1. INTRODUCTION:
Since the discovery of insulin in 1921, the methods for its administration have undergone significant transformation. Initially, insulin was delivered using glass syringes and reusable needles, which required boiling for sterilization and careful handling. These methods were cumbersome, painful, and often error-prone, limiting patient compliance and satisfaction1. With time, disposable plastic syringes became the norm, improving hygiene and convenience but still requiring the user to draw insulin from a vial—a process that remained intimidating and inconvenient for many patients, especially those with poor vision or dexterity issues2.
Rise of Insulin Pens: From Convenience to Innovation:
The limitations of vial-and-syringe systems catalyzed the development of insulin pens in the early 1980s, starting with the introduction of the NovoPen® by Novo Nordisk in 19853. These devices allowed for more precise insulin dosing, improved portability, and increased patient adherence due to their ease of use and discreet nature. Initially mechanical, insulin pens soon evolved into disposable models prefilled with insulin, making them even more accessible.
In recent years, insulin pens have entered a new phase—characterized by technological integration. Smart insulin pens now feature digital displays, memory functions, Bluetooth connectivity, and integration with smartphone apps and continuous glucose monitoring (CGM) systems4,5. These advancements aim to optimize glycemic control, reduce dosing errors, and support more personalized diabetes management.
As the healthcare industry increasingly emphasizes digital health and remote care, insulin pens are now more than just convenient drug delivery tools—they are part of a connected health ecosystem. This evolution reflects broader trends in medicine toward patient empowerment, data-driven decision-making, and integrated chronic disease management.
Scope and Aim of the Review:
This review provides a comprehensive overview of insulin pen development, focusing on the transition from traditional to smart pens. It examines current innovations, clinical and patient-centered benefits, barriers to adoption, and regulatory and market considerations. Furthermore, it explores emerging trends, such as AI-powered dosing support and sustainable design. The aim is to offer clinicians, researchers, and healthcare policymakers insights into how insulin pens are shaping the future of diabetes care and what considerations are essential to maximize their potential impact.
2. EVOLUTION OF INSULIN PENS:
Since their introduction in the 1980s, insulin pens have undergone continuous refinement, evolving from basic mechanical devices into highly sophisticated tools designed to support precise and patient-friendly insulin delivery. This section traces the technological and clinical journey of insulin pens—from early reusable and disposable models to the emergence of digital-enabled devices—highlighting key design improvements and industry milestones. These innovations reflect the shifting focus from mere convenience to enhancing dosing accuracy, patient adherence, and integration with modern diabetes care. A summary of major developments and milestones in insulin pen evolution is presented in Table 1.
First-Generation Insulin Pens: Reusable vs. Disposable:
The concept of insulin pens emerged in the mid-1980s, driven by the need to simplify insulin administration and enhance patient compliance. The first-generation insulin pens were primarily reusable devices, requiring the insertion of insulin cartridges and the replacement of needles with each use. The NovoPen®, launched by Novo Nordisk in 1985, was among the first such devices, offering improved convenience and dosing accuracy compared to traditional vial-and-syringe methods6.
These reusable pens were quickly followed by similar devices from other manufacturers, including OptiPen® (Sanofi) and HumaPen® (Eli Lilly). While reusable pens provided cost savings over time and reduced plastic waste, they still required manual cartridge replacement, which could be cumbersome for elderly patients or those with reduced manual dexterity7.
To address these concerns, manufacturers introduced disposable insulin pens, such as FlexPen® and KwikPen®, which came prefilled with insulin and were discarded once empty. These devices eliminated the need for cartridge handling and reduced the risk of user error and contamination, making them especially popular among older adults, children, and newly diagnosed patients8.
Transition to Second-Generation Pens: Dose Accuracy and Portability:
As the technology matured, second-generation insulin pens incorporated a range of enhancements. These included:
· Improved dose accuracy, with incremental dose settings as low as 0.5 units, useful for pediatric and insulin-sensitive patients9.
· Audible and tactile feedback mechanisms to confirm dose setting.
· Lighter and more ergonomic designs, enhancing portability and comfort during use.
· Memory functions, which allowed users to track the last dose administered and the time of injection, helping to avoid missed or duplicate doses10.
These advancements were not only technical improvements but also marked a shift toward patient-centered design, recognizing the importance of adherence, lifestyle integration, and usability in diabetes management.
