ATTD (Advanced Technologies and Treatments in Diabetes) 2020

February 19-22, 2020; Madrid, Spain; Exhibit Hall - Draft

Executive Highlights

  • The third floor of Feria de Madrid was a busy place, as it housed the Exhibit Hall for ATTD 2020. Our team went around the hall, chatting and learning from reps as they showcased their companies and products to ATTD attendees.

    See much of the exhibit hall coverage below – we’ll be continuing to add to it as we receive final information on some of the questions we asked! In the meantime, please make sure to check out our coverage from ATTD Days #1-4!

  • Abbott’s booth was particularly busy as providers stopped by to check out the FreeStyle Libre 2. Notably, the booth showed off accuracy data for FreeStyle Libre 2, giving us the ability to directly compare Abbott’s data with the special controls criteria set by the FDA for iCGM clearance. The adult data is published on the EU label, as well as published at IDF (“Accuracy of 14 day factory-calibrated FreeStyle Libre system with new glucose algorithm”), and the data show that the accuracy of FreeStyle Libre 2 in adults does indeed meet the iCGM special controls – the MARD shows improvement from 11.4% (FreeStyle Libre) to 9.2% (FreeStyle Libre 2). The pediatric data for FreeStyle Libre 2 has also improved – this data shown for the first time at ATTD shows MARD improvement from 13.9% to 9.7% (compared to YSI). Abbott’s FreeStyle Libre 2 pediatrics data still falls slightly short of the iCGM special controls, the accuracy in hypoglycemia is vastly improved, which is great to see. Of course, having CGM data with trend arrows and alarms is a huge step-up from SMBG.

  • Elsewhere, Dexcom, Tandem, Medtronic, and Insulet’s booths were also bustling. Dexcom had two large banners advertising pregnancy and upper-arm wear indications coming “spring 2020,” while Medtronic’s booth had a big display advertising real-world data from European MiniMed 670G users. Tandem’s understated booth had quite a few visitors, especially European providers wondering about the OUS rollout of Basal-IQ and Control-IQ. Insulet’s brightly lit booth, which included a fun lava lamp-esque display of Omnipods in water, was another popular stop for attendees.

  • See below for our coverage of Abbott, A. Menarini, Biocorp, Capillary Biomedical, Dexcom, Diabeloop, Diabnext, DreaMed, Glooko, Insulet, Medtronic, Medtrum, Roche, SOOIL, Terumo, Tandem, UndermyFork, and Ypsomed.

 

Exhibit Hall

Abbott

Abbott’s booth was busy throughout ATTD as many providers stopped by to check out the new FreeStyle Libre 2. According to reps at the booth, FreeStyle Libre 2 has still only launched in Germany and Norway, though other countries in Europe are coming soon. In the US, FreeStyle Libre 2 still remains with the FDA, where it has been since at least 1Q19. Notably, materials at the booth advertised accuracy data for FreeStyle Libre 2, giving us the ability to directly compare Abbott’s data with the special controls criteria set by the FDA for iCGM clearance. See the tables below. 

In total, Abbott’s accuracy data showed 18,926 paired points in adults and 6,584 paired points for pediatrics. We aren’t sure where the data was gathered from (i.e., Europe or US), but the data show that the accuracy of FreeStyle Libre 2 in adults does indeed meet the iCGM special controls. In emails with Abbott, we confirmed that the same set of adult data was used in the labeling for FreeStyle Libre 2 in Germany, where the device is already available (see picture from German FreeStyle Libre 2 user guide below). Note that the tables presented at the booth are binned differently (in order to reflect US iCGM specifications), but the data is the same. Despite the lengthy FDA review, Abbott’s management has maintained their confidence in eventual clearance as an iCGM. We’ve been uncertain of what’s been causing the delay with the FDA – while some have assumed it has to do with interoperability standards or accuracy in hypoglycemia, presumably it could be other things. Indeed, however, the data is certainly very positive to see:

  • The adult data shows FreeStyle Libre 2 is significantly more accurate than the original FreeStyle Libre in hypoglycemic ranges – the MARD for adults fell from 11.4% with FreeStyle Libre to 9.2% FreeStyle Libre 2 for adults (as shown at IDF 2019), while pediatrics data was shown for the first time at ATTD with MARD dropping from 13.9% to 9.7% (compared to YSI). It was surprising that this data was in the booth only and not at any presentation but we look forward to seeing it discussed more broadly in the future.

