Reusable Pen Research Articles

Estimated Sustainable Cost-Based Prices for Diabetes Medicines

The burden of diabetes is growing worldwide. The costs associated with diabetes put substantial pressure on patients and health budgets, especially in low- and middle-income countries. The prices of diabetes medicines are a key determinant for access, yet little is known about the association between manufacturing costs and current market prices. To estimate the cost of manufacturing insulins, sodium-glucose cotransporter 2 inhibitors (SGLT2Is), and glucagonlike peptide 1 agonists (GLP1As), derive sustainable cost-based prices (CBPs), and compare these with current market prices. In this economic evaluation, the cost of manufacturing insulins, SGLT2Is, and GLP1As was modeled. Active pharmaceutical ingredient cost per unit (weighted least-squares regression model using data from a commercial database of trade shipments, data from January 1, 2016, to March 31, 2023) was combined with costs of formulation and other operating expenses, plus a profit margin with an allowance for tax, to estimate CBPs. Cost-based prices were compared with current prices in 13 countries, collected in January 2023 from public databases. Countries were selected to provide representation of different income levels and geographic regions based on the availability of public databases. Estimated CBPs; lowest current market prices (2023 US dollars). In this economic evaluation of manufacturing costs, estimated CBPs for treatment with insulin in a reusable pen device could be as low as $96 (human insulin) or $111 (insulin analogues) per year for a basal-bolus regimen, $61 per year using twice-daily injections of mixed human insulin, and $50 (human insulin) or $72 (insulin analogues) per year for a once-daily basal insulin injection (for type 2 diabetes), including the cost of injection devices and needles. Cost-based prices ranged from $1.30 to $3.45 per month for SGLT2Is (except canagliflozin: $25.00-$46.79) and from $0.75 to $72.49 per month for GLP1As. These CBPs were substantially lower than current prices in the 13 countries surveyed. High prices limit access to newer diabetes medicines in many countries. The findings of this study suggest that robust generic and biosimilar competition could reduce prices to more affordable levels and enable expansion of diabetes treatment globally.

Smart connected insulin dose monitoring technologies versus standard of care: a Canadian cost-effectiveness analysis.

Aim: There is growing interest in novel insulin management systems that improve glycemic control. This study aimed to evaluate the cost-effectiveness of smart connected insulin re-usable pens or caps for disposable insulin pens versus pens without connected capabilities in the management of adult patients with Type 1 diabetes (T1DM) from a Canadian societal perspective. Materials & methods: The IQVIA Core Diabetes Model was utilized to conduct the analyses. Applying data from a non-interventional study, the connected insulin device arm was assumed to result in greater reductions (-0.67%) in glycated hemoglobin from baseline and fewer non-severe hypoglycemic events (-32.87 events/patient annually). Macro- and micro-vascular risks were predicted using the Epidemiology of Diabetes Interventions and Complications study data. Direct and indirect costs and utilities were sourced from literature. Key model outcomes included life years and quality-adjusted life-years (QALYs). Both costs and effects were annually discounted at 1.5% over a 60-year time horizon. Uncertainty was explored in scenario and probabilistic sensitivity analyses (PSA). Results: The connected insulin pen device was associated with lower mean discounted total costs (CAD221,943 vs 266,199; -CAD44,256), improvement in mean life expectancy (25.78 vs 24.29; +1.49years) and gains in QALYs (18.48 vs 16.74; +1.75 QALYs) over the patient's lifetime. Most scenario analyses confirmed the base case results. The PSA showed dominance in 99.5% of cases. Conclusion: For adults with T1DM in Canada, a connected insulin pen device is likely to be a cost-effective treatment option associated with greater clinical benefits and lower costs relative to a standard re-usable or disposable pen.

