Executive Highlights
This document contains our coverage of the exhibit hall and product theaters at ADA 2017. Immediately below, we enclose our high-level thoughts on what was often a bustling hall, followed by detailed coverage of company’s booths and product theaters. Booths highlighted in yellow were among our favorites from ADA 2017; titles highlighted in blue are new full report additions from our daily coverage.
Diabetes tech and therapy companies were out in full force at ADA 2017. Novo Nordisk’s commanding booth emphasized Tresiba (insulin degludec) and Victoza (liraglutide), with the combination product Xultophy taking a back seat. Both the standalone Lilly and Lilly/BI booths – which each commanded space on opposite ends of the exhibit hall – highlighted Jardiance’s unique CV indication (the words “Only Jardiance” repeatedly flashed within a heart shape). AZ’s booth was dominated by Farxiga (dapagliflozin), consistent with the company’s positioning of the drug as a cornerstone of its new Cardiovascular and Metabolic Disease unit. Janssen continued to highlight Invokana (canagliflozin) as the #1 prescribed SGLT-2 inhibitor in the US. Sanofi’s booth heavily featured the company’s newest offerings Toujeo (insulin glargine U300) and Soliqua (lixisenatide/insulin glargine) along with a popular virtual reality demonstration of severe hypoglycemia. Both AZ and Sanofi displayed their diabetes and cardiovascular products side by side, a testament to the blurring distinctions between those two fields.
We additionally enjoyed playing with several new devices in the exhibit hall (many for the first time!), including Medtronic’s MiniMed 670G hybrid closed loop (interesting takeaways on user interface nuances), Insulet’s OmniPod Dash PDM (major, major improvement!), Dexcom’s G5 touchscreen receiver (very durable – built like a tank to meet the Medicare requirement that it last three years), and LifeScan’s One Touch Via (manufacturing process cleared, and great to FINALLY see this in a hall). We also enjoyed visiting Abbott (FreeStyle Libre Pro), Ascensia, BD, and Tandem for a refresher on their latest offerings. Read the exhibit hall section below for a company-by-company snapshot!
- Executive Highlights
- Diabetes Technology Product Theaters
- Diabetes Therapy Product Theaters
- New Perspectives on Existing Concepts of Cardiovascular Risk
- Clinical Data Review – Comparing the Safety and Efficacy of Two Once-Daily Basal Insulins in Patients with Type 1 and Type 2 DiabeteS (Sponsored by Novo Nordisk)
- Praluent (Alirocumab) Injection—A Tailored Approach to Help Address an Unmet Need (Sponsored by Sanofi-Regeneron)
- Exhibit Hall
Diabetes Technology Product Theaters
What's Next for the Omnipod® System? Innovation at Work (Sponsored by Insulet)
Trang Ly, MD (Insulet Corporation, Bedford, MA)
In a packed product theater, Insulet provided an on-stage demo of the upcoming Bluetooth-enabled Omnipod Dash PDM (FDA submission in 2H17) and a first-ever deeper look at the user experience for the Horizon Automated Glucose Control PDM (pivotal trial next year, five-day, three-center hotel study starting next month). We snapped many never-before-seen pictures, posted here (notable shots below). Insulet CEO Patrick Sullivan actually opened the product theater, emphasizing the main topic: “meaningful innovation.” We first saw the new Bluetooth-enabled Dash PDM in the exhibit hall on Saturday, and this live on-stage demo left us equally impressed with the Android device and much-upgrade user experience. The Horizon demo was also strong, and it was actually done on an iPhone (perhaps for demo purposes only, or a sign that direct pod-to-smartphone transmission is a possibility at launch). It surprised us to see how far along the Horizon user interface is for the product – it looked quite polished, and even the Dexcom transmitter-pairing process was integrated (pictures here). The company is still wrestling with what to call the different device modes (e.g., manual vs. auto, closed loop vs. open loop, etc.), but the feedback-gathering process has been impressive: the talk paused twice and asked attendees to take a few minutes and fill out an on-seat survey to share thoughts on Dash and Horizon. (The last question on each related to willingness to prescribe the product in MDIs – Insulet’s clear target market.) Said Program Director of Advanced Technologies Jason O’Connor, “It’s so critical to not rush a product to market, just because it has functionality. It has to have the right user experience to deliver a product that is going to integrate into people’s lives. We may not be the first to market, but it does mean we’ll deliver an exceptional product.” [He then showed a picture of a lame, earlier-to-market smartwatch from Suunto vs. the far improved Apple Watch] Based on what we’ve seen, the company’s 110,000+ patients worldwide (65,000 in the US) will see very meaningful upgrades with both products.
- Insulet has now tested its algorithm in 82 patients (3,384 hours of closed loop, 70 nights). VP & Medical Director Dr. Trang Ly summarized the cumulative data in a useful table, including results from two new posters at ADA in 6-12 year olds (132-LB) and adolescents (1055-P). She noted that mean glucose is coming down and time-in-range is increasing as the studies go on, the latter now up to 85%. Dr. Ly said the algorithm is doing a “fantastic job” of doing what a good closed loop controller should do: improve time-in-range and lower mean glucose without causing more hypoglycemia. She did note that following the licensing of UCSB’s algorithm from Mode AGC, Insulet made “some substantial changes” to ensure safety.
Glycemic Outcomes |
IDE1 Adults n=24 |
IDE1A Adults n=10 |
IDE1A Adolescents n=12 |
IDE1A Pediatrics |
IDE 2 |
IDE2 |
Mean Glucose |
162 |
155 |
153 |
157 |
153 |
136 |
% Time in 70-180 mg/dl |
70% |
73% |
73% |
70% |
76% |
85% |
% Time < 70 mg/dl |
0.7% |
0.7% |
2% |
2% |
0.6% |
1.5% |
% Time >180 mg/dl |
30% |
26% |
25% |
28% |
24% |
14% |
- Insulet is about to launch into a longer duration, five-day hotel study next month at three centers. Boy is the company lucky to have Dr. Trang Ly, who has done this rodeo many times with other closed loop studies in the academic setting. Since really committing to this product last year, the company has rapidly completed a number of studies!
- Horizon will offer some user control and customizability with the algorithm, including the ability to change the target glucose. The correction factor and basal rates are also inputs to the algorithm, unlike the MiniMed 670G – which automated insulin delivery unrelated to the preprogrammed basal rates. (The only two things users can adjust in the 670G to affect basal automation are the insulin:carb ratio and the insulin action time.) Interestingly, 35% of Insulet’s Glooko-using patients use extended wave boluses and temp basals, features Insulet will now plan to incorporate into its closed loop controller – this shows the power of user data to drive important product design choices!
