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Performance of a new reusable insulin pen.

ABSTRACT: BACKGROUND: The aim of this multinational (Canada, France, Germany, United Kingdom, and United States), task and interview-based study was to compare the ease of use and performance of the ClikSTAR® (sanofi-aventis, Paris, France) insulin pen with other commonly used reusable pens based on participant and interviewer assessments. METHODS: People with diabetes (n = 654) were asked to demonstrate four pens consecutively-ClikSTAR, Lilly Luxura ® (Eli Lilly, Indianapolis, IN), and NovoPen ® 3 and 4 (Novo Nordisk, Bagsvaerd, Denmark)-according to the respective instruction manuals. The endpoint was assessed by a rating from the participants and the interviewer. While the participants focused on the pen's ease of use, the interviewer considered the participants' difficulty in preparing and delivering a 40-unit dose and their requirement for help. RESULTS: Twenty percent of U.S. participants and 24% of participants from the other countries had type 1 diabetes. Approximately 50% of participants in each group had prior insulin pen experience. A higher proportion of participants, including those with dexterity or visual impairments, reported ClikSTAR as easier to use than other pens (P < 0.05). Participants using ClikSTAR did not experience any difficulty in completing the tasks. The proportion of participants not requiring help in completing the tasks with ClikSTAR was rated as numerically higher than, or similar to, that observed with Lilly Luxura or NovoPen 3 or 4 (75%, 74%, 62%, and 65%, respectively). According to participants, ClikSTAR and NovoPen 4 emerged as the most highly rated pens. CONCLUSIONS: In comparison with other pens, ClikSTAR was significantly easier to use, which, when taken together with overall performance, meets the need of people with diabetes.

SUBMITTER: Penfornis A

PROVIDER: S-EPMC3103836 | biostudies-other | 2011 Mar

REPOSITORIES: biostudies-other

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Performance of a new reusable insulin pen.

Penfornis Alfred A

Diabetes technology & therapeutics 20110203 3

<h4>Background</h4>The aim of this multinational (Canada, France, Germany, United Kingdom, and United States), task and interview-based study was to compare the ease of use and performance of the ClikSTAR® (sanofi-aventis, Paris, France) insulin pen with other commonly used reusable pens based on participant and interviewer assessments.<h4>Methods</h4>People with diabetes (n = 654) were asked to demonstrate four pens consecutively-ClikSTAR, Lilly Luxura ® (Eli Lilly, Indianapolis, IN), and NovoP ...[more]

PMID: 21291331

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Project description:BackgroundMany individuals with type 2 diabetes in emerging countries are transitioning from vial-and-syringe insulin delivery to that of insulin pens (disposable or reusable). As with all insulin delivery methods, patient preferences and comfort are of utmost importance to optimize adherence to treatment. Patient-preferred characteristics for reusable insulin pens and barriers to appropriate injection, particularly in these regions, have not been widely reported in the clinical literature, highlighting a key information gap for clinicians considering these methods as part of a comprehensive diabetes management approach.MethodsFace-to-face interviews were conducted with people with type 1/2 diabetes, including insulin-naïve and established insulin users. After moderator demonstration, participants were evaluated on their ability to perform a six-step process to inject a 10-unit dose into a pad with the AllStar(®) (AS; Sanofi, Mumbai, India), HumaPen Ergo II(®) (HE2; Eli Lilly, Indianapolis, USA), and NovoPen 4(®) (NP4; Novo Nordisk, Bagsværd, Denmark) pens. Local pens were also tested in India, China and Brazil.ResultsA total of 503 people from India, Malaysia, Brazil, Egypt, and China participated. Participants completed the six-step process in an average, 2-3 min per pen. Participants ranked ease of overall use and ease of self-injection and dialing/reading dose as most important features for new insulin pens. When using the pens, the most difficult step was priming/safety testing, with 7-12% failing and 28-40% having difficulty; 6%, 18%, and 22% failed to hold the injection button down for the required period of time using AS, NP4, and HE2, respectively. Participants ranked AS significantly higher for nine of 12 ease-of-use features including three of the top four features considered the most important for reusable pens, while HE2 was ranked higher for two features. Local pens were ranked lowest.ConclusionsPriming the pen and injecting the dose imparted most difficulty for people with diabetes in emerging countries. Most participants found AS easiest to use overall, with differences noted between pens for individual steps of dose delivery. Identifying characteristics most preferred by patients may assist in improving adherence to insulin therapy.

