Memorandum
Executive Highlights
- The tables below include an overview of the CGM landscape, to the best of our knowledge. We acknowledge this list may be incomplete, as there are likely other stealth startups or academic groups working to commercialize CGM technology. Entries are listed by the company/institution that owns the regulatory submission.
- We begin with current and upcoming products from Abbott, Dexcom, Medtronic, and Senseonics. The subsequent table contains devices in development from earlier-stage companies, roughly in order of time to market and/or most recent updates. It’s highly possible that many of the earlier-stage options have advanced beyond the last public update we’ve covered; it’s also possible many are no longer in development.
- If you spot something you think should be changed, please send us a message. We will aim to update this list on a quarterly basis, but it is only up to date as noted above.
Abbott
- Abbott’s FreeStyle Libre 2 is available in US and OUS markets, with “over 3.5 million” users globally and an 80%-90% global retention rate. It is a 14-day wear, no-calibration, intermittent scanning (flash) continuous glucose monitor currently approved for ages 4+ years. It uses NFC and requires a scan with a reader or FreeStyle LibreLink app (Android and iOS) to see a real-time glucose value and trend. In the US, FreeStyle Libre 2 was approved as an “integrated CGM” (iCGM) in June 2020. For iOS users, the FreeStyle Libre 2 app (cleared in August 2021) provides real-time CGM capabilities, eliminating the requirement for a reader. Abbott has not offered an update on clearance/launch timelines for an analogous Android app, but the company has confirmed that such an app is under review and should be available soon. FreeStyle Libre does not require a prescription outside the US; in the US, a prescription is still required. It has been available for Medicare users since January 2018. The blinded-only FreeStyle Libre Pro (professional) CGM has been available globally for four years and through a Livongo partnership; it has the same form factor, 14-day wear time, and factory calibration as the consumer version but stores all 14 days of data on the patch. In April, at the onset of the COVID-19 pandemic, the FDA announced that it would not object to the use of FreeStyle Libre in hospital settings to monitor patients through the course of the pandemic.
- Per Abbott’s 2Q21 update, the Libre franchise has “approximately 1 million” US users. In August 2020, Abbott officially launched FreeStyle Libre 2 iCGM in the US for patients as young as four years old. The device was cleared as an iCGM in June and received approval from Health Canada in December 2020. This second-generation FreeStyle Libre device adds Bluetooth connectivity, enabling optional hypoglycemia and hyperglycemia alarms, and keeps the same scanning functionality for grabbing glucose trend data. Like the first-generation device, FreeStyle Libre 2 has 14-day wear, 1-hour warm-up, factory calibration (i.e., no fingersticks required), and is cleared for non-adjunctive use. The FDA clearance for FreeStyle Libre 2 came with a “warning/limitation” against use with AID systems based on potential interference with high doses of ascorbic acid (vitamin C). In March 2021, Health Canada temporarily authorized Freestyle Libre 2 use in all pregnant women in the hospital, regardless of whether or not they have diabetes, to enable remote care during the pandemic.
- In September 2020, Abbott announced its novel Libre Sense Glucose Sport Biosensor, “the world’s first glucose sport biosensor.” Libre Sense is “built upon Abbott’s FreeStyle Libre 2 CGM technology and is CE-Marked for consumer, over-the-counter purchase. Libre Sense was developed in partnership with Supersapiens, an Atlanta-based performance technology company, and will be compatible with Supersapiens’ digital app to create a “real-time energy management system for athletes.” The Libre Sense biosensor is worn on the back of the upper arm for up to 14 days and provides real-time glucose values via Bluetooth to the Supersapiens app. Currently, the Libre Sense biosensor is the same as the FreeStyle Libre 2 sensor, but Abbott has plans to eventually tailor the sensor to athletes (e.g., underwater performance, sweat-proof adhesive). In September 2020, Atlanta-based Supersapiens launched as the first (non-exclusive) distributor for Abbott’s Libre Sense Glucose Sport Biosensor.
- As of July 2021, Abbott is transitioning to a full European launch of FreeStyle Libre 3 after a successful limited launch in Germany. As a reminder, FreeStyle Libre 3 received CE-Marking in September 2020 and was the first FreeStyle Libre product to offer full, real-time capability, removing the “scanning” feature that has long been associated with Abbott’s CGM systems. FreeStyle Libre 3 is 70% smaller than the first two FreeStyle Libre systems at roughly the size of two stacked US pennies compared to two stacked US quarters. FreeStyle Libre 3 maintains the two-week wear, factory calibration, and pediatric and pregnancy indications in Europe all while also keeping the same pricing as Abbott’s previous FreeStyle Libre systems.
