Memorandum

Automated Insulin Delivery (AID) Competitive Landscape – April 6, 2021

Executive Highlights

  • The tables below include an overview of the automated insulin delivery landscape in the US and internationally, to the best of our knowledge. The list is organized first by products currently available (MiniMed 670G, MiniMed 780G, Tandem Control-IQ, Roche/Diabeloop/Dexcom), then by expected time to market – meaning either pivotal trial or launch (whichever has been disclosed). We have separated primary players from those that are very early stage or that rarely give updates.

  • We acknowledge this list may be incomplete, as there are likely other stealth startups or academic groups working to commercialize closed-loop technology.

  • This list only includes organizations with a declared plan/timing to conduct a pivotal study and/or launch. We have excluded longer-term R&D efforts (e.g., intraperitoneal, in-hospital), even though these could eventually be used in AID.

  • We will continuously update this list as timelines change, but it is only up to date as noted above. The included timelines are based on publicly disclosed information as indicated in the “recent coverage” column. If you see an issue, please let us know.

Already Launched

  • Roche, Diabeloop, and Dexcom’s AID system – In select European markets. The system integrates Roche’s Accu-Chek Insight pump, Diabeloop’s DBLG1 AID algorithm, and Dexcom G6. When it launched in March 2021, it became the first AID system that uses a pump with prefilled cartridges. The Roche/Diabeloop/Dexcom system is currently available in Germany, Spain, Italy, and the Netherlands with a launch in Switzerland coming “soon.”

  • Medtronic MiniMed 780G hybrid closed loop Launched in 26 OUS markets on four continents. The OUS MiniMed 780G launch was announced in October during Medtronic’s 2020 Investor and Analyst Day. MiniMed 780G received CE-marking back in June 2020 and adds automatic correction boluses, Bluetooth, mobile app connection, and remote software updates with a next-gen pump and algorithm. In the US, Medtronic has submitted 780G to the FDA as a class III PMA submission that includes adult and pediatric data, as well as data to support the approval of and 780G integration with Medtronic’s “Zeus” CGM, which will likely need non-adjunctive labeling to support MiniMed 780G’s automatic bolus features. Medtronic has declined to offer an approval timeline given the FDA’s limited capacity due to COVID-19-related efforts, but previous timelines slated approval for 1H21. See more in Medtronic 4Q20.

  • Medtronic MiniMed 770G hybrid closed loop – In US markets since November 2020. MiniMed 770G is the first AID system approved for use in 2-6-year-olds, following FDA approval in September 2020. The system also received CE-marking in June 2020. MiniMed 770G consists of the 700G pump series hardware (i.e., the pump technology from MiniMed 780G), but the same algorithm and Guardian Sensor 3 CGM as the MiniMed 670G system. MiniMed 770G includes Bluetooth connectivity and can interface with Medtronic’s new MiniMed Mobile app (App Store; Google Play). While the pump updates in 770G are minimal, the big win will come when patient can upgrade their 770G systems to the 780G algorithm for free when it launches in the US. Additionally, new CMS rules could allow for Medicare coverage of 770G starting in April 2021.

  • CamDiab’s CamAPS FX – launched in the UK. University of Cambridge spinoff CamDiab’s AID system, CamAPS FX, was CE-Marked and launched in the UK in March 2020. CamAPS FX uses an Android app (including smartphone pump control), Dexcom G6, and SOOIL Dana Diabecare RS pump. In addition to smartphone control, CamAPS FX is also the first AID system available for pregnant women and children down to one year old. As of our most recent update, CamAPS FX availability is limited to patients in 11 NHS clinics, where certified trainers are available, and has not yet secured reimbursement.

  • Tandem Control-IQ hybrid closed loop –Already enabled on “more than 100,000 pumps” globally (as of February 2021). Currently, Control-IQ is FDA cleared for ages 6 years and older. Received FDA clearance as class II iController in December 2019 and officially launched in January 2020. UnitedHealthcare announced that it would cover Control-IQ starting July 1. Control-IQ continues to roll out internationally: currently, the system is available in “more than half” of Tandem’s existing markets with plans to expand to 25 geographies by the end of 2021. Smartphone bolus control is expected to launch in 1H21 with additional algorithm enhancements and integrations with Dexcom G7 and Abbott CGMs to follow in 2H21 and 2022. See more in Tandem 4Q20.

