Key:

NZ       Nahida Zaman

MM     Molly McElwee  

NZ          This is Nahida Zaman with Diabetes Radio.  I have with me today Molly McElwee.  Molly, a very warm welcome to Diabetes Radio.

MM         Thank you, thank you for having me.

NZ          Molly, you are Clinical Research Nurse Co-ordinator at the University of Virginia School of Medicine.  Could you give our listeners some background into your research interests?

MM         Yes my background in research interests are, I guess, a form selfish in that I am a type I diabetic myself and so my interest is in creating a cure of sorts on the market which is going to be in the form of an artificial pancreas.  I participated in clinical trials for many years before coming on to this team as a nurse and co-ordinating trials myself so I saw how wonderful this device was and I wanted to see it in use and so my research interests are pursuing this with passion and to get it on the market as quickly as we can.

NZ          As a former participant in artificial pancreas trials, prior to working at the University of Virginia School of Medicine, you bring a unique perspective of a patient as well as a clinician to the table.  It must be tremendously rewarding to see artificial pancreas now entering outpatient use.

MM         Yes it is really exciting, I am overjoyed every time we see our work in clinical trials going.  The participants come in and see how this works and the excitement in their eyes is just rewarding enough because a type I diabetes, you do not get a break, there is no vacation, there is no time where you do not get to not think about your diabetes and for inpatient trials I get to say relax, we have got it for the next 24 hours and that is a huge relief so yeah having used this as a patient and having to run the trials and explain it to new participants, it is really as rewarding as it can get and I can see the use is going to change lives for everybody with type I diabetes.

NZ          Your group’s recent research culminated in the development of a device which allows patients with type I diabetes to have their disease controlled by an artificial pancreas system.  Can you please describe the device and its functionality to the Diabetes Radio listeners?

MM         Yes the device has an open source platform operating system so we are able to build the artificial pancreas which consists of insulin pump and continuous glucose monitor with specific algorithms running in the background.  We are able to build this in a module format so if you imagine people know apps so if you imagine an app for every specific algorithm so a hypoglycaemic mitigation system running in the background and the safety system so a bolus interceptor running so that you can keep the patient safe at all times.  All this technology is now in a cell phone so it is portable, you can put it in your pocket, the screen is great, it is a touch screen so you can enlarge to see things, you can with your finger expand and contract but you can see the continuous glucose monitor information, you can see the bolus information and you can see what has happened over the past 24 hours so you can look back as far as you want but it is able to really integrate the devices and a new way and run our safety systems in the background so we are building it in a module fashion because the FDA is very specific about what they want and what they need and they just actually published some guidelines on artificial pancreas for home use.  I think it was last night I got the email at seven o’clock that that came out so we are building it in a module fashion so that we can plug in and remove as needed to get this device out quickly so it will not impede the progress when they decide that they want it to look a different way.

NZ          The device was developed and tested by an international research consortium under the umbrella title Global Artificial Pancreas Project.  Can you tell us about the make-up of the Global Artificial Pancreas Project?

MM         Yes, we are members of this project, the Global Artificial Pancreas Project and also known as the International Artificial Pancreas Consortium to the University of Virginia, University of California Santa Barbara, the Mayo Clinic, Stamford University, Yale University Colorado, Oregon and Boston Universities and in Europe we have the University of Padua in Italy and the University of Montpelier in France.  Since there is no FDA in Europe, we ran the trials there first and had really great success with the outpatient trial of this and obviously it is still a trial so the patient has a nurse, an Endocrinologist and an engineer with them at all times while we are testing the device so it is a trial, it is outpatient as realistic as we can make it but you still have those three people following them around the entire time.

NZ          Could you also tell us about the role of the University of Virginia Research Team in the development of the artificial pancreas system?

