Memorandum
Executive Highlights
- The tables below include an overview of both the Connected Insulin Pen and Cap landscape and the Insulin Dose Titration landscape, to the best of our knowledge. The first table outlines currently available connected 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.
- This competitive landscape now includes a range of corporate updates and recent M&A activity, including:
- Novo Nordisk’s plans to acquire Biocorp, the developer of the Mallya smart cap;
- Medtronic’s InPen’s launch in multiple OUS markets;
- Bigfoot Biomedical had several exciting updates on its Unity platform, including FDA clearance of its Android app and its transition to the pharmacy channel; and
- Lilly’s Tempo Smart Button is now FDA approved and CE-Marked.
- Within the connected pen and pen cap landscape, a notable difference across devices is whether or not the connected pen system calculates dosing recommendations. As outlined in our competitive landscape below, currently Medtronic’s InPen and the Bigfoot Unity have dose calculating capabilities. Lilly’s Tempo System has dose calculating integrated into its pens in the US due to its partnership with Welldoc. Although not yet launched, Novo Nordisk partnered with Diabeloop earlier this year (March 2023) to integrate basal and bolus dosing recommendations in NovoPen 6 and NovoPen Echo Plus.
- Tracking insulin doses is also an important feature of connected pen systems, which varies by device. Medtronic’s InPen, Biocorp’s Mallya pen cap, Lilly’s Tempo Smart Button, Novo Nordisk’s NovoPen 6 and NovoPen Echo Plus, InsulClock, Innovation Zed’s InsulCheck Connect and InsulCheck Dose, and Ypsomed’s Ypsomate On and SmartPilot all track insulin dose. As well, the Bigfoot Unity system tracks recommended insulin dose; however, it does not record the details of the actual dose given.
- 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.
Connected Insulin Pen and Cap Competitive Landscape
- The table below includes an overview of connected 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.
Updated InPen CE-Marked in May 2021; made debut in OUS markets at ATTD 2023. Limited mail-order launch of iOS pens/app in the US began 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."
Integration with Dexcom Clarity, Glooko, and Rimidi EHR embedded diabetes management software in June 2019.
FDA cleared in February 2020 and CE-Marked in May 2021 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; US launch in April 2020 on InPen app.
Announced in August 2020, Medtronic acquired Companion Medical representing Medtronic’s entrance into the smart pen market.
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.”
Per industry symposium at EASD 2021, InPen Basal smart insulin pen cap is currently in development. |
|
Bigfoot Biomedical |
Bigfoot Unity Diabetes Management System
|
Approved by the FDA for iOS smartphones in May 2021 followed by a US launch in June 2021. FDA clearance for Bigfoot Unity Android app in March 2023.
Submitted to FDA for 510(k) clearance in July 2020 – see interview with CEO Jeffrey Brewer from 2020.
Commercial strategy transition to pharmacy channel in 2H23; presumably funded by selling intellectual property for Bigfoot Autonomy AID to Insulet in February 2023.
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.
In March 2023, Bigfoot acquired insulin titration algorithm from McGill University to incorporate into Unity platform.
Future plans to launch automatic dose titration system for Unity “~2022.”; no updates since August 2020.
Per interview with Mr. Brewer and CCO Mr. Matt Rainville in April 2023, Bigfoot userbase is approaching 1,000 people. |
|
Novo Nordisk |
NovoPen 6
NovoPen Echo Plus
Mallya smart pen cap
|
Novo Nordisk partners with Diabeloop to integrate Diabeloop’s DBL-4 pen app with NovoPen 6 and NovoPen Echo Plus, adding basal and bolus dosing recommendations to Novo Nordisk’s connected insulin pens.
NovoPen 6 and NovoPen Echo Plus successfully integrated with LibreLink in the UK in November 2022, enabling Novo Nordisk’s insulin pen dosing data to be viewed alongside Abbott CGM data. As of June 2023, NovoPens are integrated with LibreLink in 21 countries (Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, and the UK).
Biocorp’s Mallya smart pen cap for Novo Nordisk’s FlexTouch insulin pen launched in Japan in October 2022.
NovoPen 6 and NovoPen Echo Plus launch in Japan in March 2022; pens integrate with Health2Sync app to capture insulin injection timing and dosing data.
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.
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.
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.
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.
Novo Nordisk and Glooko partner to develop “digital tools for diabetes management” in January 2017. |
|
Lilly |
Tempo Personalized Diabetes Management Platform
|
FDA approval of Tempo Smart Button in September 2022; US launch began in November 2022. CE-Marked in August 2022; Lilly plans to initiate small-scale pilots in “selected countries” via collaborations with existing diabetes management ecosystem, as of November 2022.