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FreeStyle Libre Pipeline |
Timeline |
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FreeStyle Libre 3 Offers full, real-time glucose and trend-arrow information, removing “scanning” requirement. 70% smaller than the first two FreeStyle Libre systems (~2 stacked US pennies vs. ~2 stacked US quarters). Retains popular FreeStyle Libre 2 features: same pricing, two-week wear, factory calibration, optional alarms, pediatric and pregnancy indications in Europe. |
European launch underway after receiving CE-Marking in September 2020. As of JPM 2021, Abbott was “working through” reimbursement and contracting processes. FreeStyle Libre 3 “accuracy study” with 85 children (ages 4+) and adults completed in September 2020 after starting in July 2020, ahead of expectations for completion in December 2020. While not explicitly called the pivotal, we’d speculate that the trial could have generated enough data to support an FDA submission. Notably, during Abbott’s 2Q20 update, FreeStyle Libre was referred to as a “platform product,” potentially hinting at expansions beyond glucose monitoring. Management gave update on future iterations of Libre franchise during 4Q20 earnings call. |
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Insulet Omnipod 5 Integration Plans to integrate FreeStyle Libre 2 into Insulet’s Omnipod 5 hybrid closed loop system. |
Integration was “underway” as of Insulet’s 1Q21 update. Partnership announced in February 2020; reiterated at EASD 2020, JPM 2021, 2Q21 update. Omnipod 5 hybrid closed loop system slated for approval in 4Q21, with limited launch in “late” 4Q21. Plan confirms FreeStyle Libre 2 has capability to drive an AID system. FDA “warning/limitation” on FreeStyle Libre 2 use with AID systems could affect this partnership. |
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Omada Health Type 2 Diabetes Connected Care Program Omada app with Libre data flowing in; home delivery of Libre and a wireless weight scale; online physician consultation; remote prescribing of Libre; human (CDE) coaching and in-app education; peer group. |
Omada will offer the integrated program through employers and health plans. Abbott and Omada announced their major partnership back in October 2019. |
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Novo Nordisk Smart Pen Integration Will integrate NN insulin data into FreeStyle LibreLink app and LibreView data platform. |
Novo Nordisk’s Smart Pens launched OUS in 1Q21 and though they are not currently integrated with Abbott’s FreeStyle Libre platform, management reaffirmed the partnership “will come into force at a later time.” Partnership was announced in February 2019. |
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Bigfoot Unity Smart pen cap/FreeStyle Libre CGM “dose decisioning” system for MDI users. |
Launched in June 2021 following May 2021 FDA approval and 510(k) filing in July 2020; full US rollout anticipated throughout rest of 2021 and 2022. Not available for direct purchase; PWD will receive system from provider and follow pay-as-you-go subscription model. Next-gen version of Unity with automatic dose titration feature will launch in “~2022,” requiring a pivotal trial. As we understand it, this upgrade will require additional FDA submissions – learn more from our coverage of the May 2021 FDA approval. |
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Tandem Pump Integration Plan to integrate FreeStyle Libre CGM data with t:slim X2 insulin pumps. |
Per Tandem’s 4Q20 update, Abbott integration expected “as soon as possible in 2022.” Agreement finalized in June 2020, emphasizing pump-CGM interoperability. It’s unclear whether Libre 2 or 3 will be used. |
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Bigfoot Autonomy Hybrid Closed Loop System with next-gen FreeStyle Libre, Bigfoot pump, app. |
Expected to launch in ~2023, per Diabetes Mine 2019; no update during May 2021 interview with Bigfoot CEO. The AID “warning/limitation” on FreeStyle Libre 2 will likely affect this partnership and it’s unclear whether Libre 2 or 3 will be used. |
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FreeStyle Libre for Non-Glucose Analytes |
In development, but no recent updates. Notably, during Abbott’s 2Q20 update, FreeStyle Libre was referred to as a “platform product,” potentially hinting at expansions beyond glucose monitoring. |
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Sanofi Smart Pen Integration Integrates FreeStyle Libre data with insulin information from future Sanofi smart pens, titration apps, and cloud software. |
It is unclear whether this will move forward. While Sanofi discontinued “scientific” diabetes R&D in December outside type 1 cures, we certainly expect progress on insulin delivery. As of September 2019, products were targeted to come to market “within the next few years.” |
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January.ai January.ai app and algorithm provide personalized glycemic predictions, and diet and exercise recommendations based on CGM data. “Season of Me” program provides users with 2 FreeStyle Libre CGMs and a 90-day subscription to the January.ai app. |
$8.8 million seed round announced in February 2021 bringing total funding to $21 million. “Season of Me” currently available, but January.ai has yet to launch significant marketing efforts. |
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Levels New York-based start-up providing CGMs to people without diabetes to provide insights on the impact of diet and lifestyle on metabolic health. The Levels app-based platform is compatible with FreeStyle Libre sensors prescribed by an “independent network” of telehealth providers. |
As of June 2021, a full commercial launch is slated for 3Q21; the company is still in a beta testing phase with “approximately 1,000” people having already completed the program. Majority of current users are on the FreeStyle Libre system. $12 million seed funding round closed in November 2020. |
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Epic EHR International Diabetes Center successfully integrated Abbott LibreView data with Epic EHR, including AGP report and discrete glucose data |
Discussions to begin integration began in spring 2020, followed by announcement of successful completion at ADA 2021 IDC representatives are hopeful the successful integration at IDC will pave the way for other clinics and centers to build out similar integrations, particularly for those using Epic |
Dexcom
- Dexcom G6 – in US and select OUS markets. Dexcom G6 is a ten-day wear, no-calibration, real-time, class II “integrated CGM” (iCGM) with a Bluetooth-enabled, reusable (three-month) transmitter and iOS/Android apps. It is cleared for children ages 2+. Dexcom launched G6 into Medicare in October 2019 and received CE-marking for wear on the back of the arm in June 2020. In April 2020, at the on-set of the COVID-19 pandemic, the FDA announced it would not object to the in-hospital use of Dexcom G6 to monitor patients through the course of the pandemic. As of 4Q20, Dexcom had also expanded G6 into the France and Japan and made solid headway in Canada in 2Q21. In December 2020, Dexcom launched its Hello Dexcom program to provide users in the US and Canada with a free G6 sample kit and identified the program as a key revenue driver in 2Q21. Dexcom CGM data is integrated with Apple Health, Google Fit, a long list of data partners (see here), Companion Medical’s InPen, Tandem’s Basal-IQ and Control-IQ AID systems, Onduo’s connected care platform, and many other products and programs. Notably in July 2021, Dexcom received FDA clearance for its real-time APIs that will allow invited third-party developers to integrate Dexcom CGM data in real-time as opposed to the previous three hour delay. Several launched and planned AID systems are using Dexcom CGM: Tandem’s Control-IQ, Omnipod 5, Tidepool Loop, Lilly’s hybrid closed loop, Diabeloop, Beta Bionics, and others (see below or on our automated insulin delivery landscape). Read more in Dexcom’s 2Q21 and 2020 Investor Day reports from which the following pipeline table is constructed.
