Functionality and acceptability of a new electronic insulin injection pen with a memory feature

Area of Science:

• Diabetes Management
• Medical Device Technology
• Pharmacology

Background:

• The HumaPen Memoir (HPM) is a novel reusable insulin injection pen featuring electronic memory to store 16 insulin doses.
• Effective insulin delivery devices are crucial for managing diabetes and improving patient outcomes.

Purpose of the Study:

• To evaluate the functionality of the HumaPen Memoir in delivering set insulin doses.
• To assess the impact of the HPM on patient safety.
• To determine patient and healthcare professional (HCP) acceptance of the HPM.

Main Methods:

• A 6-10 week, multinational, multi-center, open-label, single-arm outpatient study.
• Participants with type 1 or type 2 diabetes used the HPM for prandial or basal insulin injections.
• Data collected on device functionality, adverse events, and patient/HCP acceptance via questionnaires and complaint forms.

Main Results:

• Of 300 participants, 7.6% reported functional complaints (2.5% electronic failures, 4.8% user-related), with no serious adverse events (AEs).
• 81.4% of participants preferred the HPM over their previous insulin pen.
• The HPM received higher ratings for features and ease of use compared to pre-study pens.

Conclusions:

• The HumaPen Memoir exhibited no major functional issues leading to serious AEs in the study.
• The study indicates a favorable benefit-risk profile for the HumaPen Memoir.
• The device demonstrated good functionality and high acceptance among patients and HCPs.