Memorandum

Advanced Technologies & Treatments for Diabetes (ATTD) 7th Annual Conference Preview – January 31, 2014

February 5-8, 2014 – Vienna, Austria

http://www2.kenes.com/attd/sci/Pages/OnlineProgram.aspx

This year, the 7th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) will take place from February 5-8 in Vienna, Austria. The profile of this conference has risen significantly over time (from a high base), and this year should be no exception based on the jam-packed schedule highlights below. Big picture, professionals across the field seem to be recognizing the strengths of this conference – over 2,000 participants came to Paris last February, growing from 1,694 in 2012, 1,400 participants in 2011, 915 participants from 2010, 770 attendees in 2009, and about 400 attendees at the inaugural meeting in 2008. ATTD 2014 has 38 workshops and sessions, an increase from 34 last year and 32 in 2012. There will be 13 symposia (with topics including prevention of hypoglycemia, the challenges of diabetes management in children and teenagers, and pumps and sensors), six plenary sessions, five oral presentation sessions (45 orals total), and 17 corporate sponsored sessions, workshops, and symposia (including four from Medtronic, two from both Roche and Tandem, and one each from Abbott, Dexcom, and Sanofi). The first day of ATTD is especially heavy with corporate sponsored events, with most programs falling in the middle of the day (in contrast to morning or evening sessions).

The artificial pancreas remains a large topic of interest at this meeting, with six session titles containing either “artificial pancreas,” “bionic pancreas,” or “closing the loop,” and a few additional sessions on algorithms for closed-loop therapies. We especially look forward to hearing results the MGH/BU Beacon Hill and the Summer Camp studies. As with ADA 2013, we expect to see data from many outpatient trials testing systems to increasingly ambitious degrees. Given the wide variety of systems in development by academia and industry, it will be illuminating to see what draws the most excitement and what has the nearest term potential to hit the market. Many eyes will be on Medtronic and its next-gen predictive low glucose management pump, though we also expect to see more and more interest in overnight closed-loop systems. 

The individual components of the artificial pancreas – CGMs and pumps – will also be at the forefront of ATTD; this year’s pump sessions have a larger focus on patch pumps than we’ve seen in the past. The continued success of Insulet’s OmniPod no doubt has played into this trend, along with the need for more insulin delivery approaches for type 2 diabetes.

This preview contains day-by-day highlights of ATTD 2014’s sessions and presentations. This conference is packed with excellent content, so we have excluded a number of talks and sessions for the sake of brevity. If you would like a more comprehensive view of the meeting’s full schedule, please see the meeting’s interactive timetable. Clicking on a session’s title will bring up a window with individual presentations, speakers, and links to abstracts. We encourage you to double-check rooms and session times in the official program, since they are subject to change.