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Dexcom CGM Integrations and Pipeline |
Timeline |
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G6 Professional CGM Fully disposable on-body transmitter, real-time and blinded modes, FDA cleared for 2+ years, 10-day wear, no calibration. |
G6 Pro website launched in June 2020, shipping began in July 2020. FDA clearance in October 2019. |
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Dexcom G7 G7 is a fully-disposable, one-piece (integrated sensor/transmitter), reduced cost, slimmer profile CGM. It will include Bluetooth-to-app, (initially) 10-day wear (see 3Q20), and a new applicator (smaller, lighter, less plastic). Per remarks at JPM 2020, G7 could contain Verily accelerometer, but Dexcom later cautioned that no plans have been finalized. |
Submitted for CE-Mark approval as of 2Q21, with OUS launch “by end of 2021.” The G7 US pivotal trial is “complete” as of July 2021; “working toward preparing” the regulatory filing for iCGM submission. The trial was posted on clincialtrails.gov in March 2021. Initially planned with launch by “end of 2020,” with broader availability in 2021. Due to COVID-19, the G7 pivotal trial was delayed. |
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Tandem Control-IQ TypeZero algorithm integrated into t:slim X2 ACE pump. Algorithm automates basal and delivers automatic correction boluses (details here) based on G6 readings. System includes a mobile app for secondary display and wireless uploads with mobile bolus functionality under FDA review. |
Officially launched in January 2020; Tandem has “nearly 270,000” users as of August 2021. FDA cleared Control-IQ in December 2019 as an interoperable control algorithm for 14+ years. Pivotal trial data at ADA 2019 and published in NEJM in October 2019. Expanded pediatric indication for children 6-13 announced in June 2020. Full results from Tandem’s pediatric pivotal trial published in NEJM in August 2020. Data presented at ADA 2020 from a small study (n=12) indicated Control-IQ could improve glycemic control in children 2-5 years old. Real-world post-clearance CLIO study at ADA 2021 showed strong A1c improvements and at Keystone 2021 showed improved quality of life. |
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Teladoc/Livongo CGM-powered insights Livongo for Diabetes users who also use Dexcom G6 will have access to “CGM-powered insights,” including “nudges” and “coaching insights” |
Data integration announced at JPM 2021 and builds on prior agreement between Livongo and Dexcom. |
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Direct-to-Apple Watch CGM No nearby smartphone required |
Was expected by 3Q20, but no updates have been given since; also see Keystone 2019. Would require the updated G6 transmitter. |
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Tidepool Loop Tidepool Loop iPhone app (hybrid closed loop algorithm – basal-only) communicating via Bluetooth with interoperable ACE pumps and iCGMs. |
Real world data from six-month observational study published in DT&T in December 2020 followed by FDA submission in January 2021. In June 2021, Tidepool CEO confirmed FDA is “fantastic to work with.” Six-month data from observational study of DIY Loop users was presented at ATTD 2020 demonstrating improved time in range and A1c outcomes. |
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Insulet Omnipod 5 powered by Horizon Hybrid Closed Loop Hybrid closed loop algorithm built into pod; pod talks direct to Dexcom G6 CGM; direct smartphone control initially on Samsung Galaxy phones and from a Dash handheld. |
Omnipod 5 hybrid closed loop system slated for approval in 4Q21, with limited launch in “late” 4Q21. Pivotal results presented at ENDO 2021 (pediatric pivotal, adult pivotal, type 2 feasibility). Pre-pivotal results presented at ADA 2020. |
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Diabeloop DBLG1 + Roche Accu-Chek Insight Pump Hybrid Closed Loop Diabeloop algorithm running on a wireless locked-down android controller, Roche Accu-Chek Insight Pump, Dexcom G6 CGM |
Partnership first announced in December 2020 with integration completed March 2021 followed by product launch; available in five OUS geographies as of July 2021. Diabeloop has additional partnerships with SFC Fluidics to bring its DBLG1 hybrid closed loop system to the US Terumo to bring its system to Japan. Given Diabeloop’s existing partnership with Dexcom, it is likely this system will also include Dexcom’s CGMs. |
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Diabeloop DBLG1 Hybrid Closed Loop Diabeloop algorithm running on a wireless locked-down Android controller, Kaleido (ViCentra) patch pump, Dexcom G6 CGM, qualitative meal bolusing. |
Initial CE Mark received in November 2018. Diabeloop is still in “pre-launch” mode in France (as we learned at ATTD 2021) with plans to expand into Germany; we speculate ~$34 million in Series B fundraising (December 2019) might enable a broader European launch. Reimbursement talks are ongoing with in France and Germany. Diabeloop received CE-Mark for its DBL-hu algorithm in people with “highly unstable” diabetes in December 2020. The hybrid closed loop system utilizes Dexcom G6 with the Kaleido patch pump. |
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Novo Nordisk Smart Pen-CGM Data Integration Pen data will presumably flow into Dexcom G6 app and Dexcom Clarity platform. |
Novo Nordisk’s smart pens launched in 1Q21 and though they are not currently integrated with Dexcom’s system, Novo Nordisk announced a formal partnership and intention to do so in October 2018. |