  • Medtronic MiniMed 670G hybrid closed loopIn US and select OUS markets with ~249,000 users globally (as of 1Q20). The pace of user base growth for MiniMed 670G has slowed in recent quarters, likely due to competition from Tandem and MiniMed 780G. The system was first approved by the FDA in 2016. In October 2020, the Centers of Medicaid and Medicare services published a new set of proposed rules which would allow for Medicare coverage of adjunctive CGMs for the first time. It is unclear if the proposed rules have been finalized, but if they have, the rules would now be in effect (started on April 1, 2021) and would open up Medicare coverage for Medtronic’s 670G and 770G systems.

  • Tandem Basal-IQ predictive low glucose suspend – In US and select OUS markets, enabled on >50,000 pumps. Basal-IQ was approved by the FDA in June 2018 for ages 6+. Basal-IQ is currently available in “more than half” of Tandem’s OUS geographies. Once users update to Control-IQ, they cannot “downgrade” to Basal-IQ.

US AID Next-Gen Pipeline and Timing – Primary Players

Company

Product

Latest Timing

Recent Coverage

Medtronic

1. MiniMed 780G  (a.k.a. Advanced Hybrid Closed Loop)

– Automatic correction boluses, Bluetooth connectivity, mobile app, and remote software updates

– Glucose set points of 120 mg/dl and 100 mg/dl

– Uses non-adjunctive Guardian Sensor 3 CGM (two cals/day)
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

2. MiniMed 770G system – pump hardware from MiniMed 700 series (Bluetooth connectivity) with MiniMed 670G algorithm; can update algorithm to 780G for free when available

 

 

 

 

 

 

 

3. MiniMed 720G system – sensor-augmented pump; uses MiniMed 700 series pump hardware and provides readings from Medtronic CGM; no AID algorithm

 

4. Seven-day extended wear infusion set

 

 

 

5. Tidepool Loop – integration with Medtronic iCGM and ACE pump with iPhone app; ADA 2019

 

 

 

 

6. Personalized Closed Loop with advanced adaptation and meal handling, >85% TIR, mean BG <130 mg/dl, phone control, goal of “100% [time in] Auto Mode Capable”

 

7. Lower-cost AID system

 

1. 780G algorithm submitted to FDA as a class III PMA submission; no approval timeline due to COVID-related work at FDA (previous expectations for 1H21)

– FDA submission includes adult and pediatric data, as well as previously submitted Zeus CGM

­– Pump hardware approved by the FDA in September 2020 (Series 700 pump hardware)

– Received CE-Marking (ages 7-80) in June; launched in 26 countries across four continents as of February 2021

– Adult pivotal data read out at ADA 2020

– Smartphone app for secondary display and wireless data uploading
 

 

 

 

 

 

2. Received CE-Marking in June and FDA approval in September 2020

– Product first announced in 1Q20 update

– Available in “countries around the world based on local market approvals and regulations”

– First AID available for 2-6 year olds in US

– US shipments began in November

 

 

3. Received CE-Marking in June after product first announced in 1Q20

– Worldwide availability depends of “local market approvals and regulations”

 

 

4. US pivotal trial completed in November 2020

– Received CE-Marking in February 2020; limited launch in EU in 1Q21

 

5. iCGM pivotal trial began at ADA, with planned FDA submission in April-Oct 2020; no ACE pump FDA submission timing disclosed

– “Really not a big focus” for Medtronic

 

 

6. FDA submission expected in November 2020-April 2021, launch by ADA 2021; no recent updates
 

 

 

7. Launch after Personalized Closed Loop (above); no recent updates

Medtronic 4Q20 (F3Q21)

(February 2021)

 

The Lancet publishes FLAIR study results, the first head-to-head RCT of closed loop systems (670G vs. 780G)

(January 2021)

 

Medtronic 3Q20

(November 2020)

 

Medtronic begins shipping MiniMed 770G in the US

(November 2020)

 

New CMS proposed rules would cover adjunctive CGM starting in April 2021

(October 2020)

 

Medtronic 2020 Investor and Analyst Day

(October 2020)

 

FDA approves Medtronic’s MiniMed 770G as the first AID system available for 2-6-year-olds in the US

(September 2020)

 

MiniMed 780G (+ 770G, 720G) Receives CE-Mark

(June 2020)

 

ADA 2020: MiniMed 780G Pivotal Trial, 780G vs. 670G, New Zealand Data; Extended-Wear Infusion Set; 780G TIR Impact with Adolescents