Wednesday, February 5

  • (3:00 – 4:30 PM, Hall II) Workshop: 7th Framework Program – Funded eHealth Systems for Diabetes. In this session, we are particularly looking forward to hearing progress within the EU’s AP@Home project – Dr. Steve Lane (Triteq Innovations, Oxford, UK) will discuss the technology developed to move an artificial pancreas from a clinical to a home environment.
  • (3:00 – 4:30 PM, Hall III) Industry Workshop: Simple Insulin Infusion for People with Type 2 Diabetes (Supported by CeQur). Some of this session will be similar to recent symposia CeQur sponsored at ADA and EASD. However, a big twist will come from new human factors data presented by Ms. Leslie Lilly (CeQur Co., Marlborough, MA) – we can’t wait to hear this. Certainly, ease of use and convenience count for a lot in any diabetes technology domain, and perhaps more so for insulin delivery in type 2 diabetes. In line with previous conference sessions, Dr. John Pickup (King’s College London School of Medicine, London, UK) will present on continuous subcutaneous insulin infusion (CSII) – we always learn SO much from him – and Dr. Ellie Strock (International Diabetes Center, Minneapolis, MN) will present on glycemic control with PaQ as measured by CGM.
  • (3:00 – 4:30 PM, Hall IV) Industry Workshop: Increase Protection from Hypoglycemia – Low Glucose Suspend Technology & New Generation Enlite Sensor (Supported by Medtronic). This workshop will focus on how Medtronic’s low glucose suspend feature (recently approved in the US). Content will almost certainly focus on the ASPIRE studies of the MiniMed 530G, though we hope to hear additional details about the features and timeline on the Enhanced Enlite sensor. The next-gen sensor received a CE Mark in September and launch has been slated following ATTD (we assume in tandem with the MiniMed 640G predictive low glucose management pump). The Enhanced Enlite has two main innovations: an 80% reduction in implanted volume size over the original Enlite and improved sensor-transmitter communication. No accuracy data has been shared yet, and the sensor will still be six-day wear.
  • (4:45 – 6:15 PM, Hall I) Workshop: Artificial Pancreas – Enhance the System’s Safety. This important session will feature two debates on critical safety issues in diabetes technology. The first will present both the US and EU regulatory perspectives on artificial pancreas safety (this reminds us of the provocative EASD session that featured the FDA and EU’s perspectives on medical devices). It’s great to see the FDA’s Dr. Stayce Beck making the trip all the way to Vienna – in this area of budgetary constraints, it’s impressive to see the FDA remaining in the center of the dialogue. The second debate will address the pros and cons of remote monitoring for the artificial pancreas – Dr. Thomas Danne (Kinderkrankenhaus, Hannover, Germany) will take the pro side and Dr. Eran Atlas (Schneider Children’s Medical Center, Petach Tikvah, Israel) will speak to the cons. This is a complicated issue that we believe will vary from one patient to another and from one system to another – children will be different from unmarried adults, and predictive low glucose suspend will be different from overnight closed-loop. Bottom line, we can’t wait to hear this.
  • (4:45 – 6:15 PM, Hall II) Industry Workshop: The Journey to Personalized Diabetes Management Solutions – Now and Next (Supported by Roche). This session will include results from a “handling study” (we assume this is human factors or feasibility) of the Accu-Chek Insight diabetes therapy system (next-gen pump + meter remote; to be launched in the EU in 2014). Dr. Hans DeVries (Academic Medical Center, Amsterdam, Netherlands) will also address the AP@home project and may well (we hope) bring new data. At Keystone 2013, Dr. DeVries debuted a prototype of a dual-chamber insulin-glucagon pump to be used in the APPEL 4 study – we wonder if he will share any updates on that front.
  • (4:45 – 6:15 PM, Hall III) Industry Workshop: Advancing Towards the Next Frontier in Glucose Monitoring: 14-day, no-calibration sensors and ambulatory glucose profile (AGP) (Supported by Abbott). We expect that this session will be similar to those we heard at IDF and EASD. At both conferences, the audience was clearly impressed with the thought of a 14-day sensor with no required fingerstick calibration. At EASD, Abbott positioned the Flash Glucose Monitoring as a replacement for BGM, but with the advantage of collecting continuous glucose data for retrospective analysis using the Ambulatory Glucose Profile. We also heard new data on the accuracy of this next-gen sensor at the Diabetes Technology Meeting in October – an MARD of 13.9% (n=62) using the FreeStyle Navigator algorithm (for context, the MARD was 8.5% MARD at EASD in 12 patients; as we understand it, the hardware and algorithms were different in the two studies.).
  • (6:30 – 9:00 PM, Hall I) Plenary Session: Opening Ceremony (followed by Networking Reception). This opening ceremony always delivers exciting local acts that engage the audience. In the past, we have seen flamenco dancers, Spanish guitar, and even a professional opera singer – perhaps a Viennese Waltz or classical music is in store this year. We love that ATTD always has a cultural bent – IDF this year definitely gave it a run for its money with the very cool traditional (Aboriginal in that case) dancing and we can’t wait to see if ATTD pulls ahead again. 