The Journey of Insulin Over 100 Years

The year 2021 marks 100 years of insulin discovery. In 1921, Banting and Best identified the pancreas as a key organ mainly responsible for carbohydrate metabolism and pathogenesis of diabetes. This work led to the purification of extract from the pancreas, which was later identified to be insulin. Since its discovery, there has been a lot of work to refine the properties of insulin and improve patient outcomes. Presently, short-acting, rapid-acting, intermediate-acting, long-acting, ultra-long-acting co-formulations, biosimilar, concentrated insulins are available and have revolutionized diabetes management and patient care. These new preparations have onset of action in a few minutes and some have their action lasting around 48 h. Also, there are a lot of advances in insulin delivery devices with the availability of ultra-fine needles and prefilled, reusable pens to hybrid closed-loop systems in which insulin is delivered as per continuous glucose monitoring recordings. Our article enfolds the milestones in insulin discovery and its evolution from the crude extract to highly designed once-weekly insulin.

USABILITY AND PATIENT ACCEPTANCE OF PREFILLED OR REUSABLE INSULIN PENS

Objective: Adherence to insulin therapy is poor in diabetic patients. Insulin pens with many different features have been developed to increase patient satisfaction and compliance to treatment. In our study, we aimed to investigate the usability and acceptance of prefilled or reusable insulin pens.Material and Methods: One hundred and twenty-six patients with a mean age of 55.3±11.1 years were included. Eighty-nine (71%) patients were female. Sixty-three patients were in prefilled pen group. A questionnaire was used to assess patients’ opinions about their use of insulin pens. Glycemic control parameters, demographic characteristics, treatment protocol and microvascular complications were recorded.Results: There was no significant difference between the two groups for age (p=0.3), gender (p=0.1), educational status (p=0.6), duration of diabetes (p=0.8), duration of insulin therapy (p=0.2) and mean insulin dose (p=0.1). Ease of use (p=0.8), ergonomics (p=0.3), ease of dose selection (p=0.6), ease of reading the dose scale (p=0.3) did not significantly differ when two groups were compared. Only the number of patients who found to change the needle as 'moderately difficult' was significantly higher in the prefilled pen group (p=0.04).Conclusion: The applicability of the treatment and patient satisfaction is as important as the treatment given to the patients. However we did not find any important difference between prefilled or reusable pen device in terms of usability and patient satisfaction.

Factors Driving Patient Preferences for Growth Hormone Treatment in Japanese Children With Growth Hormone Deficiency

Background: There are no any clear evidence to date has evaluating patients and caregiver preferences for r-hGH (recombinant-human growth hormone) injection in children in Japan. This study quantitatively evaluated the factors driving preferences for daily r-hGH injection among Japanese children with Growth Hormone Deficiency (GHD) or their respective caregivers to determine the relative importance of treatment delivery attributes. This study was performed amongst Japanese children with GHD or their caregivers who visited a specialized clinic in Japan as part of their routine care between June and July 2020. Methods: The participants were asked to complete a web-based discrete choice experiment (DCE) questionnaire using a handheld tablet device during a routine clinical visit. DCE is a quantitative method widely used in healthcare to elicit preferences from participants in the absence of revealed preference data. Choice-based conjoint analysis was used to evaluate the relative importance of attributes as choice predictors and determine utilities for each attribute. Of the 47 respondents who participated in this study, 41 were caregivers who responded on behalf of the patients, and the remaining 6 were patients who completed the DCE themselves. All participants were screened by a clinician to ensure they met all eligibility criteria. Results: The injection schedule was found to be the most important attribute for both patients and caregivers (Relative importance: 43.6%); a once-weekly injection schedule was preferred over a daily injection schedule. For maintenance of injection devices, patients had a stronger preference for reusable pens which can be used by replacing cartridges, while caregivers preferred disposable pen devices. The storage and preparation attribute was deemed more important to patients than it was to caregivers, with patients preferring storage in room temperature even if it needed an additional mixing(reconstitution) step. Both patients and caregivers showed a clear preference for devices that offered a dose setting memory. Conclusion: The results of this study showed that patients prefer a once-weekly injection schedule over a daily injection schedule. A less frequent injection schedule should enhance adherence and compliance to r-hGH treatment over the long term and will also improve QoL in children with GHD. The benefits of a less frequent injection schedule can be further explored using real-world studies.

Study on Testing Methods of Pen-injector's Dosing Accuracy

An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests. According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed. After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested. Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.