 

(June 2020)

 

End of “Preferred” Insulin Pump Agreement with UnitedHealthcare

(June 2020)

Tandem

1. Control-IQ: hybrid closed loop with Dexcom G6 CGM and TypeZero algorithm integrated into t:slim X2 ACE pump. Algorithm automates basal and delivers automatic correction boluses (details here).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1a) t:slim X2 app: allows wireless uploading of pump and CGM data

 

 

1b) Pediatric indication: clearance down to 6+ years

 

 

 

 

 

 

 

1c) Smartphone bolusing: bolus control on both iOS and Android phones

 

1d) Tandem Source: second-gen data management application (akin to Dexcom Clarity)

– Connects providers, users, and caregivers app and web-based dashboard

– Will house algorithms to drive insights and diabetes management changes

– Aim to directly integrate data from CGMs and pumps

 

 

1e) FreeStyle Libre 2/3 and Dexcom G7 integrations

 

 

 

 

 

 

 

1f) Type 2 indication

 

 

 

 

 

2. t:sport: miniaturized, no-screen tubed pump with integrated Control-IQ algorithm, smartphone or wireless handheld control, on-device bolus button, easier fill process

– Will have new syringe-driven pumping mechanism

 

 

 

 

 

3. “Fully closed loop system”: aimed for “complete bolus and basal insulin automation”

1. At least 100,000 Control-IQ users globally in “more than half” of Tandem’s existing markets, as of February; plans to launch in 25 geographies by end-of-year 2021; “more than 60%” of pump users on Basal or Control-IQ (does not include new pumps shipped with Control-IQ), as of June 2020

– US launch in January 2020

– UnitedHealthcare now covers t:slim X2 with Control-IQ, as of July 2020

– Additional Control-IQ enhancements under review with FDA: expanded body weight and correction factor ranges + indication for use with admelog

– Clinical trials for “more meaningful” system improvements to run later this year (2021)

 

1a. Secondary display and wireless data upload, “t:connect mobile” app to launched in 2Q20 and downloaded by “more than 80,000” users, as of February

 

 

 

1b. Expanded pediatric indication in June; US pivotal trial (ages 6-13) read out at ATTD 2020; real-world data from adolescents (ages 6-13) read out at ISPAD 2020

– Small study in young children (ages 2-5) shared at ADA 2020 in June, with full pivotal in children 2-6 to start in “2021”

1c. Smartphone bolusing submitted to the FDA as of November; slated for launch in 1H21

 

 

1d. Launch in “select” international markets “later this year” with a domestic launch to follow

 

 

 

 

 

 

 

 

 

 

1e) Integrate with G7 “within one month” of G7 clearance (early 2022?); Abbott integration “as soon as possible in 2022”

New integrations will be growth catalysts in 2022

– Abbott integration launch first in the US; unclear if will launch with Libre 2 or Libre 3

 

 

1f) No timeline offered; first mentioned in February; aim for indication for Control-IQ + t:sport system as a “starting point,” then create dedicated solution

 

 

 

2. Submission timing further delayed to 4Q21 (as of February), after being pushed back to “first half of 2021” and launch in the “second half of 2021” in April 2020; will be submitted with mobile app control

– Will embed Control-IQ hybrid closed loop algorithm (see above)

– Delay originally due to COVID and then due to human factors testing that revealed opportunities to improve system usability

 

 

 

3. First mentioned on Tandem’s 4Q19 call, pivotal study aimed for “2021,” no major updates, as of December 2020

Tandem 4Q20

(February 2021)

 

Tandem 3Q20

(November 2020)

 

Full results from Tandem’s Control-IQ pediatric pivotal trial (n=101) published in NEJM

(August 2020)

 

Abbott and Tandem finalize partnership

(June 2020)

 

Pediatric Indication (ages 6-13) for t:slim X2 and Control-IQ

(June 2020)

 

ADA 2020: Real-World Control-IQ, Basal-IQ, pediatric Control-IQ

(June 2020)

 

UnitedHealthcare Coverage for t:slim X2 with Control-IQ

(June 2020)

 

Acquisition of Sugarmate app

(June 2020)

Insulet

1. Omnipod 5 (f.k.a. Omnipod Horizon)

­– Hybrid closed loop algorithm built into tubeless, wearable pod; pod talks direct to Dexcom G6