  • Notably, while the pediatric data for FreeStyle Libre 2 falls slightly short of the iCGM special controls, we understand that the FDA focuses largely (some might say completely – that’s speculation on our part) on seeing adult accuracy data in range, which this certainly is.
  • From a business standpoint, the delay in launch for FreeStyle Libre 2 is not really slowing any of Abbott’s momentum (big banners on the Feria de Madrid entrance proclaimed “over two million” users for FreeStyle Libre), adding the Bluetooth connectivity and optional alarms at the same price and form factor certainly make the product even more compelling for many populations, particularly for pediatrics. We believe reducing hyperglycemia will become a bigger focus in the future for all manufacturers and we look forward to seeing more detail on this.  To this end, we really enjoyed Abbott’s “Free to Dream without Lancets” graphic at their booth, highlighting the optional alarms enabling patients to sleep in peace. That is a nice offer – on the other hand, if alarms are going off consistently, rather than avoiding annoying partners and turning off alarms, we’d suggest patients work with HCPs to fix whatever is consistently prompting hypoglycemia or hyperglycemia – that’s the power of the alarms to begin with – to spot patterns and address them!

Table 1. Comparison of FreeStyle Libre 2 accuracy data with iCGM special controls.

Performance Standard: Lower bound of one-sided 95% confidence interval

FreeStyle Libre 2 in Adults

FreeStyle Libre 2 in Pediatrics

Euglycemia: >70% within ±15% for 70-180 mg/dl

72.9%

74.8%

Euglycemia: >99% within ±40% for 70-180 mg/dl

99.4%

98.9%

Overall: >87% within ±20% over full device measuring range

88.6%

88.1%

Hypoglycemia: >85% within ±15 mg/dl for <70 mg/dl

86.6%

77.2%

Hypoglycemia: >98% within ±40 mg/dl for <70 mg/dl

99%

97.5%

Hyperglycemia: >80% within ±15% for >180 mg/dl

89.3%

84.2%

Hyperglycemia: >99% within ±40% for >180 mg/dl

99.9%

99.1%

Table 2. Summary of FreeStyle Libre 2 accuracy data.

 

Adult (n=18,926 paired points)

Pediatric (n=6,584 paired points)

% within 15 mg/dl or 15%

85.6%

83.7%

% within 20 mg/dl or 20%

92.4%

91.6%

MARD

9.2%

9.7%

Picture below taken from FreeStyle Libre 2’s German user guide (provided to us by Abbott).

  • Since there is focus on accuracy, we would make two other points:

    • We also feel it’s important to point out that peds management has improved light-years since the old days: the arrows alone make peds management significantly better, as do better accuracy and alarms. Night and day! Contextualizing improvement is very important, from our view. As a teenager, Kelly had so many ER visits – all prompted by severe hypoglycemia that could have been avoided by either arrows, or by the alarms, to say nothing of better accuracy.

    • While under 10% MARD is clearly nice to see, decisions to change doses or therapy in the cases where ongoing therapy can be optimized are very important levers to use to reach better glycemic management – we believe that to date, these are underused and that all CGM can improve performance.

A. Menarini

A. Menarini’s booth was dedicated to its CE-marked GlucoMen Day CGM “powered by Waveform” and corresponding Bluetooth meter for calibration. The system has 14-day-wear, MARD in the range of 11%-13% based on information at DTM 2018 and EASD 2019, one fingerstick calibration per day, and data-to-mobile app transfer. Reps shared that the product hopes to be submitted for FDA clearance by the end of 2020, representing a push back in timelines from original goals of launching in the US by 2020. We also learned that the company is expanding to new countries in North Africa and Middle East though specifics weren’t mentioned. A. Menarini is responsible for performing sales, marketing, training, and customer support for WaveForm’s CGM throughout Europe, the Middle East, Africa, and Latin America.

