Language Matters: Connected Pens,Smart Pens,Connected Smart Pens,or Just Digital Pens?

In the last 100 years, we have seen tremendous development in devices used for insulin application, from syringes to pre-filled disposable/reusable insulin pens, to pens with a memory function, to “connected caps/buttons.” The evolution goes from buttons or caps that are attached to a disposable pen and able to send information about the injection time/insulin dose to an app to “connected insulin pens,” which are reusable pens that allow the information on the size and timing of insulin dose to be transferred into diabetes management reports, and finally, “Smart MDI systems,” that combine data from systems for continuous glucose monitoring (CGM) with insulin-dosing information in such a way that optimal insulin doses are suggested, thus establishing a complete diabetes management system (Table 1).

Table 1.

Information About Different Insulin Pen Systems That Are Currently on the Market in At Least Some Countries.

Name	InPen	Mallaya	NovoPen 6NovoPen echo plus	Tempo cap
Company	Medtronic/Companion Medical	Biocorp/Roche	Novo Nordisk	Eli Lilly
Type of pen	Reusable	Disposable pen + reusable cap	Reusable	Disposable pen + reusable cap
Type of insulin	Bolus Lispro/Aspart No basal insulin	Bolus and Basal from different producers Eli Lilly/NovoNordisk/Sanofi	Bolus and Basal from NovoNordisk	Bolus and Basal from Eli Lilly
Incremental Steps (U)	0.5	1.0	1.0/0.5	1.0
Approval FDA/CE-mark	Yes/yes	Pending/yes	Yes/yes Yes/yes	Yes/yes
Application/Database	Specific/CareLink	Specific/Glooko planned	Several/Glooko	Specific/Glooko
Warranty (years)	1	2	3	3
Connectivity	Yes	Yes	Yes	Yes
Open API	No	No	Yes	No

Abbreviations: FDA, US Food and Drug Administration; CE mark, Conformité Européenne certification; API, application programming interface

But what is smart, or smart enough? A smart device is a device that takes input from the physical environment and uses built-in resources to perform predefined functions upon detection of specific input and then processes data before passing it on. ¹ A smart device could be considered a device able to connect to other devices. Also, the smart sensor is a crucial and integral element in the Internet of Things, the increasingly prevalent environment in which almost anything imaginable can be outfitted with a unique identifier and the ability to transmit data over the Internet or a similar network. As medical devices become increasingly connected to each other as well as to other electronic technologies, the ability of connected systems to safely, securely, and effectively exchange and use information becomes critical.

Smart devices with the ability to share information across systems and platforms can according to the US Food and Drug Administration (FDA) facilitate diabetes management by ² :

• Improving patient care,

• Reducing errors and adverse events,

• Encouraging innovation,

• Enabling more diverse datasets.

Currently, there is no consensus on the terminology used when it comes to these modern “digital pens.” As such pens often involve an app or a downloading platform, it might be appropriate to refer to them as “insulin pen systems”; however, the terminology used should not be defined by the marketing department of the manufacturer.

Terminology and adequate usage of language that describes precisely what a given device can do is not simply a semantic topic, it has a lot to do with acceptance in the market and by the health care insurance companies. This in turn means, what is the willingness to reimburse a given device, and for which price? Manufacturers of insulin pen systems might have to aim for different reimbursement categories for connected pens/caps (just collecting and sending data) or smart pens/caps (algorithm and insulin-dosing decisions in the device).

Diabetes care in the future might differ between countries depending on reimbursement for insulin pen systems. It has been shown that such smart pens are cost-saving, and their usage has been associated with a reduction in HbA1c, and improvements in time in range (TIR), time above range (TAB), time below range (TBR), and %CV (coefficient of variation) ³ ; however, until now, there has been only limited use of insulin pen systems. ⁴

Insulin pens (= caps/buttons and “simple” pens) that just collect data about insulin dosing and transfer these to an app or to the cloud are not “smart” but rather convenient. The smart part lies in the software of the apps or in the smartphones.

A key question in this context is, what is the definition of “smart”? We suggest that this means when it comes to diabetes management of patients with diabetes (PwDs), detection of missed or late insulin dosing, data analysis, data interpretation, and providing the user with recommendations for therapeutic actions (plus documentation and reporting of insulin-dosing data). In this sense, just a display of data in a graph and a “simple” data display/calculation of some descriptive parameters do not fit into this definition. If this is provided by the given pen/app, it is the user who must be smart, he or she has to detect trends/patterns of the glucose levels and come to conclusions about adequate changes in insulin therapy. One can assume that pens will come to the market that have a built-in algorithm, advising the users when to take or to adjust the next insulin dose or add carbohydrates, without the direct need for the use of an app or smartphone. For such products, the name “smart pens” is truly appropriate. However, without being directly linked to a glucose monitoring system (either a system for self-monitoring of blood glucose [SMBG] or a CGM system), all these pens are not smart when it comes to diabetes therapy. Bringing glucose data into the game will enable “closing the loop,” without the need for an insulin pump. Such combined systems (that might fit many PwDs with type 2 diabetes or at least some with type 1 diabetes) will be surely the next step, and we should have a good name reserved for these to avoid confusion.

The usage of these smart systems depends on the user’s ability to choose specific smart insulin delivery devices, not only based on the PwDs’ current needs and wishes but also depending on the needs of the health care provider (HCP)/diabetes team. However, the influence might also include merits or reviews/opinions expressed on social media. Furthermore, smarter is a word that might be used by marketing people to make devices that are not smart sound as if they perform more efficiently if they are given the descriptive name “smart.”

We are not the first to think about terminology and insulin delivery systems. Due to lack of agreement on consistent terminology, the authors discuss the best word for the letter D in Automated Insulin Delivery systems. ⁵ Regarding smart pens, a staged approach to the name used for different pens in relation to their abilities ⁶ was suggested (Figure 1). Furthermore, they discuss the potential of smart pens and smart caps, and apps that may aid in minimizing the long-term costs and complications of diabetes and improve diabetes care overall. ⁶ One wonders who (diabetes associations?) can induce a certain definition of words/terms into clinical practice.

Figure 1.

Historical development of insulin administration pen devices with increasing functions over time. ⁷