Project description:PurposeThe Respimat is a handheld, propellant-free, soft-mist inhaler. Observations by patients and physicians prompted development of an improved second-generation Respimat inhaler. Human-factor studies assessing the usability of the new inhaler and in vitro assessment of aerosol performance are important to demonstrate functionality of the updated inhaler.MethodsStudies were performed to assess any possible impact of the reusable Respimat inhaler design on aerosol performance (delivered dose [DD] and fine-particle dose [FPD]) and iteratively assess and improve usability of the new design. The tiotropium-olodaterol inhalation solution for Respimat was used as a model. The DD and FPD of the reusable Respimat inhaler (across multiple cartridges) and the disposable Respimat inhaler were determined by laser diffraction and with an alternative Andersen cascade impactor. Usability was measured across three studies involving health care professionals and patients with diagnoses of COPD, asthma, or combined disease (with and without experience with the Respimat inhaler). These studies measured performance of handling tasks and collected subjective feedback directly related to the inhaler's new or altered features, which fed into optimization of the inhaler.ResultsDDs of tiotropium and olodaterol were stable up to 15 cartridges and consistently within the upper and lower limits of the disposable Respimat inhaler. The FPD was also found to be batch-consistent over the cartridges and comparable with the reference. The usability of the reusable Respimat inhaler compared with the disposable inhaler was improved in terms of assembly and daily use. Cartridge exchange was rated as intuitive and easy to very easy.ConclusionThe new reusable Respimat is a medical inhaler developed with enhanced features that meets health care professionals' and patients' needs. Drug delivery across multiple cartridges is not affected by the design. Compared with the original disposable inhaler, the usability of the reusable inhaler has been improved, and cartridge exchange was rated as easy to perform. The reusable Respimat provides greater convenience for patients vs the disposable inhaler, with reduced environmental impact.

Project description:ObjectiveSingle-use duodenoscopes have been recently developed to eliminate risk of infection transmission from contaminated reusable duodenoscopes. We compared performances of single-use and reusable duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).DesignPatients with native papilla requiring ERCP were randomised to single-use or reusable duodenoscope. Primary outcome was comparing number of attempts to achieve successful cannulation of desired duct. Secondary outcomes were technical performance that measured duodenoscope manoeuvrability, mechanical-imaging characteristics and ability to perform therapeutic interventions, need for advanced cannulation techniques or cross-over to alternate duodenoscope group to achieve ductal access and adverse events.Results98 patients were treated using single-use (n=48) or reusable (n=50) duodenoscopes with >80% graded as low-complexity procedures. While median number of attempts to achieve successful cannulation was significantly lower for single-use cohort (2 vs 5, p=0.013), ease of passage into stomach (p=0.047), image quality (p<0.001), image stability (p<0.001) and air-water button functionality (p<0.001) were significantly worse. There was no significant difference in rate of cannulation, adverse events including mortality (one patient in each group), need to cross-over or need for advanced cannulation techniques to achieve ductal access, between cohorts. On multivariate logistic regression analysis, only duodenoscope type (single-use) was associated with less than six attempts to achieve selective cannulation (p=0.012), when adjusted for patient demographics, procedural complexity and type of intervention.ConclusionGiven the overall safety profile and similar technical performance, single-use duodenoscopes represent an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands.Trial registration numberClinicaltrials.gov number: NCT04143698.

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Performance of a new reusable insulin pen.

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Performance of a new reusable insulin pen.

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