Key Manufacturers and Milestones in Development:
The insulin pen market has been shaped by key pharmaceutical companies, each contributing significant innovations:
· Novo Nordisk: Innovators of the original NovoPen®, they have continued to lead with products like NovoPen Echo Plus® and NovoPen 6, which include digital dose tracking and Bluetooth connectivity11.
· Eli Lilly: Developers of the HumaPen® series and KwikPen®, known for their ergonomic design and broad insulin compatibility.
· Sanofi: Their SoloStar® disposable pen is widely used, and recent models like AllStar Pro® offer digital memory and reuse features12.
· Medtronic: With the acquisition of Companion Medical, Medtronic introduced the InPen™, one of the first fully integrated smart insulin pens in the U.S. market13.
Over the past decade, the industry has moved toward connectivity, integrating pens with mobile apps and CGM platforms to create comprehensive diabetes management ecosystems. This evolution reflects a broader healthcare trend emphasizing data-driven, personalized care.
Table 1: Key Milestones in Insulin Pen Development
|
Year |
Milestone |
Company/Initiative |
|
1985 |
Introduction of first insulin pen (NovoPen®) |
Novo Nordisk |
|
2000s |
Expansion of disposable insulin pens |
Sanofi (SoloSTAR®), Eli Lilly (KwikPen®) |
|
2015 |
FDA approval of InPen™ smart insulin pen |
Companion Medical |
|
2019 |
Launch of NovoPen® 6 and NovoPen® Echo Plus with memory and connectivity |
Novo Nordisk |
|
2021 |
Bigfoot Unity™ smart pen system integrated with CGMs |
Bigfoot Biomedical |
|
2023 |
Expansion of AI-driven bolus calculators in mobile apps |
Various digital health startups |
3. CURRENT INNOVATIONS IN INSULIN PENS:
The field of insulin delivery has witnessed remarkable technological advancements in recent years. Traditional insulin pens, which initially prioritized basic portability and convenience, have now evolved into smart, connected devices that integrate seamlessly with digital health ecosystems. These innovations aim to improve insulin dosing accuracy, promote adherence, enhance patient engagement, and support remote clinical monitoring. This section explores the latest developments in smart insulin pens, including Bluetooth-enabled features, integration with CGM systems, user-friendly ergonomic designs, and their role in connected healthcare environments. A comparison of traditional versus smart insulin pens is summarized in Table 2.
Digital and Smart Pens:
The latest generation of insulin pens has evolved into smart devices, integrating digital technologies to improve glycemic control, adherence, and user convenience. One of the key advancements is the incorporation of Bluetooth connectivity, which enables insulin pens to synchronize with smartphone apps for automatic dose logging. These apps often provide dose reminders, insulin-on-board (IOB) tracking, and trend analysis. For example, the InPen™ by Medtronic connects to a mobile app that helps patients make real-time dosing decisions and keeps a digital logbook14.
Another major innovation is the real-time integration with Continuous Glucose Monitoring (CGM) systems, allowing insulin dosing data to be viewed alongside glucose levels. This interoperability supports better-informed decisions, timely adjustments, and a data-driven approach to diabetes management15. Some smart pens can also notify users of missed doses and alert caregivers or healthcare providers.
Table 2: Comparison of Traditional vs. Smart Insulin Pens
|
Feature |
Traditional Insulin Pens |
Smart Insulin Pens |
|
Dose Recording |
Manual (if at all) |
Automatic, with timestamp |
|
Connectivity |
None |
Bluetooth or USB |
|
Integration with CGMs |
Not available |
Available (e.g., Bigfoot Unity, InPen) |
|
User Interface |
Mechanical dial, no digital display |
Digital dose display, alerts, reminders |
|
Data Sharing |
Not supported |
Cloud-based platforms for remote monitoring |
|
Feedback and Alerts |
None |
Audible, visual, haptic feedback |
|
Example Devices |
NovoPen® 4, SoloSTAR® |
NovoPen® 6, InPen™, Bigfoot Unity |
Reusable Smart Pens vs. Smart Caps:
The smart pen market includes both reusable pens with embedded digital features and smart caps that convert traditional pens into connected devices. NovoPen® 6 and NovoPen Echo Plus® (Novo Nordisk) are reusable smart insulin pens equipped with memory functions and near-field communication (NFC). They store data on dose amount and timing, which can be accessed via compatible apps or cloud platforms16. InPen™ by Medtronic is a Bluetooth-enabled smart pen that is also reusable, offering real-time tracking and bolus calculator support. Bigfoot Unity™, developed by Bigfoot Biomedical, uses smart pen caps rather than a smart pen itself. These caps fit onto standard disposable insulin pens and feature screens that display dosing recommendations based on CGM data and healthcare provider input17. Each approach has its advantages—smart caps are more flexible and cost-effective, while dedicated smart pens offer a more seamless and integrated user experience.