Biocorp

Biocorp’s small both featured its reusable connected pen attachment “Mallya.” The two-year device, priced at ~$122 and compatible with “all major pens,” contains two pieces, one of which clips on top of the pen and another with fits over the control dial/button. The device relays dose, time, and date to a mobile application via Bluetooth. The device received CE-marking as a class IIb device in June 2019, and reps shared that the company plans on “selling” the device in the US market by the end of the year. This would imply an FDA clearance at least several months earlier, pushing the company back on its original goal of having it in the US by the end of 2019 or 1Q20. While reps did not comment on the news, Biocorp received ~$2.2 million from Sanofi to incorporate Mallya with Sanofi’s insulin pens while Sanofi would acquire non-exclusive distribution rights to it the product worldwide. The company also has a data-sharing partnership with DreaMed to feed insulin dosing data into the MDI/basal-only Advisor Pro clinical decision support system.

Capillary Biomedical

Capillary Biomedical’s understated booth was fully dedicated to its SteadiSet Infusion set. As a reminder, this technology intends to address three major problems of insulin pump therapy: (i) slowing the body’s wound response to foreign materials by making the cannula out of a “soft polymer material”; (ii) spreading insulin out to a larger surface area of subcutaneous tissue  to enhance consistent absorption; and (iii) preventing kinking through a wire coil reinforcement on the inside of the cannula. A poster was also on display comparing the performance of SteadiSet with a traditional 90° Teflon IIS (T90) in pigs for two weeks. The data indicated that the SteadiSet Infusion Set caused less tissue trauma between two days and two weeks post-insertion and was resistant to kinking. In August of 2018, the company had raised $2.9 million in angle funding to support FDA clearance and launch by the end of 2019 – when speaking with booth representatives today, we learned that the product had secured an IDE from the FDA and was recruiting for the pivotal trial.

Dexcom

Dexcom’s booth featured large banners on each side highlighting two exciting features coming in “Spring 2020”: G6 in pregnancy and upper-arm wear. Of course, Dexcom users have been using G6 in pregnancy and on the upper arm off-label for quite some time! And, it is incredibly exciting to see pregnancy become a bigger focus area as we believe everyone with diabetes should have real-time CGM during pregnancy – full stop, no exceptions, given the upside. CE-Marking for Dexcom G6 in pregnancy was officially announced on the second day of ATTD, with launch commencing in the UK “starting spring 2020.” Notably, the NHS has already committed to offer CGM to all pregnant type 1s by 2020/2021, given the robust cost-effectiveness. Upper-arm wear of G6 is quite common, though the device is only officially indicated for abdomen wear in adults and abdomen and buttocks for pediatrics. Overall, this meeting was phenomenally strong for CGM and there were hundreds of people at Dexcom’s booth daily. Their brand is very immersive and we are sure they were reveling in the attention from conference-goers!

Diabeloop

Diabeloop’s small booth featured its DBLG1 algorithm connected to a personal handset, Dexcom G6 CGM, and Kaleido patch pump. The booth had a nice picture of the algorithm’s three layers: (i) safety first (risk of hypoglycemia evaluation); (ii) physiological framework and expert system (insulin decision management); and (iii) auto-learning (personalized parameters optimization over time). The third feature is not yet available but is “forthcoming” with additional R&D. Reps had several exciting updates, stating that the company has secured the highest level of designation for obtaining reimbursement in France and is in discussions with payers in Germany as well. In January, the company started a nine-month clinical trial (n=180) with DANA pumps in France to obtain FDA clearance, which we’d estimate would happen in late 2021 if results are positive. As of EASD 2019, Diabeloop had intended to submit the algorithm as an “iController” pathway which we also assume will happen now following Control-IQ’s clearance in December. The hybrid closed loop system received CE-marking in November 2018 and is currently in a “soft launch” mode with ~35 patients in France. Notably, the company in December also raised €31 million (~$34 million) in Series B Financing to pursue broader rollout in Europe. In a testament to the algorithm’s promise (see Lancet Digital Health paper from 2019), Diabeloop was also selected in January to join France’s French Tech 120 program, an initiative started by President and Prime Minister Emmanuel Macron to support 120 French startups experiencing hypergrowth.