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CamDiab’s CamAPS FX Cambridge MPC algorithm, Dexcom G6, and Dana R/RS pumps equipped with data streaming to Diasend/Glooko. |
Smartphone app received CE Mark in March 2020; included pregnancy and children ≥1 year-old. RCT of children and young adult type 1s presented at ADA 2021: +3.6 hrs/day improvement in Time in Range to 68%, A1c drops from 7.9% to 6.8%. CamAPS FX is the first available closed loop smartphone app. |
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Beta Bionics iLet Hybrid or fully closed loop; insulin-only or insulin+glucagon; dual chambered Gen 4 iLet touchscreen device with built-in algorithm; Dexcom and Senseonics’ Eversense CGM. |
Bihormonal iLet with Zealand dasiglucagon phase 3 pivotal to start in 2H21 as of August 2021. As of FFL 2021 – No update on insulin-only pivotal, which was supposed to conclude in “first half of 2021” with a goal launch of insulin-only iLet in “summer 2021.” |
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Lilly’s Hybrid Closed Loop Lilly’s Smart Insulin Pens |
Connected Care products are expected to launch in stages over 2019-2021. No pivotal timing shared. In May 2021, Lilly announced non-exclusive international agreements to integrate Tempo connected pen products with Dexcom and others. Lilly announced a commercialization agreement with Welldoc to integrate BlueStar with Lilly’s smart pen technology, which will also integrate Dexcom CGM data. Data from ADA 2020 demonstrated Lilly AID system using Dexcom CGM was safe in a small inpatient feasibility study. In November 2020, Lilly announced a partnership to commercialize a Ypsomed AID system, which will also include Dexcom G6 CGM. Lilly and Dexcom partnership announced in October 2020 encourages HCPs to use Dexcom G6 and G6 Pro to monitor Time in Range and postprandial glucose; aims to identify patients who could benefit from Lyumjev. |
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Welldoc BlueStar Retrospective Dexcom CGM data available in BlueStar insulin titration app. |
Partnership first announced in March 2020 with first customer in March 2021. |
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EOFlow EOPatch Insulin Pump Pump integrates CGM data in controller app. Pipeline AID system integrates with Dexcom G6 and TypeZero algorithm. |
EOPatch insulin pump launched in Korea in March 2021. Received CE-Mark in May 2021; European launch expected in 2H21. EOPatchX AID system expected to launch in “2022.” |
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TypeZero MDI Decision Support Smart CGM-Based Bolus Calculator, Bedtime and Exercise Advice, Basal Dosing Advice, etc. |
No recent timing shared, but remains in development. Interim outcomes at ATTD 2019 with Novo Pen 6. See our 2020 interview with Dexcom CEO Kevin Sayer, or our Dexcom 2018 Analyst Day report. |
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Pregnancy and Hospital Indications FDA temporarily allows in-hospital CGM use during COVID-19 pandemic for all patients (i.e., including non-diabetes applications). |
Studies are ongoing, per 3Q19. In-hospital use of G6 during COVID-19 pandemic has provided valuable learning opportunities. |
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Non-intensive Type 2 Diabetes Pilots |
Studies and pilots continue, including stealth work with UnitedHealthcare testing CGM in ~10,000 people with type 2 diabetes. Partnership with Everside Health to provide G6 CGMs to patients with type 2 launched in February 2021; in a “pilot phase” as of April 2021. |
Medtronic
- Medtronic Guardian 4 Sensor – under “active review” in the US (as a part of the MiniMed 780G package) and CE-Marked in Europe as of May 2021, slated to launch in the fall. Medtronic’s Guardian 4 builds on the company’s existing Guardian Sensor 3 CGM system; it keeps the same form-factor and seven-day wear but removes fingerstick calibrations via a novel “self-calibrating” mechanism. Additionally, Guardian 4 comes with non-adjunctive labeling, meaning patients can dose insulin based on CGM values without performing a confirmatory fingerstick. This marks a significant improvement over Guardian Sensor 3, which required two calibrations per day, as well as confirmatory fingersticks. Guardian 4 has a two-hour warm-up time, same as Guardian Sensor 3. Guardian 4 will also offer patients predictive low and high glucose alerts, similarly to Guardian Sensor 3.
- Medtronic Guardian Sensor 3 – available in US and select OUS markets as a standalone CGM and as part of the MiniMed 670G, 770G, and 780G AID systems. Guardian Sensor 3 is a seven-day CGM that requires two calibrations per day (though four per day are recommended). The standalone version is approved for 14+ years in the US, while the 670G integration is approved down to 6+ years. Medtronic’s Envision Pro professional CGM has also been available OUS since “fall” 2019 – the fully disposable, no-fingerstick-calibration, Bluetooth-enabled CGM has seven-day wear time and blinded-only operation (will not be launched in the US). Medtronic’s iPro 2 with the Enlite sensor is its professional CGM in the US, available since 2016. Medtronic announced that its MiniMed 780G Advanced Hybrid Closed-Loop system, which uses the Guardian Sensor 3, received CE-Marking in June 2020 and launched in October 2020. It is now available in “over 30 countries” across four continents, as of August’s 2Q21 update. Medtronic also launched its MiniMed 770G in September 2020 and began US shipments in November 2020. This 770G device consists of the pump hardware for the 780G system with the 670G hybrid closed-loop algorithm. Read more in Medtronic 2Q21.
