Usability, participant acceptance, and safety of a prefilled insulin injection device in a 3-month observational survey in everyday clinical practice in Australia.

Publisher: Sage Country of Publication: United States NLM ID: 101306166 Publication Model: Electronic Cited Medium: Internet ISSN: 1932-2968 (Electronic) Linking ISSN: 19322968 NLM ISO Abbreviation: J Diabetes Sci Technol Subsets: MEDLINE

Publication: 2014- : Thousand Oaks, CA : Sage
Original Publication: Foster City, CA : Diabetes Technology Society

Patient Acceptance of Health Care*; Diabetes Mellitus, Type 1/*drug therapy ; Diabetes Mellitus, Type 2/*drug therapy ; Drug Delivery Systems/*instrumentation ; Hypoglycemic Agents/*administration & dosage ; Insulin/*analogs & derivatives; Adult ; Aged ; Australia ; Consumer Product Safety ; Equipment Design ; Female ; Health Care Surveys ; Health Knowledge, Attitudes, Practice ; Humans ; Hypoglycemic Agents/adverse effects ; Injections ; Insulin/administration & dosage ; Insulin/adverse effects ; Insulin Glargine ; Insulin, Long-Acting ; Male ; Middle Aged ; Pamphlets ; Patient Education as Topic ; Patient Satisfaction ; Prospective Studies ; Time Factors ; Treatment Outcome

Background: SoloSTAR (SOL; sanofi-aventis, Paris, France) is a prefilled insulin pen device for the injection of insulin glargine and insulin glulisine. This is the first Australian survey to determine its usability, participant acceptance, and safety in clinical practice.
Methods: A 3-month, nonrandomized, noncomparative, observational survey in Australia was conducted in individuals with diabetes. Participants were given SOL pens containing glargine, the instruction leaflet, and a toll-free helpline number. Training was offered to all participants. Safety data, including product technical complaints (PTCs), were gathered from ongoing feedback given by the participant or health care professional (HCP) and by independent interviews conducted 6-10 weeks after study start.
Results: Some 2674 people consented to take part across 93 sites (150 HCPs), and 2029 participated in interviews. Of these, 52.6% had type 1 diabetes, 16.3% had manual dexterity problems, and 15.5% had poor eyesight not corrected by glasses. At the time of interview, 96.8% of participants were still using SOL. None of the eight PTCs reported were due to technical defects; most were related to handling errors. Some 62 participants reported 77 adverse events; none were related to a PTC. The vast majority of participants (95.4%) were "very satisfied" or "satisfied" with using SOL, and 89.7% of the participants had no questions or concerns using SOL on a daily basis. Similar positive findings were reported by participants with manual or dexterity impairments.
Conclusions: In this survey of everyday clinical practice, SOL had a good safety profile and was very well accepted by participants.

Comment on: J Diabetes Sci Technol. 2009 Nov;3(6):1439-41. (PMID: 20144399)

Diabetes Care. 2004 May;27(5):1047-53. (PMID: 15111519)
Clin Ther. 2007 Apr;29(4):650-60. (PMID: 17617288)
Expert Opin Drug Deliv. 2006 Sep;3(5):677-83. (PMID: 16948562)
Diabetes Care. 2005 Nov;28(11):2673-9. (PMID: 16249538)
Curr Med Res Opin. 2008 Oct;24(10):2741-9. (PMID: 18715525)
Clin Ther. 2004 Sep;26(9):1498-505. (PMID: 15531012)
Diabetes Educ. 2000 Jan-Feb;26(1):135-8, 141-6, 149-52. (PMID: 10776105)
Expert Opin Drug Deliv. 2007 Mar;4(2):165-74. (PMID: 17335413)
Postgrad Med. 1999 Oct 15;106(5):57-8, 61-4, 68. (PMID: 10560468)
Diabetes Care. 2005 Oct;28(10):2543-5. (PMID: 16186296)
Diabet Med. 2006 Jul;23(7):736-42. (PMID: 16842477)
Clin Ther. 1998 May-Jun;20(3):486-96. (PMID: 9663364)
Diabetes Technol Ther. 2001 Winter;3(4):631-3. (PMID: 11911176)
Diabetes Obes Metab. 2007 Nov;9(6):792-8. (PMID: 17924863)

0 (Hypoglycemic Agents)
0 (Insulin)
0 (Insulin, Long-Acting)
2ZM8CX04RZ (Insulin Glargine)

Date Created: 20100211 Date Completed: 20100930 Latest Revision: 20220317

20240628

PMC2787044

10.1177/193229680900300624

20144398