- Said Dr. Ly: “The pediatric population is very important to us. We’re not going to market without having done pediatric studies...What people talk about is the incredible improvement in quality of life. That’s why people use Loop and OpenAPS – it makes them feel a lot of safer at night.”
- The brilliant Dash platform allows Insulet to update the PDM’s software and add automation and concentrated insulin, but keep the same pod. We see this as compelling and quite differentiated, an approach Tandem has also taken with its t:slim X2 platform.
- Dr. Ly mentioned Insulet’s “Incredible collaboration with Glooko, which now reaches 44,000 patients in the US – they have a mean age of ~30 years, an average glucose of 185 mg/dl (eA1c: 8.1%), take 4.3 fingersticks per day, and bolus about 4.9 times per day. Presumably Insulet can start to stratify this data and learn what different centers or patients do differently – what behaviors separate those doing really well from those struggling?
MiniMed 670G System with SmartGuard HCL Technology: Driving Patient Outcomes through Automation (Sponsored by Medtronic)
Richard Bergenstal, MD (International Diabetes Center, St. Louis Park, MN) and Jennifer Sherr, MD (Yale University, New Haven, CT)
Medtronic’s MiniMed 670G product theater was standing-room-only (five-deep!), offering clinicians best practices for setting expectations, tweaking parameters, glimpses of CareLink reports, comments on Guardian Sensor 3, and two impressive before-after case studies. IDC’s Dr. Rich Bergenstal ran through the rationale for the hybrid closed loop device, emphasizing that “Current therapies cannot adjust for intra-patient variability. How can we expect one basal rate? There is no such thing as A basal rate. It’s changing every five minutes!” He joked that while he often thinks he is “clever” with complicated basal schemes, the reality is basal needs change every night and throughout the night – sometimes, the 670G is delivering much less than pre-programmed, and sometimes it delivers much more. This will be a change for HCPs!
- A slide headlined, “It is vital to set realistic expectations with patients,” shared the following advice for HCPs: Glucose levels will not be perfect – they will improve over the first few weeks as the system learns the patient and the patient learns to use the device. Trust the system and let it work as designed. The goal is to maximize time in Auto Mode. Focus on time-in-range (70-180 mg/dl) using CareLink reports and sensor glucose review screen on the pump for immediate feedback on progress. A higher degree of engagement is needed at first (i.e., respond to alerts and take action as guided) and there is a learning curve for patients and HCPs. CareLink data review is essential. Encourage patients to simply read pump screen and follow instructions.” (This last one may be paternalistic for type-A patients, though for the vast majority it will almost certainly improve outcomes.)
- Dr. Bergenstal reminded attendees that the preset Manual Mode basal rates have nothing to do with Auto Mode. Only two settings that relate to Auto Mode can actually be fine-tuned by an HCP or patient: the insulin-carb ratio and the insulin action time. As he did at ATTD, Dr. Bergenstal said that tightening the insulin:carb ratio can help with postprandial highs on the 670G. He mentioned in Q&A that the insulin action time doesn’t “play a huge role,” but it can increase the size of the manual bolus correction doses. At his clinic, the team usually uses a three-hour insulin action time, though sometimes they have moved down to 2.5 hours.
- Drs. Bergenstal and Sherr covered two fascinating MiniMed 670G case studies in young patients with high A1c’s, showing quite dramatic improvements in time-in-range. In a 14-year-old teenager previously on Dexcom CGM, the 670G drove estimated A1c from 8.5% (Manual Mode) to 7.2% (Auto Mode), with time-in-range (70-180 mg/dl) improving from 44% to 73%. “The only time you get a teenager at 93% wearing a device is if they believe the investment is worth it,” said Dr. Sherr. The second case, a 23 year-old with a baseline A1c of 8.8%, spent just 27% time-in-range in manual mode. After switching to Auto Mode, time-in-range improved markedly to 75%. While these were obviously cherrypicked case studies, it will be interesting to see the spectrum of improvement on this product – who will benefit the most? Who will not?
- Dr. Sherr praised the much-improved Guardian Sensor 3, though Medtronic is definitely emphasizing “3-4 calibrations per day.” As a reminder, two calibrations per day are required at minimum, though the MARD improves to 9.6% on 3-4 per day – this also allows Guardian to cross the “10%” MARD threshold. The paired Ascensia Contour Next Link 2.4’s strong accuracy was also a big selling point. Interestingly, Dr. Sherr said that the transmitter’s on-board chip that monitors sensor health “puts the onus back on technology” and seems to relieve her patients of self-blame when the sensor isn’t working: “Oh, I didn’t do something wrong.” This feature also reduces outliers, which are one of the most frustrating parts of wearing CGM.
- Dr. Sherr mentioned that Medtronic’s new “oval tape is like gold” and helps the sensor stay on for seven days. This is the first we can recall hearing of this tape change. Medtronic has of course retained the underwhelming clamshell transmitter, though we expect this to be phased out eventually, per the FreeStyle Libre-like transmitter pictures from the 2016 Analyst Day.
- Dr. Bergenstal showed several CareLink reports (see below), which highlight before-after glucose-profiles in Manual (red) vs. Auto Mode (blue). Those he showed confirmed data from the pivotal trial – less variability, especially overnight. We like that these reports place a big focus on time-in-range, depicted with large colored bars on the bottom left side. The before-after plots should also convince skeptical HCPs that the device is making a difference.
- Medtronic is positioning overnight use of the 670G in Auto Mode as “auto pilot,” while daytime use is “co-pilot.” We like this analogy and find it much more intuitive than “Hybrid Closed Loop."
It’s Time to Rethink Professional CGM: The New FreeStyle Libre Pro System (Sponsored by Abbott)
Daniel Einhorn, MD (UCSD, San Diego, CA)
Speaking to an overflow audience (“overflow” is actually an understatement, as every seat was filled and about 70 folks were left either sitting on the floor or standing), Dr. Daniel Einhorn espoused the tremendous benefits he has seen in his own practice with Abbott’s FreeStyle Libre Pro: “This technology is so good and has had such enormous impact on my practice and my patients, I couldn’t resist [speaking here today].” Dr. Einhorn stressed a number of the classic arguments we hear in favor of Libre Pro (highly accurate after Day 1, no calibrations, no effort on the part of patients, no disinfecting, easy start and download with a single HCP-owned reader) and his enthusiasm was evident throughout his lecture: “Anybody worthy of getting an A1c is worthy of getting this kind of monitoring because it provides that granularity that is needed for therapy decisions”; “Patients with SMBG may be way off and may not know it because they don’t understand the nuances of BG testing … So if I care enough to have you come in and talk with me, then I’m going to use Libre and look at that data.” He also addressed attendees’ angst about the real-time version of Libre, noting that that is a “different animal” but stressing that retrospective data – in and of itself – can be extremely valuable for patients and providers alike. Notably, a poll of the audience showed that only about 10-15% of the room was currently using Libre Pro in their practices (though we’re not sure what percentage of the audience were clinicians based where Pro is available). We see tremendous runway for this technology to revolutionize the glycemic picture for those unwilling/unable to wear real-time CGM.
