PMID- 16466603
OWN - NLM
STAT- MEDLINE
DCOM- 20060417
LR  - 20191210
IS  - 0300-7995 (Print)
IS  - 0300-7995 (Linking)
VI  - 22
IP  - 2
DP  - 2006 Feb
TI  - Functionality and acceptability of a new electronic insulin injection pen with a 
      memory feature.
PG  - 315-25
AB  - 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.
FAU - Venekamp, Willem J R R
AU  - Venekamp WJ
AD  - Atrium Medical Centre, Brunssum, The Netherlands. w.venekamp@atriummc.nl
FAU - Kerr, Lisa
AU  - Kerr L
FAU - Dowsett, Sherie A
AU  - Dowsett SA
FAU - Johnson, Patricia A
AU  - Johnson PA
FAU - Wimberley, Deborah
AU  - Wimberley D
FAU - McKenzie, Chris
AU  - McKenzie C
FAU - Malone, James
AU  - Malone J
FAU - Milicevic, Zvonko
AU  - Milicevic Z
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Insulin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Developed Countries
MH  - Diabetes Mellitus, Type 1/*drug therapy
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Equipment Design
MH  - Equipment Reuse
MH  - Female
MH  - Humans
MH  - Injections/*instrumentation
MH  - Insulin/*administration & dosage/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - *Patient Satisfaction
MH  - Surveys and Questionnaires
EDAT- 2006/02/10 09:00
MHDA- 2006/04/18 09:00
CRDT- 2006/02/10 09:00
PHST- 2006/02/10 09:00 [pubmed]
PHST- 2006/04/18 09:00 [medline]
PHST- 2006/02/10 09:00 [entrez]
AID - 10.1185/030079906X80477 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2006 Feb;22(2):315-25. doi: 10.1185/030079906X80477.