This or That? Instructions for Use (IFU): IF U Could Pick Your Dream Printout Format

An Instructions for Use (IFU) is a critical element of a drug delivery device system user interface that is frequently used as risk mitigation when the product cannot be effectively mitigated by the design of the device itself. However, format of a printout IFU is often selected without thoughtful consideration or even neglected while the IFU contents such as wordings and images are iteratively improved over the course of device development. There is a limited number of research papers that exist on the effects of the IFU printout format on task performance, especially with a drug delivery device. This study was to evaluate two different IFU formats (spiral bound vs accordion style) on task performance for use of a complex reusable electromechanical injection pen device system for preparing and administering medication. This study provides valuable insights for biotech/pharmaceutical industry for optimizing their IFU design by selecting more appropriate hardcopy IFU format for their drug delivery device. This will enable creating optimal user experience as well as more effectively reducing use related risks as part of overall device user interface for a complex drug delivery device system.

Qualitative risk assessment of follicle stimulating hormone injectable products

ABSTRACT Background Gonadotropin injections for fertility treatment regimens are usually self-injected, typically over 8–12 days during the assisted reproductive technology cycle. Parenteral gonadotropins are available in different formulations and administered through various systems. A user experience study and risk assessment were performed to evaluate different product types for risks to the patient when preparing and administering injections. Methods Nine women of child-bearing age each prepared and administered injections of six products representing single- and multidose vials of menotropin for reconstitution (Merional® and Menopur®), follicle stimulating hormone (FSH) reusable pen injectors with (Puregon®), and without cartridges (Gonal-f®), and single-use FSH pre-filled pens (Bemfola®). Risk assessments based on user feedback were made with reference to EU regulations for implementing practices for safe use of injectable products. Results Products requiring reconstitution with diluent in glass ampoules were associated with medium risk for sharps injury and a lower level of user confidence. Pen injectors were considered easy-to-use, with a low risk of sharps injury. Single-use pens were associated with the lowest risk of dosing errors. Conclusions The study identifies differences in the risks for both sharps injuries and dosing errors between FSH delivery options that practitioners should consider when making a treatment choice.

A pen device for injection of recombinant human growth hormone: a European usability engineering study

ABSTRACT Objective The Aluetta™ reusable pen device and instructions for use (IFU) for growth hormone (r-hGH; Saizen®, Merck KGaA, Darmstadt, Germany) administration were tested for Human-Factors Usability, to ensure it could be used safely and effectively by the intended users in the intended use environment. Research design and methods Usability testing was conducted under simulated conditions in three groups of participants: pediatric or adult patients with growth hormone deficiency (GHD), participants without GHD, and healthcare professionals (HCPs). The testing comprised a 45-minute training session, a 2-hour testing session, and a participant-feedback session. Results Twenty-six participants completed the training session and performed all critical tasks related to the pen use across three scenarios. The most difficult tasks were related to the preparation, checking, and maintenance of the device; only 8% of use errors occurred during tasks related to the injection process. Eighty-five percent considered the pen safe and effective to use without further modifications and the training to be clear and effective. Conclusions The pen device and associated materials benefited from Human Factors Engineering throughout the development process. These evaluations show that patients and HCPs could safely and effectively use the pen device, and the IFU and training were clear and effective.

Conhecimento de portadores de diabetes mellitus acerca da conservação da insulina

O objetivo deste estudo foi avaliar o conhecimento dos portadores de diabetes mellitus (DM) sobre a conservação da insulina. A pesquisa foi direcionada a 244 usuários de insulina, abordados em redes sociais voltadas para a DM, que responderam no primeiro semestre de 2018, questionário acerca da conservação da insulina. Os resultados mostraram que em relação à caneta reutilizável em uso, 80,7% guardam fora da geladeira, destes 46% a deixam fora do estojo original. O armazenamento dos frascos de insulina em uso dentro da geladeira é realizado por 84,8% da amostra, utilizando para a conservação as prateleiras (36%), porta (36,8%) e gaveta de legumes (12%). Já os frascos de insulina lacrados, nas prateleiras (47,8%), na porta (30,1 %), na gaveta de legumes (21,3%). O uso de recipiente térmico para transporte é usado por 77,7% ao ir para trabalho/escola, 84,1% para praia/piscina e 62,9% para ir da farmácia para casa. Constatou-se que o armazenamento de canetas e frascos de insulina, assim como seu transporte, ocorre de maneira inadequada em uma parcela da amostra. Através desse resultado, que evidencia um diagnóstico do conhecimento de usuários de insulina, é possível que os profissionais de saúde atualizem suas práticas de educação em saúde tornando-as mais efetivas para essa população.

