Diabetes Technology Meeting

Diabetes Technology Meeting 2020 November 12-14, 2020; Virtual; Pre-Meeting Highlights

Executive Highlights

  • During Abbott’s 30-minute product theater, PCP Dr. Eden Miller (Bend, Oregon) introduced directly compared Abbott’s FreeStyle Libre 2 with Dexcom’s G6. It’s not the first time Dexcom’s and Abbott’s marketing efforts have gone after each other (see Abbott’s 60-second ad from 2018 and Dexcom’s Investor Day 2018); however, this was the first time we’ve seen Abbott place FreeStyle Libre 2. Dr. Miller claimed FreeStyle Libre 2 has superior day 1 accuracy, alarm accuracy, ease of use, and cost. From our view, there is so much growth available in these markets, and Abbott already has an advantage with global low pricing, so we believe they could have even more focus on their own benefits without bringing a competitive narrative into the discussion.

  • Dexcom’s product theater focused on its partnership with Current Health, a remote monitoring platform for patients after hospital discharges. We are excited to see this given that those have been in the hospital are at high risk for return hospital stays – if they can stay out of the hospital, that’s a very successful ROI, given what the worst-case scenarios may be. Presenter and Current Health CMO Dr. Adam Wolfberg characterized the integration a “new approach to safe home-based management for patients discharged with uncontrolled diabetes.” The partnership with Current Health should provide more experience and data for Dexcom in a hospital-adjacent setting, in the oft-neglected area of post-discharge care.

  • Elsewhere, we heard from Ascensia/Senseonics, Lifescan, BD, and Glytec. Read our top highlights below and check out our preview for a look at the days ahead.

     

Diabetes Technology Society’s (DTS) 20th Annual Diabetes Technology will officially get underway tomorrow. This morning, the DTS hosted a pre-meeting day featuring 30-minute presentations from six companies. See more below.

DTM 2020 Preview

Top Six Highlights

1. Abbott Goes on the Offensive with FreeStyle Libre 2, Claiming Significantly Better Day 1 Accuracy, Alarm Accuracy, Ease of Use, and Pricing than Dexcom G6

During Abbott’s 30-minute product theater, Dr. Eden Miller (High Lakes Health Care) introduced FreeStyle Libre 2, directly comparing the device with Dexcom’s G6. It’s not the first time Dexcom’s and Abbott’s marketing efforts have gone after each other (see Abbott’s 60-second ad from 2018 and Dexcom’s Investor Day 2018); however, this was the first time we’ve seen Abbott place FreeStyle Libre 2 (cleared in June, launched in August) against Dexcom’s G6. The approach is not surprising: in last month’s earnings call, Abbott CEO Robert Ford argued that FreeStyle Libre 2, not FreeStyle Libre 3, had already closed the feature gap with Dexcom G6: “We’ve heard you talking about closing the gap here with Libre 3. Listen. Libre 2, in my view, has already done that, and that’s what we’re hearing from our customers here [in the US]. It’s by far the smallest, easiest sensor to use, [and has] the best accuracy – low-range, high-range, mid-range, adults, children. The readings being every minute, which is unique to Libre, allows us to get better alarm performance, and we continue to mass-produce and sell it at a fraction of the price, so you’re really not overburdening the healthcare system. So, I think that’s worked very well.”

  • Dr. Miller presented results from a head-to-head study of FreeStyle Libre 2 and Dexcom G6, showing FreeStyle Libre 2 had superior day 1 accuracy. In an Abbott-funded study published in JDST, 25 subjects wore FreeStyle Libre 2 on the upper arm and Dexcom G6 on the abdomen and had venous draws for YSI every 15 minutes for eight hours. The results showed 64% of G6 results within 20%/20 mg/dl, compared to 85% of FreeStyle Libre 2 values. Day 1 MARD for G6 was 18.5%, compared to 13.2% for FreeStyle Libre 2. It’s worth noting that both MARD values from the head-to-head study are worse than those from the pivotal studies. Abbott’s internal FreeStyle Libre 2 data calculated a 9.1% day 1 MARD, while Dexcom’s pivotal study for G6 showed a MARD of 11.5% on day 1. Potential explanations for the discrepancy include the study calculated MARD for the first 8 hours after insertion (compared to the first 24 hours for the pivotal) and Dexcom’s G6 pivotal used a manual insertion technique compared to an automatic inserter used in the head-to-head study.

