Prefilled Insulin Pen Research Articles

Patient Acceptability of a New 3.0ml Pre-filled Insulin Pen

SummaryThe objective of these two studies was to assess patient acceptance and feature preferences of the new Lilly 3.0 ml pre-filled pen. A total of 701 patients with diabetes mellitus, who required insulin, were treated for 4–6 weeks with the pre-filled pen. Patient acceptance and treatment preferences were assessed by a questionnaire completed at the end of the study period. Patients with type 1 or type 2 diabetes mellitus from South Africa (n = 371) and Croatia (n = 330) were enrolled in the study. The mean age was51.6 years (range: 18–81), and gender was 359 males and 342 females. Prior to the study, patients in South Africa (SA) had used the Novo Actraphane® (Novo Nordisk, Bagsvaerd, Denmark) pen set, and patients in Croatia (C) had used NovoPen® 1 or 2 (Novo Nordisk, Bagsvaerd, Denmark) (38.8%), NovoPen® 3 (Novo Nordisk, Bagsvaerd, Denmark) (28.8%), B-D® Pen (Becton-Dickinson, Franklin Lakes, New Jersey, USA) (18.8%), needle/syringe (10.0%), oral hypoglycaemic agents (2.1%), or unknown (1.5%).The new Lilly 3.0 ml pre-filled pen features that were rated by respondents as good to excellent on a five-point rating scale included: cartridge visibility (C = 94%, SA = 83%), ease of dose correction (C = 92%, SA = 85%), dialling of the dose (C = 89%, SA = 81%), turning of the dose knob (C = 84%, SA = 82%) and attaching needles (C = 92%, SA = 78%). Most respondents (C = 78%, SA = 75%) preferred single-unit versus two-unit dosage increments. Overall, 76% of patients in Croatia and 80% in South Africa preferred the Lilly 3.0 ml pre-filled pen to their previous delivery device; 84% and 87% of patients, respectively, would recommend the pen to another patient. Also, the majority of patients in both trials rated the new Lilly 3.0 ml pre-filled pen as being more convenient and easier to use, and indicated that it represented a significant or modest improvement over their previous insulin injection method. The results of this study confirm that the new Lilly 3.0 ml pre-filled pen is widely accepted and preferred by patients using both reusable and pre-filled devices.

Patient acceptability and safety of a new 3.0 ml pre-filled insulin pen in a clinical setting

This multi-national study was designed to examine the acceptability and safety of a new 3.0 ml pre-filled insulin pen in clinical use. There were 74 patients (60 with type 1 and 14 with type 2 diabetes) who completed the eight week study during which all insulin injections were administered using the new pens. Patients were familiar with the use of insulin pens before the study and they maintained their pre-study insulin regimens during the study. At the final visit each patient completed a questionnaire which assessed the ease of use of the new pen and compared it with the pre-study delivery system. Features of the new pen which were ranked highly included: dose correction, re-setting after dose delivery, cartridge visibility and dialling the insulin dose. More than 50% said that they would prefer to use the new pen in the future and 74% said that they would recommend the pen to other people with diabetes. Safety was assessed from adverse events, the vast majority of which were mild. Such clinical testing is important to ensure that technical improvements result in real patient benefits and this study demonstrated that the new pen had a high patient acceptability with a clinically acceptable safety profile.

Safety, efficacy, acceptability of a pre-filled insulin pen in diabetic patients over 60 years old

The aim of the study was to evaluate safety, efficacy and acceptability of a pre-filled insulin pen device (NovoLet) in diabetic patients over 60 years old already treated with insulin administered with conventional syringes. After a run-in period of 2 weeks, 60 patients participated in a randomized cross-over study with two 6-week treatment periods using the insulin pen or conventional syringes. Insulin regimens did not change during the study. Hypoglycaemic episodes did not differ significantly between both kinds of treatment and no severe hypoglycaemia was registered. Hb A1c (%) was (mean ± S.D.) 7.7 ± 1.2 and 7.9 ± 1.1 during pen and syringe treatment, respectively. Blood glucose profiles were similar during both treatment modalities except for pre-lunch blood glucose values (mmol/l) lower during pen treatment (8.7 ± 2.9 vs. 9.2 ± 2.7, P < 0.01). The insulin dose (U/day) was 31.9 ± 8.9 (pen) and 32.3 ± 9 (syringe). 54 patients found the functioning of the insulin pen easy to understand and preferred it for future treatment because the conditions of insulin administration are faster and easier than with conventional syringes. We concluded that the pre-filled insulin pen is safe, efficacious and is highly accepted in over 60 years old diabetic patients.