Medtronic announces CE-Mark for second-generation, advanced hybrid closed loop system, MiniMed 780G; slated for launch in “fall” – June 11, 2020

Launch Timing & Product Details

Medtronic plans to begin shipping MiniMed 780G in “select countries” in Europe starting “this fall.” MiniMed 780G is CE-Marked for patients ages 7-80 years old, meaning the system will launch with pediatric approval. Medtronic didn’t share any specific countries where 780G would be launched first, but presumably, this list would be similar or identical to the first countries where MiniMed 670G was launched: Belgium, Denmark, Finland, Ireland, Italy, the Netherlands, Spain, Switzerland, and the UK. Of note, Medtronic recently announced reimbursement for 670G in Germany (September 2019) and expected reimbursement in France by April 2020 (no confirmation on the company’s most recent earnings call).

Medtronic first confirmed its filing for CE-Marking for MiniMed 780G on its 4Q19 update in February. The expected launch in fall 2020 comes at a ~5-6-month delay from Medtronic’s original plans to launch by April 2020 (before the end of fiscal year 2020). Still, getting the system launched this fall in Europe will give Medtronic a nice head-start over its automated insulin delivery (AID) competitors. Tandem began rolling out Basal-IQ towards the end of 3Q19, but due to COVID-19, we believe international rollout of Control-IQ has been pushed back from original plans to launch in 2H20. Insulet’s Omnipod Horizon won’t be on the US market until 2021 and broader European rollout for Omnipod Dash has also been pushed back to 2021.

Medtronic’s second-generation automated insulin delivery (AID) system will be a significant upgrade over MiniMed 670G (launched in the US in June 2017, OUS in fall 2018). Like MiniMed 670G, MiniMed 780G will automatically adjust basal rates every five minutes, but 780G algorithm, developed in collaboration with DreaMed Diabetes, adds in automatic correction boluses. Additionally, MiniMed 780G has an adjustable target down to 100 mg/dl, compared to MiniMed 670G’s static target of 120 mg/dl. On the hardware side, MiniMed 780G’s pump adds Bluetooth connectivity, allowing for remote software updates and a mobile app for secondary data display and wireless data uploads. The second-gen system is designed to bring improvement on the usability front, reducing the number of alarms and simplifying operation. In the past, Medtronic has talked about ambitious >99% time in  closed loop goals for MiniMed 780G and we’ll be very excited to see time in closed loop numbers at ADA 2020’s MiniMed 780G presentations (see below). With the ability to deliver automatic correction boluses, 780G is also designed to be more “forgiving,” smoothing out highs when users forget or miscalculate when counting carbs or dose insulin before meals.

The user interface for MiniMed 780G (see picture above) is very similar to that of MiniMed 670G with the latest glucose reading displayed prominently on the pump. Active insulin and time are available in the corners of the display and the top-left of the display is occupied by indicators for battery level, reservoir volume, connection status, and CGM calibration status. The 780G display also includes two dots as page indicators; we’d guess the second screen shows a CGM trace. The companion app for secondary display looks sleek and attractive, with CGM and insulin delivery traces prominently displayed.

Implications for Medtronic

Getting MiniMed 780G approved puts Medtronic in a strong position to maintain and grow its share of the pump market in Europe. In the company’s most recent earnings call, Medtronic shared there were ~249,000 “trained, active users” for MiniMed 670G. Most of the recent growth in 670G users has been driven by international markets, where Medtronic faces less competition; however, the pace of growth has tapered off in recent quarters, potentially in anticipation of launch of MiniMed 780G (and no way to upgrade 670G to the 780G algorithm).

Medtronic has the benefit of three years of user and provider experience and has made improvements, particularly around user experience and usability, on its second-generation closed loop system. The company’s press announcement focuses in on usability, noting that “providers will find that managing patients on the system is simple” with only a “few settings.” On the patient side, Medtronic gives quotes from clinical trial participants that MiniMed 780G “made life with diabetes and control so much easier” and made ‘life significantly easier.” At DiabetesMine’s Closed Loop Showcase in November, Medtronic engineer Lou Lintereur showed promising patient-satisfaction metrics from a pre-pivotal study (n=12), with all patients reporting the system was the best they had every used. Seven of 12 participants rated their likelihood of recommending the system to a friend as 10/10 and eight out of 12 said the system “far exceeded expectations.” We’ll undoubtedly be keeping an eye out for patient and provider satisfaction metrics and usability when Medtronic reads out its trial data this weekend.