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). |
|
Biocorp |
Mallya (f.k.a. easylog)
|
Acquired by Novo Nordisk in June 2023.
Received FDA 510(k) clearance in December 2022. Mallya CE-Mark in June 2019; Sanofi-specific version of Mallya for Sanofi’s SoloStar insulin pens received CE-Mark in September 2022.
Biocorp and Novo Nordisk announce launch of Mallya for Novo Nordisk FlexTouch insulin pens in Japan in October 2022. Health2Sync joined partnership to integrate its diabetes management app, including insulin tracking, into the Mallya smart pen cap for Novo Nordisk’s FlexPen in March 2023.
Diabeloop partners with Biocorp in April 2022 to integrate Diabeloop’s DBL-4Pen smartphone app to titrate insulin doses with the Mallya smart pen cap and Dexcom G6 CGM.
Partnerships with Diabeloop (March 2021) and Novo Nordisk (September 2021) first announced back in 2021. Biocorp announced the official launch of Mallya in Europe, followed by South Africa and Asia, in November 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.”
Mallya integration with Amalgam’s iSageRx announced in June 2020. Sanofi paid €1 million to Biocorp, plus an additional €12 million at subsequent milestones (total ~$15 million) in January 2020. Sanofi paid $2.2 million to incorporate Mallya with Sanofi insulin pens in December 2019; Sanofi aquires non-exclusive worldwide distribution rights.
In July 2019 Sanofi paid $4.5 million to enter an “exclusive negotiation” to bring Mallya into Sanofi’s integrated diabetes care management platform.
AgaMatrix announced as commercial partner in February 2019. |
|
Sanofi |
Developing disposable and reusable connected insulin pens for both basal and bolus insulins |
State of Sanofi/Mallya pens unclear, given Novo Nordisk’s acquisition of Biocorp in June 2023.
In December 2019, Sanofi paid $2.2 million to incorporate Mallya with Sanofi insulin pens; Sanofi acquired non-exclusive world-wide distribution rights.
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.
Announced at ATTD 2019, Sanofi is developing disposable and reusable connected insulin pens. |
|
Innovation Zed |
InsulCheck Classic
InsulCheck Connect
InsulCheck Dose
|
Per ATTD 2023 exhibit hall coverage, Innovation Zed is a B2B company that partners with insulin companies to connect their specific pen app and ecosystem with Innovation Zed’s InsulCheck connected pens. InsulCheck Connect is available on the market, and InsulCheck Dose launched at ATTD 2023. InsulCheck Dose CE-Marked in February 2023. Production of the pen began in 2Q22 and company said it would be available “as an FDA registered and CE marked product."
Innovation Zed partnered with GluCare.Health in April 2023 to provide the InsulCheck pen technology as a part of GluCare.Health’s digital clinic ecosystem.
Innovation Zed partnered with A. Menarini Diagnostics to commercialize InsulCheck Connect globally in January 2020.
InsulCheck Connect (FDA-cleared and CE-Marked) launched in 2016. InsulCheck Classic (FDA-cleared & CE-Marked) launched in 2009.
|
|
Insulclock |
Insulclock
|
Currently available throughout Europe; Spain is the biggest market. Expansion to US market anticipated by the end of 2023, per exhibitors at ATTD 2023.
Cost savings analysis of Insulclock compared to Standard of Care in Spain presented at ATTD 2023; RCT (n=21 people w T1D on basal-bolus therapy and CGM) associated with +1.9 hours/day Time in Range.
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
YpsoMate SmartPilot re-usable add-on:
UnoPen SmartPilot re-usable add-on:
|
Ypsomed produced 35% more YpsoMates in fiscal FY23 compared to previous fiscal year.
Company announced YpsoMate On connected prefilled autoinjector in October 2021.
Developing “SmartPilot” reusable add on to Ypsomate to track data and transmit to mobile app as of November 2017.
|
|
Common Sensing |
Gocap
Connected D-Flex |
Intellectual Property acquired by Bigfoot Biomedical (June 2021).
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).
Announced partnership with Flex in June 2018. |
|
Haselmeier |
D-Flex Connected
|
Partnership with Common Sensing announced in June 2018. |
|
Diabnext |
Clipsulin 3XS
|
Acquired by Glooko in March 2022.
Announced at ATTD 2020, Clipsulin launched in December 2019. |
|
Pendiq |
Pendiq reusable smart pen
|
No recent updates.
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
|
No recent updates.
