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Institute Report
Optimizing Insulin Use Through Smart Pens: Challenges and Opportunities in Europe
Aug 17, 2021
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Report Summary

Diabetes management is complex, and the need to regularly monitor blood glucose levels and take steps to keep them in a specific range may impact the daily lives and social activities of people with diabetes’ (PwD). In recent years, digital health solutions such as connected devices, software and apps have offered to address fundamental challenges of measuring and managing glucose levels. Nevertheless, the unmet need for people with type 1 and type 2 diabetes remains high and achieving glycemic control through consistent and optimized insulin use is difficult and time-consuming, significantly restricting daily life. Consequently, suboptimal insulin use persists and is widespread among PwD.

This report reviews the unmet needs of PwD and takes a look at how smart insulin pens can address some of the difficulties of self-management and improve outcomes. It identifies and assesses the three main challenges that need to be overcome in order for smart pens to reach their full potential for PwD:
  1. Varying readiness of European healthcare systems for digital health solutions
  2. Difficulties demonstrating the value for components of smart systems
  3. And the current unclear positioning of smart pens versus other digital health offerings in diabetes care

Finally, this report reviews the systematic strategies that policymakers, regulators, payers, manufacturers, physicians, and patient advocacy groups can take to advance diabetes care and bring innovative solutions to people with diabetes.

Key Findings

  • In real world use, a substantial proportion of people with diabetes report missing insulin doses, as demonstrated across studies with different patient populations and insulin regimens.
  • Both PwD and healthcare providers have identified taking insulin at a prescribed time and taking insulin with meals everyday as key difficulties with insulin-based diabetes management.
  • Issues with mistimed insulin doses were reported across people with both type 1 or type 2 diabetes with one U.S.-based study demonstrating that approximately 22% of PwD sometimes or never take their insulin at the correct time.
  • Many PwD also struggle with adequate insulin dosing, with 13% of people with type 1 or type 2 diabetes reporting sometimes or never injecting the correct insulin dose in a study investigating dosing errors.
  • Adjusting the insulin dose required based on glucose levels is identified by PwD as a considerable management challenge. Errors in programming and adjusting basal insulin were observed among 7% of children and adolescents with type 1 diabetes using continuous subcutaneous insulin infusion.
  • PwD have a high burden in constantly managing their blood glucose levels and insulin dosing. Smart pens have the potential to ease this burden by automating several of the manual steps of insulin dosing and adjustment.
  • On top of the benefits of traditional insulin pens, which offer a simpler and more accurate way to deliver insulin compared to syringes by providing metered dosing, smart insulin pens also allow for automatic storage and transmission of insulin dosing data to the PwD and treatment team, thereby providing the basis for data-driven treatment optimization.

  • At present, however, access to innovative solutions such as smart pens is limited to small patient segments. The main driver for broad access is reimbursement by public healthcare systems, which in turn strongly depends on and solution’s ability to demonstrate robust evidence of its value.

  • Several smart pen systems (smart pen combined with other solutions such as applications and/or continuous glucose monitors) have collected evidence on various endpoints: improved HbA1c, improved time-in-range (TIR), better self-management, improved patient-reported outcomes and lower economic burden.
  • The level of readiness for digital health solutions varies across the major European markets, including France, Germany, Italy, Spain, and the United Kingdom. Some of the countries are more mature in their approach and have recently established frameworks for the assessment of DHS that include specific evaluation criteria — some intended to guide reimbursement decisions.
  • Existing smart pens and attachments have demonstrated value in supporting PwD with their self-management and improving outcomes. However, as the functionality and connectivity of these devices can only be seen and justified in combination with an app, the value of smart pens alone is difficult to demonstrate in isolation and evidence generation is typically done for the whole system (i.e., smart pen in combination with an app) rather than for the smart pen on its own.
  • Despite the potential of smart pens and attachments to improve diabetes care for large segments of PwD, these advantages have neither been clearly demonstrated to, nor fully understood by, various stakeholders.
  • Manufacturers can collaborate closely with payers and regulators throughout the product development and commercialization process in order to educate on, and raise awareness about, the importance and advantages of interoperable systems.
  • Although several smart pens and attachments have shown evidence in the form of improvements on various parameters ranging from HbA1c, TIR, self-management, patient-reported outcomes, and economic outcomes, more robust evidence is needed to substantiate the value of smart pens and attachments within the digital health solution space for diabetes care.
  • Currently, stakeholders such as physicians and payers remain uncertain about the positioning and potential of smart pens compared to other digital diabetes offerings such as continuous glucose monitors and pumps. In order for smart pens to be widely adopted by PwD who would benefit the most, manufacturers of such devices need to increase their efforts to first understand the needs of PwD and other stakeholders, and based on this understanding, clearly emphasize the specific benefits of smart pens.
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