Memorandum
Executive Highlights
- The tables below include an overview of the automated insulin delivery (AID) landscape in the US and internationally, to the best of our knowledge. As of the end of 2022, we estimate that the global AID userbase is approaching 900,000. The list is organized first by products currently in the commercial stage (Medtronic’s MiniMed 770G, Medtronic’s MiniMed 780G, Tandem’s Control-IQ, Insulet’s Omnipod 5, Beta Bionics’ iLet Bionic Pancreas, and Tidepool Loop), 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 AID 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.
Commercial Stage AID systems
- Beta Bionics’ insulin-only iLet Bionic Pancreas – Received FDA clearance and launched in May 2023, following FDA submission in May 2022. The insulin-only iLet Bionic Pancreas is comprised of the iLet interoperable ACE pump, the iLet Dosing Decision Software AID algorithm, and the Dexcom G6 iCGM. The system is indicated for people with type 1 diabetes ages 6+ years. The launch for the iLet is already underway, and scripts are already being written – while pump shipments won't be immediate, Beta Bionics CEO Mr. Sean Saint said that the time horizon for the first shipments is a matter of "days and not weeks." See more here.
- Tidepool Loop – Received FDA clearance in January 2023, not yet launched. This system is the first-ever FDA-cleared DIY AID algorithm to enter the market, three years after its initial 510(k) submission in December 2020. Tidepool Loop was cleared as an interoperable Automated Glycemic Controller, part of an interoperable system that has three components: (i) an integrated CGM (iCGM); (ii) an alternate controller enabled pump (ACE pump); and (iii) the Tidepool Loop algorithm + app, which will be available via a mobile app on the iOS App Store. Tidepool shared Medtronic and Insulet will not be official launch partners for Tidepool Loop, though Dexcom remains a CGM partner. See more here.
- Medtronic’s MiniMed 780G hybrid closed loop – Launched in the US and >90 OUS markets on four continents. Medtronic’s MiniMed 780G with the calibration-free Guardian 4 CGM was FDA cleared in April 2023, with a US launch slated to begin May 15, 2023. Existing MiniMed 770G users can upgrade to the 780G via a free software upgrade, while Medtronic expects first 780G shipments of pumps to new users in summer 2023. The OUS MiniMed 780G launch was announced in October during Medtronic’s 2020 Investor and Analyst Day. MiniMed 780G received CE-marking in June 2020 and adds automatic correction boluses, Bluetooth, mobile app connection, and remote software updates with a next-gen pump and algorithm. See more in Medtronic 4Q22.
- Insulet’s Omnipod 5 hybrid closed loop – Fully launched in the US in August 2022 with >100,000 users as of February 2023. The US Omnipod 5 launch is well underway following its full market launch in August 2022 and FDA clearance in February 2022. Most recently, we learned that over 11,000 HCPs are prescribing Omnipod 5 and 85% of volumes are running through the pharmacy channel. Internationally, Omnipod 5 received CE-Mark in September 2022 and is expected to launch in the UK in mid-2023 and “in the fall” in Germany, with a broader OUS launch expected in 2024. Integration with Dexcom G7 and with Abbott FreeStyle Libre CGMs “continues to progress well,” without explicit timelines shared. A pivotal in type 2 diabetes is ongoing, and the system became the second AID in the US to receive a preschool indication. See more in Insulet 1Q23.
- Tandem’s Control-IQ hybrid closed loop – As of 1Q23, 430,000 people are using Control-IQ. Currently, Control-IQ is approved for use in people with type 1 diabetes ages 6+. Control-IQ received FDA clearance as class II iController in December 2019 and officially launched in January 2020. Control-IQ continues to roll out internationally: as of February 2022, the system is available in more than 25 countries. Smartphone bolus control was FDA cleared in February 2022 and launched in the US in summer 2022 via an app update. Integration with Dexcom G7 is expected “later in 2Q23” and with Abbott CGMs in “three to six months” following FreeStyle Libre’s indication for use in AID, which occurred in March 2023. See more in Tandem 1Q23.
- 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, the Netherlands, and Switzerland, as of July 2021. See more in Roche 1Q23.
