A novel pen-based Bluetooth-enabled insulin delivery system with insulin dose tracking and advice

ABSTRACT

Introduction: Diabetes is growing in prevalence internationally. As more individuals require insulin as part of their treatment, technology evolves to optimize delivery, improve adherence, and reduce dosing errors. Insulin pens outperform vial and syringe in simplicity, dosing accuracy, and user preference. Bolus advisors improve dosing confidence and treatment adherence. The InPen System offers a novel approach to treatment via a wireless pen that syncs to a mobile application featuring a bolus advisor, enabling convenient insulin dose tracking and more accurate bolus advice among other features.

Areas covered: Existing technology for insulin delivery and bolus advice are reviewed. The mechanics and functionality of the InPen device are delineated. Findings from formative testing and usability studies of the InPen system are reported. Future directions for the InPen system in the treatment of diabetes are discussed.

Expert opinion: Diabetes management is complex and largely data-driven. The InPen System offers a promising new opportunity to avail insulin pen-users of features known to improve treatment efficacy, which have otherwise primarily been available to those using pumps. Given that the majority of insulin users do not use insulin pumps, the InPen System is poised to improve glucose control in a significant portion of the diabetes population.

KEYWORDS:

• Bolus advisor
• bolus calculator
• diabetes
• DM1
• DM2
• insulin pen
• insulin
• MDI
• T1D
• T2D

Article highlights

• Bolus advisors (BAs) simplify complex dosing decisions for the user by calculating proper insulin doses based on estimated carbohydrate intake (if calculating a meal bolus), the user’s carbohydrate factor (or insulin-to-carb ratio), correction factor (or insulin sensitivity factor), and target glucose values.

• To improve accuracy of bolus advisors it is recognized that insulin-on-board (IOB) should also be included in the dosing calculations. However, this has been difficult to achieve in bolus advisors that are not integrated into insulin pumps, as they require the user to remember to confirm or input actual insulin dose delivery information. This step is often forgotten or omitted, and without it an IOB cannot be included in the bolus calculation.

• BAs integrated into pumps are generally considered to be the most accurate available due to their ability to accurately track IOB, as compared to those integrated into glucose meters, and especially in comparison to smartphone BA apps which are unregulated by the FDA and have had their safety and accuracy called into question in several reviews.

• The majority of patients with diabetes requiring intensive insulin therapy do not use a pump and thus have not been able to benefit from the insulin dose tracking and bolus advice features available to pump users.

• The InPen System gives pen users access to more accurate dosing advice by enabling insulin dose tracking through a pen that syncs wirelessly to a bolus advisor app. This technology simplifies and improves accuracy of insulin dose calculations for pen users, and facilitates important diabetes data collection and tracking that can be used to inform clinical decision-making for diabetes specialists.

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Acknowledgment

The authors would like to acknowledge the help of J Walsh, PA CDTC Advanced Metabolic Care and Research, who provided technical editing and proofreading.

Declaration of interest

The authors received research support from: Abbott, Ascensia, BD, Boehringer Ingelheim, Companion Medical, Dexcom, Elcelyx, Glysens, Janssen, Lexicon, Lilly, Medtronic, Novo Nordisk, Sanofi, Senseonics, Versartis and Yofimeter. Consulting Honoraria from: Astra Zeneca, Bayer, BD, Calibra, Lilly, Medtronic, Novo Nordisk and Sanofi. Speaking Honoraria from: Abbott, Insulet, Medtronic, Novo Nordisk and Sanofi. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

No funding was received for the preparation of this manuscript