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Medtronic CGM Pipeline |
Timeline |
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Non-Adjunctive Guardian Sensor 3 Would enable MiniMed 670G or 770G Medicare Coverage. |
Submitted to FDA in July 2019, no updates since. Although it is speculation, we believe this project was abandoned in pursuit of non-adjunctive FDA approval of the Guardian 4 sensor. |
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MiniMed 780 (f.k.a. Advanced Hybrid Closed-Loop System) Basal modulation with automatic correction boluses, >80% Time in Range goal, adjustable target down to 100 mg/dl, fewer alarms, simpler operation. |
CE-Mark received in June 2020 with successful launch by October 2020. Pivotal trial results were presented at ADA 2020 and Medtronic has submitted the AID system to the FDA as of 4Q20. FDA approval is anticipated in 2H21. In July 2021, Clinical Trial began evaluating the effectiveness/safety of MiniMed 780G in providing glycemic control in children aged 2-6 years with type 1 diabetes (identifier: NCT04949022). |
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Companion InPen Reusable smart pen that lasts one year and tracks insulin dose, timing, and temperature. Bluetooth paired with smartphone app with integrated bolus calculator. Currently compatible with Novolog, Humalog, and Fiasp insulin cartridges. |
Real-time data integration with Guardian Connect 3 announced in November 2020. Guardian 4 CGM connectivity in Europe announced in May 2021, will be available when Guardian 4 launches. Announced in August 2020, Medtronic acquired Companion Medical representing Medtronic’s entrance into the smart pen market and offering a potential smart pen partner for Medtronic’s CGM devices. |
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Medtronic Guardian Sensor 4 iCGM (f.k.a. Zeus) Day 1 calibration only, 7-day wear, reusable transmitter. |
Pivotal trial was concluded in May. Guardian 4 was submitted to the FDA as a stand-alone CGM in October 2020 (under “active” FDA review now) and as part of Medtronic’s MiniMed 780G system in early 2021. According to comments from 3Q20, pivotal trial data from Guardian 4 should support a non-adjunctive claim which will be necessary for the sensor to run MiniMed 780G. Could integrate with Tidepool Loop, following iCGM/ACE Pump partnership announcement in June 2019. |
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Synergy iCGM Disposable transmitter, smaller on the body (square-shaped patch), day 1 calibration, 7-day wear. |
US pivotal completed in 3Q20. FDA submission delayed slightly from May timeline for “by the end of October 2021” to F3Q22 (November 1, 2021 to January 31, 2022) as of August’s 2Q21 update.
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Novo Nordisk Smart Pen-CGM Data Integration Smart Pen data to flow into Guardian Connect CGM app and presumably CareLink. |
Novo Nordisk’s Smart Pens launched in 1Q21 and though they are not currently integrated with Medtronic’s system this integration will presumably launch in the future. Medtronic/NN partnership announced September 2019. |
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Sugar.IQ Next-Gen Versions Including Insulin Dosing Advice |
“Smart guide” system for Sugar.IQ was previously expected to launch by April 2020 (FY20), adding “basic” CGM-based insulin dosing guidance, a predictive trace, and some advising. By April 2021 (FY21), Medtronic had aimed to add a “virtual optimizer,” bringing more personalized dosing (meals, activity) with the Synergy disposable sensor. No updates recently (see ADA 2019). |
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Personalized Closed Loop system Next-gen AID algorithm, leveraging the Nutrino acquisition and promising a big step up in simplicity, Time in Range, and personal adaptation. |
Launch was expected by ADA 2021. No recent updates. Mentioned as part of long-term pipeline in ADCES 2021 Medtronic symposium. |
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Project Duo Combo sensor/infusion set with 7-day wear |
Pre-clinical data read out at ADA 2021. Had planned launch for after February 2021. In August 2019, seven-day wear infusion set received IDE approval to begin a pivotal trial. |
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Klue “Gesture-sensing” and AI software driven by data from Apple Watch to detect when and how fast someone is eating or drinking |
Acquired in December 2019 with plans to incorporate into personalized closed loop system eventually. In July 2021, Clinical Trial posted evaluating subject safety of using the Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) within the MiniMed 780G system in adult subjects with type 1 diabetes in a clinic setting (identifier: NCT04964128). |
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Rockley Photonics “Clinic-on-the-wrist” device uses IR spectroscopy to measure biomarkers including glucose trends; device to enter in-house human testing |
In July 2021, Medtronic was interestingly mentioned in Rockely’s May S-4 filing, suggesting the company may be looking to pursue non-invasive glucose monitoring technologies.
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Senseonics
- Senseonics Eversense and Eversense XL – available with 90-day wear in the US and 180-day wear (Eversense XL) in Europe (“over 5,000” patients, 80% of whom are in Europe as of 3Q20). Eversense is an implantable CGM placed in the upper arm, with a reusable, externally worn transmitter affixed via a silicone-based adhesive patch. Eversense requires two calibrations per day (although the 180-day sensor will require only one per day) and launched with non-adjunctive labeling in the US in December 2019. The 180-day Eversense CGM has been submitted to the FDA, and its approval is anticipated in late 4Q21. Senseonics has secured Medicare coverage for Eversense in 2020 and has 200 million covered lives in the US. Read more in Senseonics 2Q21.
