Comparison of usability and patient preference for the new disposable insulin device Solostar versus Flexpen, lilly disposable pen, and a prototype pen: an open-label study.
BACKGROUND
Patients with diabetes have been found to have a preference for insulin pens over a vial and syringe since these devices offer improvements in compliance, freedom, and flexibility.


OBJECTIVE
This study assessed the usability, specific pen features, and patient preference for 4 prefilled, disposable, insulin pens: Solostar, Humulin/Humalog pen (Lilly pen), FlexPen, and a fourth, prototype pen, Pen X, in patients with type 1 or 2 diabetes. In 1-hour interviews, patients carried out simulated use (preparing the pens, setting a dose, and injecting into a receptacle, not the body) under observation, and answered qualitative and quantitative questions. Patients were supplied with the relevant user manual. The usability (ability and time taken to carry out handling tasks) and preference (based on 14 key pen features and overall preference) of each pen were assessed without blinding for pen make/manufacturer. During the interviews, the patients prepared each pen and performed injections into a receptacle. Comparisons were made between the pens at every step. Subgroup analyses of the usability exercises were carried out based on age (11-15 years; >/=60 years), previous pen experience, and disability (visual and dexterity).


RESULTS
In total, 510 diabetes patients (65% type 2 diabetes; 51% female; mean age, 43 years [range, 11-82 years]) from 4 countries (United States, Germany, France, and Japan) completed the study. Overall, a greater proportion of patients correctly prepared the pen and performed an injection into a receptacle with Solostar versus all comparator pens (P < 0.05). Similar findings were observed in the usability subgroup analyses based on age, previous pen experience, and visual/dexterity disabilities. A significantly (P < 0.05) higher proportion of patients expressed overall preference for Solostar (53%) versus FlexPen (31%) or Lilly pen (15%).


CONCLUSIONS
Of the 4 pens compared, both the Solostar pen and FlexPen were found to have high patient usability, and the new Solostar pen was found to have high patient preference in these patients with diabetes.
Haak
Thomas
T
Diabetes Centre Mergentheim, Bad Mergentheim, Germany. haak@diabetes-zentrum.de haak@diabetes-zentrum.de
Edelman
Steven
S
Walter
Claudia
C
Lecointre
Brigitte
B
Spollett
Gerry
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D003920:Diabetes Mellitus / Q000188:drug therapy; D004209:Disposable Equipment; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D013594:Syringes
D007004:Hypoglycemic Agents; D007328:Insulin; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine; C479079:insulin glulisine