Diabnext

Diabnext’s modest booth was almost fully dedicated to its Clipsulin 3XS connect insulin pen cap which became available for sale on its online store ($40) and Amazon at the end of December. The device uses audible clicks from most commercially available pens to keep track of insulin dosing. The product also connects to a smartphone application through Bluetooth and enables HCPs to access data. The booth also featured Diabenxt’s $30 Gluconext attachment for BGMs without Bluetooth to integrate data with the smartphone app. Reps were excited to share the wide variety of data integration partnerships the BGMs (Abbott, Ascensia, Lifescan, Roche, iSENS) and about looking for potential CGM partners in the future.

DreaMed

Providers flocked to DreaMed’s low-key booth on Thursday afternoon, shortly after results of the Advice4U study read out. The results showed that DreaMed’s Advisor Pro yielded non-inferior results to expert physician advice in n=122 young people with poorly controlled type 1 diabetes. By the time we made it to the booth, DreaMed had run out of its Advisor Pro related handouts. The booth still had handouts related to Advisor Academy and DreaMed-branded charging cables. The Advisor Academy includes webinars hosted by many top KOLs, including Drs. David Maahs, Thomas Danne, Irl Hirsch, Rich Bergenstal, Diana Isaacs, Laurel Messer, and more. At the booth, we got a demonstration of Advisor Pro in both the Glooko Population Tracker and standalone version (which uses Tidepool to obtain data) – of note, the standalone version already included a “Connect with Dexcom” button, just one day after DreaMed announced its data integration with Dexcom. As of February 14, 2020, Advisor Pro has been used by 319 patients, up from “more than 100 patients” in September. Notably, 87 of the patients who’ve used Advisor Pro started this month. As of February 14, the system has generated 474 recommendations based on 9,954 patient days of data.

Glooko

Glooko (diasend in Europe) had a large and well-positioned booth at ATTD, with multiple reps at the ready as attendees came off the escalators. Notably, the company showed its 2019 Annual Report, which identified January 1, 2019, as the day with the lowest mean Time in Range across Glooko users and September 19, 2019, as the day with the highest Time in Range. While the January 1 date did not really come as a surprise, we do wonder what could be driving September 19 to that top spot. To help attract people to the booth, Glooko also had an iPad with a short quiz on diabetes technology for the chance to win a Fitbit. The Close Concerns team took home the top spot – check it out below and great work, Albert, for the team! Very impressive modesty, we would add …

Insulet

In a fun display, Insulet’s brightly lit booth featured a tall, lava-lamp like display filled with water and Omnipods. Of course, the display was highlighting the Omnipod’s waterproofing and Insulet has made swimmers wearing Omnipod a frequently seen part of their marketing materials. Omnipod Dash began launch in the UK and Netherlands at the end of December, and rollout across Europe and Canada is expected this year. Of note, on Insulet’s 4Q19 quarterly call, the company also said they would launch Omnipod in five new markets in the Europe and Middle East in 2020. We think the no-upfront-cost, pay-as-you-go model for Omnipod Dash is a much easier sell to both payers and consumers, and the pharmacy distribution simplifies startup hassle for everyone. We love the focus on the Middle East – boy, does this region need help on improving diabetes management.

Medtronic

Medtronic’s booth was big and bustling, with a big display showing slides highlighting MiniMed 670G. The display showed off real-world data from Europe that we saw at an earlier Medtronic symposium, and compared the data side-by-side with the MiniMed 670G pivotal and MDI + CGM and MDI + BGM users. Another screen also highlights the >17,000 EMEA (Europe and Middle East) users of 670G and that 670G users meet the consensus guidelines for >70% Time in Range and <7% A1c. In another corner of the booth, Medtronic had its new “zero calibrations,” fully disposable Envision Pro CGM, which was first announced at EASD 2019. Reps were selling the professional CGM as being particularly suitable for both type 1s and type 2s who might be “less tech-savvy,” on basal-only insulin, “overwhelmed” by data or alarms (this is at least sometimes in the view of the provider, not the patient – often “Pro” use then dictates real-time use), or those who couldn’t afford personal CGM.