Diabetes Therapy Product Theaters
New Perspectives on Existing Concepts of Cardiovascular Risk
Harold Edward Bays, MD (Louisville Metabolic and Atherosclerosis Research Center, KY)
In an Amgen-sponsored but unbranded product theater, Dr. Harold Bays spoke broadly about cardiovascular disease risk globally in the United States, its modifiable and non-modifiable risk factors, and why so many patients have CVD despite available treatments to modify the risk. Dr. Bays first provided some grounding statistics around ischemic heart disease (one of the number one causes of death in the US and around the world) and then framed the rest of the discussion around the modifiable and non-modifiable factors which contribute to this high incidence rate, namely: lipid disorders, hypertension, type 2 diabetes, obesity, genetics, age/race/sex, history of CV event, smoking, and physical activity and diet. He addressed most of the risks individually, going through both the causes and some trends in treatment, and spending the most time examining lipid disorders and physical activity and diet. Dr. Bays concluded by emphasizing that though treatments that modify and reduce risk of CV events are available, a significant number of patients still have the CV.
- Dr. Bay advocated using available statins to help bring patients closer to their pre-specified LDL-C levels, while noting that they alone have not been sufficient to completely reduce risk. He acknowledged that that if patients have a high baseline cholesterol statins can only lower it so far (and in general, only lower it 50-60%), and that they often struggle with adherence to medication, or can have adverse reactions to statins, or may not have not been screened for CVD risk and do not know they need treatment. However, he attributed the trend of towards lower cholesterol levels in the US to the wider use of statins, believing that it is unlikely to be have been caused by improved nutrition or physical activity.
- Two in three Americans are overweight or obese and 80% of them are not reaching physical activity goals, a trend Dr. Bays partially blames on poor nutritional guidelines from experts. He asserted that common guides to nutrition (e.g. breakfast is the most important meal of the day) are either vague or conflicting (e.g. what is a healthy breakfast?), and speculated that the reason obesity rates in the United States are leveling off are not because we’re beginning to reverse the trend but rather because obesity rates have reached peak saturation. He recommended matching physical activity recommendations to patients based on what they are likely to actually achieve, to help create even incremental improvement, but ultimately concluded that it is very difficult to sustain improvement in these risk factors.
Clinical Data Review – Comparing the Safety and Efficacy of Two Once-Daily Basal Insulins in Patients with Type 1 and Type 2 DiabeteS (Sponsored by Novo Nordisk)
Carol Wysham, MD (University of Washington, Spokane, WA)
In this Novo Nordisk-sponsored product theater, Dr. Carol Wysham reviewed the data from the SWITCH 1 and SWITCH 2 trials demonstrating significant reductions in hypoglycemia with Novo Nordisk’s Tresiba (insulin degludec) vs. Sanofi’s Lantus (insulin glargine). In SWITCH 1, Tresiba was associated with 11% less severe and symptomatic hypoglycemia, 36% less nocturnal hypoglycemia, and 35% less severe hypoglycemia than Lantus in patients with type 1 diabetes. In SWITCH 2, Tresiba was associated with 30% less severe and symptomatic hypoglycemia and 42% less nocturnal hypoglycemia than Lantus in patients with type 2 diabetes. Novo Nordisk announced in its 1Q17 update in May that the EMA has approved a label update for Tresiba based on the SWITCH results; a corresponding FDA decision is expected by September 2017. Novo Nordisk has also submitted data from DEVOTE (which demonstrated an impressive 40% reduction in severe hypoglycemia and 53% reduction in nocturnal severe hypoglycemia with Tresiba compared to Lantus) to the FDA and the EMA. Novo Nordisk is clearly hoping that these label additions will help give Tresiba an edge over its most direct competitor, Sanofi’s Toujeo (U300 insulin glargine), which has no hypoglycemia claim in its label.
Questions and Answers
Q: Why is Tresiba not recommended in pediatric patients needing less than five units?
A: It wasn’t studied and I assume you couldn’t use that pen for that amount of insulin.
Q: Why was the fasting plasma glucose goal so low?
A: Those were the goals used in several other basal insulin studies and they found that it was a safe goal. Almost all the trials that targeted a glucose <100 mg/dl never achieved a level below 115-120 mg/dl, so the goal was to get fasting glucose more consistent.
Q: Why were the results taken at the end of the maintenance period?
A: We were looking not at what might happen during the time when we were rapidly changing the dose but assuming that during the maintenance period the dose would be fairly consistent, so the groups would be most comparable.
Q: What was the conversion for patients with type 2 diabetes on BID basal insulin?
A: Patients already on once-daily basal insulin were converted unit per unit. If they were on twice-daily insulin, the recommendation was to decrease it, although it was individualized by A1c and frequency of hypoglycemia.
Q: Why did the Tresiba trials not show A1c superiority to glargine?
A: Remember that the original trials of glargine against NPH didn’t show superiority either. The investigators had guidelines and were told to titrate to get to goal. They made the decision on whether to titrate based on strict criteria, so this result was expected. In order for hypoglycemia rates to be compared, you had to have equivalent A1c reductions. Otherwise you couldn’t really meet the FDA requirements for understanding hypoglycemia rates.
Q: Was there any difference in the types of oral medications in SWITCH 2?
A: No, the patients were pretty well balanced.
Q: In SWITCH 1, was there any difference in the timing of injections?
A: The recommendation was to give it at the same time every day but the investigators were given some leeway. Because they were comparing Tresiba to glargine, they were asked to give it at the same time every day.
Q: Was there a difference in dosage?
A: In SWITCH 1, in order to achieve the same A1c, a 3% lower dose of Tresiba was required. In SWITCH 2 it was a 4% lower dose.