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Eversense CGM Pipeline |
Timeline |
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180-day Eversense Doubles Eversense wear time and reduces daily calibrations by half to one calibration per day; same form-factor as 90-day sensor, but updated software and chemistry. |
US pivotal trial completed in summer 2020 with FDA submission in September 2020 and approval anticipated in late 4Q21, marking a delay of ~one year from initial expectations. iCGM designation was last discussed during 4Q20 earnings call; no timelines given. 180-day product pivotal data was read out at ATTD 2021. |
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365-day Eversense A full-year implanted “Gen 2” sensor with one calibration/week; real-time CGM with alerts (with transmitter), with optional flash point-in-time monitoring (no transmitter). Marketed to intensively-managed and insulin-using patients. |
IDE submission expected in late 4Q21, pivotal expected in 1H22, behind initial expectations to launch in 2021. At DTM 2019, a new sensor design was shown. |
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Freedom System A full-year implanted “Gen 2” sensor with battery. Real-time CGM with alerts (with transmitter), with optional flash glucose monitoring (no transmitter). Standalone flash monitoring without the transmitter to be non-adjunctive. Marketed to all patients (intensive, insulin-using, non-insulin patients) |
As of ADCES 2021, system is slated for launch/approval in 2024. First heard of this system at DTM 2020. |
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Beta Bionics iLet Bionic Pancreas Hybrid or fully closed loop; insulin-only or insulin+glucagon; dual chambered Gen 4 iLet touchscreen device with built-in algorithm; Dexcom and Senseonics’ Eversense CGM. |
Agreement set in 2018, pre-pivotal data from ADA 2019. Bihormonal iLet with Zealand dasiglucagon phase 3 pivotal to start in 2H21 as of August 2021. As of FFL 2021 – No update on insulin-only pivotal, which was supposed to conclude in “first half of 2021” with a goal launch of insulin-only iLet in “summer 2021.” |
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Other analyte measuring Management has confirmed that Senseonic’s Eversense sensors can measure other analytes with potential plans to expand capabilities in the future. |
As of 4Q20, Senseonics had sold “about 1 million dollars” worth of oxygen sensing technology, but plans to focus on diabetes for the near future. |
Other Early-Stage CGM Players, Including Implantable, Minimally Invasive, etc.
Last Updated: September 2, 2021. We caution that there is quite a revolving door of CGM startups from year-to-year, so some included below may no longer be in development, and we are likely missing some. Let us know if there are any not here that should be.
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Company /Institution |
Product/Key Features |
Latest Updates |
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WaveForm (AgaMatrix) |
WaveForm “Cascade”/A. Menarini “GlucoMen Day CGM” 14-day wear-time, one calibration/day, Bluetooth-to-app, alarms, remote data sharing, rechargeable transmitter (lasts up to 5 years), no acetaminophen interference, <one-hour warmup time, and “painless” insertion; readings transmitted every minute. |
Currently working to bring CGM to the US; pre-pivotal trial began, with another expected to start at the end of the summer 2021; FDA submission expected in 2022 with approval to follow in 2023 (June 2021). This is behind expectations to begin clinical trials to support PMA submission in 1Q20 and to submit in 2020 (July 2019). Now available in Europe (June 2020) following CE-Marking in November 2019, commercialization driven by distribution partner A. Menarini. |
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Nemaura Medical |
SugarBEAT Non-invasive, 24-hour wear, disposable skin patch with reusable transmitter, once daily calibration, adjunctive approval, MARD: 11.9%. |
Unofficial launch of BEAT diabetes digital weight loss and “potential” reversal of type 2 program in November 2020 with OTC access in the US expected by “late 2021.” CE Marked in June, first shipments made in August in UK (August 2019). Currently available to a “limited cohort” in the UK with broader launch expected. PMA submitted to FDA in July 2020 and expected to enter US market as wellness device later in 2020. No recent update. |
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Biolinq |
CGM Intradermal, low-cost, factory-calibrated, nickel-sized electrochemical biosensor CGM patch. Needle-free application and wear. |
First in-human trials completed March 2019, currently running clinical trials and plan to go “down the iCGM pathway.” Data from ADA 2020. Received $15 million Series A funding in March 2019, including participation from JDRF’s T1D Fund. |
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One Drop |
Wellness CGM patch 24-hour wear sensor with 7-day transmitter + reusable battery; Minimally invasive structures read interstitial fluid; Sensor looks slightly larger than FreeStyle Libre patch, applied with applicator; Factory calibration and Bluetooth connectivity expected. |
In June 2021, One Drop hired a new VP of Commercial Strategy to head One Drop’s development of a multi-analyte, minimally invasive biosensor with CGM capabilities. CGM formerly owned by Sano, which was acquired by One Drop in May 2020. No financial terms or timelines shared. Survey sent in October 2018 indicated $399 pricing for a 15-day supply, “Sano discovery kit.” Fitbit invests $6 million; ongoing manufacturing scaling; beta trials expected in 2018 (January 2018). Launch has been pushed back several times, initially planned for “2016.” |
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GraphWear |
Noninvasive CGM
Wearable noninvasive glucose monitor measuring glucose via nanotechnology.
Available as both a sensor on an adhesive patch and a wearable watch-like device. |
Announced new executive hire and board member in February 2022. Dana Cambra joined as Senior Vice President of Engineering bringing experience from the development of Dexcom G6. Woody Scal joined as an independent member of GraphWear’s board of directors bringing experience from health and fitness companies.
$20.5 million Series B closed in October 2021. |
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Movano |
CGM Wearable, non-invasive continuous glucose monitor powered by radio frequency. |
Raised $10 million in July 2020 to bring total funding since founding in 2018 to $27 million. Currently in production stages and plan to prepare for initial human trial soon. |
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Glutalor |
1. iWel CGM II 10-day wear, factory-calibrated; six-month Bluetooth transmitter; App. Readings every three mins; also available with LCD display on sensor.
2. iWel CGM III In-development, 14-day, disc-shaped, fully disposable CGM |
1. Available in China and “currently launching in Europe,” according to its website. Claims to have >50,000 users. It is CE-Marked.
2. No recent updates. |
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Medtrum |
1. A6 EasySense disposable CGM: 7-day wear, twice daily calibration, claimed MARD 9%, PLGS with patch pump, app
2. S7 System: 14-day wear, once daily calibration, secondary display mobile app 3. P7 System: No-calibration; direct smartphone control |
1. Available in six countries (Germany, Denmark, Sweden, UK, Spain, Italy) with ~200 users as of February 2019. CE-Mark received (November 2014) for ages 2+. Predictive low glucose suspend system with Medtrum’s patch pump (2-3-day wear, controlled with PDM); intended for ages 2+. 2. As of February 2019, a launch was expected in Europe by end of 2019 and “2020” in US.
