fear, people may be uncomfortable performing injections in public.
Boston-based CeQur is a company that has responded to these issues by developing its PaQ insulin delivery device. The PaQ is a simple three-day infusion patch. PaQ comes in seven pre-set basal insulin rates targeted to cover the majority of Type 2 patients, and has a bolus button that delivers two units per click of mealtime insulin. PaQ is worn on the abdomen so that users can discreetly and conveniently receive their basal and bolus insulin requirements without having to give daily injections via a needle.
Leading CeQur is CEO Doug Lawrence. Prior to joining the company, Lawrence worked for Becton Dickinson and Company, a supplier of insulin injection products, where he was vice president for Injection. Familiar with the diabetes market and with the global health challenge of the type 2 diabetes epidemic, Lawrence saw an unmet need in the injection market segment, especially considering the sheer number of type 2s who would need insulin.
DiabetesCare.net spoke with Lawrence about how the PaQ delivery device works; his goals for the product; and the timeline for when the device will be commercially available in Europe and the United States.
DiabetesCare.net: Can you provide an overview of how CeQur’s PaQ works?
Lawrence: PaQ has two components. There is an all mechanical infusion system called the reservoir, which contains the insulin required for three days and delivers both basal and bolus doses. The bolus button delivers two units of mealtime insulin with each press. People using the PaQ simply click the needed amount of insulin required to cover their meal.
The second component is a reusable component called the messenger, which monitors the status of fluid delivery. People can easily check the status of PaQ and be informed how many days of therapy remain and when it is time to dispose of the device and place on a new PaQ.
DiabetesCare.net: What will the PaQ be capable of doing that will be unique in helping insulin-using type 2 patients?
Lawrence: Essentially, the PaQ makes it easy and simple to do the right thing to keep your blood glucose on track. It enables the automatic delivery of insulin for three days. You simply fill it up and attach the device to the body.
The device is discreet; it is worn underneath the clothing. Users of the product can reach down and push the button to receive bolus insulin in a public setting and no one needs to know you are administering insulin.
We believe it will enable patients to become more adherent and we have demonstrated that it reduces the burden of insulin therapy.
DiabetesCare.net: Can you talk a little about who is the type 2 insulin using market you are targeting, and what are some of the inherit challenges for them to achieve insulin compliance?
Lawrence: Our initial market is people with type 2 in the U.S. and Europe who are not achieving targeted control on daily injection regimens. The challenges these individuals face include the burden of multiple injections throughout the day, carrying around injection devices, and assembling and disposing of these injectables properly after treatment.
It is the diligence required to do the finger sticks, mental calculations, and injections at the right times with the correct amount of insulin.
What is known is that the type 2 population is a bit older and has more difficulty successfully following their therapy plan. An article in the American Diabetes Association’s journal Diabetes Care from a few years ago showed that over half of all patients on multiple daily injections miss injections. Daily life is challenging and they do things such as skip doses. What we are talking about here is trying to lower some real barriers to successful self-management of diabetes that have been established in research.
DiabetesCare.net: What type of feedback are you receiving about the product in Europe from people with diabetes as well as providers?
Lawrence: We do have a CE Mark on the product in Europe, but we haven’t begun commercializing it yet. We will begin that next year. We have been conducting clinical trials and the feedback from the participants has been very positive. We published the results in Diabetes Care in March of this year. Participants in the trial found the device to be easy-to-use and safe, and it was highly accepted. Study participants agreed they would like to continue on PaQ, rather than the daily “pokes.”
DiabetesCare.net: Have you heard any feedback on the provider side?
Lawrence: Providers and payers recognize the burden of uncontrolled diabetes and the fact that patients are having difficulty complying. They are looking for a solution to help control diabetes, reduce the burden of adherance, and the number of patients experiencing the catastrophic consequences and complications of inadequately controlled diabetes,
DiabetesCare.net: You had mentioned that you are looking at 2015 for a rollout in Europe. Do you have a specific timeline?
Lawrence: We are expecting to have the European launch in the second half of 2015. The U.S. launch will be in 2016 following FDA 510k clearance.
DiabetesCare.net: And if we segue into the U.S. market, where are you in the FDA 510K approval process?
Lawrence: We are preparing our filing at this point, which we expect to be completed and filed in mid-2015.
DiabetesCare.net: If everything goes according to plan, do you expect a commercial release for the PaQ in the U.S. in 2016?
Lawrence: Yes. There is a clear FDA guidance document for infusion pumps and the FDA has approved similar predicate devices, so the path to U.S. approval is clearly understood.
DiabetesCare.net: In terms of insuring the PaQ, are you expecting most medical insurers in the U.S. to cover the device?
Lawrence: We believe so. There has been a real interest in a device like this for individuals who cannot control their diabetes using daily injections. And this would provide a viable alternative to what exists in the market today.
DiabetesCare.net: What are your goals for this product?
Lawrence: The primary goal is to bring an exciting new therapy to patients around the world, and to create an easier way for patients to achieve desired outcomes. We hope to build a successful business by enabling simple infusion of insulin.
To see how the PaQ works, check out this YouTube video here.