Praluent (Alirocumab) Injection—A Tailored Approach to Help Address an Unmet Need (Sponsored by Sanofi-Regeneron)
Eliot A. Brinton, MD (The Atherometabolism Institute, Salt Lake City, UT)
As the link between cardiovascular disease and type 2 diabetes becomes ever more apparent, Dr. Eliot Brinton presented a comprehensive overview of the indications and uses for Sanofi/Regeneron’s PSCK9 inhibitor Praluent (alirocumab) in this product theater. Overall, he emphasized the role of atherosclerotic cardiovascular disease (ASCVD) in the current indication for Praluent and other PCSK9 inhibitors. ASCVD is characterized by a series of conditions that include acute coronary syndrome, myocardial infarction, stable or unstable angina, ischemic stroke, transient ischemic attack, coronary or arterial revascularization, and peripheral arterial disease (ankle brachial blood pressure test result less than 90% of arm brachial test). Along with heterozygous familial hypercholesterolemia, Dr. Brinton emphasized that treatment of ASCVD combined with abnormal LDL levels is an appropriate on-label use for Praluent. That said, Dr. Brinton acknowledged that patients should not use Praluent as a first-line option and patients considering Praluent therapy should already be on maximally-tolerated statin therapy (which can be lower than the highest marketed dose in patients with statin intolerance). He then reviewed the best options to increase Praluent accessibility to patients, explaining that MyPraluent system at Sanofi-Regeneron will, in addition to providing a nurse to help the patient learn how to administer the injection, provide co-pay coverage so that commercially insured patient’s Praluent co-pay goes down “zero or virtually zero.” Dr. Brinton added that those patients on Medicare/Medicaid would need to be referred to a specialty pharmacy that can work with private foundations to provide co-pay assistance.
Exhibit Hall
Abbott
Abbott’s trademark yellow booth highlighted its blinded, retrospective FreeStyle Libre Pro. The product launched in the US last fall, meaning that this was the first ADA where Libre Pro could be demoed … and, boy, were attendees taking advantage! This was one of Abbott’s bigger booths in recent memory, and still, it was PACKED. Clearly, the high enthusiasm we saw earlier this year at ENDO has yet to abate. As expected, no update was shared on the US launch of FreeStyle Libre consumer, which remains under FDA review for both an adjunctive claim and a non-adjunctive (replacement) claim following submission in 3Q16. (The last timing update in January suggested a 2H17 US launch, though FDA is hard to predict.) On the global front, reps highlighted the recent acquisition of national reimbursement for FreeStyle Libre in France, sharing that the company ended up fielding “thousands of calls” on the very first day of the announcement. Abbott also confirmed it currently markets FreeStyle Libre consumer in 35 countries (previously “30+” as of a few weeks ago), with more than 300,000 global users.
Alere
At the Alere booth, we viewed the Afinion As100 Analyzer, a high-performing, rapid (only three minutes!) point-of-care A1c measurement device. An FDA Advisory Committee was held last July to vote on a 510(k) application for the As100 to be used for diabetes diagnosis – as a reminder, current ADA guidelines specific that only lab A1c tests may be used. The Alere rep stated that the company is still working with the FDA to obtain clearance, but are optimistic and hope to have good news in the next year. If cleared, Afinion would be the first point-of-care A1c test used for diabetes diagnosis, making it easier and faster to diagnose diabetes and prediabetes in the clinic or perhaps at other more convenient locations like pharmacies. Given the ease of use of this device, we believe this instrument could have enormous potential to aid in prevention – we eagerly await an FDA decision. It was good to see Alere at ADA, reaffirming its commitment to at least A1c diagnostics.
Amgen
Amgen in a big booth is new for ADA. Amgen’s booth was relatively small and placed in the corner of the exhibit hall, with all of its attention dedicated to its PCSK9 inhibitor Repatha (evolocumab). In its red/white/blue color scheme, Amgen promoted Repatha’s unique dosing option, as wording included “maximize LDL-C reduction in one move” and “the first and only PCSK9 inhibitor with a single monthly injection.” Other promotional material focused on the drug’s “two dosing options” and how it doesn’t require titration (“no titration necessary”). Additionally, the company seemed to focus in on the drug’s earlier challenges with determining coverage, as touch screens highlighted resources including in-office insurance support and emphasized that “91% of adults are covered” (Repatha is on the formulary of 91% of adults with prescription drug coverage). The booth also featured videos on Repatha’s clinical data and safety information, a medical info section, and cookies for attendees (we wish they had offered something a bit healthier!). Please see our Amgen 1Q17 update for more on the company’s latest.
Ascensia
Ascensia boasted a sizable booth near the rear of the exhibit hall. The company has come to ADA on the heels of a couple big partnership announcements (Insulet, Voluntis), which were both featured on handouts within the booth. Reps wouldn’t divulge any new details on either announcement, but were more than happy to chat at length about the Bluetooth-enabled Contour Next One meter and Contour app. These two products were far and away the focus of the booth, with signage prominently highlighting the ability of the Next One to light up to indicate in-range (green), low (red), and high (yellow) results. Just like at ATTD, the motif of the booth played on this association with “illumination” using slogans that read: “Seeing how everyday activities affect blood glucose. That’s illuminating”; “Their diabetes. Illuminated”. Notably, the company also exhibited the Contour Next Link 2.4 meter (though to a lesser extent vs. the Next One), which is available with Medtronic’s MiniMed 640G internationally and in the US with the 630G and 670G.
AstraZeneca
AstraZeneca’s booth was dominated by SGLT-2 inhibitor Farxiga (dapagliflozin), with only a small corner dedicated to the GLP-1 agonist Bydureon (exenatide once-weekly) pen. This emphasis is consistent with the company’s positioning of Farxiga as a cornerstone of its new Cardiovascular and Metabolic Disease unit in its 1Q17 update. The new company structure was also evident in the significant real estate devoted to cardiovascular drug Brilinta (ticagrelor); it was clear from this booth and others that the line between diabetes and cardiovascular drugs is becoming increasing blurred. AZ’s booth also included a fairly substantial research section with handouts on ongoing clinical trials, a video demonstration of the Bydureon autoinjector (currently under FDA review and a poster on the autoinjector will be presented at ADA on Sunday), and a very realistic dummy patient that apparently gave one of the security guards quite a scare this morning!
BD
We were hoping to see the MiniMed Pro infusion set with BD FlowSmart technology back on display in the exhibit hall after a hiatus relating to a halted launch, but no dice. A rep told us that BD is still “figuring it out with Medtronic … it’ll be another slow launch, we want it to go well,” confirming what we heard at AACE a little over a month ago – we agree that proceeding with caution in order to optimize patient experience is absolutely the right move. See our test drive of the set – we still believe that it has tremendous potential once the training process is optimized and manufacturing works out the kinks some experienced. Elsewhere in the booth, BD was, as one rep put it, “preaching what we’ve always preached: short needle length.” An adjacent (unbranded) BD booth called “Type 2.0 Lab” invited participants to select their top three most important features for a device to have – at the top of the leaderboard when we walked through were: flexible dosing (adjustable basal/bolus dosing), dose capture, and reduced number of injections through pump therapy. We’d note that BD is already developing products in all three of these areas!
