The enormous annual meeting of the American Diabetes Association, dubbed the Scientific Sessions, took place in steamy Orlando this past week. With ~16,000 diabetes professionals coming together over 5 days to share hundreds of presentations, symposia, research posters and strategy meetings, alongside a buzzing exhibition hall the size of an airplane hanger, it’s difficult to overstate the enormity of this world’s biggest diabetes event. (Suffice it to say one goes home with a weary head and feet.)

The big discussion themes we picked up on this year were access and affordability, and a whole 'lotta research and excitement around new closed loop systems. Also, the patient DIY community was strongly represented in some standout sessions, to the point where they felt they were finally being embraced as partners, at least in the eyes of some Nightscout group leaders:

Woot!

 

ADA’s New Women’s Group and More

For the ADA’s part, they were touting their recent advocacy efforts around access and affordability with a new white paper; overcoming stigma and health disparities; and championing investment in research – referred to as “alarmingly underfunded” with their Pathways program and suggesting a #FundtheMission campaign similar to what was done in the cancer space.

The traditional “Banting Lecture” (named after the co-discoverer of insulin) delivered this year by the ADA President of Medicine and Science Dr. Jane Reusch, included a call to action for HCPs to “Know the Story, Tell the Story.” In other words, each should consider it their personal mission to raise awareness of needed care and access to tools.

Reusch also spoke in some depth about the ADA’s Diabetes Disaster Relief Fund, given recent hurricanes, fires and other natural disasters the org was called upon to respond to.

But the biggest news from ADA is the establishment of the new Women's Interpersonal Network of the American Diabetes Association (WIN ADA), a members-only network that will both support the careers of all women in the field of diabetes, and also shine a spotlight on research on gender as a biological factor for women's health with diabetes.

Reusch also made a plea for promoting closed loop and CGM use among patients – underscoring a new wave of confidence in technology tools based on their prevalence, patient interest, and lots of new data showing positive outcomes!

We'll get to the science in the SciSessions soon, but for today: What was big on the product front exactly? Well... Abbott Libre, Dexcom G6, OmniPod's new DASH system, and a whole bunch of new stuff suddenly approved by FDA in the days leading up to the conference.

 

 

FDA Approved (!): Eversense, Basal IQ, InPen Insights

Eversense: the new implantable connected CGM system from Senseonics was undoubtedly the belle of the ball on the expo floor -- because it represents a whole new category of CGM and was just FDA approved on Friday leading into the conference. See our full coverage of that product/approval here. The booth was flooded each day, so much so that it was sometimes hard to even get a peak at the prosthetic arm they were using to demo the sensor insertion.

 

Tandem: You might say Tandem Diabetes Care was making a stunning comeback after rumors of their demise. They had a big booth front-and-center near the main entrance to the exhibit hall and were proudly displaying their just-now-FDA-approved Basal-IQ technology, a predictive low glucose suspend (PLGS) feature for their t:slim X2 insulin pump that works via Dexcom G6 (yes, the very newest model!). Of course it's designed to help reduce the frequency and duration of hypo events, shutting off insulin delivery when the BG level is predicted to drop below 80 mg/dL or if BG is currently below 70 mg/dL and falling.

But what's different about this low glucose suspend feature is that it's constant and dynamic, meaning that instead of automatically stopping delivery for a set period of time, the system immediately resumes insulin once BG values start to rise. So it might temporarily shut off delivery several times a day, or even more often, for just a few moments, until you're heading back in range. Users can choose whether they want alerts to sound each time this happens, although the point is to have this management feature working in the background, to give us PWDs less to worry about on a daily basis (!) Tandem plans to launch Basal-IQ in August, with current t:slim pumpers getting a free upgrade; the company's still determining what upgrade options it will offer those still using the Dexcom G5 model.

Goodbye, t:flex: ICYMI, Tandem has discontinued its larger 480-unit t:flex insulin pump because the demand wasn't enough to justify making it any longer. As of the end of June, this device will no longer be available for new customers but the company does plan to continue making supplies for current users until their warranty period is up.