- CamDiab’s CamAPS FX – Launched in >15 countries. CamDiab’s algorithm was CE-Marked and launched in the UK in March 2020. The algorithm is compatible for use with Dexcom G6 or Abbott’s FreeStyle Libre 3 as a part of the mylife Loop system with YpsoPump. It is also compatible with SOOIL’s DANA Diabecare RS and DANA-i pumps, but only Dexcom G6 works with those. In addition to smartphone control, CamAPS FX is also the first AID system available for pregnant women and children down to one year old. See more in Ypsomed F1H23.
- 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 in the US, following FDA approval in September 2020. The system also received CE-Marking in June 2020. MiniMed 770G uses the series 700 pump hardware (i.e., the pump technology from MiniMed 780G), but has the same algorithm and CGM as the MiniMed 670G system. MiniMed 770G includes Bluetooth connectivity and can interface with Medtronic’s MiniMed Mobile app.
- Medtronic MiniMed 670G hybrid closed loop – In US and select OUS markets (likely few users since MiniMed 770G and MiniMed 780G are available in the US and internationally). The system was first approved by the FDA in 2016.
- Tandem Basal-IQ predictive low glucose suspend – In US and select OUS markets, enabled on >50,000 pumps, although this figure is several years old and likely lower now as users transition to Control-IQ. 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 Market and Next-Gen Pipeline – 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 4 CGM, does require confirmatory fingerstick to enter low glucose management algorithm – Launched with the seven-day Extended Infusion Set – Smartphone bolus feature in the pipeline per ATTD 2021 commentary – Smartphone app for secondary display and wireless data uploading
2. MiniMed 770G system – pump hardware from MiniMed 700 series (Bluetooth connectivity) with MiniMed 670G algorithm; can update algorithm to 780G for free
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 – Features an updated connector cap designed to filter out aggregates and reduce inflammation, along with updated tubing, an extended wear adhesive patch, and a new inserter
5. 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” |
1. Received FDA clearance in April 2023 for people with type 1 diabetes aged 7+ – US launch began May 15, 2023 with free software update for existing MiniMed 770G users – Clearance initially delayed by FDA warning letter received by Medtronic in December 2021, which was resolved in April 2023 – FDA submission includes adult and pediatric data, as well as previously submitted Guardian 4 CGM (f.k.a. Zeus) – Pump hardware approved by the FDA in September 2020(Series 700 pump hardware) – Received CE-Marking (ages 7-80) in June 2020; launched in >90 countries across four continents as of February 2022 – Adult pivotal data read out at ADA 2020 along with 780G TIR Impact with Adolescents,780G vs. 670G, New Zealand Data – FLAIR study comparing 670G vs. 780G read out at ADA 2021; published in The Lancet in January 2021
2. Received CE-Marking in June 2020 and FDA approval in September 2020, indicated for people with type 1 diabetes aged 2+ – 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 2020
3. Received CE-Marking in June 2020 after product first announced in 1Q20 – Worldwide availability depends on “local market approvals and regulations”
4. Launched in the US in November 2022, following FDA approval in July 2021 – Compatible with MiniMed 770G/780G – US pivotal trial completed in November 2020 and read out at ADA 2021; feasibility data at ADA 2020 – Received CE-Marking in February 2020; available in some European counties since April 2021; being rolled out with MiniMed 780G system
5. FDA submission was previously expected in November 2020-April 2021, with launch by ADA 2021, but clearly not on that timeline; received FDA Breakthrough Designation in February 2019 – Early data set to be read out at ADA 2023 |
Medtronic announces FDA approval of MiniMed 780G AID system with calibration-free Guardian 4 CGM (April 2023)
Medtronic announces resolution of FDA warning letter (April 2023)
(February 2023)
ATTD 2023: MiniMed 780G real-world data (n=61,481) (February 2023)
(January 2023)
(November 2022)
Medtronic announces US launch of seven-day Extended Infusion Set (November 2022)