3. In development as of February 2019. |
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POCTech |
1. POCTech CT-100B 7-day wear, once daily calibration, MARD 8.7% vs. venous blood glucose; data sent to receiver/app every three minutes; CE-Marked 2. 2nd-gen CGM with 15-day wear |
1. Distribution agreement with Ascensia, sales of “Ascensia branded and boxed” CGMs was expected by end of 2019 (January 2019); we do not believe that has happened. - Possible integration into EOFlow’s AID system, EOPancreas? (June 2019). 2. Co-development agreement with Ascensia, plans for regulatory submissions “before the end of 2020” (January 2019). Potentially submitted for CE-Mark already (September 2019). |
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LifePlus |
LifeLeaf Non-invasive “watch-like” wearable CGM; spectroscopic blood glucose measurements; factory calibrated, real-time CGM |
Currently a “functioning prototype” (June 2020). Previous timeline of FDA pre-submission meeting in July 2020 with clearance by the end of 2021, which never came to fruition. No updates since. |
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i-SENS |
CareSens Air CGM 15-day wear; one calibration/day, bluetooth, fully disposable, slim design |
Aimed to launch in 4Q20/early 2021 in Korea, then internationally; see our IDF 2019 coverage. No updates since. |
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Indigo Diabetes |
CGM Implantable CGM sensor using miniature spectrometer to measure glucose and ketones; planning to launch with two-year wear, though main limitation is regulatory study length |
First clinical study started in March 2021; appearance at ATTD 2021 exhibit hall. Completed $38 million Series B in July 2020. Aiming for market approval with two-year wear by 2023, presumably in Europe first. |
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Metronom Health |
Opto-enzymatic based sensor 14-day wear, factory-calibrated; fully-disposable, pre-assembled sensor + transmitter + applicator; bluetooth; no interferences w/ common medications |
May 2021 partnership agreement with Dinova and Ascendum Capital to bring CGM to China. Before that, no updates since EASD 2018. Clinical trials were expected in October 2019, followed by a CE Mark filing in early 2020 and a mid-2020 approval, a timeline which has not been met. |
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GlySens |
Gen 3 Eclipse CGM Fully-implanted (no external components); two-year life; bluetooth-connectivity to app); aiming for 1-2 fingersticks/month, though potentially 1x/week initially; 40% smaller than the gen 2 device |
Closed Series E financing in November 2018; aimed to enter clinical studies in 2019. |
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GluSense |
Glyde CGM Implantable 0.7-inch rod (1.5 x 3.8 x 18 mm) with fluorescent biosensor: one-year implantation, expected MARD of 10% with calibration; communicates with arm-worn wearable (powers sensor and relays data to phone) |
No recent updates, website says “several more years.” Received JDRF T1D Fund Investment in March 2017. |
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Profusa |
Micro hydrogel implantable sensor Fluorescence-sensing mechanism; multiple analytes; on-body patch worn on the skin collects data from sensor and relays information to smartphone; 2-year+ life; flexible, thin-film, Bluetooth-enabled disposable patch and/or use a smartphone reader for intermittent sensing expected (i.e., like Abbott’s LibreLink) |
Raised $45 million in Series C financing in August 2018. Company still seemed focused on oxygen monitoring at that time, though glucose monitoring is in the pipeline. |
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NovioSense |
NovioSense Sensor 1-inch long, 1 mm thick flexible rod that sits on lower eyelid and transmits glucose data wirelessly to smartphone via NFC |
Phase 2 results showed median ARD of 12.5%, 95% of values in regions A+B of Clarke Error Grid (October 2018). Market clearance in EU, US, and Asia Pacific previously expected in 2019 (December 2016). |
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EyeSense |
Fibersense 29-day wear, 1 cal/day; 14.7% MARD vs. YSI; Bluetooth direct-to-phone or receiver |
As of DTM 2018, EU pivotal trial slated for 2H19, potential launch in late 2020, a timeline that has not been achieved.
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PercuSense |
Multi-analyte sensor (glucose, ketones, oxygen, lactate); 14-day wear, factory-calibrated, 30-minute warmup |
May 2019 partnership with Diabeloop and SFC Fluidics for AID system. As of DTM 2018, planned to initiate 10-person human study in 2Q19, with a potential (non-eventual) launch in ~late 2020 or beyond. Was working on grant for integrated continuous glucose and ketone sensing. |
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Continuity |
CGM Non-invasive CGM earring; vibration alerts and on smartphone; to launch with oral insulin spray |
Won 2019 James Dyson Award for student-designed products that “solve a problem.” No launch or study timelines shared.