DarioHealth
DarioHealth was present in the exhibit hall, detailing its all-in-one BGM device equipped with a headphone-jack plug-in meter, strip cartridge, and lancing device, priced at $49.99 for a starter bundle or as a monthly subscription at three tiers ($16.50-$50/month for 50-200 strips). A company rep told us that customers love the subscription model, the size of the meter (“if it’s not the world’s smallest meter, it’s close”), and parents especially love the built-in hypoglycemia alert feature, which sends messages paired with an automatic geolocation to a list of emergency contacts. Unfortunately, users still have to hit a button to send the alert, but they hope to resolve this issue in the future. The rep also touted the ongoing work to move from the current cash-pay model and obtain reimbursement (see more here). There were no updates on US Android app FDA clearance (expected in the next few months) or a German launch (“by September”), nor the company’s long term goals – AI guidance, getting into the prevention market, and other additional biomolecular tests.
Dexcom
Dexcom’s welcoming booth proudly showed off the just-approved and quickly launched Android version of G5 – already available on the Google Play store following the approval announcement earlier this week. (According to Google Play, G5 Android already has 1,000-5,000 downloads, though a somewhat harsh 3.3/5.0 rating (n=66 reviews) – many users seem to be complaining about lost signal alerts or incompatibility with their particular Android phone. Wow is this platform hard for a company to develop for, even one as experienced as Dexcom!) We also got to hold and play with the very rugged new touchscreen G5 receiver for the first time following FDA approval in March. We would describe the new receiver as “built like a tank” – it’s bigger than the current option, and the touchscreen is more resistive than one found on a consumer-grade phone. This thing looks like it could be thrown at the wall and not break, fixing the reliability issues that have challenged Dexcom’s current receiver. In addition, it meets the Medicare requirement that the durable receiver last three years to be reimbursed, a key design consideration. On the other hand, this receiver feels like much more of a medical device than the current (kind of cool) iPod-nano like receiver. The user experience is now in line with the G5 app, though using the receiver next to the iPhone or Android apps makes the choice pretty obvious for those able to use a smartphone – the G5 app is miles better than the new receiver. Of course, the phone app benefits Dexcom and users too, as Android/iPhone bring continuous data upload to Clarity/Dexcom’s cloud, continuous over-the-air app updates, integration with other apps, etc. Plus, with direct Apple Watch-to-G5 transmitter communication coming (no phone needed; see our coverage from just before ADA), there will be another phone-agnostic option for viewing Dexcom data hopefully soon.
- The booth also showed the major new additions to Dexcom Clarity, most notably adding an AGP report and the (new to us) massively improved Dexcom Clarity mobile app. See the screenshots below from the new Clarity mobile app, a spectacular improvement over the previous basic PDF-download version. It now feels like a real app! We love that time-in-range is so prominent and ALL reports are immediately accessible in a couple taps, including AGP – indeed, the standard of care continues to evolve for patients and we saw this as a major win. A rep told us that Dexcom has removed the “estimated A1c” metric from Clarity at the request of the FDA – apparently the discrepancy between CGM-derived estimated A1c and lab values was confusing, and all companies have reportedly been asked to examine this metric. Clarity also recently added a more detailed day-by-day and hour-by-hour statistics recap, which we deem incredibly valuable for patients.
- Otherwise, Dexcom marketed several handouts on non-adjunctive use of CGM, Medicare coverage of CGM (“now available” – though the ongoing talks with CMS about local coverage decisions were not mentioned), and shared printouts of the DIaMonD study testing CGM in MDI.
Diabnext
Diabnext presented its comprehensive A.I. platform (see website here) aimed at tracking multiple diabetes metrics. Clipsulin, an insulin injection recorder, is capable of clipping onto any insulin pen externally and transferring dose info to the Diabnext smartphone app – see the company’s webpage here. We saw this at CES and had pretty low confidence that this would be accurate enough to do anything meaningful. The platform also incorporates glucose monitoring, as the Gluconext device, a bulky attachment that plugs into Abbott, J&J, Ascensia, Trividia and Roche BGMs and transmits glucose readings to the Diabnext app (basically like Glooko’s original MeterSync cable). Lifestyle programs include Snapcarbs, which evaluates the carbohydrate content of a meal from a mere photograph (is it accurate?) and Vigicap, a smart cap for medications, providing reminder notifications, as well as facilitating avoidance of double doses. The Vigiscale analyzes body composition, and the Vigifit is a smart coin, smaller than a US quarter, which monitors activity when carried in a pocket. All of these products are integrated on a secure digital interface accessible by both patients and providers, who can communicate via text, call, or video appointment. Each individual program is offered at $4/month, with the Gluconext device included for free. Presales have started and are slated for rollout September 1. This company was very popular among potential investors at CES, where we last saw them – a rep at that meeting told us that about 10 venture capital firms, as well as the government of Singapore, had expressed interested in funding Diabnext. We’re definite skeptics at this point but like the idea of a fully integrated device ecosystem. Still, this seems like a LOT of devices for one small company to tackle in-house.
Eoflow
Korea-based EOFlow was present on the Exhibit Hall floor in a surprisingly sizable booth. We first came across this company at EASD 2016 and, much like we saw on the Exhibit Hall floor there, the company’s booth showed off its disposable patch pump, EOPatch (reservoir size = 200U). Reps shared confidence in a first commercial product launch “later this year” (consistent with prior guidance), though the product is under regulatory review in Korea. Other new news included: (i) their goal of making a regulatory submission in the US in 2018; (ii) a recent partnership with China-based CGM manufacturer Zhejiang POCTech Medical and plans to create a next-gen CGM-enabled pump; (iii) the recent completion of Series B financing ($5.5 million in the round); and (iv) long-term hopes to commercialize an automated insulin delivery system (reps ambitiously laid out a ~2020 timeline). As we’ve noted previously, the booth and website are not confidence inspiring, so it’s hard to take this seriously at this stage.