The addition of Bluetooth connectivity to 780G’s pump catches the hardware up to Tandem’s t:slim X2 pump. With Bluetooth, Medtronic will be able to offer remote software updates to its pumps, partially mitigating the effect of users waiting to purchase pumps until “the next, newest system” comes out. Medtronic’s marketing compares the software upgrade experience between MiniMed 780G and Tandem’s t:slim X2, noting the 780G has “Wireless/Over the Air” updates, while t:slim X2 has “Wired” updates. Overall, we don’t see this as a huge differentiator for patients as both pumps will be updateable at home and software updates are infrequent. With Bluetooth connectivity, MiniMed 780G will also be able to use their smartphones as secondary displays for pump data, in addition to wirelessly uploading their pump data, a feature that is especially important for pediatrics (and parents) and providers. Presumably, the Bluetooth connection would also give the 780G the technical capability for smartphone pump control (e.g., delivering a bolus from the phone), though Medtronic has not officially announced any intentions to bring smartphone control until its next-generation “Personalized Closed Loop” system (see below).

Slide taken from Medtronic’s ADA 2019 Analyst Briefing.

What’s Next for Medtronic?

• Along with CE-Marking for MiniMed 780G, Medtronic announced CE-Marks for MiniMed 770G and 720G. We first officially learned about MiniMed 770G on last month’s 1Q20 update; the system is made up of the pump hardware from MiniMed 700 series (i.e., has Bluetooth connectivity) and the algorithm from MiniMed 670G. The MiniMed 720G system is made up of the pump hardware from MiniMed 700 series and provides readings from a Medtronic CGM, but does not include any automated insulin delivery algorithm (i.e., sensor-augmented pump). These other systems will be available in “countries around the world based on local market approvals and regulations.”

• There were no updates on MiniMed 780G’s availability in the US. Last month, we learned that Medtronic expects FDA approval for its MiniMed 770G system (MiniMed 700 series pump + MiniMed 670G algorithm) “this summer,” with launch presumably coming shortly after. While the new pump hardware will bring some improvements (most notably, Bluetooth connectivity), much of the upgrade from 670G to 780G does come in the algorithm. For US users who purchase MiniMed 770G, they will be able to upgrade their pump software to the 780G algorithm when launched “later in the fiscal year” (Medtronic’s fiscal year 2021 ends on April 2021). It’s unclear whether Medtronic submitted the MiniMed 700 series pump as an ACE (interoperable) pump or through the traditional pump pathway; to-date, Medtronic also hasn’t shared any intentions to submit the 780G algorithm through the FDA’s new “iController” pathway (created by Control-IQ in December). On a positive note, MiniMed 770G will be available for patients as young as 2 years old, making automated insulin delivery available to 2-6 year olds for the first time in the US.

• At launch, MiniMed 780G will work with Medtronic’s Guardian Sensor 3. Guardian Sensor 3 has 7-day wear time and still requires two fingersticks/day. In the US, we are still waiting for word on Medtronic’s filing for non-adjunctive labeling for Guardian Sensor 3 (filed in July 2019) – we believe this labeling would be required for MiniMed 780G to provide automated correction boluses. For now, CGM remains the weakest link in Medtronic’s AID offering. Submissions to “regulatory agencies” (i.e., FDA and CE) for the “Zeus” CGM are expected by the “end of summer.” Zeus will retain the same form factor, reusable transmitter, and 7-day wear as Guardian Sensor 3, but will be day 1 calibration only (vs. 2 fingersticks/day) and meet the FDA’s iCGM criteria. Presumably, Zeus will also be compatible with MiniMed 780G when launched.

• At ATTD 2020, Medtronic announced CE-Marking for its 7-day extended-wear infusion set, though we didn’t hear any potential launch timings. In the US, the extended-wear infusion set has IDE approval and according to this ClinicalTrials.gov page, the trial is expected to complete in October 2020. Getting infusion set wear to 7-days would be a nice convenience and usability win for patients and this year’s ADA will feature several abstracts related to extended-wear infusion sets.

• Medtronic’s Personalized Closed Loop (PCL) system is slated for FDA submission in November 2020-April 2021 with launch by ADA 2021. The system raises goals to “100% [time in] Auto Mode Capable” and “>85% Time in Range.” Additionally, the system will have smartphone control and have meal and activity prediction, eliminating the need for carb counting.

• Since announcing sponsorship of Tidepool Loop about one year ago, we haven’t heard any updates from Medtronic. Though there is certainly at least a remote possibility the 780G hardware (already submitted to FDA) was filed as an interoperable ACE pump, this hasn’t been confirmed.

