Voluntis’ Insulia basal insulin titration software receives FDA clearance and CE Mark; 1H17 launch in US and Europe; first of its kind to be FDA cleared – December 6, 2016

This morning, Voluntis announced that it has received both FDA clearance and a CE Mark approval for Insulia, its prescription-only basal insulin titration software (Apple iOS, Android, web). Insulia is a first-in-class insulin titration software to receive FDA clearance, and will be available to patients and healthcare providers in the US and Europe in the first half of 2017. The software has been in development for over six years. The go-to-market model is still being worked out, though Voluntis is partnered with Sanofi and Roche connected meters in Europe to enable passive data upload.

CEO Mr. Pierre Leurent told us that a basal-bolus version of Insulia has also received a CE Mark and is already available in France (Diabeo); the US will just have the basal version to start, though the intent is to bring the basal-bolus titration guidance to the US too.

Insulia initially supports Lantus and Levemir, but Voluntis is working to add Toujeo, Basaglar, and Tresiba in successive iterations (at least two of these are expected in a new version of Insulia in 1H17). The press release focuses on the basal-only titration for type 2s, though Voluntis’ Diabeo (basal-bolus) has shown efficacy in type 1s.  

The product seems very scalable. After a provider prescribes Insulia, a patient receives an activation code granting access to the software on a smartphone (iOS and Android) or on the web. Providers set up a personalized titration plan based on the patient’s profile, insulin prescription, and blood glucose goals. Insulia then provides daily, automated insulin dosing recommendations based on fingerstick BGM values, without a provider confirmation needed (unlike Glooko’s basal insulin titration system, or MIDS; 510(k) submission by end of 2016). Insulia can support both manual blood glucose entry or can connect to wireless meters (Sanofi and Roche BGMs are supported in Europe); manual BGM data entry will be the initial option in the US, and CGM is in the pipeline. We see this patient-facing recommendation engine as a big plus, since removing the HCP after system setup makes it more scalable. Insulia also provides automatically generated educational coaching messages (e.g., progress updates, prompts to input more BGM data, hypoglycemia tips). HCPs can monitor patients remotely in a web portal.

The pictures of the Insulia smartphone user interface (see below) show a pretty basic app that gets the job done – it shows the treatment plan (BG goals, insulin dose), clearly displays the current recommended dose (Morning – 14 units), and lets users manually log BGs and doses. There are no frills here, and the company has presumably focused on the underlying algorithms and human factors safety more than a glitzy user interface.

The business model and go-to-market strategy are unclear, though Voluntis can pursue several options depending on the market. In France, the software is currently reimbursed under the national payer (60 million covered lives!). In the US, presumably providers or health systems could cover the standalone software and offer it to their patients, or a launch could occur in direct partnership with connected BGMs – e.g., Insulia is offered as a companion software, similar to the J&J LifeScan/WellDoc and Roche/mySugr partnerships. Mr. Leurent said that existing partners will be involved in the launch of the product, and the company has previously adopted this device-software integrated strategy in coagulation management with Roche.

We are elated to see this clearance, as insulin dose titration represents one of the lowest hanging fruits in diabetes – it’s impossible for most patients and HCPs to continuously and accurately titrate basal insulin, leading to significant under-treatment and clinical inertia. Well-known algorithms exist to easily and more safely titrate insulin, even with just BGM data. Such algorithm-driven care also has an obvious role to play in value based healthcare: more efficient and safer use of insulin, titrated automatically every day, will hopefully save providers time to focus on population health and giving terrific in-person care.

• The basal/basal-bolus insulin dose titration software landscape is heating up and includes: Sanofi’s MyStar Dose Coach BGM (available in Europe), Glooko’s mobile insulin dosing system (FDA submission expected by end of 2016), DreaMed’s MD Logic Pump Advisor with Glooko (beginning a study soon), TypeZero’s inControl Advice (shown at DTM), Glytec (Glucommander Outpatient, compelling late-breaking poster at ADA 2016), Hygieia’s d-Nav service (reimbursement study with BCBS ongoing in Michigan), Patients Pending’s Timesulin Dose Capture (smart cap with dose titration component), and many others that have alluded to this area (e.g., BD’s Smart Sense pen needles, Bigfoot Biomedical, Sanofi/Verily’s Onduo, etc.).