Insulet
Insulet’s busy booth showed off the new Bluetooth-enabled OmniPod Dash PDM for the first time. Reps gladly took us through the PDM’s brand new user interface on the locked down, consumer-grade Android phone (see picture below) – and boy is it a major improvement in form factor and user experience over the current PDM, and a definite upgrade over the “prototype” from ADA two years ago. We’re glad to see IOB prominently displayed on the home screen, clear display of last blood glucose and last bolus, easy access to take a bolus (center button on the bottom), a simple swipe to display the current basal profile graphically and key pod status, a nicely laid out bolus calculator (click to see all the math in detail), and great use of a side-bar menu to put less-used functions and settings. The off-the-shelf Android phone is very slim and retains the touchscreen quality and consumer-grade hardware that we’ve all come to expect out of modern devices. This does not feel like a medical device – that is for sure! After the demo, booth-goers filled out a market research survey soliciting opinions and feedback. We noticed several survey questions on expectations for battery life, and it will be interesting to see what longevity Insulet comes to market with – as a locked down Android phone not running cellular (micro USB charge), we assume it would last multiple days on a single charge (this is our speculation). As a reminder, an FDA submission for this product is expected in 2H17, enabling a possible late 2017/early 2018 launch. Along the perimeter of the booth, attendees could also demo the pod and get a free copy of our own Adam Brown’s bestselling diabetes guide, Bright Spots & Landmines.
- Ascensia’s Bluetooth-enabled Contour Next BGM was situated next to each Dash PDM – we didn’t get to demo the integration, but it was great to see this on display so soon after the integration announcement just two days ago! Users can also enter a BG manually using an on-screen scroll wheel (like the One Drop app) or via typing the number.
- Other UI/UX features in Dash: It’s easier to view and change basal segments, a feature placed quite prominently in the app’s user flow (one swipe from the main home screen). (Arguably this does not warrant being so upfront, given how infrequently patients and HCPs are changing basal profiles. We agree that Dash has made it much easier to do so!) The food library has also been revamped and expanded, and Dash has a nice “Shopping Cart”-like feature to add multiple foods into one meal. Users can also see a progress bar as a bolus is delivered and cancel it while in progress. We did notice the phone has a camera, which in a future version of the UI/UX could possibly enable pictures of meals overlaid with CGM and insulin data.
Intarcia
Intarcia had a smaller presence at the exhibit hall this year, with only a small medical information booth, presumably due to the fact that it’s ITCA 650 device has been submitted to the FDA and the company must be very careful about pre-marketing. Notably, Intarcia sponsored its very first corporate symposium at this year’s ADA, and it is clearly focused on reaching and educating providers about ITCA 650 through new and alternative channels.
J&J – Janssen
The Janssen section occupied approximately two-thirds of J&J’s booth and devoted about equal attention to standalone Invokana (canagliflozin) and Invokamet (canagliflozin/metformin). The booth had attracted a decent amount of foot traffic when we stopped by, with people lining up to sample sugar-free iced vanilla lattes and “donate a photo” (you get your picture taken, J&J donates $1 to the ADA). As at recent conferences, the Invokana materials featured data showing superiority vs. Merck’s Januvia (sitagliptin) and banners trumpeting the product’s status as the #1 prescribed SGLT-2 inhibitor in the US. While Invokana continues to lead the class for now, the trend lines do not look great for J&J: US Invokana sales dropped 17% YOY in 1Q17. We expect that future within-class competition among SGLT-2 inhibitors will depend heavily on the CANVAS results that will be reported on Monday. If the results suggest an SGLT-2 inhibitor class effect on cardiovascular outcomes, Invokana’s first-in-class status should serve it well in the US. On the other hand, if the results are substantially less impressive (or feature a more mixed safety message) than those from EMPA-REG OUTCOME, we would expect Lilly/BI’s Jardiance (empagliflozin) to make significant market share gains.
J&J – OneTouch
Crowds flocked to the OneTouch portion of the J&J booth – fresh green makeover and all – to see the OneTouch Via bolus-only insulin delivery patch device in the flesh for the first time in an exhibit hall. Reps disclosed that the product’s updated manufacturing process (submitted in November) received FDA 510(k) clearance on Wednesday, but did not give any specifics on the launch timing front. We truly appreciated the logic behind the lack of timing updates, despite guidance from ADA 2016 calling for an “early 2017” launch and a December email exchange indicating a 1H17 launch: “We are focused on ensuring a perfect launch for patients. That means getting reimbursement and training down. Our goal is that no patient will start on Via and not continue.” Contrary to what we were told in the December email, the rep indicated that the launch, when it does happen, will not be focused, but “filled to capacity.” We assume J&J will start with a limited release to learn from early users, make sure manufacturing and access is in place, build inventory, etc. We do expect strong patient demand for this product, given what we’ve seen on social media. It was great to finally get to hold the device, and it was clear that booth-goers were intrigued – we overheard one who was amazed by the patch’s small form factor, and another who was complaining about the limited basal options of other patch pumps (of course, OneTouch Via doesn’t have basal capabilities – this device requires a separate prescription for insulin and pen/syringe delivery device). We believe the supreme discretion offered by the Via will make it a very viable asset for a J&J diabetes business that is currently exploring strategic options, including sale.
- The inspired OneTouch reps were also detailing a new and improved version of the OneTouch Reveal app (Apple Store, Google Play) for its Bluetooth-enabled BGMs, complete with a timeline feature, a logbook, and sharing capabilities. The timeline tracks important blood glucose events, calling attention to patterns – it also features weekly content with general diabetes information, though the goal is to make the content more personalized. The logbook makes it easy to visualize blood glucose readings with contextual information. The “share” feature allows users to share their last reading or a report a email or text, or even over the cloud, with a clinician. The upgrade also includes the introduction of physician- and patient-facing web apps.
- There was no launch timing update on the OneTouch Vibe Plus integration with Dexcom G5 (approved for ages two and up in December), but the company is “moving toward commercialization.” This would be a nice stepping-stone on the way to a hypoglycemia-hyperglycemia minimizer closed loop system.
- We were glad to see that WellDoc once again represented at the OneTouch booth, marketing the BlueStar/OneTouch Verio Flex BGM integration allowing passive blood glucose data transmission into the type 2 diabetes management software. A WellDoc rep told us that the integration hasn’t quite rolled out to patients yet, but she was over the moon about this partnership as well as others (namely Samsung).
