Accuracy and preference assessment of prefilled insulin pen versus vial and syringe with diabetes patients, caregivers, and healthcare professionals

Pfützner, Andreas; Bailey, Timothy S.; Campos, Carlos; Kahn, Douglas; Ambers, Ellen; Niemeyer, Marcus; Guerrero, German; Klonoff, David C.; Nayberg, Irina

doi:10.1185/03007995.2013.775112

Cited by 33 publications

(23 citation statements)

References 25 publications

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“…Pen injectors were significantly more accurate than syringes but variability in dosing was similar for both 33. Subsequently, improved accuracy of prefilled insulin pens as opposed to vial and syringe methods has been demonstrated 58. Therefore, pen injectors may be favourable; however, education is required if patients are transferred between different devices 33.…”

Section: Resultsmentioning

confidence: 99%

Accuracy of intravenous and enteral preparations involving small volumes for paediatric use: a review

et al. 2017

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Section: Resultsmentioning

confidence: 99%

Accuracy of intravenous and enteral preparations involving small volumes for paediatric use: a review

et al. 2017

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“…However, BEGIN: HIGH DOSE demonstrated noninferior glycemic control between degludec and glargine U100, suggesting a similar adherence to treatment with the two basal insulins 18 . We can still speculate that despite a lack of studies investigating patient preference and adherence in pen injectors, patients prefer devices which are easier to use 9,13,[30][31][32] , and previous studies have demonstrated that ease of use corresponds to improved adherence 12,13,30,33 . Therefore, it may be inferred that patient preference may be a marker for adherence.…”

Section: Discussionmentioning

confidence: 97%

“…Consequently, insulin pen injectors are preferred by patients when compared with vial and syringe 6 , offering demonstrable and immediate benefits as shown by the improved persistence and adherence to basal insulin therapy in insulin-naïve patients with T2D 7,8 . The relative features of different pen injectors, impacting their ease of use and acceptability, as well as improved accuracy of dosing 9,10 , should therefore be a consideration when choosing insulin therapy, as these may influence patient preference and adherence to treatment 9,[11][12][13][14] .…”

Section: Introductionmentioning

confidence: 99%

Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes

Warren

Brod

Håkan‐Bloch

et al. 2019

Current Medical Research and Opinion

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Objective: Type 2 diabetes (T2D) is associated with insulin resistance and deteriorated glycemic control that can be restored with insulin injections. Choice of insulin pen injector may affect complexity, adherence, efficacy of treatment and health-related quality of life. We describe detailed patientreported outcomes (PROs) on treatment impact and preference comparing insulin degludec (degludec) using FlexTouch 1 versus insulin glargine U100 (glargine U100) with SoloStar 2 pen injector. Methods: In this randomized, multicenter (USA), open-label, crossover, treat-to-target study (NCT01570751), patients with T2D using high-dose insulin (!81 U/day from vials) were randomized (n ¼ 145) 1:1 to 16 weeks of degludec U200 (3 mL FlexTouch) followed by 16 weeks of glargine U100 (3 mL SoloStar) or vice versa. PRO questionnaires assessed treatment impact and patient preference of pen injectors. Results: Significantly more patients (p < .01) considered FlexTouch "extremely easy" for learning (62.5 vs. 43.0%), maintaining (63.2 vs. 42.2%) and adjusting the dose (63.2 vs. 44.4%), and significantly more were "very" or "extremely confident" in using the device (60.3 vs. 36.3%) and in its accuracy (50.7 vs. 30.4%) versus SoloStar. Significantly more were "not at all bothered" by device discomfort (74.3 vs. 54.1%), whereas device size (83.8 vs. 80.0%) or public use (69.9 vs. 60.7%) were numerically in favor of FlexTouch. Significantly more patients preferred degludec treatment with FlexTouch (59 vs. 22%), preferred to continue (67 vs. 15%) and recommend (67 vs. 14%) use of FlexTouch compared with SoloStar with glargine U100. Conclusions: In this randomized, crossover trial, lower treatment impact and higher patient preference were reported for FlexTouch versus SoloStar pen injectors. ARTICLE HISTORY

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“…Dosing errors with injectable agents such as insulin or exenatide once weekly can result in inadequate glycemic control or hypoglycemia in the event of overdose. 17,18 Pen injectors have helped greatly to 19,20 However, multidose pen injectors could introduce dosing errors if the dose is incorrectly dialed or if the dose display is misread. 21 The single-use dual-chamber pen allows for the delivery of only 1 dose with no titration and mitigates concerns of overdose.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Dual-Chamber Pen Design for the Injection of Exenatide Once Weekly for the Treatment of Type 2 Diabetes

LaRue

Malloy

2015

J Diabetes Sci Technol

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Exenatide is the first-in-class glucagon-like peptide-1 receptor agonist (GLP-1RA) originally approved in 2005 by the US Food and Drug Administration (FDA) as a twice daily premeal subcutaneous injection administered by pen for the treatment of hyperglycemia in patients with type 2 diabetes mellitus (T2DM).1 GLP-1RAs increase glucose-dependent insulin secretion, suppress glucagon secretion, and slow gastric emptying.2 The exenatide molecule shares approximately 53% structural similarity to human GLP-1 but is resistant to enzymatic degradation by dipeptidyl peptidase-4 resulting in a prolonged physiological response and an increased halflife of 2.4 hours compared with 2 minutes for native GLP-1. [1][2][3] In 2012, the US FDA approved a long-acting formulation of exenatide for once-weekly administration that can be administered regardless of meal times; 4 European Medicines Agency approval occurred in 2011. The long-acting, sustained release of exenatide is achieved by dispersion of the parent exenatide molecule in poly-(D,L-lactide-co-glycolide) polymer microspheres approximately 0.06 mm in diameter. Similar polymer material has been used in surgical sutures, bone plates, and orthopedic implants for decades. 5These exenatide-containing microspheres must be suspended Methods: Design development goals were established, and validation tests (dose accuracy, torque/force requirements, usability, and ease-of-use) were performed. Dose accuracy was tested under a variety of conditions. After 10 exploratory studies in 329 patients, the final design's usability and ease-of-use were tested in untrained health care practitioners (HCPs; n = 16) and untrained/trained patients (n = 30/17). Usability testing evaluated completion of multiple setup, dose preparation, and injection steps. Ease-of-use impression was assessed using a scale of 1−7 (1 = very difficult, 7 = very easy). Results:The dual-chamber pen successfully met development goals and delivered target volume (650 µL ± 10%) under tested conditions (mean 644.7-649.3 µL), with torque and force requirements below prespecified maximum values. In the final user study, most participants (≥87%) correctly completed pen setup, dose preparation, and injection steps. Mean easeof-use scores were 5.8, 6.3, and 6.5 out of 7 in untrained HCPs, untrained patients, and trained patients, respectively. Conclusion:With self-education or minimal training, participants accurately and precisely suspended, mixed, and delivered exenatide-containing microspheres using the dual-chamber pen with high ease-of-use scores. The dual-chamber pen was FDA-approved in February 2014.

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Accuracy and preference assessment of prefilled insulin pen versus vial and syringe with diabetes patients, caregivers, and healthcare professionals

Cited by 33 publications

References 25 publications

Accuracy of intravenous and enteral preparations involving small volumes for paediatric use: a review

Accuracy of intravenous and enteral preparations involving small volumes for paediatric use: a review

Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes

Evaluation of the Dual-Chamber Pen Design for the Injection of Exenatide Once Weekly for the Treatment of Type 2 Diabetes

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