The 11th Annual Diabetes Technology Meeting: Low Glucose Suspend Research Set to Begin in the US; Artificial Pancreas Studies Abroad, and the World’s Latest Advances in Glucose Measurement
A few weeks ago we headed south from San Francisco to Burlingame, CA, where we saw one of the most exciting Diabetes Technology Meetings in recent memory. Below, we discuss some of the most notable topics, including: progress at every step toward the artificial pancreas, the extremely accurate performance of a new blood glucose meter that just launched in Europe, and a strong emphasis on wireless connectivity to other devices (and to the entire Internet)…
a refresher on glucose (cruise) control
As we’ve written about before, one of the Holy Grails in diabetes technology is the development of an “artificial pancreas” – a product that could continuously monitor glucose levels and automatically deliver insulin in response (see the NewNowNext in diaTribe #31 and the Artificial Pancreas section of our free e-book, Targeting a Cure for Type 1 Diabetes). The long-term goal is to develop a “fully closed loop” – a system that requires no inputs from the person using it. Such a system would likely deliver additional hormones such as glucagon, which raises blood sugar in case of hypoglycemia.
In the nearer-term, researchers are working to wirelessly connect today’s insulin pumps and subcutaneous CGM sensors. Due to current insulin “lag time,” sensor inaccuracy, the difficulty of forecasting glucose control with today’s software, and other factors, such a system wouldn’t yet be able to give perfect, flat glycemic control all the time. However, it could reliably deliver insulin or glucagon when glucose is going especially high or low. In this way the system could dramatically decrease the amount of time that most patients spend in hypoglycemia or hyperglycemia. Dr. Aaron Kowalski, JDRF’s Assistant Vice President of Treatment Therapies and diaTribeadvisory board member, recently said that he expects this sort of “control-to-range” system to be commercially available by the end of 2016. (A “control-to-range” system would aim to keep blood glucose in a range, e.g., 80-180 mg/dl, instead of targeting a set value like 100 mg/dl). Based on two demonstrations we saw at the Diabetes Technology Meeting, we are also optimistic about the strength of the technology, although early on, there will certainly be frustrations like with any new technology.
prototype artificial pancreas “apps” in action
Dr. Patrick Keith-Hynes (University of Virginia, Charlottesville, VA) and Dr. Claudio Cobelli (University of Padova, Padova, Italy) led the first of two artificial pancreas demonstrations. Their research team has developed a way to wirelessly connect a Dexcom Seven Plus CGM, an Insulet OmniPod pump, and an Android cell phone application that runs the system. We note that the system is still a prototype and is designed for research, not commercial use. Still, it was cool to see, and it helped us get a sense of what upcoming commercialized devices might look like.
The home screen of the UVA research app features a traffic light icon that shows people whether their glucose is in the target range (green light), slightly too high or low (yellow light), or in more dangerous territory (red light) – a quick, intuitive, and cool-sounding way for someone to get a sense of things with one look at the phone. People can also tell the system when they are about to start exercising and they can manually dial in mealtime boluses (this is an example of a hybrid artificial pancreas, which provides automated basal glucose control but still requires mealtime dosing of insulin). On a positive note, the system is designed to work with a variety of different insulin pumps, CGM sensors, or software algorithms. Thus it can be widely used by researchers around the world. So far the system has been tested twice outside the hospital, once in Italy and once in France, and overall it performed well both times.
In the second artificial pancreas demonstration, Dr. Michael Kremliovsky (Medtronic Diabetes) showed off Medtronic’s own early-stage artificial pancreas system. The prototype consists of two CGM sensors, an insulin pump, and a mobile phone that controls it all (though for the version of the product that eventually comes to market, Medtronic plans to put all the software in the pump rather than using a phone). Both the UVA and the Medtronic systems connect to the Internet so that researchers can remotely monitor patients and see how the system is performing. Indeed, Dr. Kremliovsky displayed real-time CGM and insulin pump information from a patient testing the system in Australia!