Analysis of patient and nurse preferences for self-administered FSH injection devices in select European markets.

PurposeThe purpose of this study was to assess product-specific features for a variety of self-administered injection devices and identify key factors that patients and nurses in select European markets find most important when selecting injection devices for self-administration of recombinant human follicle-stimulating hormone and urinary human follicle-stimulating hormone for fertility/reproductive therapy.Patients and methodsPatients (N=402) in France, Italy, Spain, Germany, the UK, the Netherlands, and Belgium, as well as reproductive/fertility nurses (N=40) in Germany, Italy, France, Spain, and the Czech Republic were surveyed. All patients were previously prescribed a follicle-stimulating hormone (FSH) treatment for either in vitro fertilization or ovulation induction. Patient and nurse preferences for attributes across all injection devices in the market were obtained via an online questionnaire and evaluated using the maximum differential scaling (MaxDiff) and conjoint analyses, which captured the relative importance of the selected FSH injection device attributes to determine specific qualities in overall product preference.ResultsBoth the MaxDiff and conjoint analyses indicated that, for patients and nurses, the ideal FSH injection device would be a highly accurate, multi-use reusable pen injector with a dial-back function that would be easy for both use and education/instruction. Patients and nurses each selected attributes pertinent to their own experiences with the FSH injection device. Categorically, patients valued factors that resulted in minimal impact on daily life, including reduced injection volume to minimize injection-site pain, as well as a reusable device that would be easy to use; nurses placed greater value on a device that would be easy to teach in order to instruct the greatest number of patients while minimizing risk.ConclusionPatient and nurse preferences were aligned on certain selected attributes of the FSH products. Although this study was an unbranded examination of attributes across all injection devices currently in the market, results demonstrated that the preferred product attributes were all characteristics of the Ovaleap® Pen.

A new pen device for injection of recombinant human growth hormone: a convenience, functionality and usability evaluation study.

PurposeAdherence to recombinant human growth hormone (r-hGH) is critical to growth and other outcomes in patients with growth disorders, but the requirement for daily injections means that ease of use is an important factor. This study assessed the perceived ease of use and functionality of the prototype of a reusable pen injector (pen device) for r-hGH that incorporates several advanced features.Participants and methodsSemi-structured 60-minute qualitative interviews were conducted in 5 countries with 57 health care professionals (HCPs) and 30 patients with GH deficiency/caregivers administering r-hGH to patients, including children. HCPs had to be responsible for training in the use of r-hGH pen devices and to see ≥4 r-hGH patients/caregivers per month. Patients/caregivers had to have experience with r-hGH administration for at least 6 months.ResultsThirty-seven (65%) of HCPs described the pen device as “simple” or “easy” to use. The aluminum body was generally perceived as attractive, high quality and comfortable to hold and operate. The ease of preparation and use made it suitable for both children and adults. The ability to dial back the r-hGH dose, if entered incorrectly, was mentioned as a major benefit, because other devices need several user steps to reset. Patients/caregivers felt the pen device was easy to use and the injection-feedback features reassured them that the full dose had been given. Overall, 40 (70%) HCPs and 16 (52%) patients/caregivers were likely to recommend or request the pen device. Moreover, patients/caregivers rated the pen device higher than their current reusable pens and almost equal to the leading disposable device for ease of learning, preparation, administration and ease of use.ConclusionThe prototype pen device successfully met its design objectives and was very well accepted by HCPs and patients/caregivers for its ease of use, appearance and functionality.