MM         Yes the entire artificial pancreas project is a group effort but the most recent advancement in making the device mobile in the Android cell phone happened here in our offices by Patrick Keith-Hynes who is one of our brilliant engineers here so this latest development is ours and we are running it with out partnerships in Europe so we are an integral part of this but we are really trying to push the boundaries and run with these trials as fast as we can to get this to patient population as quickly as we can and safely as we can because we realise this is a life saving device and we really, really can see the value of that and this is a great night time rose and the whole dead in bed syndrome when someone dies of hyperglycaemia at night, this is a device that can prevent that so we really, really want that out there so we really are working 24/7 to try to get this device out as soon as we can.

NZ          What role does the device’s smart algorithm play in regulating the wearer’s blood sugar levels?

MM         The smart algorithms, and I am going to answer this as a non-engineer, is intelligent at detecting trends in the blood sugar and to know how and when to intervene so there is a hyperglycaemic intervention system as well as a hypoglycaemic intervention system and these allow customised use for the patient to set those areas and remain in their comfort zone with interventions happening as needed so it is smart, it can detect trends as you are dropping rapidly, it can cut off the basal, it will cancel boluses, it will basically keep insulin from getting into the system until your blood sugar is up and corrected which can happen at night in your sleep so this could actually be happening in the background without you having to even worry about it.  Those are very, very smart algorithms.

NZ          Does this free the patient from the effort of monitoring?

MM         Yes and no so right now monitoring diabetes, people still live full lives with their type I diabetes but they are always thinking about it in the background.  They are still going to have to test their blood sugar to calibrate the continuous glucose monitor and to double check the device but the day to day management of type I diabetes will change dramatically.

NZ          A study took place in which two patients with type I diabetes attained near normal glucose levels after spending one night outside of a hospital whilst using the artificial pancreas system.  Can you please describe the objectives and design of the study?

MM         The objective of the study is to use the device, see the device under normal circumstances.  The subject arrived at the hospital and got hooked up to all the devices and then went out to dinner so most type I diabetics will know going out to dinner is a challenge on a regular day so we decided we would put this system to a real test so we would give it a real go, order off the menu and we will announce the meal to the artificial pancreas and see how it handles it and it handled it beautifully.  We also observed it overnight, again in the morning with breakfast, taking walks outside, we tried to keep things as normal as possible but the idea is let us absorb it just to see if we can observe this in a normal circumstance and see how it behaves and it behaved beautifully and the patients are really excited to be going out to dinner and trying these regular things and not being stuck in a hospital for 24 hours to test something so the study design is let us see how it works in real life and the outcome is it works great.

NZ          Do you have any results?

MM         The results have not been published yet but we did present some preliminary results at the Diabetes Technology Conference this past October in San Francisco so people stayed within range and people did wonderfully but again I cannot speak of the non-published results yet.

NZ          So the patients were able to achieve an unparalleled level of life quality in an outpatient setting whilst using the device.

MM         Yes they were and the sad part is that they have to take it off when the trial is done and I think we were all sad about that.  It is an unparallel, the whole quality for the patient and their loved ones who worry about them every day so it is very exciting and I cannot wait to be using this in outpatient trials in the US.

NZ          How important a milestone is this?

MM         This is so important a milestone.  The big milestone coming up to see how this is going to go for the future is will the FDA let us go outpatient with this device any time soon so it is a very big milestone to have this run in Europe and see that it runs safely and it went really, really well but the true test is going to be will the FDA let us do this outpatient so that will be the next important milestone but it is a pretty big accomplishment.

NZ          How close are we to seeing the artificial pancreas system in routine clinical use?

MM         In my dream world that is in the next year or two but realistically it may take a few more years than that dependent upon how the FDA decides to govern this process.  There is nothing like this that has been done, in their defence they are trying to keep everyone safe.  In our defence we are trying to keep everyone safe so just can we agree that this is the best way to do it so I am sure we will be under tight scrutiny and we will be jumping through lots of hoops but we are dedicated to seeing this happen so we will jump through what we have to do to make this work.

NZ          Molly McElwee at the University of Virginia School of Medicine, thank you so much for taking the time to speak with us today.