medtronic gets the go-ahead for major us trials of its new pump and cgm sensor
As a reminder, the first step toward an artificial pancreas is called a “low glucose suspend” (LGS) system – a pump that stops dosing insulin when the glucose sensor reads hypoglycemia. Medtronic’s Veo – the first commercial LGS device – has been available internationally since 2009. However, because of a more conservative approach by the FDA, LGS still has not come to patients in the US. Although LGS systems have the potential to prevent coma or even death from low blood glucose, the FDA is concerned that they could also increase the risk of too-high glucose (for example, if the pump mistakenly suspended when blood sugar was actually in the normal or high range, a user’s blood sugar might go dangerously high). However, studies show that when the Veo suspends insulin delivery, blood sugar rises approximately 20-30 mg/dl/hour. Most researchers believe that the huge benefit such a device offers in terms of protection from severe hypoglycemia far outweighs the small chance of the system improperly suspending insulin delivery.
Fortunately, the FDA has now given Medtronic the green light to conduct ASPIRE, the first major outpatient trial of a low glucose suspend product in the US. Notably, the US version of the Veo will use Medtronic’s new Enlite sensor, which can be worn for six days at a time. (For reviews of the Enlite, see Test Drive in diaTribe #32 and Thinking Like a Pancreas in diaTribe #36.) As of this writing, Medtronic is still in the final planning stages of ASPIRE, which as we understand it will seek to enroll a minimum of 260 patients. However, the company did recently begin a large trial of the Enlite sensor, expected to complete in April 2012, according to Clinicaltrials.gov (for more information, see this issue’s TrialWatch). Medtronic has not announced its target timeline for launching the US version of the Veo; as always this will depend on how fast the studies enroll and how quickly the FDA reviews the regulatory submissions.
The next step after LGS systems (and before a hybrid or control-to-range product discussed above) will be predictive low-glucose suspend products. As their name suggests, predictive LGS devices can stop insulin delivery if their algorithms predict that hypoglycemia will occur within the next half-hour. In other words, these devices would hopefully avert hypoglycemia before it happens. A team of researchers from Stanford University and the University of Colorado, led by diaTribe advisory board member Dr. Bruce Buckingham, recently got FDA authorization to conduct the nation’s first outpatient study of a predictive LGS system. Dr. Buckingham showed at the meeting that the researchers’ prototype, which uses Medtronic technology, has performed solidly in controlled research settings. Thus, interest in this upcoming study is high.
early looks at new glucose-monitoring technologies
In addition to sessions on the artificial pancreas, several presenters focused specifically on new approaches to CGM and fingerstick blood glucose meters (BGM). Two of the most powerful presentations we saw came from Dr. Richard Stadterman and Dr. David Simmons of Bayer, who discussed studies of the company’s novel BGM. Based on the data shown, the new Bayer meter would be by far among the most accurate on the market; we hope that its performance is borne out in the official trials required for US submission. Bayer has already launched the device (called Contour XT) in Italy, Spain, and Portugal, and we look forward to learning more about people’s experiences as it becomes more widely used.
Additionally, we saw information from several companies developing implantable CGM (e.g., Sensors for Medicine and Science, Inc.) and noninvasive CGM (e.g., C8 MediSensors). Unfortunately the data presented were too early-stage to tell how these products would fare in the real world. Also, we expect that they are at least a few years from reaching the market here in the US, and FDA requirements for such systems will likely be quite stringent.
Last but not least among new glucose monitoring technology at the meeting, Wireless Medical’s system attracted a good deal of attention. The firm is led by Dov Moran, better known as the inventor of the USB flash drive. Harnessing this expertise in miniature electronics, Mr. Moran and his team are working on a small chip that they say could enable any blood glucose meter or CGM to send data online without wires or even a cell phone. Mr. Moran did not say how far along in development this chip is or how the company would plan to introduce it. But at the very least, it is an intriguing example of today’s research environment and the new goals that scientists are targeting. As a reminder, Telcare received FDA approval in August for a related product: a wireless-enabled blood glucose meter (for more information, see NewNowNext in diaTribe #35). Wireless Medical’s technology would take Telcare’s technology a step further by enabling any meter or CGM to wirelessly upload data online. –JPS