Medtronic announces Health Canada license for MiniMed 780G (November 2022)
(October 2022)
ISPAD 2022: RWD and Simplified Meal Reporting for MiniMed 780G (October 2022)
EASD 2022: MiniMed 670G in older adults (>60 years old): Randomized cross-over ORACL study (September 2022)
Medtronic ADAPT RCT comparing MiniMed 780G to MDI published in The Lancet Diabetes & Endocrinology (September 2022)
(August 2022)
(May 2022)
(April 2022)
Medtronic appoints Que Dallara new EVP and President of the Diabetes Operating Unit (March 2022)
|
|
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. Pediatric indication:clearance down to 6+ years; trials underway to support indication down to age 2
1b. Smartphone bolusing: bolus control on both iOS and Android phones as of August 2022
1c. Tandem Source: second-gen data management application (akin to Dexcom Clarity) – Connects providers, users, and caregivers via app and web-based dashboard – Will house algorithms to drive insights and diabetes management changes – Aim to directly integrate data from CGMs and pumps
1d. FreeStyle Libre 2/3 and Dexcom G7 integrations
1e. Type 2 indication
1f. SteadiSet seven-day infusion set – Tandem acquired Capillary Biomedical in July 2022 – Received IDE approval in January 2022
1g. Control-IQ 1.5 – Expanded body weight and correction factor ranges – Should include expanded age indications and potentially others including type 2 diabetes
1h. Control-IQ 2.0 – More aggressive algorithm, simplification of bolus workflow, personalization – Management hints pivotal to start in 2024 during 1Q23 financial update
2. Tandem Mobi (f.k.a. t:sport): miniaturized, no-screen tubed pump with integrated Control-IQ algorithm, smartphone or wireless handheld control, on-device bolus button, easier fill process – Uses new 4” infusion set – Algorithm runs on the pump even if phone is out of range – Will have new syringe-driven pumping mechanism – Rebranded in December 2021 at Tandem R&D Day – Current t:slim X2 users will be able to upgrade to Mobi ahead of warranty expiration
3. t:silm X3 – Next-gen tubed pump in development
4. Sigi patch pump:Acquired from AMF Medical, deal announced in December 2022 and closed in January 2023 – Patch pump consists of three pieces: a disposable adhesive pad and flexible cannula that patients can wear for three days “or longer”; a rechargeable pump that will last for “years” and snaps into the on-skin pad; and a disposable “easy-lock” cap to seal in compatible prefilled insulin cartridges
5. “Fully closed loop system”: aimed for “complete bolus and basal insulin automation” |
1. 430,000 Control-IQ users globally in 25+ countries, as of May 2023; tw0-thirds of pump users on Basal or Control-IQ (does not include new pumps shipped with Control-IQ), as of December 2021 – Smartphone bolus approved in February 2022, launched in Summer 2022 – US launch in January 2020
1a. Expanded pediatric indication in June 2020; US pivotal trial (ages 6-13) read out at ATTD 2020; real-world data from adolescents (ages 6-13) read out at ISPAD 2020 – Preschool (ages 2-5) pivotal (PEDAP) data published in NEJM in March 2023, following initial readout at ISPAD 2022 – Preschool regulatory submission by end of 2022, per November 2022 commentary
1b. Smartphone bolusing launched as of Summer 2022, following submission to the FDA in November 2020 and approved in February 2022 – Data set to be presented at ADA 2023
1c. Set to launch in “summer 2023” as of February 2023. This comes slightly delayed from the company’s original launch timeline of “later” in 2021 for international markets with a US launch to follow
1d. Integrate with G7 “later in 2Q23” as of February 2023, following G7 clearance in December 2022; Abbott integration set to begin with a scaled launch “in 3Q23,” following FreeStyle Libre’s AID indication, which it received in March 2023
1e. Tandem is “preparing for” a pivotal trial, following feasibility study which began in November 2021; completed enrollment as of August 2022, and was read out at DTM 2022 – FDA submission slated for “late 2023/2024” as of April 2022
1f. Pivotal to begin in 2023 as of February 2023
1g. Expected to launch in 2024 as of May 2023
1h. Tandem is running a second clinical study on Control-IQ 2.0 as of May 2023 – More substantial Control-IQ algorithm changes will require FDA approval – The clinical trials for these “more meaningful” system improvements first began at UVA, as of November 2021