– Direct smartphone control, initially on Samsung Galaxy phones only (iOS users must use dedicated PDM)

–Target setpoints can be set between 110 mg/dl and 150 mg/dl; can set different targets for different times of day

– HypoProtect feature (temporarily set glucose target to 150 mg/dl and restrict insulin delivery)

– Built-in smart bolus calculator in the app and controller that is informed by CGM values and trends

– Eventual integration with Dexcom G7 and Abbott FreeStyle Libre 2, as well as control for iPhones

 

 

2. Tidepool Loop integration (see below)

1. Three-month pivotal trial read out at ENDO 2021 (adult + pediatric)

– Started in December 2019 and completed as of EASD 2020 after 3-month pause due to “software anomaly”; updated protocols due to COVID-19

– Three-month, single-arm study; n=240 (128 type 1s ages 14-70; 112 type 1s ages 6-13)

Expected to launch with limited market release in “first half 2021” with larger ramp up at end of 2021/early 2022, as of March 2021

– Pre-school pivotal (ages 2-6, n=80) completed as of February, data being compiled for FDA submission

– Feasibility study in type 2s (n=30-40) started enrolling in September; preliminary data (n=4) presented at ENDO 2021

 

 

 

 

2. Depends on Tidepool’s FDA progress (see below); Tidepool Loop submitted to the FDA in December

Insulet hosts webinars and investor presentations highlighting Omnipod 5 pivotal data and successes in broad populations

(March 2021)

 

ENDO 2021: Omnipod 5 pivotal read-out; pediatric pivotal; type 2 feasibility

(March 2021)

 

Insulet 4Q20

(February 2021)

 

JPM 2021

(January 2021)

 

Omnipod 5 pre-pivotal published in DT&T including detailed system description

(December 2020)

 

Insulet 3Q20

(November 2020)

 

Insulet 2Q20

(August 2020)

 

Horizon Pivotal Resumed

(June 2020)

 

ADA 2020: Horizon Pre-Pivotal, Exhibit Hall

(June 2020)

 

Insulet 1Q20

(May 2020)

 

Horizon Pivotal Paused

(March 2020)

Tidepool

Tidepool Loop iPhone app (hybrid closed loop algorithm – basal-only)

– Communicates via Bluetooth with interoperable ACE pumps and iCGMs

– Insulet, Dexcom, and Medtronic are official iCGM and ACE pump partners

– Talks ongoing with other device companies – two have reached “term sheet” stage

Submitted to FDA in December 2020 for 510(k) clearance

– Will initially launch with Dexcom, Insulet, and iPhone compatibility

Six-month data from Tidepool/Jaeb observational study read out at ATTD 2020. Results also published in DT&T in October

ENDO 2021: Tidepool’s Brandon Arbiter: Device Interoperability is a Given at Tidepool, “We Don’t Ask Why, But How”

(March 2021)

 

Tidepool Loop 510(k) submission (January 2021)

 

Tidepool/Jaeb study published in DT&T

(December 2020)

 

Tidepool opts to downsize, laying off 40% of team due to financial impact of COVID-19

(November 2020)

 

ATTD 2020

(February 2020)

 

Cambridge (CamDiab)

CamAPS FX: University of Cambridge-developed MPC algorithm on Android phones, Dexcom G6, and Dana R/RS pumps equipped smartphone control and with data streaming to Diasend/Glooko

No recent updates; FDA submission as iController aimed for “2020”

Only available in select diabetes clinics in the UK and EU that self-fund and undergo online training

DTM 2020: Quotable Quotes from CamAPS users

(November 2020)

 

Diabetes Mine 2020: Qualitative User Experience (June 2020)

 

CamAPS FX CE-Mark and UK Launch

(March 2020)

Beta Bionics

Bionic Pancreas iLet

­– Dual chambered Gen 4 iLet touchscreen device with built-in algorithm

– Integrates with Dexcom and Senseonics’ Eversense CGMs.