InPen: Also just FDA approved on Friday was Companion Medical's Insights by InPen -- the data portion of the app that pairs with their cool new smart pen. Last year, the InPen system became the only FDA-cleared smart insulin pen with a diabetes management app that allowed pen users to begin to track doses and collect the kind of data that's only been available to pumpers to date. Now, their comprehensive Insights app includes average glucose, average total daily dose, dose calculator usage, missed doses, and detailed daily views. The company is calling this a milestone that will change the landscape, since it was previously impossible to track data this way from people on MDI (daily insulin shots). This could even feed new national research on the habits and outcomes of pen users, they say.

DreaMed: Yet another FDA approval in the lineup was the OK for Isreali-based DreaMed Diabetes to market their DreaMed Advisor Pro app for optimization of insulin pump settings. You may remember DreaMed as one of a number of companies developing closed loop algorithms for an eventual Artificial Pancreas system. Now they've packaged a piece of their technology as "a cloud-based digital solution generating insulin delivery recommendations by analyzing information from CGM, self-monitoring blood glucose (SMBG), and insulin pump data... applying event-driven adaptive learning." It uses AI to "refine its understanding for each individual and sends recommendations to the healthcare provider on how to optimize a patient's insulin pump settings for basal rate, carbohydrate ratio (CR) and correction factor (CF)." In anticipation of this offering, they had already signed an agreement with D-data platform provider Glooko to integrate the Advisor Pro tool into that platform. A very cool application of artificial intelligence in diabetes care, and great option for pumpers using Glooko!

 

Abbott Libre

The Abbott Libre Flash glucose monitoring system (approved for US sale last September) was certainly a star in its own right, with a packed-house Product Theater presentation and crowded booth. This new system is "factory calibrated," so does away with the need for any fingersticks calibrations at all, and is available at lower cost. One study presented found that people who used Libre spend an average of $120 less per month without the need to purchase test strips.

On the outcomes front, the company released results of a combined analysis of 17 past studies showing that users had an average .56-point reduction in A1C and spent significantly more time in range. Interestingly, this data comes from 250,000 "real-world" patients not recruited by Abbott, spanning type 1, type 2 and different age groups, including teens and young adults.

In a statement, Abbott's Director of Clinical and Computational Research Tim Dunn said, "From a glucose-control level, we are seeing a really strong relationship between people who check their glucose more often and their control."

They tell us FreeStyle Libre is now being used by more than 650,000 people across more than 42 countries, and that Abbott has secured partial or full reimbursement for the system in 28 countries, including France, Ireland, Japan, the United Kingdom.

One sticking point (no pun intended) is the fact that the US is still awaiting approval of the LibreLink app, data manager for this system. Still no word on exact timing of that. 

 

Dexcom

The company was showing off its newest G6 model, with a flatter sensor, increased accuracy, Low and High predictive alerts, and a redesigned companion phone app. In fact, CEO Kevin Sayer tells us, "G6 is entirely different from previous products – the membranes, parts and algorithms. We changed everything."

They were excited that G6 was able to head off FDA's new "iCGM category" allowing for faster filing time. When asked about the challenge of meeting market demand, he said, "We're also we are 10 times bigger as a company now than at the G4 launch" (when they originally ran into shipping delays).

When asked about other challenges, Sayer admitted: "We struggle with transmission range, and with connection gaps. We actually designed the device to have Bluetooth shut off inbetween to extend the sensor life and to conserve battery... (but) we now need to re-engineer the system so Bluetooth gaps go away." Agreed!

Still, Sayer says in future generations they'll be able to eliminate the need for a receiver altogether, even before they solve the Bluetooth issues entirely.

He says right now, it's "all hands on deck with the G6, and getting that launched in Europe next. Then there will be G6 derivatives (incremental upgrades), followed by a fully disposable platform, which will be the G7." The latter is part of their work with Verily developing more T2 and consumer-focused CGMs.

"Right now, the sensors cost too much to be disposable," he says, so the first product they'll roll out with Verily will be based on the G6, but "smaller and simpler for people to pay for... and just the sensor, with less functionality and 14-day wear."

They're also looking to build in AI that learns users habits and can adjust settings accordingly. He'd like to see customization like an "I want to go to bed now" button that lets the system know to activate your sleep settings.