2. Expected to launch in 2H23 as of May 2023, following FDA submission during 3Q22 – Will embed Control-IQ hybrid closed loop algorithm (see above)
3. Expected launch in “12-18” months as of May 2023
4. Launch timeline slated for 2027 as of December 2022 –Management confirmed in February 2023 that Tandem has shut down its internal patch pump R&D
5. First mentioned on Tandem’s 4Q19 call, pivotal study previously aimed for “2021”; in 1Q23, Mr. Sheridan said Tandem is working toward this sphere “ultimately,” but that this will be “out in time” |
(May 2023)
The New England Journal of Medicine publishes Tandem’s PEDAP Control-IQ preschool pivotal trial (March 2023)
(February 2023)
Tandem’s acquisition of AMF Medical, developer of Sigi patch pump, officially closes (January 2023)
(January 2023)
Tandem to acquire AMF Medical, developer of Sigi patch pump, for up to $216 million (December 2022)
(November 2022) (August 2022)
(May 2022)
ATTD 2022: Control-IQ Real World data (April 2022)
FDA clears Tandem’s mobile bolus control feature for t:slim X2 and Control-IQ (February 2022)
(December 2021)
|
|
Insulet |
1. Omnipod 5 (f.k.a. Omnipod Horizon): Hybrid closed loop algorithm built into tubeless, wearable pod; pod talks direct to Dexcom G6 – Approved for people with type 1 diabetes aged 2+ – Direct smartphone control, initially on Samsung Galaxy phones only (iOS 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 – Activity feature (temporarily sets glucose target to 150 mg/dl and restricts insulin delivery) – Built-in smart bolus calculator in the app and controller that is informed by CGM values and trend arrow
1a. AID Integration with Dexcom G7 and Abbott FreeStyle Libre 2/3
1b. iOS smartphone control – Currently iOS users must use a dedicated PDM
1c. Type 2 indication – Feasibility study in type 2s (n=30) in extension phase (as of November 2021) after readout at ATTD 2022 – SECURE-T2D Omnipod 5 type 2 pivotal currently enrolling (n=350, 20 centers)
|
1. >100,000 users as of February 2023, following FDA clearance in January 2022 – Full US launch began in August 2022 – Received expanded indication for pediatrics (aged 2+) later in August 2022 – Three-month pivotal trial read out at ENDO 2021 (adult+ pediatric); published in Diabetes Care in August 2021; extension phase data read out at ADA 2021 (six-month extension) and EASD 2021(nine-month extension)
1a. Timelines unclear – Dexcom: As of February 2023, Insulet plans to launch Omnipod 5 outside the US with Dexcom G6, suggesting that this integration may not happen until 2024; Dexcom CEO Mr. Sayer said it could take “six months or longer” for integration – Abbott: Integration with a FreeStyle Libre CGM is “likely to require a submission” per 4Q21 commentary; work is already underway
1b. Timeline unclear – Requires an FDA submission – At ATTD 2022, Insulet said progress was “incredible” on the integration, but no formal word since then
1c. Pivotal expected to complete in December 2023 – SECURE-T2D Omnipod 5 type 2 pivotal received IDE approval in February 2023 and study completion expected in December 2023 |
(May 2023)
ATTD 2023: First-ever Omnipod 5 real-world dataset (n=31,691) (February 2023)
(February 2023)
(February 2023)
(January 2023)
(November 2022)
(August 2022)
(August 2022)
(August 2022)
FDA clears Insulet’s Omnipod 5 AID system (January 2022)
Omnipod 5 pediatric and adult pivotal trials published in Diabetes Care (August 2021)
ADA 2021: Preschool pivotal; OP5 pivotal six-month extension (June 2021)
ATTD 2021: Post-hoc OP5 pivotal analysis on people with high rates of hypoglycemia (June 2021) |
|
Tidepool |
1. Tidepool Loop: iPhone app that integrates with interoperable ACE pump and iCGMs (Dexcom G6) –Dexcom is the only current launch partner, following news that Medtronic and Insulet would not be partners at launch – Simplified user experience with an extended bolus feature, adjustable carb entries – Customizable correction ranges of any commercial system, allowing users to select a correction range as low 87 mg/dL and as high as 180 mg/dL – As of January 2023, Tidepool has development partnerships with “additional yet-to-be-named medical device companies for future inclusion of their components”
1a. Android app – Tidepool Loop currently only available on iOS devices |