Medtrum

Shanghai-based Medtrum advertised three integrated patch pump and CGM offerings. The company currently has a predictive low-glucose-suspend system available in six European countries with ~200 users based on what we heard at ATTD 2019. The current A6 system has a semi-disposable tubeless patch pump controlled by a handheld device, a seven-day CGM (two calibrations/day), and predictive low-glucose suspend. The A7 system adds a secondary display mobile app and improve the CGM to 14-day wear and one calibration/day. A P7 system currently in R&D adds direct smartphone control and no CGM calibrations. The company also displayed its S7 CGM as a standalone. Of note, Medtrum owns both the tubeless patch pump and CGM in its portfolio.

Novo Nordisk

It was terrific to see Novo Nordisk exhibiting at this meeting – smart devices were shown at the booth, rather than insulin and GLP-1 as we are used to seeing at other meetings. Novo Nordisk was very popular at the meeting, with the company’s on-site event “sold out” and another 70+ people listening in via headphones. We loved the company’s curved screens showing off partnerships between smart insulin pens and multiple partners. See here to a link to some of their social media showing the upside to better information collection and analysis. Also see below more from Roche on the partnership with Novo Nordisk.

Roche

Roche’s reps gave us a look at the company’s new InsulinStart service (announced in 4Q19), the RocheDiabetes Care Platform, and its data integration partnership with Novo Nordisk’s future NovoPen 6 and Echo Plus. The InsulinStart program utilizes text messaging (SMS) to assist type 2 patients transitioning away from oral therapy to insulin. The service sends to text message to participants every day, one in the morning and the other in the evening. The morning message reminds participants to measure their blood glucose before breakfast while the evening message recommends the amount of insulin participants should inject based on the measured sugar levels and insulin data participants share. Roche’s Accu-Chek SmartPix software provides HCPs involved in the program reports on how insulin titration has changed day-by-day, further contextualizing their recommendations. Initial data has shown that participants can lower their glucose levels into target range within 4-12 weeks! Participants set a target range at the beginning of the program of the program, and the service automatically ends once this range is reached.

The RocheDiabetes Care Platform, also announced in 4Q19, provides reports and graphs indicating blood glucose levels and statistics, status cards for assessing hypoglycemia risk, glucose levels, and glycemic variability. The dashboard is interactive and allows quick views or expandable views to zone in on particular data. Healthcare providers can also choose from a variety of features such “Pattern Detection,” “Strip Management for Hospital Pick-Up,” or “Home Delivery” to tailor care regimens. The open, device-agnostic platform can capture and store data from over 130 diabetes devices and platforms including BGMs, insulin pumps, pens, or other applications that capture glucose, insulin, or carb counting data. It also uses algorithms to provide actionable guidance on care plans.

 

The final demonstration was with Novo Nordisk’s smart pen data partnership to integrate insulin injection data from the NovoPen6 and Echo Plus (expected to launch in 2Q20). Using the phone’s NFC capability, the rep was able to scan the pen which then transmitted dosing data into the mySugr app. Users are also able to manually add comments about the dose (e.g. grams of food consumed and exercise) to contextualize the readings. The data integration partnership was first announced in October 2018 although we have not heard much about it since. Of note, mySugr was granted accreditation from the Association of Diabetes Care & Education Specialists (ADCES; formerly known as AADE). A rep shared that there are “more than two million users in 79 countries.”

Other products we’ve previously seen included the recently CE-marked Accu-Chek SugarView, a “meter-free BGM” using Accu-Chek Active test strips and a smartphone camera. With the smartphone app, users scan a test strip without blood using the app, lance their finger, wipe blood onto the active test strip, and scan the strip again. SugarView can only provide glucose reading ranges which go from “low” to “very high.” The app can also provide information on how to act based on blood glucose values. The product is meant for emerging markets and is available in Nigeria, the Philippines, Mexico, India, and Pakistan. We also got a look at the Accu-Chek Solo patch pump which most recently launched in Australia!