User Interface and Ergonomics Enhancements:
Modern insulin pens are undergoing significant user interface enhancements aimed at improving usability, accuracy, and user confidence during insulin administration. One of the most impactful innovations is the incorporation of visual dose displays, such as digital screens that clearly show the set dose and battery status, helping patients verify accuracy before injection. In addition to visual feedback, audible clicks and haptic responses—vibrations or tactile signals—have been added to confirm dose setting and injection completion. These features help reduce uncertainty, especially in low-light conditions or for individuals with visual impairments. Furthermore, modern pens are designed with one-hand usability in mind, incorporating smoother button mechanics and optimized grip ergonomics. These refinements make it easier for elderly patients or those with reduced manual dexterity to manage their insulin injections independently and safely18. Such ergonomic improvements play a crucial role in promoting proper injection technique, minimizing fatigue, and preventing dosing errors, ultimately supporting better adherence and glycemic control.
Integration with Digital Health Ecosystems:
Insulin pens are increasingly becoming integral components of broader digital health ecosystems that seamlessly connect patients, caregivers, and healthcare providers. These ecosystems enable remote monitoring, allowing clinicians to access real-time data on insulin usage and glucose levels, which supports timely and informed clinical decisions. The integration with telemedicine platforms further enhances care by facilitating data-driven virtual consultations and enabling healthcare professionals to promptly intervene when patients deviate from their prescribed regimens19. Additionally, cloud-based analytics tools aggregate and analyze insulin and glucose data at both the individual and population levels, offering insights that support personalized treatment adjustments and proactive diabetes management. This interconnected approach reflects the broader transformation in healthcare toward patient-centered care, precision medicine, and value-based outcomes, emphasizing not just the control of disease but also the improvement of quality of life and long-term health outcomes.
4. CLINICAL AND PATIENT-CENTERED BENEFITS:
Beyond technical advancements, modern insulin pens—particularly smart pens—offer substantial clinical and psychosocial benefits. These devices support not only improved glycemic outcomes but also foster patient engagement, satisfaction, and quality of life. This section explores the wide-ranging impact of smart insulin pens on adherence, empowerment, and self-management, as illustrated in Figure 1.
Improved Adherence and Glycemic Control:
One of the most significant advantages of modern insulin pens—especially smart pens—is their positive impact on medication adherence and glycemic control. By simplifying the insulin administration process, offering dose reminders, and recording injection data, smart pens help reduce the frequency of missed or incorrect doses. Studies have shown that patients using smart insulin pens demonstrate greater consistency in dosing and significantly increased time-in-range (TIR) compared to those using traditional pens or syringes20. For example, research on connected pens such as the InPen™ and NovoPen® 6 revealed improvements in HbA1c levels and a decrease in hypoglycemic events through better tracking and decision support features21,22.
Patient Satisfaction and Empowerment:
Modern insulin pens also contribute to higher patient satisfaction by promoting a greater sense of control and autonomy in diabetes management. The user-friendly interfaces, visual feedback mechanisms, and integration with mobile health apps enable patients to actively participate in their treatment. This empowerment fosters confidence and reduces the psychological burden often associated with intensive insulin therapy23. Patients report feeling more in control and less anxious about dosing, particularly when using pens that offer dose history, alerts, and real-time support tools24.
Figure 1: Key Clinical and Patient Benefits of Smart Insulin Pens
Impact on Quality of Life and Diabetes Self-Management:
The design and features of current insulin pens positively influence quality of life by reducing the complexity and stigma of insulin administration. With discreet, portable designs and minimal preparation required, these devices blend more easily into everyday life. As a result, patients often experience improved emotional well-being, greater social comfort, and fewer disruptions to their routine25. Additionally, features such as dosing accuracy, fewer hypoglycemic events, and better alignment with CGM data contribute to enhanced diabetes self-management. Smart pens also allow for easier communication with healthcare providers through data sharing, fostering a collaborative care model that improves both clinical outcomes and patient engagement26.