1. FDA clearance in January 2023, after submission to FDA in December 2020 for 510(k) clearance –Launch timeline unclear – Will initially launch with Dexcom and iPhone compatibility – Six-month data from Tidepool/Jaeb observational study read out at ATTD 2020; results also published in DT&T in December 2020
1a. First announced in May 2023, when Tidepool received funding to begin developing the app from “generous anonymous donor” – No announced timelines |
Tidepool secures funding to develop Android compatibility for Tidepool Loop (May 2023)
(January 2023)
DiabetesMine Fall Innovation Days 2022: Company Update (November 2022)
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) |
|
Beta Bionics |
1. Insulin-only iLet Bionic Pancreas – Single-chambered Gen 4 iLet touchscreen device with built-in algorithm – 1.6 ml insulin cartridge, both manual fill and prefilled Novo Nordisk PumpCart – Integrates with Dexcom G6 CGM – Qualitative meal bolusing (e.g., large, medium, small), only bodyweight to startup; target is qualitative (usual, higher, lower) – Secondary display mobile app
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. Received FDA clearance in May 2023, following submission in in May 2022 – Following insulin-only pivotal study read out at ATTD 2022 and publication in NEJMin September 2022 – Pivotal began in “summer” 2020; enrollment complete by FFL 2020; was set to achieve primary completion in August 2021; data lock for pivotal in December 2021; extension study to complete in January 2022 per December 2021 update – Feasibility study of insulin-only iLet AID system in primary care setting is currently recruiting – 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 set to begin “by the end of 2023” with Zealand dasiglucagon. Delayed from August 2022 expectations to start in early 2023 – 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 – Follows promising pre-pivotal results read out at ADA 2021 – 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
|
FDA clears Beta Bionics’ insulin-only iLet Bionic Pancreas (May 2023)
Interview with Beta Bionics CEO Mr. Sean Saint and CMO Dr. Steven Russell (April 2023)
(January 2023)
(March 2023)
Beta Bionics’ insulin-only iLet pivotal results published in The New England Journal of Medicine (September 2022)
(November 2022)
(August 2022)
(August 2022)
Beta Bionics appoints Gilad Glick to Board of Directors and Veena Rao to Chief Commercial Officer (May 2022)
(May 2022)
(May 2022)
ATTD 2022: Readout of insulin-only iLet (April 2022)
(February 2022)
(December 2021)
ADA 2021: Short cross-over RCT with bi-hormonal vs. insulin-only systems (June 2021)
Zealand R&D Day: Update on Partnership with Beta Bionics (March 2021) |
International AID Market and Pipeline – Primary Players
|
Company / Academic Group |
Product |
Latest Timing |
Recent Coverage |
|
Insulet |
1. Omnipod 5: – See details above |
1. CE-Marked in September 2022, launch expected in mid-2023 in the UK and “in the fall” in Germany, with a broader launch expected in 2024, as of May 2023 |
(May 2023)
ATTD 2023: First-ever Omnipod 5 real-world dataset (n=31,691) (February 2023)
(February 2023)
(February 2023)
(January 2023)
(November 2022)
Insulet announces CE-Mark for Omnipod 5 AID system; launch in “select countries” slated for mid-2023 (September 2022)
(August 2022)
(August 2022)
(August 2022)
FDA clears Insulet’s Omnipod 5 AID system (January 2022)
Omnipod 5 pediatric and adult pivotal trials published in Diabetes Care (August 2021) |
|
Cambridge (CamDiab) |
1. CamAPS FX: – Cambridge MPC algorithm on an Android phone – Compatible with Dexcom G6 or Abbott FreeStyle Libre 3; DANA Diabecare RS, DANA-i pumps, mylife YpsoPump – Approved for people with type 1 diabetes aged 1+ and pregnant women – Equipped with smartphone control, integrates with Glooko and Diasend
2. CamAPS HX: – Cambridge CamAPS HX algorithm; fully closed loop (specified for people with type 2 diabetes and end-stage renal disease on dialysis) – Android phones, Dexcom G6, Dana RS and DANA-i pumps with smartphone control and data streaming to Glooko/Diasend
|