 

SOOIL

SOOIL had its DANA Diabecare-I Bluetooth pump on full display. Of note, reps shared that the pump has received “verbal CE-marking,” with an official announcement expected to come in the “next two to three weeks.” We also learned that the company is pursuing a feasibility study in the “middle” of 2020 with hopes to secure FDA clearance by the end of the year as an ACE pump. These timelines are similar to those we heard at EASD 2019. The booth also had a sign depicting Diabeloop’s DBLG1 as the company’s algorithm partner – this information had not been previously shared.

Terumo

Japanese medical technology had on its three-day wear patch pump which launched in June 2019. Similar to its booth at EASD 2019, the demo product had large “not-yet CE-marked” stickers. The device has been submitted though for CE-marking and hopes to secure the indication before May 2020 when new EU regulations for medical devices take effect. The pump features a three-day disposable component that connects to a piece with reusable electronics, a controller handset that can be transferred to a smartphone through NFC, and a one-button insertion process.

Tandem

Tandem’s smaller, corner booth was busy, as many providers and patients flocked over to learn about Basal-IQ and of course, Control-IQ – see well-known blogger Kerri Sparling’s view today in diaTribe on Control-IQ “First Impressions of Control IQ”. Handouts given to HCPs highlighted the Control-IQ pivotal trial results, in particular showing off the additional 2.6 hours per day spent in range – that is music to the ears of patients, that is for sure (as is evidenced by the strong demand). Tandem’s Device Updater, which enables remote software updates for pumps finished rollout in Tandem’s European countries towards the end of 3Q19. In Tandem’s latest quarterly call, we learned that Basal-IQ is now available in “more than half” of Tandem’s international geographies and that Control-IQ is expected to launch in the back half of the year. Notably, t:slim X2 will be launching in France, Germany, and the Benelux countries (Belgium, Netherlands, and Luxembourg) sometime in “early 2020.”

UndermyFork

UndermyFork’s two representatives provided a small demo of its app that combines CGM data with meal to give users a view of how food choices impact blood sugar through the lens of a Time in Range-focused interface. The company also showed a demo in November at Diabetes Mine. Users log meals with pictures which are then classified by postprandial time-in-range. The app also has a smart photo recognition feature to recognize specific foods that are in the meal and also allows users to search for meals they previously had. Former Close Concerns tech lead Adam Brown and Kelly both use this app (Adam wrote about it in diaTribe in November, 2019, and Kelly began using it immediately), and based on their experience, the app correctly identifies food ~70% of the time. Kelly cares less about whether it identifies the food she is eating (it nearly always does) as she does about getting the readings that show whether her two-hour numbers were right (when they aren’t, she “gets it” or figures out where carb counting may’ve needed help). As of now, the app is currently available on iPhone and the company plans on expanding it to Android later this year. Blood sugar data is currently integrated with Dexcom CGMs via Apple health and FreeStyle Libre for those using the off-label MiaoMiao/ Blucon add-on (though we are not recommending this), and several BGMs although the company also hopes to work with all CGMs later this year. Reps shared that the user base is ~1,000 (we’re shocked for a free app that it is not higher) and that the vast majority are in the United States. The company is actively fundraising and hopes to add insulin logging features in the future – check out our report from the Diabetes Mine meeting for a deeper dive!

Ypsomed

The Ypsomed booth featured live-demos of its YpsoPump. A rep confirmed what we learned on the company’s F1H20 call in November, stating that it hopes to have the pump submitted to the FDA by the end of the year. By the time YpsoPump plans on launching in the US, it will face tough competition with Tandem’s t:slim X2 pump and Omnipod Dash although certainly this is the time for pump expansion, given all the killer apps now enabling automated insulin delivery. We are very aware of but didn’t see any formal updates on the YpsoPod patch pump, which, based on our estimates, may launch in 2022-2023.

 

--by Ani Gururaj, Albert Cai, and Kelly Close