  • Dr. Miller compared FreeStyle Libre 2’s every minute measuring frequency to Dexcom G6’s every five-minute measuring frequency. Dr. Miller highlighted this point by noting FreeStyle Libre 2 records 1,440 readings per day compared to 288 readings per day from G6. In general, given that a decade or less ago, most intensively managed patients were just getting four or six values a day – so, 300 or 600 or 1,000 or 1,400 tests a day are much more similar than once a day or six times a day. Ultimately, while we consider 288 and 1,440 to be quite similar, the point is both systems provide more than enough data to accurately assess Time in Range and create informative ambulatory glucose profiles. Perhaps more relevant, Dr. Miller also noted that this allows FreeStyle Libre 2 to send an alert the minute a user goes low, while the alert could be up to 5 minutes delayed with G6 (“that’s a lot of minutes to go get some juice”). Again, we don’t consider this a meaningful difference as Dexcom G6 has predictive low glucose alerts (vs. FreeStyle Libre 2’s threshold-based alerts) which are utilized by the vast majority of G6 users (see ATTD 2020). 

  • Dr. Miller highlighted higher alarm accuracy with FreeStyle Libre 2 compared to Dexcom G6. In adults, the positive detection rate (sensitivity) for hypoglycemia (<70 mg/dl) with FreeStyle Libre 2 was 89%, compared to 86% for Dexcom G6. For pediatrics, the difference was larger with FreeStyle Libre 2 at 94% and G6 at 82%. In adults, FreeStyle Libre 2 also produced fewer false hypoglycemia alarms. In adults, false alarm rates were 14% for FreeStyle Libre 2 and 15% for G6. In pediatrics, the difference was again greater with FreeStyle Libre 2 at 20% and G6 at 32%. It’s important to note that all of these values come from label comparisons, rather than any actual head-to-head study. Ultimately, accuracy with both is outstanding – from our view, given the arrows, less accuracy is really needed than with SMBG, though many patients care deeply about perceived accuracy. Either way, we don’t believe that either has any issues with accuracy.

 

  • Then, the next part of the presentation focused on insertion ease of use. Here, again, we don’t see either device having major advantages over the other. Both are spectacular. While we are not surprised that according to Abbott’s small internal head-to-head test of 70 MDI users, the majority of users found FreeStyle Libre 2 easier to insert than a “leading competitor,” we see the difference as one is an A+ and the other is an A. Dr. Miller provided her own experience as a clinician noting that she almost all of her patients insert FreeStyle Libre 2 on their own at home with no issues (not at the clinic) – presumably this would also be true with the Dexcom, but the Libre 2 does have smaller packaging (that said, neither would win any contests on being environmentally friendly – and thank God in our view that that was not the top priority starting out, though we are happy that the environmental friendliness for both products is increasing in importance). Bottom line, both companies have easy-to-use, spring-loaded, one-button inserters; while Dexcom G6 has a reusable transmitter component, the FreeStyle Libre 2 is fully-disposable. Again, overall, we don’t feel that these differences would be the deciding factor for most patients – for most in the US, out of pocket cost and ability to work with other technology may be bigger factors for those using the Dexcom and out of pocket cost and discretion may be bigger factors for the Libre 2. This is speculation of course – for more information on the actual perspectives of thousands of patients, contact dQ&A, the diabetes market research company, and Close Concerns’ sister organization.  