1. Launched in >15 countries – First launched in the UK via CamDiab – Ypsomed’s partnership announcement with CamDiab in March 2022 – Ypsomed’s partnership with Dexcom announced in May 2020 and with Abbott in April 2022 – mylife Loop launched with Dexcom CGM in early summer 2022 and with Abbott CGM in Germany in November 2023, with broader European launch expected in 2023 – The Lancet published two RCTs on CamAPS FX AID use in youth (ages 6-18) and older adults (ages 60+) in March 2022 – Four-month RCT of CamAPS FX in very young children published in NEJM in January 2021 – RCT in youth ages 6-18 read out at ADA 2021
2. RCT in type 2 diabetes published in Nature Medicine in January 2023, following read out at EASD 2022 – Feasibility study in type 2s with end-stage renal disease on dialysispublished in August 2021
|
(January 2023)
(November 2022)
Ypsomed announces launch of mylife Loop AID system in Germany with CamAPS FX and FreeStyle Libre 3 (November 2022)
EASD 2022: Four-month crossover RCT evaluating CamAPS HX AID in T2D (Septemeber 2022)
Ypsomed launches smartphone bolus feature; confirms launch of mylife CamAPS FX AID system (August 2022)
(May 2022)
(April 2022)
Ypsomed and CamDiab partner to create mylife CamAPS FX AID system (March 2022)
(March 2022)
NEJM publishes KidsAP02 RCT of preschoolers on CamAPS FX (January 2022)
EASD 2021: KidsAP02 result readout (September 2021)
AP-Renal study published in Nature Medicine (August 2021)
ADA 2021: RCT in youth ages 6-18 (June 2021)
ATTD 2021: App usage by age group; clinical trial pipeline (June 2021)
CamAPS FX CE-Mark and UK Launch (March 2020) |
|
Medtronic |
1. MiniMed 780G: – See details above
2. Seven-day wear infusion set: – See details above |
1. Available in >90 countries on four continents, as of February 2023 – European launch of 780G announced at Medtronic 2020 Investor Day in October 2020 – CE-Mark received (ages 7-80) in June 2020 – New Zealand study for CE-Marking presented at ADA 2020 – Real-world data published in DT&T in April 2021; read out at ATTD 2021; EASD 2021
2. Launched in 19 countries as of February 2023, after launch began in November 2020 in Finland – CE-Marking announcement in February 2020 – “Positive customer feedback” thus far |
Medtronic announces FDA approval of MiniMed 780G AID system with calibration-free Guardian 4 CGM (April 2023)
Medtronic announces resolution of FDA warning letter (April 2023)
(February 2023)
(February 2023)
(January 2023)
Medtronic announces Health Canada license for its seven-day Extended Infusion Set (EIS) (December 2022)
(November 2022)
Medtronic announces US launch of seven-day Extended Infusion Set (November 2022)
Medtronic announces Health Canada license for MiniMed 780G (November 2022)
(October 2022)
(October 2022)
EASD 2022: MiniMed 670G in older adults (>60 years old): Randomized cross-over ORACL study (September 2022)
Medtronic ADAPT RCT comparing MiniMed 780G to MDI published in The Lancet Diabetes & Endocrinology (September 2022)
(August 2022)
(May 2022)
(April 2022)
Medtronic appoints Que Dallara new EVP and President of the Diabetes Operating Unit (March 2022) |
|
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 patch pump, Dexcom G6 CGM, qualitative meal bolusing
3. Diabeloop / EOFlow system – Diabeloop DBLG1 algorithm with EOFlow’s EOPatch tubeless insulin patch pump and an unnamed “third-party” CGM – EOPatch insulin patch pump: tubeless, ~3.5-day wear time, locked-down smartphone control, Bluetooth connectivity, smartphone app insulin delivery – Diabeloop and EOFlow are co-developing a dedicated smartphone app for the system and will feature a dedicated handset
4. Diabeloop DBL-hu systemfor 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
5. Diabeloop/Terumo AID system with Terumo insulin patch pump and Diabeloop DBLG1 algorithm; likely with Dexcom G6 CGM
6. SFC Fluidics partnership – Plans to develop an integrated AID system using SFC Fluidics’ “Panda” patch pump |
1. Launched in Germany, Spain, Italy, the Netherlands, and Switzerland as of July 2021; real-world data read out at EASD 2021 – Combined system first launched in March 2021 – Partnership with Roche to “advance the management of insulin pump therapy” announced in December 2020 – First AID system available with pump that has a pre-filled cartridge
2. Launched in Europe as of December 2021; Kaleido’s $74 million Series C (December 2021) and ~$34 million in Series B fundraising (December 2019) will enable a broader European launch. Although the launch geographies have not been disclosed, it is likely France and/or Germany based on previous commentary
