By Grace Liberty
Diabetes management has steadily advanced along with the development of new technology. An important step in improving insulin delivery was the introduction of smart insulin pens that enhanced dosing accuracy and convenience of use. Smart Insulin Pens (SIPs) revolutionized diabetes care by introducing real time wireless connectivity, digital dose tracking, and integration with personalized dosing support. With automatic dose capture, reviewing insulin dose data became more effective, especially when paired with blood glucose data. This technology enabled patients, healthcare providers, and diabetes care teams to make data driven decisions and recommendations in real time. Improved diabetes management decisions became possible within a continuous and asynchronous framework with the use of SIPs. Manufacturers of insulin pens aim their efforts at further automation with more advanced software and integrated machine learning within SIPs. The role of technological advancements in diabetes care cannot be dismissed or undermined due to numerous benefits and opportunities modernized diabetes care carries. However, there are important challenges and vulnerabilities associated with technological advancements that this blogpost aims to discuss.
As of 2021, the CDC reported that approximately 38.4 million Americans, about 12% of the population, have been diagnosed with diabetes, with the statistic steadily rising.[1] This staggering number reflects a growing public health concern that necessitates effective management and treatment strategies. Diabetes is a complex metabolic disorder that requires a multifaceted approach to treatment, tailored to individual needs and circumstances. Among those diagnosed, approximately 8.6 million individuals rely on insulin for managing their condition on a daily basis, highlighting the critical importance of availability of insulin and comprehensive diabetes care.[2] Essential to effective diabetes management is an access to an array of healthcare resources, encompassing healthcare professionals, pharmaceutical interventions, monitoring technologies, and educational initiatives.[3] Overall, the management of diabetes requires a comprehensive and individualized approach reliant on the use of biomedical technologies such as blood glucose monitoring devices and insulin injection devices, one of which is an insulin pen.
Insulin pens were first introduced in 1985 by Novo Nordisk with a pen called the NovoPen. Smart insulin pens were then developed in 2007 with Eli Lilly’s HumaPen MEMOIR. Novo Nordisk shortly followed with the NovoPen Echo in 2009. The first smart pen to receive FDA approval was Medtronic’s InPen in 2017.[4] These insulin pens were novel because they allowed ease of transportation and administration of insulin. The new discrete design could allow users to feel more comfortable with injections of insulin in public. Especially beneficial to children since the dial on the pen allows for smaller, more controlled doses (0.5 U).[5] The pen also come in various shapes and colors to reduce stigma around using a pen. This technology has continued to evolve with new pens from Novo Nordisk, and competitors like Eli Lilly and Sanofi-Aventis.[6] Connected insulin pens (SIPs), also known as smart pens, redefined the landscape of diabetes management through their integration of technology. These pens stand out for their intelligent features, such as automatic dose tracking, personalized dosage suggestions based on real-time glucose data, and the presence of an intuitive screen on the device itself that allows for easy access to important information. By using sophisticated algorithms and wireless connectivity, SIPs empower users to make informed decisions about their insulin therapy, providing a level of precision and convenience previously unattainable with traditional insulin pens.
Opportunities
SIPs offer various features that can significantly alleviate the burden of diabetes management. These features include automatic recording of insulin dose information, tracking of insulin-on-board, bolus calculators, and missed dose alerts. Additionally, SIPs are able to connect to devices such as smartphones through Bluetooth or Near Field Communication (NFC), to provide an integrated, user-friendly experience for the patient, further enhancing technological utility and accessibility.