 

  • Finally, Dr. Miller compared the accessibility of FreeStyle Libre 2, compared to Dexcom G6. This is the primary area where we believe Abbott has advantages, from an out of pocket perspective though CGM coverage has also improved so much for certain demographics (intensively managed) that the differences are not big for some. Firstly, Dr. Miller said that FreeStyle Libre 2 is easier to prescribe with less paperwork and prior authorization hassle required through the pharmacy channel – this is definitely the case from what we have heard. Dexcom continues to work on expanding its pharmacy channel, but a majority of patients are still getting G6 through DME, as we understand it. Dr. Miller estimated the monthly out-of-pocket cost for a patient with a high deductible at ~$445 for “Other CGM,” compared to ~$122 for FreeStyle Libre 2. This is a bit larger a difference than we traditionally cite (see here and here), though Abbott is consistently characterized as the lowest-cost CGM offering. We imagine that won’t be true forever. 

  • To close, Dr. Miller made a powerful plea for access to CGM for more people with diabetes. In particular, Dr. Miller noted that everyone, including people with type 2 diabetes, deserve access to CGM. Additionally, healthcare providers for people with diabetes deserve access to the rich data provided by CGM. At this year’s ADA, Dr. Miller herself presented a poster (84-LB) showing significant A1c reductions for people with type 2 diabetes on long-acting insulin or non-insulin therapy. From our view, this was fairly simplistic – everyone with diabetes on CGM at this stage would cost hundreds of billions of dollars and there are many people who have diabetes that is quite stable because they manage consistently healthy food, exercise, and sleep; others may require medicine, and it is medicine that has been optimized and is checked once or twice a year through professional CGM. From our view, investment in CGM for these individuals, as long as they don’t experience severe hypoglycemia, is not the best value. There are tens of millions of patients elsewhere whose time in range is very low and they need CGM to help identify therapeutic interventions as well as nutrition and exercise interventions as well as interventions on the behavioral front. For them, CGM is a very valuable investment – for others, professional CGM may be enough. 

2. Dexcom Product Theater: Dexcom G6 Integration with Current Health Remote Patient Monitoring Solution for After a Hospital Discharge

Dexcom’s product theater focused on its partnership with Current Health, a remote monitoring platform for patients after their hospital discharges. Presenter and Current Health CMO Dr. Adam Wolfberg called the integration a “new approach to safe home-based management for patients discharged with uncontrolled diabetes.” Current Health’s internal solution includes an arm-worn wearable monitor, a clinical dashboard for patient review and monitoring, and telehealth video visits. The wearable monitor is FDA-cleared and offers real-time monitoring of respiration rate, oxygen saturation, mobility and step count, heart rate, and body temperature, transmitting the data to the HCPs patient review dashboard. The device appears to be non-invasive, but is considerably larger and bulkier than Dexcom G6 (see picture below). Through Current Health’s partnership with Dexcom, G6 data also feeds into the Current Health platform. Current Health provides patients with all of the devices they need to engage in remote monitoring from home, including a tablet for video visits with providers and a home hub for WiFi if needed. The clinical dashboard allows providers to monitor all their patients at once and stratifies patients by level of risk and clinical status. On the dashboard, alarms are triggered by vital signs abnormalities (e.g., hypoglycemia, hyperglycemia, sustained high heart rate) that can be personalized the patient’s conditions. The platform also allows providers to view trends in vital signs in graphical and tabular formats, which allows providers to pick up on deterioration or where changes in care might be necessary. In addition to Dexcom integration for glucose data, Current Health has partnerships with Vivalnk for monitoring axillary temperature, MIR for spirometry, and Omron for blood pressure.

  • The partnership with Current Health should provide more experience and data for Dexcom in a hospital-adjacent setting. Post-discharge care is also an underserved area. Dr. Wolfberg estimated that 15% of hospital readmissions are avoidable and 20% of discharged patients are readmitted within 30 days. This is especially true for patients with diabetes: 20% of 30-day unplanned hospital readmissions involve a patient with diabetes, and patients with diabetes face myriad challenges managing their diabetes post-acute care, including closely monitoring their glucose, titrating their medications, making lifestyle and dietary changes, and managing stress.