3. Partnership first announced in January 2023, launch expected in Europe at the “end of 2023” as of January 2023 – All three components are CE-Marked – Technical feasibility of the integration of the pump and the algorithm was verified via a “Hackathon [in the summer of 2022]”
4. CE-Marked in December 2020, in discussions with FDA for submission as of June 2022
5. No launch timelines shared for Japan or Europe; CE-Marked in November 2020 – AID partnership is expansion of existing partnership and was announced in November 2021
6. Expanded partnership with SFC Fluidics in January 2021; launch timing unclear – Panda received FDA breakthrough designation from the FDA in November 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 |
(April 2023)
(February 2023)
ATTD 2023:Diabeloop real-world data (February 2023)
EOFlow and Diabeloop announce partnership to bring an AID system to market (January 2023)
(November 2022)
(July 2022)
DiabetesMine Summer D-Data Exhange: Product Demo (June 2022)
(April 2022)
Diabeloop and Terumo expand partnership to bring AID system to Europe (November 2021)
(December 2021)
EASD 2021: Real-world data from Diabeloop / Roche / Dexcom system users (September 2021)
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)
(November 2020) |
|
Tandem |
1. Control-IQ – See details above
2. Mobi (f.k.a t:sport) – See details above
3. t:silm X3 – Next-gen tubed pump
4. Sigi patch pump: – See details above |
1. Launched in all of Tandem’s existing markets, as of May 2022 – Launched in 20 geographies by end of 2021; had previously planned to launch in 25 geographies by the end of 2021
2. No recent updatesfor OUS
3. Expected launch in “12-18” months as of May 2023, but unclear about US vs. OUS timeline
4. Launch timeline slated for 2027 as of December 2022 –Management confirmed in February 2023 that it has shut down its internal patch pump R&D
|
The New England Journal of Medicinepublishes Tandem’s PEDAP Control-IQ preschool pivotal trial (March 2023)
(February 2023)
Tandem’s acquisition of AMF Medical, developer of Sigi patch pump, officially closes (January 2023)
(January 2023)
Tandem to acquire AMF Medical, developer of Sigi patch pump, for up to $216 million (December 2022)
(November 2022) (August 2022)
(May 2022)
ATTD 2022: Control-IQ Real World data (April 2022)
FDA clears Tandem’s mobile bolus control feature for t:slim X2 and Control-IQ (February 2022)
(December 2021)
DTM 2021: Control-IQ RWE from CLIO Study (November 2021)
ISPAD 2021: Control-IQ RWE in children + adolescents; more peds Control-IQ (October 2021)
EASD 2021: Control-IQ in high hypoglycemia risk PWD (September 2021)
Keystone 2021: CLIO data on QOL and device satisfaction (July 2021)
ADA 2021: Control-IQ in older type 1s; sub-analysis of CLIO by race (June 2021) |
Earlier-Stage Players and/or Those with Rare Updates
|
Company / Academic Group |
Product |
Latest Timing |
Recent Coverage |
|
University of Virginia (UVA) |
RocketAP: – Zone-based model predictive controller (similar to Control-IQ which was also developed by UVA) with additional meal prediction features – New bolus priming system module designed to detect unannounced meals and deliver bolus ahead of lengthy hyperglycemia episode – Multistage MPC that allows for disturbance (e.g., exercise, eating) prediction for the following two hours and optimal dose to address |
Data on RocketAP vs. Control-IQ presented at ATTD 2022, data on efficacy of hypoglycemia rebound prevention layer algorithm presented at DTM 2022 |
(November 2022)
(April 2022)
(November 2021)
(June 2021) |
|
WaveForm (AgaMatrix Holdings) |
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 2020 driven by A. Menarini; FDA iCGM filing in “2020” and US launch in “2021” as of November 2020, but no recent updates – Commercial agreement with Bayer to bring Waveform’s CGM to China announced in June 2020 – Based on November 2021timeline, reduced calibration version of Cascade CGM expected to receive CE-Mark in December 2021; no update on whether this timeline was achieved, seems unlikely |
(November 2021)
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 or smartphone control 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; no recent updates
2. Previously expected to launch in 2019 in Europe; no recent updates 3. In R&D phase; no recent updates |
(February 2020)