Lilly
The Lilly-only booth at ADA 2017 was essentially an enlarged version of its recent booths at AACE 2017 and ENDO 2017. The front and center of the booth cleared a wide path for caffeine-deprived attendees to make a beeline for the espresso stand – Lilly has quickly achieved a reputation for best espresso in exhibit halls, in our humble (but very expert) opinion. The first line of product information, flanking either side of the espresso bar, featured SGLT-2 inhibitor Jardiance (empagliflozin), biosimilar Basaglar (insulin glargine), and GLP-1 agonist Trulicity. The signage for Jardiance was particularly eye-catching – in addition to touting the new CV indication for Jardiance, Lilly really drove the point home with animations of the words “Only Jardiance” coming together to form a heart shape. Directly, behind the Jardiance signage, Lilly strongly highlighted the rest of the empagliflozin franchise (Synjardy and Glyxambi), debuting the tagline “Meet more of your patients’ needs with the rest of the Jardiance family” for the first time. Once-weekly Synjardy XR (empagliflozin/metformin) won the label “partnered for convenience,” while Glyxambi (empagliflozin/linagliptin) was headlined with “partnered for power.” Additional square footage in the booth was also devoted to the Humulin U500 KwikPen, Humalog U200 KwikPen, and the DPP-4 inhibitor Tradjenta (linagliptin) franchise. We were also pleased to see the continued presence of the Patient Access and Affordability section – which is now newly promoting the new InsideRx partnership, in addition to Lilly’s Blink Health collaboration.
Lilly/BI
Capturing the attendees at the very other end of the exhibit hall, the partnered Lilly/BI booth featured a huge, outer swath of the booth devoted to Jardiance, with the product’s signature teal coloring (a departure from the minimalist white and gray tones of the rest of the booth). Most notably, a giant, teal plastic heart sculpture commanded the attention of passerby. Upon placing a hand on the display in front of the heart, upbeat music and a steady heartbeat sound began to play, while facts about the CV indication for Jardiance flashed on the heart (“Only Jardiance,” and statements highlighting the ADA Standards of Care inclusion, the size of the EMPA-REG OUTCOME trial, and more). According to a Lilly representative, the displayed messages change with each 38th person that interacts with the display – representing the 38% risk reduction for CV death in EMPA-REG OUTCOME that supported the indication.
Mannkind
MannKind’s small booth for inhaled mealtime insulin Afrezza was centered on the same playful message we saw at AACE 2017 last month: INsulin, 12-15 minutes; OUTsulin, three hours. The company is clearly focused on the faster onset/offset of Afrezza, which leads to lower hypoglycemia risk and improved patient quality of life, though an “ultra-rapid-acting” label claim for the product is still under FDA review (a decision is expected by September). We do hope Afrezza receives this designation, at which point we imagine MannKind’s marketing around this theme will ramp up. We truly believe in the value of faster onset/offset for prandial insulins, a therapy area that is currently lagging behind patient need, since available options aren’t good enough and still cause far too much hypoglycemia. A blown-up model of the inhalation device was mounted on the booth’s back wall, and conference attendees could read additional information about Afrezza on a video monitor or on printed handouts.
Merck
Merck presented with a relatively large booth near the center of the exhibit hall, with the majority of the marketing focused on its Januvia (sitagliptin) franchise. Most of the booth’s boards promoted Januvia, while a couple promoted its combination product Janumet (sitagliptin/metformin); and approximately one-fifth of the booth’s real estate was dedicated to the company’s vaccine Pneumovax 23 (pneumococcal vaccine polyvalent). As usual, Merck brought a patient-centric atmosphere, with large table touch screens, in which attendees could choose to follow different patients and review their medical histories and labs. Additionally, the boards featured named patients, alongside clinical trial data showing strong FPG and PPG reductions and artistic explanations of the DPP-4 inhibitors’ mechanism of action. In addition to a medical affairs section, the booth had its fair share of interactive activities including the opportunity to create a customized wall chart, a virtual reality station, and a puzzle challenge – not to mention the company’s popular frozen yogurt parfait offerings. To learn about Merck’s latest updates, please see our 1Q17 update.
Medtronic
Medtronic’s bustling, expansive booth was filled along the perimeter with the company’s latest products, including the MiniMed 670G hybrid closed loop (finally – in the US not under glass!) and the Bluetooth-enabled standalone Guardian Connect Mobile CGM available outside the US (under FDA review and currently in human factors testing, per today’s Analyst Day). We got to demo the MiniMed 670G pump for the first time and found several things interesting about the user interface. First, automated basal dosing actually appears as pink dots on the 670G’s trend graph screen and is denoted as a “micro bolus” (e.g., 0.15 units) – we wonder if this terminology discrepancy between a “micro bolus” and “automated basal delivery” could be confusing for some patients. On the other hand, it is semantics and they are the same thing in practice – a basal rate is simply a series of micro-boluses. We were also reminded of the tough balance between transparency (what is the algorithm doing?) and simplicity (keep the under-the-hood nuances to a minimum) – from what we saw, the 670G errs on the side of less clarity about what the system is doing at any given time to keep glucose in range. For instance, if glucose is trending high, the 670G would increase basal insulin delivery, but it’s hard to know as a user how much additional basal insulin the system has delivered to keep blood glucose in range (unless one scrolls to every pink dot and tallies them up). The “active insulin” metric on the 670G home screen also does not include increased basal insulin delivery from hybrid closed loop (it’s only from manual boluses), and there is no CGM “projection” – in our view, this could make it hard to know if additional bolus insulin is needed. We’ll be interested to see how patients feel about this, since some might like any insulin that is delivered over the pre-programmed basal to be considered “active insulin.” (This could be useful for decision making, but could also be confusing and unnecessary for most non-type-A users.) We’re also not clear on how aggressive the 670G’s auto-basal can be – can it deliver 2x or 3x or 4x the pre-programmed basal? Reps reminded us that the Guardian Sensor 3 recommends 3-4 calibrations per day and has shown an MARD under 10% with that scheme – “the only sensor FDA approved to power a hybrid closed loop system.” Attendees could examine the sensor through a popular virtual reality experience, though we didn’t have a chance to try it ourselves.
Nightscout
As always, we enjoyed our visit to the Nightscout booth and are still amazed and hugely appreciative of their massive accomplishments. One volunteer at the booth stated that the DIY CGM display has “gotten rid of a lot of my lows and highs… It’s been life-saving.” Nightscout founders hope their efforts will urge industry and FDA to expedite the process of opening up data (in a secure fashion) by sending a strong message clearly demonstrating what the diabetes patient community wants and the lengths they will go to achieve it.