5. CHALLENGES AND LIMITATIONS
While smart insulin pens offer numerous clinical and user benefits, their adoption is not without obstacles. Cost, accessibility, data privacy, and usability concerns continue to limit widespread integration—especially in resource-limited settings. This section outlines key challenges that must be addressed to ensure equitable and effective implementation of these technologies across diverse patient populations.
Cost and Accessibility, Especially in Low-Resource Settings
Despite the advantages of modern and smart insulin pens, cost remains a significant barrier to widespread adoption. Smart insulin pens and associated apps are often more expensive than conventional pens or syringes, which limits their availability, particularly in low- and middle-income countries. In many regions, insulin itself is already a major expense for patients; adding the cost of high-tech delivery devices can make these innovations unattainable27. Additionally, health systems in low-resource settings may lack reimbursement policies for advanced insulin delivery tools, further reducing access28.
Data Privacy and Security Concerns:
As insulin pens become increasingly digitally connected, concerns over data privacy and security have grown. These smart devices collect sensitive health information—including insulin doses, glucose levels, and timestamps—which may be stored on cloud-based platforms or transmitted to healthcare providers. If not properly secured, this data could be vulnerable to breaches, potentially exposing personal health information29. Furthermore, questions around ownership of data, third-party access, and compliance with regulations like GDPR and HIPAA remain contentious in the digital health landscape30.
Device Compatibility with Insulin Types and Brands
Another challenge is the lack of universal compatibility between smart pens and various insulin formulations. Most smart pens are designed to work with specific insulin brands or cartridge sizes, which limits their flexibility. For example, a user prescribed a biosimilar or a non-proprietary insulin may find it incompatible with available smart pen models31. This fragmentation not only restricts patient choice but also creates challenges for healthcare providers trying to standardize device recommendations across populations.
Training and Digital Literacy Barriers:
Adoption of smart insulin pens requires a learning curve, and some patients—particularly the elderly or those with low digital literacy—may find it difficult to use connected features effectively. Functions like app pairing, data syncing, or interpreting analytics may be confusing without proper instruction. In a real-world setting, limited access to technical support, language barriers, and lack of training for healthcare providers can further exacerbate this issue32. Ensuring effective implementation therefore requires investment in patient education, provider training, and ongoing tech support.
6. REGULATORY AND MARKET LANDSCAPE:
The adoption of smart insulin pens is shaped by regulatory approval, insurance coverage, and market growth. This section highlights key regulatory requirements, reimbursement challenges, and global trends influencing their accessibility and integration into diabetes care.
Current Regulatory Requirements (FDA, EMA, etc.)
Smart insulin pens and connected diabetes management devices fall under the category of medical devices and are subject to regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In the United States, smart insulin pens are typically classified as Class II medical devices, requiring 510(k) clearance to demonstrate that they are substantially equivalent to an existing approved device33. The FDA also evaluates digital features—such as dose logging and Bluetooth connectivity—for safety and cybersecurity under its Digital Health Software Precertification Program.
In Europe, the EMA works alongside notified bodies under the Medical Devices Regulation (MDR 2017/745), which came into full effect in 2021. Smart insulin pens must comply with stringent safety, performance, and post-market surveillance requirements before entering the market34. Additionally, manufacturers must ensure interoperability and software validation, particularly when devices connect with mobile apps or CGMs.
Reimbursement Policies and Insurance Coverage:
Insurance reimbursement plays a crucial role in patient access to smart insulin pens. In many countries, these devices are not yet fully covered under national health insurance schemes or private insurance plans. In the U.S., while traditional insulin pens are often reimbursed, coverage for smart pens may be limited or conditional upon prior authorization35. Some private insurers offer partial reimbursement if the patient demonstrates clinical need, such as poor glycemic control with conventional methods.
In Europe, reimbursement varies widely. Countries like Sweden and Denmark have incorporated connected insulin pens into their national formularies, while others lag due to cost-effectiveness concerns and lack of standardized evaluation metrics36. Broader adoption will likely depend on real-world evidence showing improvements in clinical outcomes and reduced long-term healthcare costs.
