OBJECTIVE: The HumaPen Memoir (HPM) is a new reusable insulin injection pen. It possesses an electronic component so that 16 insulin doses are stored in the memory. This study's aim was to evaluate the functionality of the device (i.e., ability to deliver a set dose of insulin), its impact on patient safety, and patient/healthcare professional (HCP) acceptance. RESEARCH DESIGN AND METHODS: In this 6-10-week (3 visit) multinational, multi-centre, open-label, single-arm outpatient study, participants with type 1 or type 2 diabetes were assigned to inject either their prandial or basal insulin dose using the HPM and instructed to record all complaints with the study pen or user manual. Investigators submitted a complaint form to the sponsor for each participant complaint, and for adverse events (AEs) potentially related to the study pen. Where a complaint was possibly related to a pen malfunction, the pen was returned to the sponsor for assessment. Participant/HCP acceptance of the HPM was evaluated using questionnaires. RESULTS: Of the 300 participants (mean age 52 [SD 15] years), 58% were male and 62% had type 2 diabetes. The mean duration of pre-study pen use was 7 years. The average exposure to the HPM was 8.2 (SD 1.6) weeks. Overall, 314 study pens were used (14 were replacements). Functional complaints were reported for 24 devices (7.6%), of which 8 (2.5%) were permanent electronic failures, and 15 (4.8%) were user-related (1 pen not returned for assessment). None of these functional issues resulted in a serious AE. Non-functional complaints were reported for 33 devices (10.5%). There were no pen-related hypoglycemic episodes and 2 pen-related hyperglycemic episodes were reported. The majority of participants (81.4%) preferred the HPM over their pre-study pen. The new insulin pen was generally rated higher than the pre-study pen for pen features and tasks associated with everyday pen use. CONCLUSIONS: No major functional issue of the HPM resulting in a serious AE was reported in this study. Based on the study results this new insulin pen demonstrated a favorable benefit-risk profile.
OBJECTIVE: The HumaPen Memoir (HPM) is a new reusable insulin injection pen. It possesses an electronic component so that 16 insulin doses are stored in the memory. This study's aim was to evaluate the functionality of the device (i.e., ability to deliver a set dose of insulin), its impact on patient safety, and patient/healthcare professional (HCP) acceptance. RESEARCH DESIGN AND METHODS: In this 6-10-week (3 visit) multinational, multi-centre, open-label, single-arm outpatient study, participants with type 1 or type 2 diabetes were assigned to inject either their prandial or basal insulin dose using the HPM and instructed to record all complaints with the study pen or user manual. Investigators submitted a complaint form to the sponsor for each participant complaint, and for adverse events (AEs) potentially related to the study pen. Where a complaint was possibly related to a pen malfunction, the pen was returned to the sponsor for assessment. Participant/HCP acceptance of the HPM was evaluated using questionnaires. RESULTS: Of the 300 participants (mean age 52 [SD 15] years), 58% were male and 62% had type 2 diabetes. The mean duration of pre-study pen use was 7 years. The average exposure to the HPM was 8.2 (SD 1.6) weeks. Overall, 314 study pens were used (14 were replacements). Functional complaints were reported for 24 devices (7.6%), of which 8 (2.5%) were permanent electronic failures, and 15 (4.8%) were user-related (1 pen not returned for assessment). None of these functional issues resulted in a serious AE. Non-functional complaints were reported for 33 devices (10.5%). There were no pen-related hypoglycemic episodes and 2 pen-related hyperglycemic episodes were reported. The majority of participants (81.4%) preferred the HPM over their pre-study pen. The new insulinpen was generally rated higher than the pre-study pen for pen features and tasks associated with everyday pen use. CONCLUSIONS: No major functional issue of the HPM resulting in a serious AE was reported in this study. Based on the study results this new insulinpen demonstrated a favorable benefit-risk profile.
Authors: Lutz Heinemann; Oliver Schnell; Bernhard Gehr; Nanette C Schloot; Sven W Görgens; Christoph Görgen Journal: J Diabetes Sci Technol Date: 2021-01-11
Authors: Andreas M Pleil; Miriam Kimel; Julie McCormack; Natasa Rajicic; Judith Hey-Hadavi Journal: Health Qual Life Outcomes Date: 2012-10-09 Impact factor: 3.186