What about the new competition, we asked? "Libre has increased our focus, and increased awareness of CGM overall. It's made us think and move faster, expanding the market. If it has impact on anything, it would be pricing. We have to ask ourselves, what can we build at what price? We want a more fully featured Dexcom product at a Libre price."

Good to know!

 

OmniPod DASH

Insulet, makers of the popular Omnipod tubeless pump, were excited about the flashy display of their new DASH platform, just FDA approved on June 4.

We got to touch and play with a sample in their booth. DASH basically replaces the current PDM controller with a locked-down Android phone with Wi-Fi connectivity, that brings a number of new features and advantages, including:

  • phone touchscreen with easy scrolling, as opposed to the manual button-push on the old PDM that required you tap through the entire alphabet to set a new basal program, for example
  • IOB (insulin on board) is displayed on the homescreen
  • sports an improved food database based on FoodKing, with 80,000 items
  • software can be remotely updated over the air
  • allows for duplicating and copying basal rate patterns and setting 0-unit basal rates as needed
  • ability to manually enter BG and other data as well as personalizing meal entries for quick access

Insulet hosted an evening event at ADA with a DASH user panel, where we learned just how much patient feedback went into designing this new system. Kudos to this company for setting up a full "lab" to co-design with users!

FYI for Omnipod fans: the new system has two disadvantages, or at least changes, to know about.

  • First, the new Android controller no longer includes a built-in fingerstick meter, which many liked because it eliminated the need need to carry and extra device.
  • Second, because it's essentially a cell phone, the new system takes lithium ion batteries that require recharging -- so it's like having another phone that needs recharging regularly.

But other than that, we're pretty excited about the DASH system, that makes the Omnipod system even easier to use and is clearly a stepping stone to an eventual system controlled straight from your smartphone, with no need for a separate device.

 

Medtronic

Per usual, Medtronic had a gigantic display booth that was continually hopping with activity. They were quite proud that on June 21, the Medtronic 670G (first approved in Sept. 2016 and launched last year) was finally FDA-OKd for pediatric use in ages 7-13. The company was also showing off its stand-alone Guardian Connect CGM that just recently launched following regulatory approval earlier in the year.

Sugar.IQ: Along with the stand-alone CGM, Medtronic has launched its Sugar.IQ "diabetes assistant" mobile app, which comes from its IBM Watson partnership. This AI-powered app continually analyzes how users' glucose levels respond to food intake, insulin dosages, daily routines, and other factors, to reveal patterns that can help PWDs keep their glucose levels in target range. Right now the app is available for iOS phones only, and can only be used with the Guardian Connect CGM and insulin injection therapy. The company plans to offer it to its pump customers as well in the near future.

Nutrino Foodprint: Medtronic was also showing off a new mobile app feature focused on nutrition, dubbed Foodprint, that comes from a partnership with the startup Nutrino. Users can log their food by taking a picture of each snack or meal, and the AI-powered program matches each food entry with the CGM data following the meal. Every 6 days, the app's synced with all the D-data to create a "Foodprint" report showing glucose levels, time-in-range and patterns.

For now, Foodprint is only available as a feature of the iPro2 MyLog app paired with the blinded CGM version specific for HCPs. But the company tells us they'll soon offer it also for use within their Sugar.IQ app for Guardian Connect and Minimed 670G systems, and future D-devices.

Note that the Foodprint report assigns a letter grade of A-F to each of user's logged meals, based on the post-meal glucose readings. So a meal that spiked BG might get a D or F. "The intent is to help understand someone's reaction to foods and have a meaningful discussion about those results," the company says.

However, some folks pointed out this grading system is akin to food shaming, as it makes people feel judged about what they choose to eat. The idea being that this Foodprint grading system may fly in the face of pushing back on viewing BG values as "good" or "bad."

It'll be interesting to see how users respond as this app gains traction...

Tidepool Data Testing: We couldn't help but smile at seeing our friends at the open-source data org Tidepool on the scene at ADA, excited about their announcement that the non-profit's data-sharing platform is now beta testing support for Medtronic 630G, 640G, and 670G devices. They were actively recruiting Medtronic 6-series users who happened to be at ADA to come try it out and connect their D-devices at the Tidepool booth!