Insulia Screenshots

• Users can view the prescribed treatment plan at any time, showing the blood glucose goals quite clearly. Insulia will use well-known insulin titration algorithms, though physicians can customize each plan. Patients will receive an updated basal insulin dose recommendation every day based on blood glucose levels entered into the app (see below). Mr. Leurent emphasized that the software allows significant flexibility so that healthcare providers can adjust as they find appropriate.

• The dose recommendation screen is very clean, clearly displaying the dose, buttons for “refuse” and “confirm,” and a details menu (to presumably give more background on the calculation). One of the big questions for insulin titration algorithms is whether patients in the real world (not clinical trial setting) will actually stay engaged with the software and follow the recommended changes. We certainly hope so. We could also envision a future system that includes a smart pen/pen cap integration for passive tracking of doses – to confirm the recommendation was delivered – but clearly Voluntis believes Insulia can provide enough value without that feature. Perhaps the more interesting question is how much additional value a connected pen/cap would add to this system?

• Voluntis seems very committed to interoperability and partnership, and we wonder how it will come to market in the US. The company has already experimented with nursing service collaborations in Europe and has previously developed diabetes apps (e.g., Diabeo) with Sanofi. As noted above, Voluntis is also partnered with Sanofi and Roche connected BGMs in Europe. We see many other potential partners too, including connected BGMs (Ascensia Contour Next One, LifeScan Verio Flex, Livongo, One Drop Chrome), sensors (Abbott, Dexcom, Medtronic), and data management platforms and other apps (Glooko, mySugr, Tidepool).
• Mr. Leurent alluded to “several clinical trials in the past 10 years” and an extensive human factors studies program. One such study, published in a March 2011 Diabetes Care issue, demonstrated that use of Diabeo, Voluntis’ basal-bolus titration app, resulted in a significantly greater A1c reduction (~0.7%-0.9%) at an overall lower cost relative to usual care. There are more clinical trials in the pipeline, including a one-year study evaluating the Diabeo system in poorly controlled type 1s and type 2s on basal-bolus therapy – the impressively large 696-patient, 12-month study has an expected primary completion date this month, per clinicaltrials.gov (it’s currently recruiting, though the page has not been updated since July).
• Mr. Leurent raved about the FDA clearance process: “The FDA regulatory framework for digital health is getting clearer. Our collaboration with FDA is great. We really like the advice, feedback, and guidance.” The device side of FDA continues to impress with its transparency and willingness to work with manufacturers – we didn’t hear specifics from Mr. Leurent, but we learned at DiabetesMine’s Innovation Summit that Medtronic had monthly meetings with FDA for 2.5 years leading up to September’s MiniMed 670G hybrid closed loop approval.
• Mr. Leurent noted that it may be part of the R&D roadmap to include CGM integration in the future. TypeZero showed off its inControl Advice system at DTM, which uses CGM to titrate basal-bolus insulin in MDIs. 

Close Concerns Questions

Q: How will Voluntis come to market in the US and different EU countries? Who will pay for the software? Will it be integrated into a BGM device or marketed as a standalone app?

Q: Will patients in the real world (not clinical trial setting) actually stay engaged with dose titration software and follow the recommended changes?

Q: How open are providers to prescribing an app? Will Voluntis scale Insulia faster than WellDoc has scaled BlueStar?

Q: How much additional value would a connected pen/cap add to Insulia? Are connected pens/caps unncessary for basal and basal-bolus titration?

Q:  How will basal-bolus titration with BGM or CGM compare to automated insulin delivery? How will insulin dose titration software compare to or augment human coaching services (e.g., Livongo, mySugr, OneDrop)?

Q: Insulia is marketed towards type 2s, though will the basal-bolus version be approved and marketed to type 1s?

Q: What kind of real-world clinical outcomes can Insulia drive? What might the average annual cost savings be?

-- by Brian Levine, Adam Brown, and Kelly Close