One popular smart pen is the NovoPen Echo, which automatically transmits data about insulin administration, including time and dosage, to a smartphone application.[7] It also provides reminders for insulin intake and alerts users of suboptimal temperature conditions, ensuring the potency and safety of insulin. The integration of cloud-based sharing technology further enhances the utility of these smart pens by facilitating real-time data sharing between patients and healthcare providers. The data collected not only improves personalized treatment plans but also contributes to better clinical outcomes at lower costs compared to standard care.[8] By providing continuous glucose monitoring and personalized insights, the NovoPen Echo holds the potential to enhance glycemic control and reduce glucose variability, thereby improving the quality of life for individuals with diabetes.[9]
There have been recent developments with apps that are compatible with smart insulin pens. Diabeloop corporation has pioneered a smartphone app that integrates a proprietary self-learning algorithm, offering dynamic titration of both basal and bolus insulin doses.[10] This app is connected to the smart pen and a continuous glucose monitor (CGM), providing users with a comprehensive diabetes management solution. This integrated system achieves a level of personalization by considering various factors such as meals, physical activities, and glucose trends. Also, the app utilizes the entire patient history to fine-tune bolus amounts based on the individual's response to previous doses. With minimal input required from users, the DBL-4penTM app automatically recommends the optimal insulin dose in real-time, streamlining the delivery process via the connected pen and eliminating the need for manual calculations. This user-friendly and intuitive solution represents a significant advancement in diabetes care, offering enhanced convenience and precision for individuals managing diabetes. Despite these advantages, the adoption of connected pens and pen caps remains relatively low among insulin users due to several factors, including limited awareness among healthcare professionals, inadequate initial training for prescribers, and challenges in device setup.[11]
Challenges and Vulnerabilities
Despite their advantages, insulin pens also bring about concerns regarding cybersecurity risks and accessibility barriers. As these devices become increasingly connected to smartphones and other digital platforms, they become vulnerable to potential cyberattacks and data breaches. Hacking incidents could compromise sensitive patient information or even manipulate insulin dosages, posing health risks to users.[12] A class action lawsuit was filed against Medtronic on August 30th due to a breach with their InPen app.[13] Personal information used for tracking in the app was disclosed to Google and other third parties. The lawsuit claims that Medtronic collected and transmitted users' personal data without consent or authorization.[14] The breach, discovered in April 2023, potentially affected users dating back to September 2020.
The reliance on technology for insulin delivery introduces concerns about power sources and battery life. If the pen's power charge were to fail unexpectedly, it could disrupt insulin administration and jeopardize the user's health. Novo Nordisk’s pen does not require a chargeable power source, but their pens require a battery to display the data of the latest dose.[15] These smart pens require a power source to not only display information on the pen, but also to connect to smartphones for a more in-depth diabetes management.
Healthcare providers face several barriers to effective smart insulin pens (SIPs) integration into diabetes management. One significant challenge is the lack of appropriate training and communication about SIPs with patients.[16] Many providers may not have received sufficient education on the features and benefits of SIPs, resulting in inadequate guidance for patients considering these devices. The rapid pace of technological advancements in diabetes care may leave healthcare professionals struggling to stay updated on the latest SIP options and functionalities. As a result, there is often limited awareness among healthcare providers about the various types of SIPs available and how to incorporate them into comprehensive diabetes management plans. Additionally, some providers may have reservations about the reliability or efficacy of SIPs compared to traditional insulin delivery methods, further contributing to their underutilization in clinical practice.
Patients encounter various obstacles that hinder their access to and utilization of SIPs. Affordability is a primary concern, as the high cost of SIPs and limited insurance coverage may render them inaccessible to many individuals with diabetes, particularly those from marginalized or low-income communities.[17] Furthermore, patients may not receive adequate education and training on how to use SIPs effectively, including setting up the devices, interpreting data, and troubleshooting common issues. This lack of education can lead to frustration and disengagement among patients, ultimately resulting in suboptimal outcomes. Additionally, technological barriers, such as difficulties in downloading and using smartphone apps required for SIPs, can impede patient adoption, especially among older adults or those with limited digital literacy. Language barriers and concerns specific to pediatric patients, such as managing SIPs in school settings or addressing parents' anxieties about their child's insulin administration, contribute to the challenges faced by patients seeking to use SIPs. Also, the requirement for compatible apps and connectivity may potentially exacerbate healthcare disparities and add to the overall cost burden of diabetes management.