  • Using Rebecca, a 72-year-old female with type 2 diabetes and congestive heart failure (CHF) as a case study, Dr. Wolfberg and Dr. Egils Bogdanovics (Charlotte Hungerford Hospital) took us through Rebecca’s post-discharge care after an admission for CHF exacerbation. After receiving a personalized kit of supplies and remote monitoring devices based on her conditions and needs, Rebecca used the tablet to interact with her provider and received reminders to upload data on her blood pressure and weight on a regular basis. Through the Current Health platform, Rebecca’s provider was able to monitor her vitals, food logs, and symptoms, review her history and test results, manage her medications and insulin doses, order prescription refills, and check in virtually to make clinical changes and discuss diet and exercise. Dr. Bogdanovics argued that this is particularly useful for a chronic condition like diabetes, in that it gives the provider the opportunity to adjust the patient’s insulin immediately when they are trending regularly out of range and readjust it if necessary. 

3. Ascensia Product Theater: Senseonics CMO Dr. Fran Kaufman Discusses Diabetes Technology Before, During, and After COVID-19

At Ascensia’s pre-meeting session, Dr. Fran Kaufman (Senseonics) started off by reminding viewers about the recent commercialization agreement between Senseonics and Ascensia. The partnership gives Ascensia exclusive distribution rights to Eversense for five years as well as responsibility for the majority of Eversense sales and marketing efforts. As we learned earlier this week, a team of 1o Ascensia sales representatives began “pilot” sales and marketing efforts as Senseonics reinitiated US commercial activities on October 1. Dr. Kaufman is hopeful for the future of the partnership saying, “it enables us to have a bright future helping more patients and providers.”

  • Prior to COVID-19, Dr. Kaufman emphasized the increased uptake of CGM and growing acceptance of Time in Range, though she acknowledged that improvements in population level glycemic control have lagged behind the technology. Specifically, Dr. Kaufman said she was “perplexed” and disheartened by data from T1D exchange indicating no significant improvement in glycemic control or A1c from 2010-2012 to 2016-2018. However, instead of focusing on these results, Dr. Kaufman took a more positive approach outlining the history and importance of glucose monitoring beginning with the landmark DCCT results. BGM revolutionized diabetes care for many patients, but CGM, as described by Dr. Kaufman “took it to another level.” Dr. Kaufman provided clinical and real-world data demonstrating the impact of CGM specifically highlighting recent data from the 180-day Eversense product in Italy in which CGM drove significant A1c reductions with the majority of patients reaching almost 70% Time in Range after six months. With greater penetration of CGM, Time in Range and other glucometrics (i.e., time below 70 mg/dl, time >180 mg/dl, ambulatory glucose profiles) have also become a larger part of diabetes management helping provide greater context for a patient’s glycemic control beyond A1c. However, as already mentioned, these advancements in technology have not always correlated with improved glycemic control.

  • During the COVID-19 pandemic, Dr. Kaufman focused on three emerging themes: (i) the complicated relationship between COVID-19 and glycemic control and the impact of COVID-19 on people with diabetes; (ii) the necessity of telehealth and remote monitoring; and (iii) a greater recognition of the power of CGM and Time in Range. Dr. Kaufman highlighted the disturbingly high COVID-19 mortality rates for people with uncontrolled glycemia compared to people with well-controlled diabetes (42% vs 15% according to Bode et al.) In her discussion of telehealth, Dr. Kaufman highlighted two publications, “Role of Non-profit Organizations During COVID-10 for Diabetes Care” by Helmsley’s David Panzirer, and “Top 10 Tips for successfully Implementing a Diabetes Telehealth Program” by Drs. Stephanie Crosser, Jennifer Raymond, and Aaron Neinstein. Turning back to Senseonics, Dr. Kaufman was proud to report that even during the pandemic, Senseonics has been able to use telehealth and remote technologies to train providers to perform Eversense insertions/removals.

  • Looking ahead to a future without COVID-19, Dr. Kaufman is confident telehealth and CGM will be “here to stay.”Dr. Kaufman is hopeful there will continue to be support for both telehealth and CGM as the standard of care, especially for patients in more remote areas where virtual specialty clinics have the potential to significantly improve outcomes. Most notably, Dr. Kaufman highlighted predictions from JP Morgan which indicate CGM adoption in the US among type 1s is expected to reach 87% by 2023 with adoption among type 2s reaching 27% by the same time. We are hopeful that more widespread adoption could help improve population level outcomes – in particular, people with diabetes on SUs need CGM because they are at high risk for severe hypoglycemia (as we understand it, claims for SH for those on SUs and insulin run in the billions of dollars per year, according to 2016 Truven data).