– Qualitative meal bolusing (e.g., large, medium, small), only bodyweight to startup

– Secondary display mobile app

 

1. Insulin-only iLet

– 1.6 ml insulin cartridge, both manual fill and prefilled Novo Nordisk PumpCart

 

 

 

 

 

 

 

 

 

 

 

2. Bi-hormonal iLet (insulin + glucagon)

– 1.6 ml insulin cartridge, both manual fill and prefilled Novo Nordisk PumpCart

– Zealand 1ml prefilled glucagon cartridge (4 mg; dasiglucagon)

 

 

 

 

 

 

 

 

 

 

 

1. Insulin-only pivotal study began in “summer” 2020 and set to achieve primary completion in August 2021

– As of FFL 2020, enrollment complete; clearance targeted for “mid-2021”

– 440 participants ages 6+ years, three-month RCT comparing iLet with usual care

– Home-use bridging studies with Dexcom & Eversense CGMs, in both insulin-only and bi-hormonal configurations, read out at ADA 2019

 

 

 

 

2. Bi-hormonal pivotal/phase 3 study to start in 2H21 with Zealand dasiglucagon, a delay from July 2020 expectations for a 1H21 start; 12 months of data collection

– Three interventions: (i) bihormonal iLet with dasiglucagon; (ii) insulin-only iLet; (iii) “usual care”

– Pediatric (n~350) and adult (n~350) type 1s

– Primary endpoint: A1c reduction of bihormonal vs. insulin-only iLet at 26 weeks

– Secondary endpoints: long-term safety and efficacy over 52 weeks; non-inferiority in time <70 mg/dl

– Latest information from Zealand R&D Day

FDA PMA reviews of the bi-hormonal system – including a chronic indication for Zealand’s dasiglucagon – are expected in 1H22 (adults) and 2H22 (teens).

Bi-hormonal iLet clearance in “2022, maybe early 2023” based on July 2020 timeline (likely delayed ~6 months)

– Small home-use study (n=10) comparing bi-hormonal vs. insulin-only presented at ADA 2020

– At ADA 2020, read out data showing 100 mg/dl glucose target reduces mean glucose and increases TIR w/out increasing hypoglycemia for bi-hormonal

– Per Zealand 1Q20, dual hormone AP system on track for “late 2020” phase 3 start

Zealand R&D Day: Update on Partnership with Beta Bionics

(March 2021)

 

FFL 2020

(July 2020)

 

ADA 2020: iLet Insulin-Only Pivotal Enrollment & Home-Use Bi-Hormonal vs. Insulin-Only, 100 mg/dL Set Point for Bi-Hormonal, Ultra-Rapid vs. Rapid Insulin

(June 2020)

 

Lilly

1. Partnership with Ypsomed announced in November: gives Lilly exclusive US and non-exclusive global commercial rights for Ypsomed’s YpsoPump and future mylife AID system

 

 

 

 

 

 

2. Hybrid Closed Loop System with Lilly’s proprietary pump, likely discontinued following Ypsomed partnership

– Pump is “a white disk about the size of a shoe-polish tin” that carries 3-day supply of insulin; Dexcom G6 CGM; Class AP algorithm

– Pump has an infusion set, no screen, and can be worn direct on the body or in the pocket. It will be controlled wirelessly from a handheld and possibly directly from an app.  See more details here.

1. Closed loop system expected to launch in 2023; system = YpsoPump (durable pump), Dexcom CGM, and myLife Control smartphone app

– YpsoPump CE-marked in 2019 with FDA submission as traditional pump slated for June 2021 followed by ACE pump submission in December 2021 with approval expected by “mid-2022”

 

 

2. Halted internal pump development efforts, based on remarks from November; other Connected Care products are expected to launch in stages over 2019-2021, presumably starting with the smart pen that was under FDA review as of April. No pivotal timing ever shared.

– First “phase 1” trial completed in February 2018.  

– AID still in “phase 2” per 1Q20 update, but likely discontinued as of November

– First Lilly AID data presented at ADA 2020

Lilly obtains exclusive US rights for Ypsomed AID (November 2020)

 

ADA 2020: First Lilly AID Data, Predictive Low Glucose Suspend Feature, Connected Pen (June 2020)

 

Lilly 1Q20 (April 2020)

 

Lilly and Dexcom Partner (December 2019)

 

Lilly 2019 Investor Meeting

(December 2018)

Lilly Diabetes Blogger Summit at the Cambridge Innovation Center (May 2018)

Bigfoot Biomedical

Bigfoot Autonomy automated insulin delivery service (previously “Loop”)

– Disposable pump body married to durable controller with an embedded control algorithm

– Pump talks directly to next-gen FreeStyle Libre CGM. Smartphone to serve as the window to the system and user interface

– “Automatic dose titration” feature in future-gen versions of Unity smart pen and Autonomy AID