Trends in Global Market Adoption and Competition
The global market for insulin pens—including both traditional and smart versions—is growing steadily. The global insulin pen market was valued at approximately USD 40 billion in 2022 and is projected to grow at a CAGR of 6–8% through 203037. Key players include Novo Nordisk, Sanofi, Eli Lilly, Medtronic, and Bigfoot Biomedical, all of which are investing in smart technologies and digital health integrations.
Adoption is particularly strong in Europe and North America, where digital infrastructure and reimbursement mechanisms are more advanced. Emerging markets in Asia-Pacific and Latin America are seeing slower but rising uptake, driven by increased awareness and government focus on diabetes management. However, market penetration is still challenged by affordability, regulatory variability, and lack of digital literacy in some regions38.
In terms of competition, companies are expanding into partnerships with digital health firms and app developers to create end-to-end solutions. For instance, Medtronic’s acquisition of Companion Medical (developer of InPen™) and collaborations between Novo Nordisk and Glooko exemplify this trend39.
7. FUTURE DIRECTIONS:
As smart insulin pens continue to evolve, emerging technologies are expanding their capabilities beyond basic dose delivery. Innovations such as AI-powered guidance, semi-automated systems, and personalized treatment strategies are reshaping the future of diabetes care. This section explores the next frontier in insulin pen development, focusing on how data integration, automation, and miniaturization could drive more effective, user-friendly, and individualized management options.
AI-Powered Dosing Guidance and Decision Support:
Artificial intelligence (AI) is poised to revolutionize diabetes management through personalized dosing recommendations and decision support. By analyzing large datasets—including insulin dosage history, continuous glucose monitoring (CGM) readings, meal intake, and physical activity—AI algorithms can provide real-time suggestions for insulin titration. These systems can also alert patients to potential hypo- or hyperglycemia events and propose preventative strategies40. Integration of AI into insulin pens and associated mobile apps enhances decision-making, reduces cognitive burden, and supports improved clinical outcomes41.
Closed-Loop and Semi-Automated Insulin Delivery Systems:
While traditionally associated with insulin pumps, closed-loop (automated) insulin delivery concepts are now being explored in conjunction with smart pens and patch-based systems. These systems aim to simulate pancreatic function by automatically adjusting insulin delivery in response to glucose trends. Semi-automated solutions using connected insulin pens, CGMs, and AI-based apps can already provide insulin dosing suggestions, paving the way for future closed-loop designs outside of pump therapy42. For individuals preferring pens over pumps, this development could offer the benefits of automation without the complexity of wearable pump systems.
Personalized Medicine Approaches:
The convergence of genomics, metabolomics, and digital health tools is laying the foundation for precision medicine in diabetes care. Smart insulin pens can facilitate personalized therapy by capturing detailed patient data over time, which can be used to tailor insulin regimens based on individual variability in insulin sensitivity, lifestyle, and metabolic response43. Emerging research is exploring how machine learning models can predict optimal insulin types and dosing schedules for each patient, moving beyond standardized treatment protocols44.
Potential for Further Miniaturization and Wearable Hybrid Systems:
Future innovations may lead to smaller, lighter, and more discreet insulin pens, potentially integrating wearable sensor technology or patch-style delivery mechanisms. Miniaturization could make pens more comfortable and less conspicuous, addressing concerns related to stigma or portability. Additionally, the combination of wearable CGMs and smart insulin delivery modules could lead to hybrid systems that closely mimic pancreatic function while preserving the freedom and flexibility of pen-based therapy45.
These innovations will require robust clinical validation, interdisciplinary collaboration, and supportive regulatory frameworks to ensure safety, accessibility, and equitable distribution. However, the trajectory of smart insulin pens and related technologies signals a promising shift toward more personalized, proactive, and connected diabetes care.
8. CONCLUSION:
Insulin pens have progressed from basic injection tools to advanced, connected devices that support personalized diabetes management. Smart insulin pens with features like dose tracking, Bluetooth connectivity, and app integration have significantly improved adherence, glycemic control, and patient empowerment. However, challenges such as cost, limited access, data privacy, and digital literacy still hinder their global adoption. Addressing these barriers is essential to ensure equitable access and safe use across diverse populations. A key factor in future development is the integration of patient feedback, which helps refine usability, ergonomics, and real-world functionality. As healthcare shifts toward digital and personalized approaches, insulin pens are well-positioned to become central to data-driven and patient-centered diabetes care. With continued innovation, insulin pens will not only improve clinical outcomes but also support broader goals of remote monitoring, telemedicine, and precision health.
