title: Acceptability and safety of a new 3.0 ml re-usable insulin pen (HumaPen) in clinical use.
abstract: A new re-usable insulin pen (the HumaPen) was tested in a multinational study in patients with Type 1 (45.1%) or Type 2 (54.9%) diabetes. Prior to study entry, patients used either syringes or a comparison pen. Patients changed to the HumaPen for all insulin injections during the 5-to 7-week study and a 12- to 13-week extension period. Acceptability of the HumaPen was assessed from a questionnaire completed at the end of the study by 72 previous syringe users and 209 previous pen users. HumaPen features considered easy/very easy by pre-study syringe users or pre-study pen users were correcting a mis-dialled dose (97.2%; 95.1%, respectively), reading the dose numbers (95.8%; 97.1%) and ease of learning (95.8%; 92.3%). Convenience, comfort and ease of use were stated to be better by a majority of pre-study syringe users and similar by pre-study pen users. At the end of the initial study, 73.6% of syringe users and 55.5% of previous pen users said they would continue to use the HumaPen, and 171 patients continued into the extension. As expected, the most common adverse event was hyperglycaemia but the majority were mild and none caused discontinuation from HumaPen use. The main reason for not continuing into the extension period, and for return of pens, was the injection force, which was subsequently reduced by modification of design and production prior to launch. The HumaPen therefore appeared well accepted and safe in this global study and a majority said they would recommend it to other patients.
authors.affiliation: Eli Lilly and Company, Lilly Research Centre, Windlesham, Surrey, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Martin
authors.forename: J A
authors.initials: JA
authors.lastname: Llewelyn
authors.forename: S
authors.initials: S
authors.lastname: Ristic
authors.forename: P C
authors.initials: PC
authors.lastname: Bates
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004867:Equipment Design; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000209:etiology; D007267:Injections / Q000009:adverse effects / Q000295:instrumentation*; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D012646:Self Administration; D011795:Surveys and Questionnaires
chemical_list: D007328:Insulin