Smartphone-Linked Insulin Pen System for Diabetes Launched in US

Liam Davenport

December 18, 2017

A new reusable insulin injector pen combined with a smartphone app that helps insulin-dependent diabetes patients calculate their doses and keeps track of injection data is now available in the United States.

The InPen system (Companion Medical) is devised for diabetes patients aged ≥ 12 years who are using multiple daily subcutaneous insulin injections and who cannot or will not use an insulin pump.

Compatible with U-100 Humalog (Lilly) or Novolog (Novo Nordisk) rapid-acting insulin cartridges, the system pairs with an app to track insulin therapy and help patients calculate mealtime and correction doses, as well as display reminders.

In a press release, the company says that the system, which is available only with a prescription, is currently on sale in the United States and is covered by several insurance plans.

It is, however, not yet available in retail pharmacies, with prescriptions instead forwarded to the company for fulfilment.

Sean Saint, CEO of Companion Medical, said: "The InPen system is a significant step toward true integrated diabetes management. Our team has worked diligently to develop a solution for people living with diabetes who want the benefits of an insulin pump without the cost or burden of being tethered to a device."

InPen Will Be Covered by Several Large Insurers

Discussing InPen's launch, the diabetes-advocacy website Close Concerns describes the availability of the InPen system as a "major win" for both multiple daily insulin injectors and their clinicians and calls its coverage by several large US insurers "a big victory."

It reports that the device will be reimbursed at tier 3, with the majority of patients having out-of-pocket copays of $0 or $50. Some others will have a copay of $120, while there is one documented case at $334.

"Given that the reusable pen lasts for a year, we see this as outstanding reimbursement out of the gate for a small company launching a new category in a tough healthcare environment," Close Concerns observes.

The discounted price for individuals without insurance coverage is currently $549, making it more expensive than disposable pens but far cheaper than an insulin pump.

InPen, which was granted 510(k) clearance by the US FDA in June 2016, combines an insulin injector pen with Bluetooth wireless technology to track insulin, including priming, doses via a smartphone app.

The app is currently compatible with devices running iOS10 and later and is available from the Apple Store. The company is working on an Android version, which it hopes to release toward mid-2018.

The system tracks the history and timing of doses, calculates and recommends optimal dosing, reminds users when to take their insulin, displays the last dose and insulin on board, monitors insulin temperature, and generates reports for healthcare providers.

Before using the app, healthcare professionals are required to input patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin-sensitivity parameters.

Users can then input data from blood glucose meters or continuous glucose monitors (CGMs) into the AppleHealth system. This integrates with the InPen app to allow insulin doses to be calculated based on previous injections, blood glucose, and carbohydrate intake.

The company says that it has conducted studies to demonstrate that patients can enter the data easily and use the app to calculate doses. By factoring insulin on board into the calculations, the system helps prevent insulin stacking, and it automatically differentiates between prime and therapy doses.

The InPen device, which is the same size and weight as a traditional insulin pen and comes in three colors, does not require batteries or recharging, as it is fitted with a nonrechargeable lithium battery that lasts for 1 year of use.

The InPen system has a host of competitors hot on its heels, with a number of similar "smart" insulin-dosing devices expected to be in trials and entering the market over the next few years.

These include products developed by traditional pharma companies such as Novo Nordisk and Lilly, as well as tech firms such as Common Sensing and Bigfoot Biomedical.

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