Expected to launch in ~2023, after the Bigfoot Unity smart pen system launches in late 2020/early 2021 and the next-gen Bigfoot Unity system launches in ~2022

Bigfoot adds new commercial team leadership in preparation for first-gen Unity launch

(December 2020)

 

Bigfoot Unity submitted to FDA + interview with Bigfoot CEO Jeffrey Brewer

(August 2020)

 

Bigfoot’s $55m Series C, FDA submission of first-gen Unity “in a month”

(June 2020)

 

Bigfoot Appoints Dr. Jim Malone CMO

(June 2020)

 

Bigfoot’s $45m Series C

(January 2020)

 

Diabetes Mine 2019 (November 2019)

International AID Pipeline and Timing – Primary Players

Company / Academic Group

Product

Latest Timing

Recent Coverage

Cambridge (CamDiab)

CamAPS FX: Cambridge MPC algorithm on Android phones, Dexcom G6, and Dana R/RS pumps equipped smartphone control and with data streaming to Diasend/Glooko

Launched in UK in select NHS clinics in March 2020 down to 1 years and for pregnant women for £70-£80/month (~$86-$98/month)

CamAPS FX CE-Mark and UK Launch

(March 2020)

Medtronic

1. MiniMed 780G (see above for details)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2. Seven-day wear infusion set

1. Available in 26 countries on four continents, as of February

­– Per 4Q20 call commentary, real-world users achieving strong TIR (“90s”) and staying in Auto Mode longer

– European launch of 780G announced at Medtronic 2020 Investor day in October

– CE-Mark received (ages 7-80) in June

– New Zealand study for CE-Marking presented at ADA 2020

 

 

 

 

2. “EU limited launch” in 1Q21, as of February; launch began in November in Finland

– CE-Marking announcement in February 2020

Medtronic 4Q20

(February 2021)

 

Medtronic 3Q20

(November 2020)

 

Medtronic 2020 Investor and Analyst Day

(October 2020)

 

MiniMed 780G (+ 770G, 720G) Receives CE-Mark

(June 2020)

 

ADA 2020: MiniMed 780G Pivotal Trial, 780G vs. 670G, New Zealand Data; Extended-Wear Infusion Set; 780G TIR Impact with Adolescents

 

(June 2020)

 

Medtronic 7-day Wear Infusion Set Receives CE-Marking

(February 2020)

Diabeloop

1. Diabeloop/Roche/Dexcom System

– Diabeloop DBLG1 algorithm on wireless locked-down Android controller, Roche Accu-Chek Insight pump, Dexcom G6 CGM

– DBLG1 algorithm offers predictive low-glucose suspend, basal rate adjustment automation, and automatic correction boluses

 

 

 

 

2. Diabeloop/Kaleido/Dexcom System

– Diabeloop algorithm running on a wireless locked-down Android controller, Kaleido (formerly ViCentra) patch pump, Dexcom G6 CGM, qualitative meal bolusing.

 

 

 

 

 

 

 

 

 

 

 

3. Diabeloop DBL-hu system for patients with “highly unstable” (a.k.a. brittle diabetes) diabetes

– Updated version of DBLG1 system allowing increased personalization adapted to the glycemic profiles of patients with highly unstable diabetes

1. Now available in Germany, Spain, Italy, and the Netherlands with launch in Switzerland coming “soon” as of March 2021

– Partnership with Roche to “advance the management of insulin pump therapy” announced in December

– First AID system available with pump that has a pre-filled cartridge

 

2. Still in “pre-launch” mode in France, though ~$34 million in Series B fundraising (December 2019) will enable a broader European launch. Reimbursement talks are ongoing in France. CE-Mark received in November 2018.

– “Expands presence” in Germany, aims to make AID system available “as soon as possible” (June)

Pediatric trials have begun at three European centers (6-12 yrs)

 

 

 

 

3. CE-Marked in December; no public launch timelines

 

 

Roche, Diabeloop, and Dexcom AID system launches in Europe

(March 2021)

 

Roche’s Accu-Chek Insight pump now integrated with Diabeloop’s DBLG1 AID algorithm

(March 2021)

 

Roche partners with Diabeloop marking entrance into AID field

(December 2020)

 

Diabeloop receives CE-mark for DBL-hu AID algorithm for patients with highly unstable diabetes

(December 2020)

 

Diabeloop announces integration plans with Terumo’s patch pump for new AID system

(November 2020)