Insulin: An evolving paradigm in diabetes management

Insulin therapy is vital for the treatment of type 1 diabetes, and is increasingly being used in type 2 diabetes. Danny D Meetoo describes the aims of insulin therapy and methods of insulin delivery The global incidence of diabetes mellitus has reached an alarming epidemic proportion. Of this large proportion, 5–10% are affected by type 1 diabetes while the remaining 90% have type 2 diabetes. Insulin therapy is vital in the former category, while this therapeutic mode is often included at a stage of the latter category to prevent respective hyperglycaemia and related micro and macrovascular complications. The modern prefilled and re-usable pen devices used as insulin delivery systems hold many advantages over the conventional approach, which was often associated with dosage errors. The ease and flexibility offered by pen devices into a busy lifestyle aims to improve diabetes management with much less effort and without affecting people's quality of life. Despite the promise of future developments in insulin delivery, serious consideration should always be given to cost implications in the management of diabetes.

Initial experience and evaluation of reusable insulin pen devices among patients with diabetes in emerging countries.

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.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-014-0081-z) contains supplementary material, which is available to authorized users.

Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults.

Previous research has reported that ease of use of and preference for a delivery device are associated with greater patient compliance – an important factor in achieving optimal therapeutic results. The objective of this study was to assess the ease-of-use of a new disposable pen (GoQuick®, Pfizer, Inc.) versus the current reusable pen (GENOTROPIN Pen®, Pfizer, Inc.) to inject a daily dose of recombinant DNA origin human growth hormone, Genotropin® (somatropin) in standard practice. In this randomized, crossover, multicenter, multinational, open-label study, ease-of-use of and preference for the two pens were assessed in three treatment-naïve populations: 1) parents of very young children; 2) parent–child dyads; and 3) adults via use of a validated self-report Injection Pen Assessment Questionnaire (IPAQ) after 2 months of at-home-use experience. The primary endpoint was the proportion of participants who reported the new disposable pen to be no different from or easier to use than the current reusable pen. Safety was also assessed and reported according to local legal requirements. Of the 120 screened patients, 119 were included in the ease-of-use analysis and all were included in the safety analyses. In all, 67.2% found the new somatropin disposable pen to be no different from or easier to use than the reusable pen (95% confidence interval: 58.8–75.7). Most adverse events were mild or moderate. No deaths or device- or treatment-related serious adverse events were reported. These results suggest that improvements made to the reusable somatropin pen are tangible and recognizable to treatment-naïve patients and their caregivers, child–caregiver dyads, and adults, and may positively impact continued compliance with therapy.Registry informationClinicalTrials.gov identifier: NCT01112865.

A randomized, cross-over comparison of preference between two reusable insulin pen devices in pen-naïve adults with diabetes

Objective:To evaluate final preference and ease-of-use attributes of two reusable pen injectors, HPS (HumaPen Savvio) and HPL (HumaPen Luxura), in adults with type 1 or type 2 diabetes.Research design and methods:This was a 1 day, randomized, two-period crossover, open-label, simulated-injection study in 203 pen-naïve subjects (mean age 58.4 years).Main outcome measures:Functional and ease-of-use attributes of insulin pen injectors were evaluated using a 16-item survey (7 point scale) where higher scores reflected greater preference and equal scores reflected no preference. The primary objective was final pen preference, with statistical gate-keeping to the ease of detecting an insufficient remaining dose (IRD) of insulin upon dose selection.Results:For final overall pen preference, HPS was chosen by 150 of 203 subjects (73.9%, 95% confidence interval [CI] = 67.3%–79.8%). For the IRD item, ‘It is easy to know when there is not enough insulin left in the cartridge for the dose I need before I inject’, HPS was preferred by 94 of 107 subjects with a preference (87.9%, 95% CI = 80.1%–93.4%). In 14 of the remaining 15 survey items, 64.3% to 87.7% of subjects with a preference statistically significantly preferred HPS over HPL. To confirm the results, subjects with no preference for either pen, which ranged between 95 and 148, were included in a Bayesian analysis.Key limitations:Injection simulation, use of an unvalidated survey, and office setting which did not allow for direct clinical experience with the devices.Conclusions:The majority of pen-naïve subjects preferred HPS over HPL. For all ease-of-use attributes, the majority of subjects with a preference chose HPS over HPL. Some attributes of both pens were equally acceptable, as many subjects had no preference.