 

Mannkind's Afrezza

Mannkind was in the house with a booth for its inhaled insulin Afrezza, and as users ourselves, our team always likes seeing the giant Dreamboat inhaler on the display wall. Many more conference-goers seemed much more familiar with Afrezza than we recall in years past.

This year, Mannkind was showing off positive study results from its STAT and AFFINITY studies that looked at improved time in range and reduced hypoglycemia. The STAT study involved 60 type 1 patients and is the first randomized, controlled study to use CGM with Afrezza. Compared to injected insulin, and using "supplemental doses" of at 1 and/or 2 hours post-meal, Afrezza:

  • Significantly improved all-day glucose time-in-range by an average of 1.5 hours, or 12%
  • Significantly decreased daytime glucose variability by 17%
  • Significantly reduced the time spent in hypoglycemia (i.e., <70 mg/dl) by 41% or approximately 23 minutes per day

The AFFINITY study, also with type 1s, showed that compared to injected insulin aspart, Afrezza:

  • Significantly lowers the rate of hypoglycemia in T1D while providing similar or better glycemic control (54.1 events per subject vs. 78.2 events per subject, a reduction of 31%)
  • On average, shows 26% less hypoglycemia across a range of HbA1c levels, allowing the same degree of glycemic control with less hypoglycemia than insulin aspart 

This is of course just the kind of evidence the company needs to bump up provider confidence and therefore prescriptions.

Meanwhile, the company has kicked off a limited TV ad campaign and they hosted an investor and analyst meeting in New York City on June 27 (yesterday). They also held a diabetes blogger event a few months ago that brought them some nice coverage among the DOC patient community (our team was unable to attend, but as noted, we do use Afrezza ourselves).

 

More from the ADA Expo Floor

Of course, there were other CGM wannabes at this big conference -- though none are currently coming to market in the US for several years at least.

EOFLOW is a Korean-based company developing a knock-off Omnipod patch pump, along with a knock-off Dexcom CGM and phone-based app controller. They tell us they're at least a year off from completing studies, but plan to launch a 1.0 version in the US in 2019 that will include a larger CGM sensor, and then upgrade to a sleek round disk version that resembles the Misfit activity tracker. The system will have a low glucose suspend function (which will probably become standard on all combo systems before long), and eventually they'll expand with future closed loop capabilities for insulin dosing. This company is quite convinced their system has advantages over existing products, as evidenced by this comparison chart.

Glutalor, a Pennsylvania med-tech company developing a system called the iWel mobile CGM, is one we've seen at this conference before and they were back showing off their system. This also looks like an OmniPod patch with a little button on the top for insertion. It would send readings for 7 days directly to a smartphone for readouts, alerts, etc. Although interesting, this is the third year in a row we're told they have no ETA yet on launching in the US.

 

Insulin Manufacturers:

Interestingly, the three big insulin makers -- Lilly, Novo, and Sanofi -- were not as visible on the exhibit hall floor as they traditionally have been. While Sanofi had a dominating presence with its company name in huge letters, Novo and Lilly were more subtle with product-branded marketing displays.

Notably, Sanofi did announce its next-generation plans to partner with Verily (formerly Google Life Sciences) and Sensile Medical in New Jersey to create an "all-in-one" insulin patch pump -- much like Lilly announced in late 2017 with its pipeline for a hybrid patch-tubed pump and pen technology. Sanofi says they are focusing on Type 2 diabetes, and there's no word on timing at this point.

We also noticed that unlike the 2017 SciSessions conference, none of the insulin-makers had referred to the access/affordability issue in their displays -- despite this being a giant elephant in the room. Instead, the Pharma companies had a theme of going beyond insulin (both type 2 and type 1, actually) and using their other non-insulin drugs to better compliment therapies.

One big booth actually titled “Go Beyond Insulin with Type 1 Diabetes” was backed by Sanofi, presumably priming the market for their new drug Sotagliflozin, brand name Zynquista, which is under FDA review now.

It's a new SGLT-1 / SGLT-2 drug developed jointly by Lexicon Pharmaceuticals and Sanofi. If approved, Zynquista will be the first oral anti-diabetic drug approved in the US for use by adults with type 1 diabetes, in combination with insulin (!). And FDA decision on Sotagliflozin is expected on March 22, 2019.

