Executive Highlights
- The tables below include an overview of both the Smart Insulin Pen and Cap landscape and the Insulin Dose Titration landscape, to the best of our knowledge. The first table outlines currently available smart insulin pens and caps as well as publicly disclosed future projects and timelines. The second table provides and overview of players currently offering or working to bring insulin dose titration systems to market. Due to partnerships and overlap between the two fields we have created this combined competitive landscape. Entries in both tables are listed by the company or institution that owns the regulatory submission.
- We acknowledge this list may be incomplete, as there are likely stealth start-ups and academic groups working to develop smart insulin pens and titration systems.
- We will continuously update this list as timelines change, but it is only up to date as noted above. All the information included comes from publicly disclosed information or our own coverage. If you spot something you think should be changed, please email us.
Smart Insulin Pen and Cap Competitive Landscape
- The table below includes an overview of smart pen/cap competitive landscape, as far as we aware. This list may be incomplete, as there are likely other stealth startups, large companies, or academic group working to commercialize this technology.
Company |
Product + features |
Timing/approval updates + recent coverage |
Medtronic |
Medtronic/Companion Medical InPen
|
FDA cleared in August 2016, US launch in 2017, CE-Marked in July 2018, though EU launch of first-gen InPen never happened. Limited mail-order launch of iOS pens/app in the US in early December 2017. ~70% of purchases are being reimbursed with an average co-pay of $50-$60 nationwide. Not going to broad, retail pharmacies "for the time being." Android FDA clearance, US launch by 4Q18 (July 2018). Integration with Dexcom Clarity, Glooko, and Rimidi EHR embedded diabetes management software in June 2019. FDA cleared in February 2020 for dose calculations based on fixed meal dosing or “meal estimation.” Calculator takes into account current glucose level and active insulin; first FDA cleared dose calculator that doesn’t require carb counting; launched in April 2020 on InPen app. As of JPM 2020: 17,000 InPens were sold in 2019, 8,000 sold in 4Q19 alone; smart pen market growing faster than “entire pump industry combined.” Announced in August 2020, Medtronic acquired Companion Medical representing Medtronic’s entrance into the smart pen market. Updated InPen CE-Marked in May 2021; launch slated for Fall 2021, though no update as of 3Q21. Per industry symposium at EASD 2021, InPen Basal smart insulin pen cap is currently in development. |
Bigfoot Biomedical |
Bigfoot Unity Diabetes Management System
|
Submitted to FDA for 510(k) clearance in July 2020 – see interview with CEO Jeffrey Brewer. As of DiabetesMine Summer 2021 D-Data Exchange: working to develop a system that is compatible with half-unit pens; could potentially be used to pursue pediatric indication. Approved by the FDA in May 2021 followed by a US launch in June. Future plans to launch automatic dose titration system for Unity “~2022.” Bigfoot Autonomy hybrid-closed loop system expected “~2023.” |
Novo Nordisk |
NovoPen 6
NovoPen Echo Plus
|
Novo Nordisk and Glooko partner to develop “digital tools for diabetes management” in January 2017. Novo Nordisk releases both devices and announces that they have been CE-Marked since 2018; non-exclusive integration partnerships with Roche, Dexcom, and Glooko were also announced. NovoPen 6 and Echo Plus initially slated to launch in early 2019; Reusable Bluetooth pen attachment for reusable FlexTouch pens later in 2019 (October 2018). Early results from the TypeZero MDI dosing system (using NovoPen 6) presented at ATTD 2019 showed system did not lead to overall population benefits compared to control; decision support was only useful to those to actually used its services. Announced at ATTD 2019, Novo Nordisk will integrate NovoPen 6 and NovoPen Echo data with Medtronic CGMs. EU launch pushed back to 2Q20 (DTM 2019). Pens launched in Sweden (March 2021) and Denmark (May 2021). As far as we know, Novo Nordisk has not yet submitted either connected pen to the FDA. Per company website, integration with Abbott “available soon.” Partnership announced in September 2021 with Biocorp to develop specific version of Mallya smart pen cap for FlexTouch insulin pens. SWEDEN6 trial results (published in 2020) shared at DTM 2021, similar glycemic data from ATTD 2021. |
Lilly |
Tempo Personalized Diabetes Management Platform
Will be a 510(k) or PMA, depending on use of BGM or CGM |
US connected device submitted to FDA per 1Q19 update; pen was cleared but awaiting guidance on “component parts.” Non-exclusive partnership with Dexcom in 2019 to use Dexcom CGM in smart pen systems; already partnered for clinical trials; first CGM partnership for Lilly. Lilly signed international agreements with Roche, Glooko, myDiabby, and Dexcom to integrate data with smart pens (May 2021). Also announced that Tempo Smart Button was slated for CE-Marking “later in 2021.” Timeline reiterated at EASD 2021, though likely pushed back into 2022. |
Biocorp |
Mallya (f.k.a. easylog)
|