Insulin: an evolving paradigm in diabetes management

The global incidence of diabetes mellitus has reached an alarming epidemic proportion. Of this large proportion, 5–10% are affected by type 1 diabetes while the remaining 90% with type 2 diabetes. In the UK, estimates suggest that this condition affects 2.9 million people. Insulin therapy is vital in the former category while this therapeutic mode is often included at a stage of the latter category to prevent respective hyperglycaemia and related micro and macrovascular complications. The modern pre-filled and re-usable pen devices used as insulin delivery system hold many advantages over the conventional approach which was often associated with dosage errors. The ease and flexibility offered by pen devices into a busy lifestyle aims to improve diabetes management with much less effort without impacting on people’s quality of life. Despite the promise of future developments in insulin delivery, serious considerations to cost implications should always be given in the management of diabetes.

New ways of insulin delivery

New ways of insulin delivery

Psychometric Assessment of the Injection Pen Assessment Questionnaire (IPAQ): measuring ease of use and preference with injection pens for human growth hormone

PurposeTo examine the psychometric properties of the Injection Pen Assessment Questionnaire (IPAQ) including the following: 1) item and scale characteristics (e.g., frequencies, item distributions, and factor structure), 2) reliability, and 3) validity.MethodsFocus groups and one-on-one dyad interviews guided the development of the IPAQ. The IPAQ was subsequently tested in 136 parent–child dyads in a Phase 3, 2-month, open-label, multicenter trial for a new Genotropin® disposable pen. Factor analysis was performed to inform the development of a scoring algorithm, and reliability and validity of the IPAQ were evaluated using the data from this two months study. Psychometric analyses were conducted separately for each injection pen.ResultsConfirmatory factor analysis provides evidence supporting a second order factor solution for four subscales and a total IPAQ score. These factor analysis results support the conceptual framework developed from previous qualitative research in patient dyads using the reusable pen. However, the IPAQ subscales did not consistently meet acceptable internal consistency reliability for some group level comparisons. Cronbach’s alphas for the total IPAQ score for both pens were 0.85, exceeding acceptable levels of reliability for group comparisons.ConclusionsThe total IPAQ score is a useful measure for evaluating ease of use and preference for injection pens in clinical trials among patient dyads receiving hGH. The psychometric properties of the individual subscales, mainly the lower internal consistency reliability of some of the subscales and the predictive validity findings, do not support the use of subscale scores alone as a primary endpoint.

A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction with the SoloSTAR Insulin Injection Device in Type 1 and Type 2 Diabetes

This study evaluated patient satisfaction with SoloSTAR® (sanofi-aventis), a prefilled insulin pen device for injection of insulin glargine or insulin glulisine. This was a 6-8-week multicenter (n = 652), observational, prospective Pan-European and Canadian registry study in patients with diabetes mellitus (n = 6542) who recently switched to or started treatment with insulin glargine and/or insulin glulisine using SoloSTAR or were insulin naïve. At the baseline visit, patients were asked to evaluate their satisfaction with their previous device, if applicable. After 6-8 weeks of SoloSTAR use, patients were asked to rate their satisfaction. Overall, 6481 patients (mean age 54 years, 48.7% male, 72% type 2 diabetes) were analyzed in this study. Of these, 4995 (77.1%) patients had used insulin before the study and 1641 (32.9%) and 3395 (68.0%) patients had previously used prefilled and/or reusable pens, respectively. During the study, SoloSTAR was used to administer insulin glargine and/or insulin glulisine by 97.3% and 36.0% of patients, respectively (both: 27.0%). Most patients rated SoloSTAR as "excellent/good" for ease of use (97.9%), learning to use (98.3%), selecting the dose (97.6%), and reading the dose (95.1%). Most patients rated ease of use (88.4%) and injecting a dose (84.5%) with SoloSTAR as "much easier/easier" versus their previous pen. Overall, 98% planned to continue using SoloSTAR. No safety concerns were reported. This European and Canadian survey shows that SoloSTAR was well accepted in this large patient population. Most patients preferred SoloSTAR to their previous pen and planned to continue SoloSTAR use.