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DiaMonTech |
D-Sensor Non-invasive wristband CGM with data logging and alarm functions; patented mid-infrared light technology |
Syncs with Android and iOS; aiming for 2024-2025 launch as of June 2021. |
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GraphWear |
Graphene-based sensor Provides biological information (including blood glucose) from sweat |
Closed a $20.5 million Series B round (October 2021); funding to be used to support clinical trials and eventual FDA clearance. Feasibility study in 2020, but no results released to date. As of April 2018, $4.2 million raised in Series A round; US launch slated for 2021-2022, although unlikely to meet. |
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Integrated Medical Sensors |
IMS Miniature (3 mm x 0.6 mm; “less than half a sesame seed”) wireless electrochemical glucose sensor: 3-6-month wear; $1/day projected sensor cost; Wearable wireless transmitter and smart reader |
Last update in February 2018: 12.5% MARD in animal studies; still preparing for human studies per company website. Top ten finalist for 2018 T1D Exchange Diabetes Innovation Challenge (May 2018); Winner of 2016 T1D Exchange Diabetes Innovation Challenge (October 2016). |
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Theranova |
Intraperitoneal CGM |
Preclinical and clinical stage. As of November 2018, was initiating a “first of its kind” study in collaboration with JDRF and Prof. Eric Renard investigating IP vs. subcutaneous glucose sensing while delivering insulin IP (sensor type not specified). |
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PK Vitality |
K’Watch Smartwatch has electrochemical sensor (K’apsul) on the bottom that comes in contact with the skin, pulls up a drop of interstitial fluid via microneedles. Each K’apsul will work for minimum 7 days; Current MARD ~13% in vivo (swine); projected cost ~$200/watch, <$100/month for consumables |
As of CES 2017, was looking to raise a seed round. Website indicates it does not have a CE-Mark yet. Previously planned for further preclinical testing in 2019, clinical testing in 2020, and market availability at the end of 2021. |
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Biorasis |
Glucowizzard Rice grain-sized (0.5 x 5 mm), long-term, injectable/implantable CGM; one calibration/week, six-month sensor life objective; communicates with wrist-worn wearable in real-time; inserted on top side of wrist so watch can power with light and receive glucose measurements from LED light source through skin |
Last update at DTM 2018: Tested in rats, mini-pigs, rabbits, and dogs showing: high-stability to 55 days; 9.8% error over 14 days; 5-10 min lag time; HCT will fund first human transplantation; expected to be sensing element for PhysioLogic Device’s IP-IP closed loop system. |
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Arkray |
Glucose dehydrogenase-dependent DiET (direct electron transfer) CGM On-body component (sensor + transmitter) worn on abdomen plus mobile app; sensor electrode 0.25 mm in diameter; 9.9% MARD demonstrated in internal feasibility study |
No timing update since November 2016. Clinical trials were expected in the US and Japan between 1Q17 and 2018. |
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University of Bath |
Adhesive patch Draws glucose out from fluid between cells via array of miniature sensors; wireless connection to phone/smartwatch; readings taken every 10-15 mins; Zero-cal |
No recent updates. Found to be accurate in pig skin and healthy human volunteers throughout day; next steps are: (i) refine design to optimize number of sensors; (ii) demonstrate functionality over 24-hours; and (iii) conduct clinical trials (April 2018). |
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LifeCare |
SenCell Implantable osmotic micro sensor (2 x 1 x 0.5 cm); streams to watch and smartphone; could theoretically last indefinitely since not chemistry-consuming (min. 6 months) |
As of DTM 2018, was set to enter human pilots in 2H19. In proof-of-concept pig study, glucose readings tracked well with Dexcom reference trace (November 2016). Working with CantiMED, which 3-D prints nano-pressure sensors. Went public on Norwegian Merkur Market in July 2018. |
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Apple (rumored) |
Non-invasive (optical) CGM |
No recent updates of substance. Rockley Photonics, rumored Apple partner, unveils non-invasive glucose monitoring device (July 2021). Future Apple Watch to include non-invasive glucose monitoring add-on band? (May 2017). Project in-development for at least five years and progressed to clinical feasibility studies (April 2017). Dr. David Klonoff “knows someone” working on the project (April 2017). |
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Know Labs |
1. KnowU flash glucose montior Pocket-sized Bio-RFID sensor with charging base; smartphone connectivity;
2. UBand wearable CGM Watch-like wearable CGM with smartphone connectivity to the Know Labs app.
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1. Product was unveiled in September 2021; expected to begin FDA pre-approval process in 2022. Report on company’s website shows accuracy of Bio-RFID technology compared to (i) Accu-Chek Fingerstick; (ii) Dexcom G6; and (iii) FreeStyle Libre 14-day. From October 2021 update video on the company’s website it appears as if it will target a medical indication as opposed to the wellness market.
2. First announced in November 2019; uses same Bio-RFID technology as KnowU.
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Innovation Zed |
Non-invasive (optical) CGM |
Announced plans to begin research that would support development of a non-invasive CGM (October 2021) |
Discontinued Systems
The list below is obviously not comprehensive! Send us products we’re missing.
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Alcon (formerly Novartis subsidiary)/Verily |
Glucose-sensing contact lens: Smart lens would continuously measure glucose levels via tear fluid and wirelessly send the results to a mobile device. |
Put “on hold” – we interpret to mean that the glucose-sensing contact lens is shelved – due to issues with measuring glucose reliably/accurately in tears (November 2018). Dr. David Klonoff: Verily still working on it but in a silent period (April 2017). US patent obtained (April 2015). |
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Roche |
Accu-Chek Insight CGM: Seven-day wear, two calibrations/day; ~10.6% MARD, 5.5-min lag time; round adhesive, on-body transmitter (roughly two thumb drives in size), and a slightly intimidating syringe-like insertion device. Bluetooth transmitter sends data to an Android smartphone app (primary display) |
Roche shelved the Accu-Chek Insight CGM in favor of focusing on the distribution of Senseonics’ Eversense, a good strategic move. |
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BD |
Optical-based, glucose-binding protein CGM |
Discontinued in July 2014 related to core technology and issues that emerged in human testing. |
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C8 Medisensors |
Non-invasive, optical-based CGM (raman spectroscopy); looked like a utility belt |
Bankrupt as of 2013; see EASD 2011 exhibit hall write-up for specifics on technology. |
--by Armaan Nallicheri, Hanna Gutow, Katie Mahoney, and Kelly Close