AgaMatrix announced as commercial partner in February 2019. Received CE-Mark in June 2019; FDA submission expected in late 2019/1Q20, but no updates. In July 2019 Sanofi paid $4.5 million to enter an “exclusive negotiation” to bring Mallya into Sanofi’s integrated diabetes care management platform. Sanofi paid $2.2 million to incorporate Mallya with Sanofi insulin pens in December 2019; Sanofi aquires non-exclusive worldwide distribution rights. Sanofi paid €1 million to Biocorp, plus an additional €12 million at subsequent milestones (total ~$15 million) in January 2020. Mallya integration with Amalgam’s iSageRx announced in June 2020. Signed non-exclusive distribution agreement with Roche in July 2020 to bring Mallya to French pharmacies and integrate Mallya into Roche’s “digital diabetes ecosystem.” Biocorp announced the official launch of Mallya in Europe, followed by South Africa and Asia, in November 2020. Partnerships with Diabeloop to integrate DBLG1 AID algorithm with Mallya smart caps (March 2021) and Novo Nordisk (September 2021). |
Common Sensing |
Gocap
Connected D-Flex |
Conversation with President James White in June 2016: Seeking pharma partner and pilots as of June (Sanofi is an investor). Device was listed with the FDA in Summer 2016. 510(k) exempt for now (likely until dose calculator/other ambitious advice included). Beginning 125-patient study at Joslin in 2016. GoCap and One Drop to be used in Innovation Health and Sanofi digital health pilot investigating patient outcomes and medication adherence in adults (September 2017). Announced at Diabetes Mine 2017: plan is to charge $25/month per user. $6.6 million in Series A; NovoLog-compatible cap imminent; Next-gen pen with longer battery life, enhanced accuracy expected in mid-2019 (April 2018). Used in Good Measure’s subscription diabetes bundle (June 2018). Gocap Beta program launches with limited stock of Lantus Gocaps (January 2018). Intellectual Property acquired by Bigfoot Biomedical (June 2021).
Announced partnership with Flex in June 2018. |
Insulclock |
Insulclock
|
Emory Study with 24-week crossover trial design assessing Insulclock in type 2 users expected to complete in 2018. DTT paper published in 2019 assessing Insulclock accuracy demonstrated Insulclock can detect 7 types of insulin pens with 97% accuracy; only 3%-7% error rate for insulin doses. Poster presented at ADA 2020 indicated Insulclock reminders drove significant A1c reductions in type 2 patients with uncontrolled type 2. |
Ypsomed |
YpsoMate On Connected Pre-Filled Autoinjector
UnoPen attachment:
SmartPilot:
|
Developing “SmartPilot” reusable add on to Ypsomate to track data and transmit to mobile app as of November 2017. Company announced YpsoMate On connected prefilled autoinjector (October 2021). |
Diabnext |
Clipsulin 3XS
|
Announced at ATTD 2020, Clipsulin launched in December 2019. |
Pendiq |
Pendiq reusable smart pen
|
Follow-up model due to launch “late summer 2016” (according to website). German launch with Roche in 2H17 announced at EASD 2017. |
Emperra |
ESYSTAsmart insulin pen
|
Launched in April in Europe. EASD 2016 Exhibit Hall reps said it is reimbursed by insurance in Germany. The cash pay price is very expensive: 192 euros for a single pen and 616 euros (!) for a pen and meter. |
Sanofi/Verily |
Developing disposable and reusable connected insulin pens for both basal and bolus insulins |
Announced at ATTD 2019, Sanofi is developing disposable and reusable connected insulin pens. In July 2019 Sanofi paid $4.5 million to enter an “exclusive negotiation” to bring Biocorp’s Mallya smart cap into Sanofi’s integrated diabetes care management platform. In December 2019 Sanofi paid $2.2 million to incorporate Mallya with Sanofi insulin pens; Sanofi acquired non-exclusive world-wide distribution rights. |
BD |
Smart Sense (smart pen needle technology)
Expected to be “affordable” |
Announced at Analyst Day in November 2016. Launch by September 2018 (FY18). Not yet submitted to FDA. Smart pen needle program paused in February 2018. |
Insulin Dose Titration Competitive Landscape
- The table below provides a non-exhaustive landscape of players currently delivering or hoping to bring insulin titration to the market. The landscape is certainly heating up with many of these players partnering with the smart pen/cap developers listed above.
Company |
Product + Features |
Timing/approval updates + recent coverage |
Welldoc |
BlueStar
|
Launched in 2013. FDA cleared for CGM integration in November 2019; Dexcom G6 partnership announced in March 2020. First customer for joint program was a Fortune 100 company (April 2021). Received FDA clearance in June 2020 for basal insulin titration, marking eighth 510(k) clearance. Collaboration and licensing agreement with Lilly to commercialize titration app for Lilly connected pens (February 2021). Company announced ninth FDA clearance to include bolus and premixed insulin for patients with type 2 (September 2021) following submission (November 2020). BlueStar chronic care support available via LifeScan OneTouch Solutions Portal (October 2021). |
DreaMed |
Advisor Pro
|
Advisor Pro received CE-Mark in February 2018. Advisor Pro cleared by FDA in June 2018, targeting end of summer US launch. Cleared for use with SMBG and pump in November 2018. Testing with Tidepool data management platform in February 2019. As of ATTD 2019: Advisor Pro delayed US and Europe roll-out due to software challenges; working with individual clinics to overcome hurdles. Advisor Dose bolus calculator announced at ATTD 2019 to be “in-development.” FDA cleared and CE-Marked to optimize pump settings based on only BGM data in September 2019. Advice4U trial presented at ATTD 2020 indicated non-inferiority of Advisory Pro to expert provider advice. Soft launch of “virtual diabetes management service” in April 2020; Advisor Pro settings overseen by provider and sent to patient remotely. Multiple presentations at ATTD 2021: data demonstrating non-inferiority to expert provider recommendations for both type 1s and type 2s on MDI, along with data on real-world use of the Advisor Pro Platform. FDA cleared for MDI users with type 1 and type 2 diabetes (October 2021).