Thursday, February 6

  • (8:30 – 10:00 AM, Hall I) Parallel Session: Various Algorithms in Order to Cope with Glucose Control. Dr. Peter Chase (Barbara Davis Center, Aurora, CO) will discuss a randomized trial of a “Home System to Reduce Nocturnal Hypoglycemia in Type 1 Diabetes.” It appears that this talk will address predictive low glucose suspend. Dr. Danne will similarly address this topic through what we assume is a Medtronic-sponsored study of (“Predictive Low Glucose Management with Sensor Augmented CSII in Response to Exercise”). We wonder if Dr. Danne’s study used the commercial version of the MiniMed 640G, which is slated to launch in the EU by July 31, 2014. We’ve been very enthusiastic about the potential of PLGS to reduce both the occurrence of hypoglycemia in the first place, as well as its severity once it occurs. It looks to be a big step up in efficacy from threshold/low glucose suspend.
  • (8:30 – 10:00 AM, Hall III) Industry Workshop: Optimizing Insulin Pump Use Through Human Factors Research (Supported by Tandem Diabetes Care). We are particularly excited to see Dr. Nate Heintzman (University of California at San Diego, San Diego, CA) present a preliminary analysis of self-reported patient outcomes for users of the t:slim insulin pump. Additionally, Dr. Noel Schaeffer (Tandem Diabetes Care, San Diego, CA) will highlight the usability differences and training duration between two insulin pumps – we expect both of these studies will offer some marketing taglines for Tandem. As we noted in our test drive on the pump in diaTribe, the t:slim really excels on user interface and human factors. Following the company’s IPO, we look forward to hearing the company’s first financial results call in March to better understand how the market has adopted the pump. We believe it is much better designed than many competitive products out there, though that is only one piece of the puzzle in an increasingly competitive insulin pump space.
  • (12:20 PM – 1:00 PM, Exhibition Area) International Fair of New Technologies in Diabetes (Supported by industry). In this session, presentations will come from a broad swatch of companies developing new products: Makomba (a virtual world set to teach kids with diabetes about best practices); Integrity Applications (on its noninvasive ear-clip and realistic expectations, which measures glucose through ultrasound, thermal, and electromagnetic detection); Risk Medical Health (products for the management of diabetic retinopathy, such as RetinaRisk); and Geob International Sdn Bhd (Hypoband, a smartphone-linked cold sweat alarm that detects hypoglycemia).
  • (1:00 – 2:20 PM, Hall I) Parallel Session: Pumps and Sensors. Dr. Rita Basu (Mayo Clinic, Rochester, MN) will speak on the “Time Lag of Glucose Between Intravascular and Interstitial Compartment; Implications for Glucose Sensing” – this made a splash when it came out in the literature last year (Basu et al., Diabetes 2013), as it debunked the myth that the lag is ~10-15 minutes (it’s more like ~5 minutes). Dr. Irl Hirsch (University of Washington, Seattle, WA) will speak on the “Current Strategies for the Treatment of the Severely Insulin Resistant Patient,” and Dr. John Pickup will follow with a talk on “Patient Narratives on their Experiences of CGM.” This should offer some fantastic perspective for those developing new sensors. Dr. Ragnar Hanas (Uddevalla Hospital, Uddevalla, Sweden) will end the session with, “Patient Barriers to the Use of Pumps and Sensors” – certainly a big question that everyone wants answered!
  • (4:30 – 6:00 PM, Hall I) Parallel Session: Prevention of Hypoglycemia. Dr. Satish Garg (Barbara Davis Center, Aurora, CO) will present on the ASPIRE in-home study, the results of which we heard at ADA 2013 – patients experienced a 32% reduction in nocturnal hypoglycemic events and a 38% reduction in mean area under the curve (magnitude plus duration) of nocturnal hypoglycemia events. We hope new sub-analyses or additional nuance is shared. As a reminder, the MiniMed 530G – the US version of the Veo – was approved by the FDA in September 2013. This session also includes talks on novel strategies to limit hypoglycemia during exercise, as well as the importance of preventing hypoglycemia.
  •  (4:30 – 6:00 PM, Hall II) Innovation in the Treatment of Diabetes (Supported by industry). This first talk in this session has a very interesting title, “Meaningful Support of Basal Insulin Treated Type 2 Patients Beyond SMBG Results – What does it take?” We expect education and ongoing support will be mentioned as critical components, and given the meeting’s focus, hope that some specific technologies are mentioned. In the same session, we cannot wait to hear Insulet’s first Medical Directors Dr. Howard Zisser (Insulet, Bedford, MA) discuss patch pumps – this will be his first public talk as an Insulet employee since he joined the company in October.
  • (4:30 – 6:00 PM, Hall III) Industry Workshop: Dexcom G4 Platinum: The Pathway to Superior Accuracy, Clinical Outcomes, and the Artificial Pancreas (Supported by Dexcom). We expect that this workshop will be packed due to the all-star cast of speakers. Dr. Hans DeVries will start off the session with a brand new study we have not previously hear of –  “Comparison of Two Real Time CGM Systems: Outcomes of the SPACE 2 Study.” The study will compare the accuracy of Dexcom’s G4 Platinum CGM to Medtronic’s Enlite sensor in a head to head study – this has been a major point of debate to date. As a reminder, Medtronic’s label for the Enlite quotes an MARD of ~13.6%, much higher than what Dr. Steven Russell found in an ADA 2013 study (17.9%). Later in this session, Dr. Ed Damiano (Boston University, Boston, MA) will present on “Sensor Accuracy in a Head to Head Study,” which we assume will reprise that particular ADA 2013 study. We are also looking forward to Dr. Steven Edelman’s (University of California at San Diego, San Diego, CA) talk, “How do Patients with Diabetes Respond to Trend Arrows in the Real World: Feedback from Successful CGM Users.” The behavioral side of CGM is a critical question and one that has not been extensively explored in our view.