 

DTM 2020 Startup Showcase

(November 2020)

 

EASD 2020 Exhibit Hall

(September 2020)

 

ADA 2020: 6-Month Follow-Up Data

(June 2020)

 

ATTD 2020: Exhibit Hall  

(February 2020)

 

EASD 2019

(September 2019)

Tandem

1. Control-IQ hybrid closed loop (see product details above)

 

 

 

 

 

 

 

 

 

 

2. t:sport – miniaturized, no-screen tubed pump with Control-IQ

1. Launched in “more than half” of Tandem’s existing markets, as of February

– Plans to launch in 25 geographies by the end of 2021

– Received regulatory approval in Canada in November with plans to ship new pumps in 1Q21

 

 

 

 

2. No recent updates for OUS; CE-Mark submission previously expected in 2020; major updates/delays for US (see above)

 

Tandem 4Q20

(February 2021)

 

Control-IQ receives regulatory approval from Health Canada

(November 2020)

 

Tandem 3Q20

(November 2020)

 

Tandem 2Q20

(July 2020)

 

ADA 2020: Real-World Control-IQ, Basal-IQ, pediatric Control-IQ

(June 2020)

 

Tandem 1Q20

(April 2020)

 

Ypsomed

1. YpsoPump

– Partnership with Lilly announced in November: gives Lilly exclusive US and non-exclusive global commercial rights for Ypsomed’s YpsoPump and future mylife AID system

 

 

 

 

 

 

 

 

2. mylife AID system: Closed loop system with YpsoPump (durable pump), Dexcom CGM, and myLife Control smartphone app expected to launch in 2023.

– Partnership with Dexcom announced in May

– Signed deal for access to “TypeZero’s algorithm” (presumably inControl)

 

 

 

 

 

3. Joined JDRF’s open protocol AID initiative in August 2018.

1. ~14,500 YpsoPump users in Europe and Australia. Health Canada approval came in May 2019, with launch “imminent.” In talks with one CGM company

– Need ~50,000 users for product to be profitable 

– In Canada, received reimbursement in Ontario and in negotiations in British Columbia

 

 

 

2. Will be ready for a regulatory pathway in ~2 years; currently updating YpsoPump to be open-protocol (i.e., ACE pump)

– Data integration with Dexcom by end of 2020

– Smartphone bolusing by “end of Q1 2021”

– Closed loop by 2023

 

 

 

 

 

3. Had planned to ship “open-protocol” YpsoPumps to Baker Institute (Australia) for closed loop algorithm clinical trials; no update in FY20 report

Lilly obtains exclusive US commercialization rights for Ypsomed’s YpsoPump and future mylife AID system

(November 2020)

 

Diabetes Mine Innovation Days 2020 Product Demo

(November 2020)

 

Ypsomed F1H1

(November 2020)

 

EASD 2020 Exhibit Hall

(September 2020)

 

Ypsomed FY20

(May 2020)

 

Ypsomed and Dexcom Partnership

(May 2020)

 

ATTD 2020: Exhibit Hall

(February 2020)

 

Ypsomed F1H20

(November 2019)

Earlier-Stage Players and/or Those with Rare Updates

Company / Academic Group

Product

Latest Timing

Recent Coverage

WaveForm (AgaMatrix)

AID system: Plans to develop a “vertically integrated” AID system with its own CGM, a pump it owns or has built, and a licensed algorithm from OHSU.

No AID system updates in a long time

– Waveform’s Glucomen CGM (previously known as Cascade) CE Marked in November 2019; European launch in June driven by A. Menarini; FDA iCGM filing in “2020” and US launch in “2021” as of November

– Commercial agreement with Bayer to bring Waveform’s CGM to China announced in June

Waveform Commercial Agreement with Bayer

(June 2020)

 

WaveForm Receives CE Mark for Cascade CGM

(November 2019)

Medtrum

1. A6 system – predictive low glucose suspend, semi-disposable patch pump, 7-day CGM, handheld controller

2. A7 system: adds secondary display app, 14-day CGM

3. P7 system – direct smartphone control and no-calibration CGM

1. Available in six European countries, with ~200 users as of February 2019

 

2. Previously expected to launch in 2019 in Europe; no recent updates

3. In R&D phase; no recent updates

ATTD 2020

(February 2020)

 

ATTD 2019

(February 2019)

