INJECTION TECHNOLOGY - Patient Centricity in Insulin Injection: Using Technology to Improve Self-Administration

INTRODUCTION

For the past century, insulin injection has been used to treat diabetes mellitus, which is caused by the body not being able to produce enough of, or properly utilize, its own insulin. While there have been a number of methods of insulin delivery developed throughout the years, such as insulin pumps or even inhalers, the most common method remains daily self-administered injection through the use of syringes or insulin pens.

There are many reasons why people with diabetes might choose injections over a pump. Pumps are significantly more ex­pensive, and insurance coverage concerns are a deterrent. Alter­nately, some people choose not to continuously wear a device due to lifestyle preferences. A pump can only be removed for short periods of time, which is undesirable for some prospective users. Adding to the perceived inconvenience, certain activities, such as those involving water or contact sports, require extra con­sideration to protect an insulin pump. Another factor is ease of use; a pump is a complex device that can be difficult to learn to use and maintain — and errors in usage can lead to serious com­plications, such as severe hypoglycemia.

However, there remain a number of challenges to those who self-administer their insulin injections. For some, particularly older people, dimin­ished manual dexterity and eyesight can make it physically difficult to carry out their own injections. Additionally, multiple daily injections (MDIs) can be painful and cause scarring. Other challenges are less physi­cal, such as fear of needles, or difficulty determining how much insulin to use and remembering doses.

Advances in injection technology that make insulin self-administration easier are growing ever more important in patient-centric diabetes care. For a long time, this primarily meant the development of injec­tion aids. Now, advances in smart technol­ogy have opened up new options for people with diabetes. The following will ex­plore how injection technology has made self-administration of insulin easier, and how it will continue to develop into the fu­ture.

OVERCOMING CHALLENGES WITH INJECTION AIDS

For some time, people with diabetes who use MDIs had to rely on injection aids to assist with any difficulty in self-adminis­tration. There are many kinds of injection aids, including modifications or attach­ments to traditional syringes or insulin pens. These aids typically help with physi­cal challenges — such as by adding mag­nification to better read the numbers on a syringe. Several of these can meaningfully assist insulin users with the act of injection.

One example is the automatic insulin injector, which allows patients to insert a needle at the push of a button. A spring-loaded mechanism that actuates the nee­dle behind a shield offers users control over drug delivery by manually pressing the syringe’s plunger. Models, such as the Inject-Ease^® from AmbiMedinc, are com­patible with multiple syringe sizes and use spacer rings to control injection depth. Au­tomatic injectors offer assistance to those with limited dexterity who might otherwise have difficulty properly inserting a needle or reaching the insertion point. Addition­ally, they provide an easier means of de­livery for those who fear needles.

A different kind of aid is the tempo­rary injection port, which is a short-term cannula that allows for multiple injections with just one skin puncture. A needle intro­duces a soft cannula that will remain in the patient’s skin for several days, allowing the patient to use the same site to inject insulin with either a syringe or pen. For those who need as many as four injections a day, this significantly reduces the number of needle punctures: one 3-day port can eliminate the need for 11 additional injection sites. This can reduce pain, bruising, and scar­ring sometimes caused by MDIs, removing a deterrent to self-administration.

Another meaningful modification of injection devices has been to allow users to inject with just one hand. Often, patients use one hand to pinch tissue at the injec­tion site to ensure the needle enters fatty tissue rather than muscle, while the other hand injects the insulin. Aids such as the TickleFLEX Insulin Injection Aid, are exten­sions that can be added to an insulin pen to increase the available area for injection by using arms to gather tissue on their own. This means insulin users are no longer limited to areas that can be reached by both hands, and reduces the scarring and the risk of lipohypertrophy caused by repeated injection in the same site.

These injection aids have, for the most part, been in use for several years. Though they do not significantly alter the basic function of syringes and insulin pens, they do provide solutions to material problems that many people with diabetes face in ad­ministering their own injections. Still, there are difficulties — particularly related to the cognitive strain presented by tracking, re­membering, and calculating insulin doses — that these aids cannot solve, which re­quire new and innovative approaches.

THE RISE OF SMART INJECTION TECHNOLOGY

Currently, advances in technology are taking insulin injection one step further. As more and more everyday items, from re­frigerators to thermostats, are gaining smart connectivity for user convenience, so too are insulin delivery devices. Data con­nection and compatibility with devices, such as phones, are enabling people with diabetes to have more information at their disposal about their health and are help­ing them make decisions regarding insulin dosing.

For people using MDIs, smart insulin pens represent new possibilities for mak­ing their administration routine easier. One of the key advantages of these de­vices is the ability to sync up with, and process data from, a continuous glucose monitor (CGM). Rather than requiring as many as 10 finger pricks a day to check blood glucose levels, a CGM is a tiny sen­sor that is inserted beneath the skin to measure blood glucose every few minutes on an ongoing basis. These readings can then be sent to a smart pen, which processes the information and uses it to provide dosing recommendations that help users decide the right amount to take based on current data. Because calculating the correct dosage with every injection can be mentally taxing for people with di­abetes, having a recommendation based on their current levels removes a huge bur­den.

Smart pens can also help users by tracking doses. Insulin injections can be­come so routine that people with diabetes sometimes have trouble remembering when they have last administered a dose, or what that dose was. With smart pens, insulin users no longer need to rely on memory or on keeping their own log. In­stead, dose history is automatically recorded and stored for easy reference. More importantly, the pen can provide re­minders when it is time for another injec­tion.

Another function of smart pens is to provide notifications for a variety of user concerns. For example, if the insulin is ex­posed to high temperatures that might render it unusable, or if it is set to expire soon, the pen can let the user know so that the cartridge can be replaced.

All of this is made even easier for smart pen users by the fact that most smart pens work with an associated mobile app. The smart pens automatically upload information, such as dose history or blood glucose levels, to the app for easy access, in addition to including helpful tools, such as dose calculators. As the use of smart­phones has become the norm in countries around the world, this creates an easy in­tegration of the smartpen and the advan­tages it offers into everyday life.

A number of developers are seeing the potential offered by smart insulin pens. A recently released study showed that the Medtronic InPen^TM, the first smart pen to be approved by the FDA, increased the amount of time that patients spent in their desired blood glucose range, among other positive results.¹

Other smart insulin pens are entering the market as well. The Bigfoot Unity^TM Di­abetes Management System was approved by the FDA in May, offering greater levels of decision support, including a con­nected insulin pen cap that tracks long- and short-term insulin doses. Other phar­maceutical companies, such as Lilly and Novo Nordisk, currently have smart insulin pens in development.

Smart patches may soon provide an­other option for patients who cannot or do not want to use pumps. Transdermal insulin patches, which use preloaded mi­croneedles to deliver insulin subcuta­neously, have been available for some time. However, researchers have been working to develop patches made with a glucose-responsive polymeric matrix that can respond to blood glucose and release insulin accordingly.² While these patches are still early in testing, they may someday present a less invasive and less painful choice that requires little daily intervention on the part of the user.

THE PURSUIT OF A CLOSED LOOP

Smart pens are only the beginning for people with diabetes looking for an im­proved experience with self-administra­tion. As developers set their sights on more ambitious goals for insulin injection sys­tems, and as technology advances, the options for insulin users will grow.

Ultimately, one of the major goals of injection technology going forward is to create a fully closed loop system, also re­ferred to as an artificial pancreas, which calculates and measures the appropriate dosing to manage the user’s blood glu­cose levels without any outside interven­tion. While there is some level of automation in insulin delivery, the technol­ogy currently approved for use is only a hybrid closed loop, which means that the user must intervene to compensate for mealtime spikes in blood glucose levels. In many cases, a fully closed-loop system refers to an insulin pump — but not al­ways.

Even for people who use MDIs, auto­mated insulin delivery is on the horizon. Though these individuals will still need to administer the physical injections, ad­vances in monitoring and the algorithms used to calculate correct dosing will mean it will take progressively less decision-mak­ing or input on the part of the user. The goal is to someday make the process so fully automated that the user will only have to perform the injection, and the smart pen and related technology will do the rest.

Advances in artificial intelligence (AI) may have a large role to play in achieving that closed loop. AI is being integrated with injection devices to better assess fluc­tuations in blood glucose levels and to de­termine whether they are being caused by meals, allowing for faster and more ap­propriate insulin response.³ As better AI further develops, users will need to do less, and eventually, little to no mental work to ensure they are taking the right dose at the right time, making self-administration pro­gressively easier.

KEEPING PATIENT NEEDS IN MIND

Though injection devices, such as sy­ringes and insulin pens, have remained the standard for people with diabetes for a long time, there is still a great deal of room to grow in making those devices easier to use. While injection technology is making great strides in its ability to main­tain users’ health, it remains just as impor­tant to continue to find ways to minimize the everyday challenges they face in ad­ministering their own insulin injections. Ad­vances, such as smart pens and closed loop systems, offer the opportunity for in­sulin users to reduce some of the mental burden that comes with MDIs and make injection a smoother part of their routine. And after all, technology can only help if people are able to use it.

REFERENCES

1. Medtronic InPen^TM Real-World Data and Extended Infusion Set* Pivotal Trial Results Demonstrate Strong Clin­ical Outcomes and Positive User Ex­perience. Medtronic. June 28, 2021. Accessed July 6, 2021. https://news.medtronic.com/2021-06-28-Medtronic-InPen-TM-Real-World-Data-and-Extended-Infusion-Set-Pivotal-Trial-Results-Demonstrate-Strong-Clinical-Outcomes-and-Posi­tive-User-Experience.
2. Schaffer, R. The future of insulin: Pills, patches, weekly formulation could change diabetes management. En­docrine Today. May 2020. https://www.healio.com/news/en­docrinology/20200518/the-future-of-insulin-pills-patches-weekly-formulation-could-change-diabetes-manage­ment. Accessed July 6, 2021.
3. McDermid, E. AI may facilitate fully closed-loop insulin delivery. Medicine Matters. June 5, 2021. Accessed July 6, 2021. https://diabetes.medicine­matters.com/attd-2021/artificial-pan­creas-systems/ai-fully-closed-loop-in­sulin-delivery-type-1-diabetes/19231864.

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David T. Novotny is the General Manager & Global Head of ICON’s Medical Device and Diagnostic Research business unit. He has more than 18 years of experience within the medical device, diagnostic, biotech, and clinical industries. He has held leadership roles in Sponsor and CROs companies as well as in-clinic appointments. He is also an industry consultant and author to the life-science industry for the past 10 years across the product development lifecycle and clinical research field. His working experience includes strategic business development, quality systems, technology integration, business optimization, clinical operations including program management and market access. His global expertise in operations and market intelligence enables him to support clients in key markets like North America, EMEA, and Asia.