There was no formal mention of this medication in the booth, but we understand trial data was presented on Sunday showing increased time in range.

 

Closed loop systems:

None of the smaller companies developing closed loop systems (Beta Bionics, Bigfoot, etc.) had a booth at ADA but all had teams present of course. Multiple studies showing positive results were released to much fanfare, including a press conference on Saturday. The Diabeloop system developed in France was getting a lot of attention for its international study showing that "a powerful and customizable algorithm system for type 1 diabetes treatment that may enable patients to significantly and durably reduce their glucose levels without an increase in hypoglycemic events."

Speaking of customizable, Diabeloop CEO Erik Huneker French tells us their system in being creating dynamically and incrementally by PWDs alone. For example, they just added a unique feature called "Zen mode" to quiet your CGM after meals, when you know you're going to be high for a period and don't want or need alerts.

 

Insulin titration tools:

New tech tools to help people fine-tune their insulin dosing is a growing area! Aside from the new offerings from DreaMed and Inpen described above, we noted -

Glytec, the Massachussetts-based provider of in-hospital and now outpatient insulin management optimization tools, had a sizable booth and was touting lots of impressive new progress. For one thing, they've just added the iGlucose cell-enabled smart meter to the collection of devices their software is compatible with. Their in-hospital system has shown significant reductions in hypoglycemic events, and better transition to insulin therapy outside the hospital -- all good! (Disclaimer: 'Mine editor Amy Tenderich sits on Glytec's Advisory Board)

Mellitus Health has a fairly new offering to help clinicians in any setting better titrate insulin doses. The Los Angeles-based company was founded by Dr. Mayer Davidson, former President of the ADA and 2016 ADA Physician Clinician of the Year, and includes the famed Dr. Anne Peters of USC on its medical board. We're gold the platform provides protocols for 125 different combinations of insulin therapy, and data showing positive effect on A1C levels was presented at ADA this year. 

Voluntis, makers of the Insulia platform for insulin management also had a small booth that was well-visited. Insulia is an app providing insulin dose recommendations and educational coaching messages in response to BG values that is integrated with the Livongo meter, the WellDoc app, and others. They just announced a partnership with Monarch Medical Technologies to integrate Insulia into their EndoTool System, an FDA-cleared software suite for precise inpatient and outpatient insulin dosing recommendations.

 

Nutrition tools:

Whisk was creating some hype as the winner of the Ascensia Diabetes Challenge global innovation competition, actually announced and previewed for the first time at our Friday #Ddata18 technology event. Whisk is a "culinary coach" app based on an artificial intelligence-powered "Digital Dietician" that's currently available for consumers in the UK and US. The Digital Dietician combines factors including users’ personal taste preferences, time constraints, goals, budgets, dietary restrictions and allergies, to suggest the nutritionally tailored recipes. The platform then connects directly to the online shopping platforms of some of the world’s leading grocery retailers, so you can put ingredients for the selected recipe right into your online basket to purchase. Ascensia is planning to work with Whisk to build a version that links to BG data, to make tailored recipe recommendations for people with diabetes that are optimized to their own BG trends. Pretty cool!

Palette, another startup creating an innovative food platform, was on hand with a small booth at ADA. Referred to as a "GPS for health," it uses a voice-enabled smart placemat (Palette) that accurately tracks your meals’ nutrition. It communicates with an app that uses your information to devise personalized recommendations based on your nutritional history, medical condition, physical characteristics and food preferences. Users can also track their personal dietary and behavior goals, medication, and contacts of providers and caregivers. Users receive instant feedback on recorded progress and can interact with providers, caregivers and family members on nutrition information and recipe building if desired.

 

And Yet...

Despite all of this progress, excitement, and clinical data showing the impact of technology, it seems Americans with diabetes continue to do poorly overall, according to Dr. Joseph Wolfsdorf, in his talk during the "Joint ADA/ISPAD Symposium―25 Years after the Announcement of the DCCT Results—What Is the Status of Type 1 Diabetes in Youth, and How Can We Do Better?"

 

Grrr...