Novo Nordisk
Novo Nordisk’s bright, modern booth was hard to miss as one of the largest displays in the exhibit hall – with people lining up to have their A1c measured, as is ADA tradition. A bustling social space filled with sleek low-slung white couches and light wood tables, the booth was focused largely on Tresiba (insulin degludec) and Victoza (liraglutide), with a lesser amount of signage promoting the newly-launched combination product Xultophy (insulin degludec/liraglutide). Tresiba materials featured a skydiving/parachute motif with the slogan “a proven A1c descent” – complete with a corresponding virtual reality headset experience (these seem to be popping up everywhere in exhibit halls!) in which visitors could simulate skydiving from an airplane. Data featured in the booth focused especially on the flexible dosing indication on Tresiba’s label and the fact that it is the only basal insulin pen with a max injection dose up to 160 units – this latter point is clearly part of Novo Nordisk’s efforts to position Tresiba for patients with type 2 diabetes and higher insulin requirements. Victoza materials highlighted the drug’s “3-for-1 benefits” – A1c efficacy, weight loss, and low rate of minor hypoglycemia – and emphasized that it is the #1 prescribed GLP-1 agonist globally (perhaps a nod to the increasing competition in the GLP-1 agonist space). Demo stations were interspersed within the booth where company representatives guided visitors through the use of each product’s corresponding pen. Aside from products, we were thrilled to see a sizable portion of the booth devoted to encouraging visitors to join the company’s annual ADA 5K run, and a sizeable presence from members of Team Novo Nordisk – bikes and all.
A separate, smaller booth was devoted entirely to obesity medication Saxenda (liraglutide 3.0 mg), beckoning providers to “help your patients with obesity get the reductions they need.” The booth featured a photo of a women holding a larger pair of jeans – the classic “before and after” weight loss pose – with the phrases “excess weight,” “high cholesterol,” “large waistline,” and “high blood pressure,” emblazoned on the pants. Notably, the promotional materials referred to Saxenda as “the first and only GLP-1 agonist for chronic weight management” – we got the sense that Novo Nordisk is very much trying to drive home the message that obesity, like diabetes, requires ongoing therapeutic management, unlike the “diet pills” of the past. The presence of an exclusively obesity-focused booth further underscores Novo Nordisk’s fairly recent strategic commitment to increasing R&D in this challenging space.
Panasonic
The Panasonic booth showed off reusable auto-injectors enabled with dose capture and equipped with single and dual cartridges – the focus was on the general device category, presumably as the company aims to move into diabetes on the therapy side. (Separately, it owns Ascensia Diabetes Care.) The injectors seem well-suited for children and those with needle-phobia, as the needle is not exposed, and the system includes rewards and music aimed at engagement. A rep said that elderly patients who tend to have a hard time self-injecting also find these automated devices easier, further reducing burden. Dose information is tracked electronically and sent to an app. The rep added that Panasonic is still in talks with potential partners and that he believes insurance companies will eventually provide reimbursement given demonstrated reduction in healthcare costs. We’ll be interested to follow this and were quite surprised to see Panasonic showing injection devices here. Could it eventually become a supplier for once-weekly GLP-1s or perhaps even basal/bolus insulin, much like Ypsomed?
Sanofi
Sanofi occupied a commanding booth at the center of the bustling exhibit hall, featuring both its diabetes and cardiovascular franchises. Newly-launched Soliqua (insulin glargine/lixisenatide) was the clear focal point (dominating the booth’s main overhead banner) with signage also dedicated to Toujeo (insulin glargine U300) and the PCSK9 inhibitor Praluent (alirocumab). Demarcated by the product’s signature dark blue, purple, and gold color scheme, Soliqua materials emphasized the combination product’s ability to “help patients put high A1c behind them.” Amidst a giant statue of a percentage sign, presumably representing the notion of an A1c goal, Sanofi representatives ran through touchscreen displays of clinical data on Soliqua and how to initiate this in therapy in patients. This messaging was largely centered on how to initiate for people hoping to intensify existing Lantus therapy (“continue current therapy, or start something different?”). These displays were quite popular, indicating a growing interest among physicians in this long-awaited new drug. Toujeo materials focused on a patient vignette of Ray, “a musician and father living with type 2 diabetes,” and applauded Toujeo’s ability to “play to stay in range” and “get patients in tune with their goals.” Amidst touchscreens displaying the clinical data, further signage reminded the booth’s visitors that Toujeo has a “more stable and prolonged action profile than Lantus,” perhaps subtly encouraging physicians to switch their patients from the dominant (and off-patent) Lantus to a regimen involving the similar but more advanced Toujeo. In the Praluent corner stood two giant statues of blue and green arrows, crashing down toward the ground to parallel the drug’s LDL cholesterol-lowering action. Signage here emphasized Praluent’s efficacy and ease of use, posting large statistics boasting the drug’s “more than 60% LDL reduction” and the fact that “up to 80% of patients achieved their goal” when taking Praluent. As at recent conferences (and in stark contrast to previous years), there was hardly a mention of former star product Lantus (insulin glargine). Giant SoloStar pens for Toujeo, Lantus, and Soliqua were interspersed within the booth, and an engrossing virtual reality experience depicting “hypoglycemia at 30,000 feet” that drew an eager crowd. In a separate location, Sanofi’s unbranded Glycemic Explorer booth made a reappearance – this is becoming somewhat of a fixture, present at the exhibit halls of AACE, ENDO, and last year’s ADA.
Tandem
Following a successful Media Day earlier at ADA, Tandem didn’t have much more to divulge in its booth: One employee lamented that the t:slim X2-Dexcom G5 approval hasn’t yet come through – we hear it could happen any day now; it would’ve been nice for the company to be able to detail it at ADA, especially right across the aisle from Medtronic’s booth. In line with the predictive low glucose suspend data presented in an oral at ADA, a rep hinted that Tandem’s PLGS device with Dexcom’s G5 simply “does its job.” The pivotal study, which is preparing for enrollment, will have 90 patients and could “hopefully” be approved by FDA early in 2018. As usual, Tandem reps were extremely complimentary of all interactions that they have with the FDA CDRH division.
Trividia
The Trividia booth displayed their diverse assortment of BGMs. The True Metrix is the most basic, but boasts the most contextual event tags, while the True Metrix Go is smaller, twists onto a vial of True Metrix test strips and has download capacity to the True Manager PC program. The True Metrix Air is the most advanced and, per the Trividia rep, the most popular, equipped with Bluetooth connectivity to the True Metrix Air app and capable of storing 1000 results with time and date. The app provides charts, graphs and customizable notes to facilitate actionable engagement. Users can also share data with healthcare providers, friends, and family. All three meters are covered by most private insurance plans, Medicare Part B, and most Medicaid plans. As a reminder, Trividia is formerly Nipro Diagnostics.
-- by Adam Brown, John Erdman, Helen Gao, Varun Iyengar, Brian Levine, Emily Regier, Maeve Serino, Lisa Vance, and Kelly Close