(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
4. EOPatch 3.0: – Seven-day patch pump prototype – Larger, heavier, and holds 50% more insulin than EOPatch – Would be priced lower than EOPatch 3.5-day |
1. Launched in Korea, Europe, and the UAE – Received CE-Mark with smartphone control in May 2021; launched in September 2022 through distribution agreement with Menarini of Italy for the Western European market (under the brand name GlucoMen Day Pump), which was announced in 2019 – Launched in Korea in March 2021; distributed through pharmaceutical and consumer health giant Huons – Received approval from the UAE Ministry of Health and Prevention in September 2022, following submission in 2021. Launch was expected to begin in 2H22 – Approved in Indonesia as of December 2022
2. FDA 510(k) submitted in December 2022, initially targeted for an “early 2023” US launch as of May 2021 – Management hopes to secure a formal distribution agreement by the end of 1H23 – Feasibility trial (n=15) in Australia to start “soon,” as of May 2021 – Pivotal trial (n=105) in Korea to start in 2021, no update on whether this happened
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 February 2018 – Received FDA Breakthrough Device Designation in March 2019
4. Slated for 2024 launch,though company has said that the device would only receive substantial attention following EOPatch X pivotal – Will first launch in Korea, but maybe simultaneously in US |
(March 2023)
(February 2023)
EOFlow and Diabeloop announce partnership to bring an AID system to market (January 2023)
EOFlow submits 510(k) for EOPatch to the FDA (December 2022)
(November 2022)
EOFlow receives approval for EOPatch pump in UAE; EOPatch pump launches in Europe (September 2022)
EOFlow receives CE-Mark for EOPatch insulin patch pump with smartphone control (May 2021)
Korean startup EOFlow launches EOPatch insulin patch pump in Korea (March 2021)
(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; launch timing unclear – 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 |
SFC Fluidics re-ups partnership with Diabeloop (January 2021)
SFC Fluidics partners with Diabeloop and PercuSense (May 2019) |
|
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 – Commercial launch planned for early 2024 according to Keystone 2022 commentary – “Several groups” have been able to start with an “AP” treatment, as of December 2021 |
Keystone 2022: Update on launch timing (July 2022) (December 2021)
(December 2020)
(April 2020)
(March 2020)
(March 2020) |
Discontinued AID projects
|
Company / Academic Group |
Product |
Latest Timing |
Recent Coverage |
|
Cellnovo |
Cellnovo patch pump with integrated TypeZero inControl AP algorithm; and a Dexcom CGM |
Stopped commercial operations and manufacturing in April 2019; assets could be acquired by another company. No recent updates |
Cellnovo stops commercial operations and manufacturing (April 2019)
|
|
Roche, Senseonics, and 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 – Joined JDRF Open Protocol Initiative as of ATTD 2018 |
(November 2019)
|
|
Lilly |
1. Partnership with Ypsomed announced in November 2021: gives Lilly exclusive US and non-exclusive global commercial rights for Ypsomed’s YpsoPump and future mylife AID system – System consists of YpsoPump (durable pump), Dexcom CGM, and myLife Control smartphone app – YpsoPump CE-Marked in 2019
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. Officially discontinued as of December 2022 – ACE submission expected “in 2022” and FDA approval expected in 2023, as of November 2021; intends to have Dexcom connectivity – Previously expected 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 2020; 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 2019. 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 |
(December 2022)
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)
(December 2018)
Lilly Diabetes Blogger Summit at the Cambridge Innovation Center (May 2018) |
|
Bigfoot Biomedical |
Bigfoot Autonomyautomated 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 |
Presumably discontinued due to IP sale to Insulet in February 2023 |
(February 2023)
(June 2021)
Bigfoot Unity receives FDA approval (May 2021)
Bigfoot Unity submitted to FDA + interview with Bigfoot CEO Jeffrey Brewer (August 2020) |
--by Katie Lingen, Armaan Nallicheri, and Kelly Close