At the clinical and the operational level, barriers to SIP integration include administrative hurdles that delay the prescription and initiation process. These hurdles may include prior authorization requirements, confusion regarding prescription destinations (pharmacy or durable medical equipment company), and gaps in coordination between prescribing and training processes.[18] Moreover, the increasing reliance on telemedicine for healthcare visits poses challenges for patients who are less tech-savvy or lack reliable internet access, leading to disconnection and communication issues during remote consultations. Addressing these clinic and operational-level barriers is crucial for streamlining the SIP prescription and initiation process, ensuring timely access to SIPs, and providing comprehensive support to patients throughout their diabetes management journey. Efforts to improve provider education, enhance patient support mechanisms, and streamline administrative processes can help overcome these barriers and facilitate the widespread adoption of SIPs as valuable tools in diabetes care.
Conclusion
The management of diabetes is a complex and evolving challenge that requires time and innovative solutions. These technological advancements have the potential to further transform the landscape of diabetes care, empowering both patients and healthcare providers to make informed care decisions in real-time. The analysis of emerging technologies like smart insulin pens is crucial for several reasons. While new innovations promise exciting advancements in diabetes management, it's essential to recognize that they also bring new challenges and risks. Increased digitalization and connectivity, inherent in smart devices, can expose users to cybersecurity threats and unauthorized access to sensitive health data. Understanding these potential vulnerabilities is vital for mitigating risks and ensuring the safety and privacy of patients' health information.
The landscape of diabetes treatment continues to change with advancements in machine learning and other emerging technologies. These innovations offer a promising future for further development and optimization of treatment strategies. For example, machine learning algorithms can analyze vast amounts of patient data to identify patterns and predict individual responses to different treatment regimens. By harnessing the power of artificial intelligence, healthcare providers can tailor treatment plans to better meet the unique needs of each patient, ultimately improving outcomes and quality of life for many.
In addition to machine learning, ongoing research and development efforts, such as liver-targeted insulin delivery, underscore the commitment to continuous innovation in diabetes care. Technologies like Diasome's liver-targeted insulin represent a leap forward in treatment approaches by aiming to mimic normal physiological insulin distribution.[19] By directing insulin specifically to the liver, these advancements have the potential to significantly enhance glucose control after meals and reduce the incidence of hypoglycemia, addressing key challenges in diabetes management.
In conclusion, this brief analysis serves to foster a deeper understanding of the opportunities and challenges presented by new technologies in diabetes care. Learning about technological tools and innovations such as smart insulin pens and liver-targeted insulin delivery, we can not only help to optimize diabetes management strategies but also customize technological solution with patient’s individual needs to improve their health outcomes and their quality of life. It also encourages ongoing dialogue and collaboration among healthcare professionals, researchers, and technology developers to ensure that advancements translate into tangible benefits for patients. Through this collective effort, we can continue to push the boundaries of diabetes care and pave the way for a brighter future for all those affected by this chronic condition.