4. Lifescan Product Theater: Multi-National Study (n=353) Shows that 80% of HCPs Consider OneTouch Verio Reflect as the Best BGM for Type 1s and the Best Meter to Help Patients Stay In Range

During Lifescan’s product theater, Dr. Mike Grady (Lifescan Director of Clinical Affairs) presented data from a multi-national study (n=353), which surveyed HCPs for their views of four BGM systems: Roche’s Accu-Chek Guide, Ascensia’s Contour Next One, Abbott’s FreeStyle Lite, and Lifescan’s OneTouch Verio Reflect. HCPs surveyed included endocrinologists (n=151), PCPs (n=102), and diabetes nurses (n=100) from the US (n=70), Canada (n=71), France (n=70), Germany, n=70), and Italy (n=72). The study provided side by side comparative images of the respective features of all 4 BGMs and found that overall, HCPs chose the OneTouch Verio Reflect meter as the best BGM for patients with diabetes, the best BGM to help patients improve diabetes management, and the best BGM to help patients stay in range. During the presentation, Dr. Grady drew attention to four very meaningful findings:

  • 77% agreed that OneTouch Verio Reflect has the best display to track progress toward personal glycemic goals;

  • 73% rated OneTouch Verio Reflect as having the best tools for patients on insulin therapy;

  • 78% agreed that OneTouch Verio Reflect provides the best insights to support patients in decision-making; and

  • 79% rated OneTouch Verio Reflect as #1 for having the best features for reviewing and interpreting data.

Although these four results were highlighted, for all 13 questions, at least 70% of HCPs surveyed chose OneTouch Verio Reflect the best BGM for supporting patients and HCPs in specific self-management aims (results for questions 1 to 7 below).

Perhaps most notably, in a later iteration of the survey (results below), 80% of HCP participants felt that OneTouch Verio Reflect is the best BGM for type 1s, and 68% agreed that OneTouch Verio Reflect is the best BGM for type 2s. The study was conducted in partnership with Dr. Juan Frias (National Research Institute), Christie Beatson (Barbara Davis Center), and Deborah Greenwood (Health San Antonio School of Nursing, former President of ADCES).

  • The Lifescan OneTouch Verio Reflect meter does have an attractive, color interface that includes a valuable Time in Range feature. Lifescan also has a popular and free OneTouch Reveal App with automatic notifications, goal setting, a color-coded glucose logbook, an A1c “comparator,” and the ability to share data. This is a very highly-rated app – with over 1 million installs total, it’s the #1 downloaded diabetes app globally as we understand it. Additionally, Lifescan announced a couple of weeks ago a partnership with Cecelia Health to bring DCES coaching into the OneTouch Reveal App. 

5. BD Product Theater: Dr. Timothy Bailey and Mr. Brian Pflug on the Value of Reliable Insulin Injection Depth and Mitigating Intramuscular Injections

During BD’s product theater Dr. Timothy Bailey (President & CEO AMCR Institute) joined Dr. Brian Pflug (BD Diabetes Care) to discuss the benefits of BD’s 4mm BD Nano 2nd Gen pen needle and the importance of avoiding intramuscular (IM) insulin injections. Dr. Bailey began the presentation with an overview of the importance of subcutaneous insulin injection for optimal absorption. Unfortunately, as Dr. Bailey explained, suboptimal insulin absorption, especially as a result of IM injection has been associated with lower glucose levels and bouts of otherwise unexplained hypoglycemia. To assess the optimal needle length for insulin injection, Dr. Bailey presented data from a study on skin thickness in adults, finding an average skin thickness of 1.87 mm in the thigh and 2.41 mm in the buttocks with no significant variations related to age, gender, or ethnicity (Gibney et al., 2010). Building on this data, Dr. Bailey also presented results from a BD study of needle length and “calculated injection tissue depth,” comparing 4 mm and 5 mm needles. Results indicated that while neither needle led to any intradermal injections, out of the 1208 trials done with each length, the 4 mm needle resulted in only 5 IM injections (0.4%) while the 5 mm needle resulted in 22 IM injections (1.8%).

