title: Ease of use and patient preference injection simulation study comparing two prefilled insulin pens.
abstract: OBJECTIVE
  To determine patient ease of use and preference for the Humalog KwikPen* (prefilled insulin lispro [Humalog dagger] pen, Eli Lilly and Company, Indianapolis, IN, USA) (insulin lispro pen) versus the Next Generation FlexPen double dagger (prefilled insulin aspart [NovoRapid section sign ] pen, Novo Nordisk A/S, Bagsvaerd, Denmark) (insulin aspart pen).
  
  
  METHODS
  This was a randomized, open-label, 2-period, 8-sequence crossover study in insulin pen-naïve patients with diabetes. Randomized patients (N = 367) received device training, then simulated low- (15 U) and high- (60 U) dose insulin injections with an appliance. Patients rated pens using an ease of use questionnaire and were asked separately for final pen preferences.
  
  
  METHODS
  The Insulin Device 'Ease of Use' Battery is a 10-item questionnaire with a 7-point scale (higher scores reflect greater ease of use). The primary objective was to determine pen preference for 'easy to press to inject my dose' (by comparing composite scores [low- plus high-dose]). Secondary objectives were to determine pen preference on select questionnaire items (from composite scores), final pen preference, and summary responses for all questionnaire items.
  
  
  RESULTS
  On the primary endpoint, 'easy to press to inject my dose,' a statistically significant majority of patients with a preference chose the insulin lispro pen over the insulin aspart pen (68.4%, 95% CI = 62.7-73.6%). Statistically significant majorities of patients with a preference also favored the insulin lispro pen on secondary items: 'easy to hold in my hand when I inject' (64.9%, 95% CI = 58.8-70.7%), 'easy to use when I am in a public place' (67.5%, 95% CI = 61.0-73.6%), and 'overall easy to use' (69.9%, 95% CI = 63.9-75.4%). A statistically significant majority of patients had a final preference for the insulin lispro pen (67.3%, 95% CI = 62.2-72.1%).
  
  
  CONCLUSIONS
  Among pen-naïve patients with diabetes who had a preference, the majority preferred the insulin lispro pen over the insulin aspart pen with regard to ease of use. Study limitations included open-label design and injection simulation, use of an unvalidated questionnaire, and enrollment of mostly insulin-naïve patients.
authors.affiliation: Eli Lilly and Company, Indianapolis, IN 46285, USA. peclark@lilly.com
authors.forename: Paula E
authors.initials: PE
authors.lastname: Clark
authors.forename: Virginia
authors.initials: V
authors.lastname: Valentine
authors.forename: Jennifer N
authors.initials: JN
authors.lastname: Bodie
authors.forename: Samiha
authors.initials: S
authors.lastname: Sarwat
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D018592:Cross-Over Studies; D003920:Diabetes Mellitus / Q000188:drug therapy; D004209:Disposable Equipment / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007267:Injections; D007328:Insulin / Q000008:administration & dosage* / Q000031:analogs & derivatives; D007332:Insulin Infusion Systems / Q000706:statistics & numerical data*; D061268:Insulin Lispro; D008297:Male; D008875:Middle Aged; D057240:Patient Preference / Q000706:statistics & numerical data; D017060:Patient Satisfaction; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro