INJECTION TECHNOLOGY – Patient Centricity in Insulin Injection: Using Technology to Improve Self-Administration
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 InPenTM, 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 UnityTM 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.
- Medtronic InPenTM 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.
- 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.
- 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.
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