EOFlow

1. EOPatch insulin patch pump: tubeless, ~3.5-day wear time, locked-down smartphone control, Bluetooth connectivity, app can connect to Dexcom G6 and control insulin delivery

 

 

 

 

 

 

 

2. EOPatchX: AID system that integrates EOPatch pump with Dexcom G6 and TypeZero’s algorithm

 

 

 

 

3. EOPancreas System: single-patch, on-body CGM/algorithm/pump patch

– Partnering with China-based POCTech for the CGM technology in the all-in-one patch

1. Launched in Korea in March 2021 and will be available to customers in “early April”

– Distributed through pharmaceutical and consumer health giant Huons

– European launch expected in 2H21, following a CE-Marking

– Exclusive distribution agreement with Menarini of Italy for the Western European market announced in 2019

 

2. Targeted for an “early 2023” US launch, as of April 2021

– Feasibility trial (n=15) in Australia to start “soon,” as of April 2021

– Pivotal trial (n=105) in Korea to start in 2021

 

3. Targeted for an ambitious “2023” launch

­– Initial commercialization expected throughout Asia

–  JDRF partnership to fund this work, as well as EOPatchX, was announced in 2019

Received FDA Breakthrough Device Designation in March 2019

Korean startup EOFlow launches EOPatch insulin patch pump in Korea

(March 2021)

 

EASD 2019

(September 2019)

 

EOFlow receives FDA Breakthrough Device Designation for single on-body AID patch, EOPancreas  

(March 2019)

SFC Fluidics

AID system: Open protocol, fully interoperable patch pump that seamlessly integrates with interoperable CGMs and third-party AID algorithms, which “may include DIY solutions”

Expanded partnership with Diabeloop in January 2021 to develop an integrated AID system using  SFC Fluidics’ “Panda” patch pump

– Panda received FDA breakthrough designation from the FDA in Nov 2020

– Announced partnerships with Diabeloop for algorithm and PercuSense for CGM in May 2019

– Received two-year JDRF funding in August 2018 to develop an open-protocol, interoperable patch pump

– Launch timing unclear

SFC Fluidics re-ups partnership with Diabeloop (January 2021)

 

SFC Fluidics partners with Diabeloop and PercuSense

(May 2019)

AMF Medical

Sigi patch pump: smartphone-controlled rechargeable insulin pump compatible with prefilled insulin cartridges

– Smaller and thinner than both Insulet’s Omnipod and Roche’s AccuChek Solo “micropump”

– Semi-disposable

Aiming to complete product development by late 2021/2022 and to start testing the device in people in 2022; FDA and CE submissions slated for late 2023/early 2024 with ramped up commercial rollouts in 2024 and 2025

– Has built a proof-of-principle and user experience prototype

– Has participated in a pre-sub meeting with the FDA

Swiss-based AMF Medical brings its Sigi patch pump out of stealth mode, launches website

(February 2021)

Inreda

Bihormonal AID system: Bihormonal pump, two CGM sensors for redundancy, fully automated (no meal announcement).

– Currently designing an AID system for children with feedback from children with diabetes, as of April update

– Second AID system that would be “smaller and lighter” for increased comfort and wearability is in the works

CE-Marked in March 2020 but additional studies planned; small study completed in summer 2019, ahead of larger studies in 2020; reimbursement expected for 2023

Winter Newsletter (in Dutch)

(December 2020)

 

Spring Newsletter (in Dutch)

(April 2020)

 

CE-Marked

(March 2020)

 

Inreda company website update

(March 2020)

Cellnovo

Cellnovo patch pump with integrated TypeZero inControl AP algorithm; and a Dexcom CGM

Separately used in Diabeloop system (above) and PEPPER project

Stopped commercial operations and manufacturing in April; assets could be acquired by another company.

No recent updates

Cellnovo stops commercial operations and manufacturing

(April 2019)

 

Roche, Senseonics, & TypeZero

Roche Accu-Chek Insight pump with Senseonics Eversense XL CGM (180 day implantable) and TypeZero inControl AP algorithm

Appears to be discontinued following dissolution of partnership between Roche and Senseonics and new partnership with Diabeloop; trial on hold as of November 2019 – presumably related to Dexcom’s acquisition of TypeZero; no recent updates

– Senseonics’ financial troubles (as of 1Q20) might further complicate this collaboration

– Joined JDRF Open Protocol Initiative as of ATTD 2018

Senseonics 3Q19

(November 2019)

 

 

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