Friday, February 7

  • (8:00 – 9:40 AM, Hall I) Plenary Session: Closing the Loop. Dr. Damiano will speak on the Summer Camp Studies of the bionic pancreas, data we have really been looking forward to ever since we got a snippet in late 2013. The brilliant Dr. Roman Hovorka (University of Cambridge, Cambridge, UK) will discuss “Home, home, home… Sweet Home,” which we hope will provide the latest on his impressively long in-home studies (the last update came on Day #4 of IDF 2013.). Immediately following, Dr. Boris Kovatchev (University of Virginia, Charlottesville, VA) will highlight results from transitional and home trials of outpatient closed-loop Control” – see our diaTribe test drive on Kelly’s experience wearing the UVa closed-loop system overnight. Drs. Moshe Phillip (Tel Aviv University, Petah Tikva, Israel), Thomas Danne, and Tadej Battelino (University Children’s Hospital, Ljubljana, Slovenia) will also present six-week data from the DREAM system testing overnight closed-loop in patients’ homes. Last, we will pay close attention to Dr. Ananda Basu’s (Mayo Clinic, Rochester, MN) talk on, adding physical activity data to closed-loop algorithms – this has been an ongoing question over the past several years, though we believe activity monitors and algorithms have improved to the point where this is now increasingly feasible.  
  • (10:30 AM – 12:00 PM, Hall I) Industry Symposium: Technology & Innovation in Clinical Practice – Improving Patients’ Lives (Supported by Medtronic). The talk we’re most looking forward to in this session is “Sensor Innovation: The Next Step in Closing the Loop” – we suspect Mr. Rajiv Shah (Medtronic Diabetes, Northridge, CA) will discuss the company’s robust sensor pipeline (Enlite Enhanced, optical sensor, an orthogonally redundant sensor, and smart algorithms). Other talks during this session will discuss intraperitoneal insulin delivery and managing hypoglycemia.
  • (12:10 PM – 1:00 PM, Exhibition Hall) International Fair of New Technologies in Diabetes (Supported by industry). In this slew of company presentations, we are particularly looking forward to hearing from LabStyle Innovations on its smartphone-based BGM, as well as Xeris on its stabilized liquid glucagon (the last updates on both can be found in our JPM Day #1 and Day #2 reports, respectively). We particularly hope to hear the latest timing on Xeris’ three-pronged glucagon program to develop an auto-injector for severe hypoglycemia (phase 2 complete; results expected at ADA), a mini-dose pen for moderate hypoglycemia (phase 2 slated to begin in February at Baylor), and a pump-able liquid glucagon for use in the artificial pancreas (clinical trial expected to start in late 1Q14 at Oregon using the Insulet OmniPod).
  • (1:00 – 2:30 PM, Hall I) JDRF/ATTD – Artificial Pancreas Systems – Delivering Products to People with Diabetes (Supported by industry). We expect that this session will provide a variety of perspectives on the CGMs and pumps used in the artificial pancreas; three talks are dedicated to “CGM and AP Systems” and three to “Insulin Pumps and AP Systems.” Representatives from Animas, Dexcom, Medtronic, Roche, and Tandem will present. We expect this will be a rapid-fire session, with each company giving a short presentation on its future pipeline.
  • (1:00 – 2:30 PM, Hall III) Mealtime Insulins (Supported by industry). It’s great to see a session dedicated to ultrafast insulins, a key unmet need for patients and especially the artificial pancreas. We will hear a talk on Afrezza (currently under FDA review, with an April 15 PDUFA date), Halozyme’s recombinant human hyaluronidase, and Insuline’s injection site warming technology. We hope the talk on Halozyme’s hyaluronidase shares some data from the phase 4 study testing Hylenex preadministration in 400 insulin pumpers – at JPM, the plan was to share results at “a major medical meeting” in 2014 (we assume ADA, though perhaps some interim data will be disclosed). As a reminder, Halozyme and Yale also have an ongoing closed-loop study, which began on October 15, 2013.
  • (3:00 – 4:30 PM, Hall I) Industry Symposium: The Bionic Pancreas – a Bi-hormonal Closed-Loop Artificial Pancreas (Supported by Tandem Diabetes Care). We expect this session will be absolutely packed with attendees eager to hear about Dr. Ed Damiano’s bionic pancreas, including how it was built and used in the Beacon Hill and the Summer Camp studies (with new data, we hope!). We heard a glimpse of what the results might be at CarbDM’s second anniversary – extremely exciting and encouraging to say the least). Our very own Kelly Close will also provide a patient perspective on her experience participating in the Beacon Hill Study – see her diaTribe test drive.
  • (4:30 – 6:00 PM, Hall III) Oral Presentations. One notable talk in this session will discuss the cost implications of real-time CGM in hypoglycemia unaware patients – this is absolutely the population that stands to benefit the most from this technology, and we expect to see some compelling stats. Another talk will discuss Medtronic’s orthogonally redundant glucose sensor (optical + glucose oxidase) – we have not heard much about this since the Helmsley Charitable Trust/JDRF partnership was announced. On the more basic research side, it will also be valuable to hear a presentation on sensor design principles for reliable and accurate glucose monitoring.
  • (4:30 – 6:00 PM, Hall IV) Oral Presentations. During this set of oral presentations, we’ll hear updates on a few insulin delivery devices that don’t need tubing: CeQur’s PaQ (development and use of the pump), Debiotech’s JewelPUMP (accuracy vs. traditional pumps), and a discussion of the research design/methods of OPT2MISE (a much awaited Medtronic-supported RCT comparing insulin pump therapy to MDI in patients with type 2 diabetes).