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. |
|
BD |
Smart Sense (smart pen needle technology)
|
No recent updates.
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 connected pen/cap developers listed above.
|
Company |
Product + Features |
Timing/approval updates + recent coverage |
|
Welldoc |
BlueStar
|
Roche Diabetes Care Japan partnered with Astellas Pharma to commercialize Roche’s Accu-Chek Guide Me BGM with Welldoc’s BlueStar in March 2023.
Dr. Richard Bergenstal (International Diabetes Center) presented real world Welldoc BlueStar data for type 2 non-intensive insulin users at ATTD 2023.
Real world data of Welldoc BlueStar with Dexcom G6 CGM presented at DTM 2022.
Private iteration of BlueStar launched in Lilly’s Tempo Personalized Diabetes Management system in US in November 2022.
Collaboration and licensing agreement with Lilly to commercialize titration app for Lilly connected pens (February 2021).
Received FDA clearance in June 2020 for basal insulin titration, marking eighth 510(k) clearance. BlueStar chronic care support available via LifeScan OneTouch Solutions Portal (October 2021).
Company announced ninth FDA clearance to include bolus and premixed insulin for patients with type 2 (September 2021) following submission (November 2020).
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).
Launched in 2013. |
|
DreaMed |
endo.digital
|
Per the company, as of June 2023, preliminary data of reimbursement documentation feature demonstrates an increase of capturing endocrinology services CPT code (95251) by ~40%.
Medtronic licensed fuzzy logic algorithms from DreaMed for its future fully closed-loop AID system per Dr. Madhuri Vasudevan at AACE 2023.
Satisfaction data for people with T1D presented at ATTD 2023. Data also showed significant time saving to providers workflow.
FDA cleared for insulin injection users with type 1 and type 2 diabetes (October 2021).
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.
Soft launch of “virtual diabetes management service” in April 2020; Advisor Pro settings overseen by provider and sent to patient remotely.
Advice4U trial presented at ATTD 2020 indicated non-inferiority of Advisory Pro to expert provider advice. Results published in Nature Medicine.
FDA cleared and CE-Marked to optimize pump settings based on only BGM data in September 2019. Advisor Dose bolus calculator announced at ATTD 2019 to be “in-development.”
As of ATTD 2019: Advisor Pro delayed US and Europe roll-out due to software challenges; working with individual clinics to overcome hurdles. Testing with Tidepool data management platform in February 2019.
Advisor Pro cleared by FDA in June 2018, targeting end of summer US launch.
Cleared for use with SMBG and pump in November 2018.
Advisor Pro received CE-Mark in February 2018. |
|
Amalgam Rx |
iSageRx & DoseCheck (Non-exclusive white label licensed by Novo)
|
Amalgam Rx expanded partnership with Novo Nordisk in December 2022 to commercialize Novo Nordisk’s white labeled version of iSage Rx, named Dose Check. Dose Check was CE-Marked in June 2021.
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).
iSageRx integration with Biocorp’s Mallya device announced in June 2020.
Pilot study at Kansas University Diabetes Institute (ADA 2019).
Collaboration with Novo Nordisk to launch white-labeled version of iSage in Brazil under the name DoseCheck (June 2019).
Basal+GLP-1 basal-bolus FDA clearance expected by the end of 2017, but no recent updates.
In June 2017, Hygieia and iSage Rx launch Technology Collaboration.
Launched May 1, 2017 for iOS and Android after receiving FDA clearance for basal insulin titration. |
|
Hygieia |
d-Nav |
Extended Series B of $22 million closed in May 2023. Hygieia appointed Dr. Doug Lawrence as CEO in August 2022 to lead expansion of d-Nav.
As of ADCES 2022, d-Nav was working with three endocrinology practices in the US, with plans to have 20 partners by the end of 2023.
Northern Ireland National Health Service (the first international licensee of d-Nav) extended its software license in June 2022.
In Israel, Hygieia has a pilot program with Clalit, the largest Israeli integrated health system, and added a license with the Movement Group, a prominent health and wellness provider in June 2022.
$17 million Series B to drive d-Nav expansion outside southeast Michigan (December 2021).
Type 2 insulin titration app cleared by the FDA in February 2019.
Announced at ATTD 2019: RCT published in The Lancet.
Data presented at ADA 2018 indicated 2.3% A1c reductions at six months. |
|
Glytec |
eGlycemic Management System
|
Glytec unveiled GluoMetrics analytics platform for hospitals to monitor inpatient glycemic outcomes in April 2023; GlucoMetrics is a part of Glytec’s larger eGlycemic Management System (eGMS).