MiniMed 780G-Related Abstracts at ADA 2020

This weekend’s ADA 2020 will feature several abstracts related MiniMed 780G. Click here for our full preview of ADA 2020 and our ADA 2020 Resource Hub. The times below are in US Central time.

• (Friday, June 12^th, 2:00 PM) US Advanced Hybrid Closed-Loop (AHCL) Pivotal Safety Study. In what’s sure to be a packed (virtual) room, Dr. Bruce Bode (Emory University) will read out results from the adult pivotal trial for MiniMed 780G in the US. Like the 670G pivotal, the 780G pivotal is single-arm, i.e., it will compare the same patients before and after using 780G.

• (Friday, June 12^th, 2:30 PM) FLAIR—An NIDDK-Sponsored International, Multi-site Randomized Crossover Trial of AHCL vs. 670G. Following Dr. Bode, International Diabetes Center’s Dr. Rich Bergenstal will read out data from FLAIR (n=113), a cross-over trial comparing MiniMed 780G with 670G. Notably, this is the first ever head-to-head comparison of an AID system with a commercially available AID system.

• (Friday, June 12^th, 3:00 PM) New Zealand AHCL Randomized Crossover Trial (CE Mark Dataset). Friday’s triumvirate of MiniMed 780G read-outs finishes with University of Otago’s Dr. Martin de Bock. The study from New Zealand served as the clinical trial supporting 780G’s CE-Mark submission and today’s announced approval.

• (Sunday, June 14^th, 3:15 PM) Improved Glycemic Outcomes with Medtronic Minimed Advanced Hybrid Closed-Loop Delivery: Results from a Randomized Crossover Trial Comparing Automated Insulin Delivery with Predictive Low Glucose Suspend in People with Type 1 Diabetes. Dr. Martin de Bock’s oral presentation will read out data (n=60) comparing MiniMed 780G with MiniMed 640G (predictive low glucose suspend).

• (Sundary, June 14^th, 5:15 PM) Postprandial Glucose Control Using the Medtronic Advanced Hybrid Closed-Loop System: Faster-Acting Insulin Aspart vs. Insulin Aspart. University of Melbourne’s Dr. Melissa Lee will compared glycemic outcomes from using MiniMed 780G with Fiasp vs. insulin aspart.

• MiniMed 780G-related posters include:

  • “Safety and Glycemic Outcomes of the MiniMed Advanced Hybrid Closed-Loop (AHCL) System in Subjects with T1D” (97-LB)

  • “Improved Technology Satisfaction and Sleep Quality with Medtronic Minimed Advanced Hybrid Closed-Loop Delivery Compared with Predictive Low Glucose Suspend in People with Type 1 Diabetes in a Randomized Crossover Trial” (979-P)

  • “Unannounced Meals at Home with the Medtronic Advanced Hybrid Closed-Loop” (1014-P)

  • “Personalized Hybrid Closed-Loop Therapy Using a Digital Twin in Patients with Type 1 Diabetes: At-Home Data” (1006-P)

  • “Six Months At-Home Hybrid Closed-Loop vs. Manual Insulin Delivery with Finger-Stick Blood Glucose Monitoring in Adults with Type 1 Diabetes: A Randomized Controlled Trial” (999-P).

Close Concerns’ Questions

• Where will Medtronic first launch MiniMed 780G? Will launch be gradually rolled out or is there enough capacity to go straight into a full-scale launch?

• What is the demand for MiniMed 780G? As the pandemic lingers, if clinics and hospitals are still closed, how willing are patients and providers to initiate pump or AID therapy?

• How much of an improvement in percentage of time in closed loop will we see with 780G vs. 670G? Glycemic outcomes? Patient satisfaction?

• Was the pump hardware for 780G submitted as an ACE pump in the US? Will the MiniMed 780G be cleared as an “iController”?

• Can 780G reinvigorate Medtronic’s pump business, particularly in the US?

• How quickly can Medtronic deliver on its CGM pipeline and catch up to competitors?

• How usable is MiniMed 780G for HCPs? How long will it take Medtronic to train HCPs on its use?

• Will these next-gen AID user experiences drive significantly larger uptake of pumps and CGM? Will the uptake be rapid (1-3 years) or gradual (5+ years)? When we will we see the vast majority of type 1s on AID? For how many years will cost remain a gating factor?

--by Albert Cai and Kelly Close