Saturday, February 8

  • (8:30 – 10:00 AM, Hall I) Parallel Session: Towards Product Development of the Artificial Pancreas. This session will include Dr. Moshe Phillip presenting results on nocturnal vs. 24-hour closed-loop control. Additionally, we’ll hear from Dr. Howard Zisser on “AP Product Development (the Cutting Edge) vs. AP Basic Research (the Bleeding Edge)” – now that is a talk worth listening to. We believe the discussion at the end of the session will be filled with insightful comments, as several heavyweights will be in the room (Drs. Roman Hovorka, Boris Kovatchev, and Eric Renard (Montpellier University, Montpellier, France) will round out the panel.
  • (8:30 – 10:00 AM, Hall III) Oral Presentations. This session will be packed with lots of learning on the artificial pancreas. One talk we are especially looking forward to is, “Safety of an Overnight Closed Loop System with Induced Calibration Error” – great to see studies pushing systems in more real-world scenarios . Additionally, we will also see how the artificial pancreas handles meals with a talk, “Clinical Trial of an Artificial Pancreas with Large Unannounced Meals.” A third presentation by Dr. Trang Ly (Stanford University, Stanford, CA) will cover “Overnight Closed-loop Control with a Proportional-integral-derivative Based Algorithm in Children and Adolescents with Type 1 Diabetes.” We’ll also hear some early user satisfaction and safety data on Medtronic’s Connected Care Device.
  • (8:30 – 10:00 AM, Hall IV) Oral Presentations. During this session, we’ll hear about intradermal insulin infusion, which we expect are new results from BD’s latest study. Additionally, Dr. Andreas Pfützner (IKFE, Mainz, Germany) will present on “Effectiveness of Titration Algorithms with Insulin Glargine in Patients with Type 2 Diabetes Mellitus.” We also look forward to hearing Dr. Richard Bergenstal (International Diabetes center, Minneapolis, MN) on Sanofi’s U300 glargine.
  • (10:30 AM – 12:00 PM, Hall I) ATTD Yearbook. This yearbook will be packed in talks from the top leaders in the diabetes and obesity fields. Talks include: Dr. Hirsch’s “SMBG Overview,” Dr. Garg’s “New Therapies for Diabetes Management,” “Continuous Glucose Monitoring in 2013,” Dr. Pickup’s “Insulin Pumps,” Dr. Eyal Dassau’s (University of California, Santa Barbara, CA) “Closing the Loop,” “New Insulins and Insulin Therapy,” Dr. Neal Kaufman’s (DPS Health, Los Angeles, CA) “Using Health Information Technology to Prevent and Treat Diabetes,” Dr. Walter Pories’ (East Carolina University, Greenville, NC) “Metabolic Surgery is No Longer Just Bariatric Surgery,” Dr. Skyler’s “Type 1 Diabetes Mellitus: Immune Intervention,” Dr. Michael Riddell’s (Muscle Health Research Centre, Toronto, Canada) “Physical Activity and Exercise,” Dr. Shlomit Shalitin’s (Tel Aviv University, Tel Aviv, Israel) “Diabetes Technology and Treatment in the Pediatric Age Group,” and Dr. Bruce Buckingham’s (Stanford University, Stanford, CA) “Diabetes Technology and the Human Factor.”
  • (3:00 – 3:40 PM, Hall I) Plenary Session. Dr. Jay Skyler (University of Miami Miller School of Medicine, Miami, FL) will try to address the question: “Can Type 1 Diabetes Really Be Cured?” (in twenty minutes!). Continuing the discussion of ultrafast insulins, Dr. Bruce Bode (Emory University, Atlanta, GA) will present a talk, “Ultrafast Acting Insulin, Where We Are and Where We Are Heading.”

-- by Hannah Martin, Adam Brown, Katherine Sanders, and Kelly Close