Smart Insulin Pens and Caps and Insulin Dose Titration Competitive Landscape – December 29, 2021

Company

Product + features

Timing/approval updates + recent coverage

Medtronic

Medtronic/Companion Medical InPen

• Reusable InPen lasts 1 year, tracks insulin dose and timing, monitors insulin temperature
• Compatible with Novolog, Humalog, and Fiasp insulin cartridges
• Bluetooth paired smartphone app (iOS, Android) with integrated bolus calculator
• Insulin on board and bolus calculation for carb counting, meal estimation, and fixed dose regimens
• Integration with Senseonics, Dexcom, and Medtronic CGMs (Guardian Sensor 3 in the US and Guardian 4 in Europe) Guardian 4
• FDA cleared for pediatric use (7+) or “under the supervision of an adult caregiver”

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

• Technology acquired from Timesulin in June 2017
• Bluetooth-enabled reusable smart cap for disposable and durable insulin pens; first generation Unity system composed of two pen caps, FreeStyle Libre 2, pen needles, back-up BGM and supplies
• White-colored insulin pen cap fits over rapid-acting insulin pens; black-colored insulin pen cap fits over long-acting insulin pens
• Both caps send insulin dose data (time, temperature, and recommended dose) to a paired smartphone app; app sends data to provider-facing Bigfoot Clinic Hub portal; app includes real-time hypo alerts (from FreeStyle Libre 2) and notifies user of potential missed basal doses
• Rapid-acting pen cap also serves as reader for FreeStyle Libre 2; cap uses glucose data to generate dose recommendation shown on the cap’s display

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

• CE-Marked and launched in Sweden, Denmark, and the UK
• Reusable pen with last insulin dose and time of injection on the end of the pen
• 800-dose memory, five-year battery life with NFC connectivity
• Compatible with both basal and bolus insulin cartridges
• Adjustments down to 1U of insulin with 60U max dose
• Data integration agreements with Medtronic, Abbott, Roche, Glooko, and Dexcom

NovoPen Echo Plus

• Same feature set with 0.5U adjustment increments and 30U max dose

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

• Connected smart pen system based on the disposable Kwik Pen platform
• Consists of Tempo Smart Button, Tempo Pen, and compatible app capable of titrating basal, bolus, and basal + bolus
• Tempo Smart Button attaches to the top of Tempo Pen enables data transfer via Bluetooth connectivity
• Lilly does not intend to launch Tempo Pen without the other components of the system
• Compatible with Tempo Pens for Basaglar 100 units/mL, Humalog 100 units/mL, and Lyumjev 100 units/mL

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)

• Reusable smart cap compatible with “all major pens” (disposable only so far), lasts two years; priced at ~$122
• Two-piece cap with one piece clipped to top of pen and second piece over the control dial/button
• Relays dose, time, and date to app via Bluetooth; app has reminders and alerts
• Data sharing partnership with DreaMed to send insulin dosing data to MDI/basal-only Advisor Pro clinical decision support system

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

• Reusable smart cap for disposable insulin pens, lasts one year
• Uses a light sensing technology to read how much insulin is in the pen and how much was just delivered (measures within ±1-unit)
• Rechargeable battery lasts a week or more on a two-hour micro-USB charge
• Compatible with Lantus and Apidra, plans to support a total of six types of insulin
• Listed with the FDA in summer 2016; 510(k) exempt for now (no dose calculator or other titration advice)

Connected D-Flex

• Partnered with Haselmeier and Flex in May 2018 to make smart, disposable pen platform based on the 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

• Reusable smart cap compatible with Lilly’s Kwikpen, Novo Nordisk’s Flextouch, and Sanofi’s Solostar; priced at €249, lasts 5 years, battery charge lasts 3 days with charging time of 1.5 hours
• Tracks insulin dose, time, type of insulin, and temperature

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

• Wirelessly transfer data to smartphones using a Near Field Communication (NFC) label (partnership with Norwegian-based Thinfilm); not for use with insulin but has applications for other injectable diabetes therapies

UnoPen attachment:

• Reusable smart addition to disposable pen

 SmartPilot: 

• Reusable add-on sleeve that transforms the single-use disposable YpsoMate auto-injector into a connected device via Bluetooth and NFC
• Passively tracks and transmits data to a mobile app including injection time and the sequence of handling steps (pressing against skin, triggering the injection, holding the auto-injector during the injection, and the end-of-injection)

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

• Reusable smart cap compatible with “most” insulin pens including Lilly, Sanofi, and Novo Nordisk
• Uses audible clicks from insulin pens to track insulin use
• Transmits via Bluetooth to “digital self-monitoring log-book” on smartphone; allows HCPs access to data
• Available to purchase on Amazon for $40

Announced at ATTD 2020, Clipsulin launched in December 2019.

Pendiq

Pendiq reusable smart pen

• Saves injection history on pen, downloadable via USB to computer, motor-driven, doses displayed on small screen on device, rechargeable battery

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

• Reusable pen sends dosing data via Bluetooth to a smartphone phone app, small on-device screen

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)

• Reusable sleeve captures dose information from disposable pens
• Durable (lasting ~1 year)
• Universally compatible with all existing disposable pens
• Can be used with any BD pen needle
• Sends data to paired smartphone app

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.

Company

Product + Features

Timing/approval updates + recent coverage

Welldoc

BlueStar

• Insulin dosing support
• Personalized, real-time 24/7 feedback
• Basal titration support
• Integrated data from BGMs, CGMs, pharmacies, labs, and activity trackers
• Behavioral health coaching and educational content

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

• Supports insulin pump and MDI therapy
• Partnerships with Harvard and Schneider Children’s for fingersticks; Glooko partnership; Dexcom G6 CGM data integration with Advisor Pro; partnership with Biocorp
• Partnerships with Medtronic for Advanced Hybrid Closed Loop system
• App includes bolus calculator and data uploader

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

• Supports basal insulin regimens for people with type 2 diabetes over the age of 21
• Partnered with Hygieia; goal to support insulin titration for many devices

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

• Supports “all types of insulin regimens” (i.e., basal and bolus) for people with type 2 diabetes
• App can connect with any BGM that shares data via the cloud and is available for iOS and Android
•  

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

• Supports basal insulin titration
• Basal-bolus, basal+GLP-1, NPH “still in the works”
• Partnerships with Onduo, Livongo, Sanofi, Ascensia, and Welldoc

Diabeo

• Basal-bolus system
• Partnership with Sanofi

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

• Supports basal titration
• Data partnership with Abbott and FreeStyle Libre CGM

MyStar Dose Coach BGM

• Supports basal titration

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

• Supports basal-bolus titration for inpatients
• Partnerships with Livongo, AgaMatrix, Telcare, and Onduo

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)

• Supports basal titration

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

• Supports bolus titration (Humalog)

Received FDA clearance in January 2017.

No recent updates.

Novo Nordisk

Insulin Dose Titration

• Partnership with Amalgam Rx

“Digital therapeutic” projects

• To leverage CGM/BGM, smart pen, and algorithms to “guide a patient safely and effectively”

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

• Supports basal-bolus titration
• Partnership with Senseonics (“on hold” as of November 2019)

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

• Works with “every type of insulin”

• Partnership with Smart Meter to integrate iGlucose BGM with 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

• Support basal titration

FDA cleared, no launch timeline.