title: Pen Devices for Insulin Self-Administration Compared With Needle and Vial: Systematic Review of the Literature and Meta-Analysis.
abstract: Pen devices offer advantages compared with vial and syringe (VaS). The purpose of this article was to evaluate efficacy of pen devices compared to VaS.
  
  
  
  A systematic review of literature was performed in 8 different databases. References were independently screened and selected. Primary observational or experimental studies comparing pen devices with VaS for insulin administrations were included. Studies on specific populations were excluded. Risk of bias was evaluated using appropriate tools. Data on glycosylated hemoglobin (HbA1c), hypoglycemia, adherence, persistence, patient preference, and quality of life (QOL) were collected. Meta-analysis was performed when appropriate. Heterogeneity and risk of publication bias were evaluated. Otherwise, descriptive analyses of the available data was done.
  
  
  
  In all, 10 348 articles were screened. A total of 17 studies were finally selected: 7 experimental and 10 analytical. The populations of the included articles were mainly composed of adults with type 2 diabetes mellitus. Important risk of bias was found in all of the articles, particularly experimental studies. Meta-analyses were performed for HbA1c, hypoglycemia, adherence and persistence. Pen device showed better results in mean HbA1c change, patients with hypoglycemia, adherence and persistence compared to VaS. No difference was observed in number of patients achieving <7% HbA1c. Preference studies showed a tendency favoring pen devices, however nonvalidated tools were used. One QoL study showed improvements in some subscales of SF-36.
  
  
  
  There is evidence that pen devices offer benefits in clinical and, less clearly, patient-reported outcomes compared to VaS for insulin administration. However, these results should be taken with caution.
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia.
authors.forename: Pieralessandro
authors.initials: P
authors.lastname: Lasalvia
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia.
authors.forename: Julián Esteban
authors.initials: JE
authors.lastname: Barahona-Correa
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia.
authors.forename: Diana Marcela
authors.initials: DM
authors.lastname: Romero-Alvernia
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia.
authors.forename: Sebastián
authors.initials: S
authors.lastname: Gil-Tamayo
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia NeuroEconomix SAS, Bogota, Colombia.
authors.forename: Camilo
authors.initials: C
authors.lastname: Castañeda-Cardona
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia.
authors.forename: Juan Gabriel
authors.initials: JG
authors.lastname: Bayona
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia.
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Triana
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia.
authors.forename: Andrés Felipe
authors.initials: AF
authors.lastname: Laserna
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia.
authors.forename: Miguel
authors.initials: M
authors.lastname: Mejía-Torres
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia.
authors.forename: Paula
authors.initials: P
authors.lastname: Restrepo-Jimenez
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia.
authors.forename: Juliana
authors.initials: J
authors.lastname: Jimenez-Zapata
authors.affiliation: Pontificia Universidad Javeriana, Medical School, Bogota, Colombia diego.rosselli@gmail.com.
authors.forename: Diego
authors.initials: D
authors.lastname: Rosselli
mesh_terms: D003920:Diabetes Mellitus / Q000188:drug therapy*; D004209:Disposable Equipment; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D009339:Needles; D012646:Self Administration / Q000295:instrumentation*; D013594:Syringes
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin
keywords: diabetes mellitus; equipment and supplies; glycosylated; hemoglobin A; insulin; medication adherence; patient preference