Plans to integrate inpatient CGM within eGMS announced at HDM 2022.
Glucommander pre-post analysis presented at HDM 2022.
Dr. Bruce Bode (Atlanta Diabetes Associates) says Glucommander works “extremely well” at ADA Clinical Update Course 2022.
As of January 2022, Glytec’s eGMS is currently implemented at over 60 health systems, representing 300 hospitals in the US to treat over 100,000 patients annually.
Glytec partners with Nebraska Medicine to support R&D of eGMS in January 2022.
In January 2022, Glytec announced it had received HITRUST CSF® Certification.
At ADA 2022, presented a poster outlining the safety and efficacy of using Glucommander to treat euDKA - the largest descriptive analysis of a nationwide cohort conducted to date.
At SHM 2022, presented a poster outlining how analysis of Glucommander data shows that the 15/15 rule of thumb is insufficient at treating most patients with severe hypoglycemia <40 mg/dL.
Glytec partners with Roche Diagnostics USA in January 2022 to integrate Glucommander with Roche’s cobas pulse connected point of care blood glucose monitoring system.
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.
$21 million in funding to support R&D efforts (April 2021).
Announced at ATTD 2020, Glucommander is now used in over 200 hospitals.
As of August 2017, the eGlycemic Management System was used to treat >150k patients in a year. Pilot study underway as of 2017 with Agamatrix to integrate Jazz Wireless 2 Bluetooth BGM with eGlycemic Management System. |
|
Glooko |
Mobile Insulin Dosing Software (MIDS)
|
Glooko integrates Hedia smartphone bolus calculator into remote patient monitoring platform in April 2023. See Close Concern’s Interview with CEO Mr. Russ Johannesson for more insights into Glooko.
Glooko granted ISO 27001 certification for remote patient monitoring platform in February 2023.
Glooko: xbird AI for Precision Engagement presented at DiabetesMine Fall Innovation Days 2022.
“Rising T1DE Alliance,” data integration initiative, presented at ISPAD 2022.
Glooko-sponsored session on remote patient monitoring platforms in clinican settings emphasize data is central to CDCES’s work at ADCES 2022.
Launches “Academy” online diabetes technology education program in Ireland in July 2022.
Glooko invest in “Just in Time Adaptive Interventions” and AI-power coaching, per Diabetes UK Professional Conference 2022.
Acquires diabetes management platform DIABNEXT to drive expansion in France in March 2022.
Glooko collaborates with the Johns Hopkins Healthcare Solutions Blossom program for diabetes management in March 2022.
Glooko acquires medical AI developer xbird in January 2022.
$30 million Series D to drive commercialization initiatives and expansion into additional therapy areas (March 2021).
Data presented at ADA 2020 demonstrated noninferiority to conventional titration (paper based titration tool).
As of ADA 2019 MIDS was “just starting” to launch. Piloting at small number of clinics in June 2018 with more extensive roll out by the end of 2018. Received FDA clearance in February 2018. |
|
Sanofi |
My Dose Coach
MyStar Dose Coach BGM
|
No recent updates.
Partnership w/Abbott to share FreeStyle Libre data with titration apps (September 2019); no specific timeline.
Announced at ADA 2019, My Dose Coach rolled out in India; 58% discontinued the app. As of ATTD 2019, ~3,500 people using Sanofi titration products annually. Launched in June 2017.
Available in the EU. |
|
Lilly |
GoDose
|
No recent updates.
Received FDA clearance in January 2017. |
|
TypeZero (Dexcom) |
inControl Advice
|
No recent updates.
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.
Pilot data from UVA study of CGM-based MDI support in June 2018.
Pivotal trial for Senseonics partnered decision-support system to be announced “soon” as of August 2017.
Initially shown at DTM 2016. |
|
Voluntis |
Insulia
Diabeo
|
No recent updates.
Partnership with Biocon to integrate biosimilar insulins for type 2 patients (July 2020).
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).
Launched Insulia savings program with a $0 copay in December 2017.
Available in France as of December 2016. |
|
Mellitus Health |
Insulin Insights
|
No recent updates.
Data presented at ATTD 2019 showed significant A1c reductions at 3 and 6 months.
Data from pilot study presented at ADA 2018 demonstrating strong A1c reductions.
Available in 30 “countries and clinics” in Europe and the US as of February 2018.
Cleared by the FDA in June 2017. |
|
ALRT |
Insulin Dose Adjustment (IDA) Feature
|
FDA cleared, no launch timeline. |
--by Talia Pikounis, Armaan Nallicheri, and Kelly Close