9. REFERENCES:
1. Bliss M. The Discovery of Insulin. University of Chicago Press; 2007.
2. Heinemann L, Fleming GA, Petrie JR, Holl RW, Bergenstal RM, Peters AL. Insulin injection technique: Recommendations for best practice. Mayo Clin Proc. 2015; 90(9): 1231–1255.
3. Owens DR, Zinman B, Bolli G. Alternative routes of insulin delivery. Diabet Med. 2003; 20(11):886–898.
4. Adolfsson P, Hartvig NV, Kaas A, Møller JB. Increased time in range and fewer missed bolus injections after introduction of a smart connected insulin pen. Diabetes Technol Ther. 2020; 22(10):709–718.
5. Bergenstal RM, Nimri R, Beck RW, et al. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): A multicentre, randomized, crossover trial. Lancet. 2021; 397(10270): 208–219.
6. Owens DR, Zinman B, Bolli GB. Insulin glargine: A review of its therapeutic efficacy in the treatment of diabetes mellitus. Drugs. 2001; 61(11): 1599–1628.
7. Heinemann L. Reusable insulin pens and disposable insulin pens: Past, present and future. J Diabetes Sci Technol. 2008;2(5):826–828.
8. Niskanen L, Veves A, Frier BM. The future of insulin delivery: Innovation, simplification, and outcomes. Diabetes Metab Res Rev. 2010;26(2):108–114.
9. Anderson JH Jr, Brunelle RL, Koivisto VA, et al. Reduction of postprandial hyperglycemia and frequency of hypoglycemia with insulin analogs. Diabetes Care. 1997; 20(1):77–84.
10. Adolfsson P, Hartvig NV, Kaas A, Møller JB. Increased time in range and fewer missed bolus injections after introduction of a smart connected insulin pen. Diabetes Technol Ther. 2020; 22(10):709–718.
11. Novo Nordisk. Digital Health: Smart insulin pens and connected diabetes care. 2021. [Available at: https://www.novonordisk.com]
12. Sanofi. AllStar Pro®: Technical specifications and user guide. 2020.
13. Medtronic. InPen™ Smart Insulin Pen: Product Overview. 2021.
14. Medtronic. InPen™ Smart Insulin Pen: Product Overview. 2021.
15. Bergenstal RM, Nimri R, Beck RW, et al. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): A multicentre, randomized, crossover trial. Lancet. 2021; 397(10270): 208–219.
16. Novo Nordisk. NovoPen® 6 and NovoPen Echo® Plus: Connected devices for insulin tracking. 2021. [Available from: https://www.novonordisk.com]
17. Bigfoot Biomedical. Bigfoot Unity™ Diabetes Management System. 2022. [Available from: https://www.bigfootbiomedical.com]
18. Heinemann L. Insulin pen use: Achievements and limitations. J Diabetes Sci Technol. 2008; 2(5): 830–838.
19. Bashi N, Karunanithi M, Fatehi F, Ding H, Walters D. Remote monitoring of patients with heart failure: An overview of systematic reviews. J Med Internet Res. 2017; 19(1): e18.
20. Adolfsson P, Hartvig NV, Kaas A, Møller JB. Increased time in range and fewer missed bolus injections after introduction of a smart connected insulin pen. Diabetes Technol Ther. 2020; 22(10): 709–718.
21. Kordonouri O, Hartmann R, Pankowska E, et al. The benefit of dose memory and other smart features in insulin pens. J Diabetes Sci Technol. 2017; 11(3): 567–573.
22. Schmidt S, Meldgaard M, Serifovski N, et al. Smart insulin pens improve glycemic control in people with type 1 diabetes. Diabetes Care. 2021; 44(9):e180–e182.
23. Polonsky WH, Fisher L, Hessler D, Edelman SV. Patient perspectives on self-monitoring of blood glucose: The meaning of success. Diabetes Educ. 2011; 37(4): 501–508.