[1] Centers for Disease Control and Prevention. (2022, October 25). By the numbers: Diabetes in America. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/health-equity/diabetes-by-the-numbers.html
[2] American Diabetes Association announces support for Insulin Act at Senate Press Conference. American Diabetes Association Announces Support for INSULIN Act at Senate Press Conference | ADA. (2022, June 22). https://diabetes.org/newsroom/american-diabetes-association-announces-support-for-insulin-act-at-senate-press-conference
[3] Reviewing Insulin Pen Usage in the United States. US Pharmacist. (2022, April 14). https://www.readcube.com/library/b0cb7c25-631b-4713-81f8-3bb909eb9dcc:dfd152c5-185f-4992-9af7-7c8a8a7c334f
[4] Lingen, K., Pikounis, T., Bellini, N., & Isaacs, D. (2023). Advantages and disadvantages of connected insulin pens in diabetes management. Endocrine connections, 12(11), e230108. https://doi.org/10.1530/EC-23-0108
[5] Ilkowitz, J., Wissing, V., & Gallagher, M. P. (2022). Pediatric Smart Insulin Pen Use: The Next Best Thing. Journal of diabetes science and technology, 16(3), 635–640. https://doi.org/10.1177/19322968211041362
[6] Knox, R. (2020, October 9). Insulin insulated: Barriers to competition and affordability in the United States insulin market. OUP Academic. https://academic.oup.com/jlb/article/7/1/lsaa061/5918811
[7][7] Olsen, B. S., Lilleøre, S. K., Korsholm, C. N., & Kracht, T. (2010). Novopen Echo® for the delivery of insulin: a comparison of usability, functionality and preference among pediatric subjects, their parents, and health care professionals. Journal of diabetes science and technology, 4(6), 1468–1475. https://doi.org/10.1177/193229681000400622
[8] Lingen, K., Pikounis, T., Bellini, N., & Isaacs, D. (2023). Advantages and disadvantages of connected insulin pens in diabetes management. Endocrine connections, 12(11), e230108. https://doi.org/10.1530/EC-23-0108
[9] Hyllested-Winge, J., Sparre, T., & Pedersen, L. K. (2018). NovoPen Echo(®) insulin delivery device. Medical devices (Auckland, N.Z.), 9, 11–18. https://doi.org/10.2147/MDER.S59229
[10] Chico, A., Navas de Solís, S., Lainez, M., Rius, F., & Cuesta, M. (2023). Efficacy, Safety, and Satisfaction with the Accu-Chek Insight with Diabeloop Closed-Loop System in Subjects with Type 1 Diabetes: A Multicenter Real-World Study. Diabetes technology & therapeutics, 25(4), 242–249. https://doi.org/10.1089/dia.2022.0449
[11] Al-Tabakha, M. M., & Arida, A. I. (2008). Recent challenges in insulin delivery systems: a review. Indian journal of pharmaceutical sciences, 70(3), 278–286. https://doi.org/10.4103/0250-474X.42968
[12] Finkle, J. (2024, February 20). Insulin pump vulnerable to hacking. Scientific American. https://www.scientificamerican.com/article/insulin-pump-vulnerable-to-hacking/
[13] Medtronic Alerts InPen app users about disclosures of personal ... HIPPA Journal. (2023). https://www.hipaajournal.com/medtronic-inpen-app-disclosures-pii-google/
[15] Diabetes UK. (2023, March 6). Smart insulin pens: How they work, and your experiences of using them. Diabetes UK. https://www.diabetes.org.uk/about-us/news-and-views/smart-insulin-pens-how-they-work-and-your-experiences-using-them
[16] Ospelt, E., Noor, N., Sanchez, J., Nelson, G., Rioles, N., Malik, F. S., Basina, M., Indyk, J., Vendrame, F., Schmitt, J., Scott, M. L., & Ebekozien, O. (2022). Facilitators and Barriers to Smart Insulin Pen Use: A Mixed-Method Study of Multidisciplinary Stakeholders From Diabetes Teams in the United States. Clinical diabetes : a publication of the American Diabetes Association, 41(1), 56–67. https://doi.org/10.2337/cd22-0068
[17] Leading the fight for insulin affordability. Insulin Cost & Affordability | ADA. (2024). https://diabetes.org/tools-resources/affordable insulin#:~:text=My%2499Insulin%3A%20For%20%2499,insulins%20with%20a%20prescription.
[18] Truong, T. H., Nguyen, T. T., Armor, B. L., & Farley, J. R. (2017). Errors in the Administration Technique of Insulin Pen Devices: A Result of Insufficient Education. Diabetes therapy : research, treatment and education of diabetes and related disorders, 8(2), 221–226. https://doi.org/10.1007/s13300-017-0242-y
[19] Hopcroft, A. (2023, November 14). Could liver-targeted insulin be the future of type 1 diabetes care?. diaTribe. https://diatribe.org/could-liver-targeted-insulin-be-future-type-1-diabetes-care