  • Following Dr. Bailey’s presentation, Dr. Pflug discussed the potentially detrimental effect of excessive force while injecting insulin. Specifically, Dr. Pflug explained that even if patients are using the shorter 4mm needle to deliver insulin, there is still a potential for IM injection should the patient insert the needle with too much force (e.g., the patient inserts the needle until the surrounding skin dimples). According to data presented by Mr. Pflug from a multi-site study of 230 adult MDIs (type 1 or type 2 diabetes) in Canada, the majority of patients reported injection behaviors consistent with excessive force and risk of IM injection. In an attempt to mitigate the potential for IM injections, BD ran a study evaluating the impact of various levels of force on the mean insulin deposit depth of the BD Nano 2nd Gen pen needle compared to three top competitors (Whooley et al., 2019). All needles had the same 4 mm length, but the three competitors all had a cylindrical posted hub, compared to BD’s “contoured” hub (see picture below). Results indicated the BD Nano 2nd Gen needle had the lowest mean deposit depth at 4.25 mm compared to 4.97 mm, 5.85 mm, and 5.64 mm for the three competitors. Additionally, BD’s needle was shown to have the least variation in insulin deposit depth. Dr. Pflug concluded by saying “the reengineered (BD Nano 2nd Gen) hub design may reduce the impact of unintended individual technique differences by improving target injection depth consistency and reducing IM injection potential.”

6. Glytec Product Theater: eGlycemic Management System in “Nearly 300 Hospitals” Providing Glucose Dosing Insights “Across the Continuum of Care”

Glytec’s 15-minute product theater focused on the company’s eGlycemic Management System (eGMS) emphasizing improved hospital workflows and integrated data. Glytec’s eGMS is a software package available to hospitals providing insulin dosing advice, data analytics, and real-time glycemic data integration into patients’ electronic medical records. The software centers around Glytec’s Glucommander point of care insulin dosing decision support system and consist of five other components: (i) GlucoMetrics to provide monthly data on high-level glycemic management across a hospital; (ii) GlucoSurveillance to identify hospitalized patients with poor glycemic control who could benefit from intervention with Glucommander; (iii) SmartClick to provide real-time integration of glycemic data into EMRs; (iv) GlucoView to provide a dashboard for providers to easily assess all patients using Glucommander with alerts for blood glucose checks to improve workflow; and (v) the GlyCloud platform allowing for remote work, uploads, and updates and facilitating easy data sharing. Notably Glucommander and Glytec’s eGMS are available for patients “across the continuum of care” from the emergency department to the ICU to outpatient care. Upon hospital admission, providers can begin to use Glucommander IV for their patients and only need to input a patient’s current glucose values and a provider prescribed insulin infusion rate. As patients progress, they can move to Glucommander transition and Glucommander SubQ moving safely from intravenous to subcutaneous insulin delivery. Finally, as patients are ready for discharge, Glucommander includes a “Hospital-to-Home” (H2H) module and an outpatient cloud-supported “insulin management solution” to aid patients in transitioning back to self-managed diabetes care.

  • In 2019, Glucommander managed insulin dosing for 62,170 IV patients with less than 0.01% of patients experiencing severe hypoglycemia (<40 mg/dl) and only 0.56% of patients reporting blood glucose <70 mg/dl. Glucommander also managed 78,815 patients on its SubQ platform with only 0.09% of patients experiencing blood glucose <40 mg/dl and 1.8% with glucose <70 mg/dl. Overall in 2019, Glucommander managed >140,000 patients more than 25,000 of whom had severe kidney disease and more than 10,000 of whom had DKA. Across all its patients, Glucommander delivered 1.8 million IV insulin doses.

 

 

--by Hanna Gutow, Katie Mahoney, Albert Cai, and Kelly Close