|
Amalgam Rx |
iSageRx
|
Launched May 1, 2017 for iOS and Android after receiving FDA clearance for basal insulin titration. Basal+GLP-1 basal-bolus FDA clearance expected by the end of 2017, but no recent updates. Collaboration with Novo Nordisk to launch white-labeled version of iSage in Brazil under the name DoseCheck (June 2019). Pilot study at Kansas University Diabetes Institute (ADA 2019). iSageRx integration with Biocorp’s Mallya device announced in June 2020. Amalgam acquired EHR technology company Avhana Health in January 2021, opening up a new world of commercial and clinical opportunities for iSageRx; software integrated with all major EHRs (Epic, Cerner, Athena, and AllScripts) CE-Marking for Dose Check in June 2021, global distribution partnership with Novo Nordisk for white labeled version of DoseCheck. |
Hygieia |
d-Nav |
Data presented at ADA 2018 indicated 2.3% A1c reductions at six months. Announced at ATTD 2019: RCT published in The Lancet. Type 2 insulin titration app cleared by the FDA in February 2019. $17 million Series B to drive d-Nav expansion outside southeast Michigan (December 2021). |
Voluntis |
Insulia
Diabeo
|
Launched Insulia savings program with a $0 copay in December 2017. IPO in June 2018 on Euronext Paris; patients enrolled in 10 US states; exploring inpatient/outpatient titration. Piloting in UK, available in France, Germany, Canada, and some US states (ADA 2019). Partnership with Biocon to integrate biosimilar insulins for type 2 patients (July 2020).
Available in France as of December 2016. |
Sanofi |
My Dose Coach
MyStar Dose Coach BGM
|
Launched in June 2017. As of ATTD 2019, ~3,500 people using Sanofi titration products annually. Announced at ADA 2019, My Dose Coach rolled out in India; 58% discontinued the app. Partnership w/Abbott to share FreeStyle Libre data with titration apps (September 2019); no specific timeline.
Available in the EU. |
Glytec |
eGlycemic Management System |
Pilot study underway as of 2017 with Agamatrix to integrate Jazz Wireless 2 Bluetooth BGM with eGlycemic Management System. As of August 2017, the eGlycemic Management System was used to treat >150k patients in a year. Announced at ATTD 2020, Glucommander is now used in over 200 hospitals. $21 million in funding to support R&D efforts (April 2021). At ADA 2021: two posters highlighted outcomes in patients with renal disease (eGFR <60 ml/min/1.73 m2, n=13,775) and type 1 diabetes (n=15,478), both showing Glucommander’s algorithm and decision support was associated with low glycemic variability and hypoglycemia. |
Glooko |
Mobile Insulin Dosing Software (MIDS)
|
Received FDA clearance in February 2018. Piloting at small number of clinics in June 2018 with more extensive roll out by the end of 2018. As of ADA 2019 MIDS was “just starting” to launch. Data presented at ADA 2020 demonstrated noninferiority to conventional titration (paper based titration tool). $30 million Series D to drive commercialization initiatives and expansion into additional therapy areas (March 2021). |
Lilly |
GoDose
|
Received FDA clearance in January 2017. No recent updates. |
Novo Nordisk |
Insulin Dose Titration
“Digital therapeutic” projects
|
Global distribution partnership with Amalgam Rx for white labeled version of DoseCheck.
Working on “very actively” as of DTM 2019. |
Type Zero (Dexcom) |
inControl Advice
|
Initially shown at DTM 2016. Pivotal trial for Senseonics partnered decision-support system to be announced “soon” as of August 2017. Pilot data from UVA study of CGM-based MDI support in June 2018. Data presented at ATTD 2019 on dosing support for CGM and MDI preliminary results indicating time in range improvement across groups; decision support only works when it’s used which varied across study participants. |
Mellitus Health |
Insulin Insights
|
Cleared by the FDA in June 2017. Available in 30 “countries and clinics” in Europe and the US as of February 2018. Data from pilot study presented at ADA 2018 demonstrating strong A1c reductions. Data presented at ATTD 2019 showed significant A1c reductions at 3 and 6 months. |
ALRT |
Insulin Dose Adjustment (IDA) Feature
|
FDA cleared, no launch timeline. |
--by Armaan Nallicheri, Hanna Gutow, and Kelly Close