24. Al Hayek AA, Robert AA, Al Dawish MA. Evaluation of insulin injection technique among patients with diabetes mellitus. Diabetes Ther. 2020; 11(6): 1227–1235.
25. Stuckey HL, Peyrot M, Curran M, et al. Personal accounts of the negative and positive impact of diabetes on quality of life: A patient survey. Health Qual Life Outcomes. 2014; 12:104.
26. Nørgaard K, Scaramuzza A, Bratina N, et al. Data sharing from smart insulin pens improves communication and treatment satisfaction. Diabetes Technol Ther. 2022; 24(2): 111–118.
27. Beran D, Ewen M, Laing R. Constraints and challenges in access to insulin: A global perspective. Lancet Diabetes Endocrinol. 2016; 4(3):275–285.
28. Atun R, Davies JI, Gale EA, et al. Diabetes in sub-Saharan Africa: From clinical care to health policy. Lancet Diabetes Endocrinol. 2017;5(8):622–667.
29. Nebeker C, Torous J, Bartlett Ellis RJ. Building the case for actionable ethics in digital health research supported by artificial intelligence. BMC Med. 2019;17(1):137.
30. Meingast M, Roosta T, Sastry S. Security and privacy issues with health care information technology. Conf Proc IEEE Eng Med Biol Soc. 2006; 1:5453–5458.
31. Heinemann L, Fleming GA, Petrie JR, et al. Insulin pens and new injection technologies: Delivery options for insulin therapy. Diabetes Technol Ther. 2015;17(9):654–662.
32. Rahi M, Rahman MM, Latif ZA. Knowledge and barriers to diabetes technology use in resource-constrained settings. J Diabetes Sci Technol. 2020;14(2):333–340.
33. U.S. Food and Drug Administration (FDA). Premarket Notification 510(k). 2021. Available from: https://www.fda.gov/medical-devices
34. European Commission. Medical Devices Regulation (EU) 2017/745. 2021. Available from: https://health.ec.europa.eu
35. American Diabetes Association. Standards of Medical Care in Diabetes—2023. Diabetes Care. 2023;46(Suppl 1):S1–S291.
36. Heinemann L, Hompesch M, Pickup JC. Insulin pump risks and benefits: A clinical appraisal of pump safety standards, adverse event reporting, and research needs. J Diabetes Sci Technol. 2015; 9(5):1143–1152.
37. Grand View Research. Insulin Pen Market Size, Share & Trends Analysis Report, 2023–2030. 2023. Available from: https://www.grandviewresearch.com
38. IQVIA Institute. Advancing Diabetes Outcomes Through Technology. 2022. Available from: https://www.iqvia.com
39. Medtronic Newsroom. Medtronic acquires Companion Medical, maker of the InPen smart insulin pen. 2020. Available from: https://news.medtronic.com
40. Cappon G, Vettoretti M, Sparacino G, Facchinetti A. A neural-network-based approach to personalize insulin bolus calculation using CGM data. IEEE J Biomed Health Inform. 2019; 23(2): 874–881.
41. O'Connor A, Livingstone SJ, Colhoun HM, et al. big data and artificial intelligence in diabetes care: Opportunities and challenges. Diabetologia. 2021; 64(1): 57–67.
42. Boughton CK, Hovorka R. Advances in artificial pancreas systems. Sci Transl Med. 2019; 11(507): eaaw4949.
43. Maruthur NM, Gribble MO, Bennett WL, et al. Personalized diabetes management: Moving from evidence-based medicine to precision health. Lancet Diabetes Endocrinol. 2021; 9(3):170–180.
44. Zaharieva DP, Arroyo JS, Marathe PH. Personalized insulin therapy: Closing the loop between prediction and action. Diabetes Obes Metab. 2020; 22(Suppl 1):28–36.
45. Peters AL, Ahmann AJ, Battelino T, et al. Advances in technology for diabetes care: Closing the loop from hospital to home. J Diabetes Sci Technol. 2020; 14(4):783–792.
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Received on 26.04.2025 Revised on 14.05.2025 Accepted on 29.05.2025 Published on 22.07.2025 Available online from July 26, 2025 Res.J. Pharmacology and Pharmacodynamics.2025;17(3):213-219. DOI: 10.52711/2321-5836.2025.00035 ©A and V Publications All right reserved
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