1. Introduction

2. Methods

3. Results

4. Discussion

Original Research

Assessment for ease of use andpreference of a new prefilledinsulin pen (FlexTouch DegludecU100/U200) versus the SoloSTARinsulin pen by patients withdiabetes and healthcareprofessionalsAndreas Pfutzner†, Thomas Forst, Marcus Niemeyer & Timothy Bailey†Diabetes Center and Practice, Mainz, Germany

Objective: FlexTouch� (FT) is a new prefilled insulin pen with no push-button

extension and a low injection force used to deliver several basal insulins,

including insulin degludec across a wide dose range (1 -- 80 units with FT

100 IU/ml [FT100] and 2 -- 160 units with 200 IU/ml [FT200]). This study was

carried out to evaluate whether the novel features of FT affect the preferen-

ces of the device among patients with diabetes and healthcare professionals

compared with the widely used SoloSTAR� pen.

Research design and methods: A multicenter, randomized, open-label,

crossover study compared FT100 and FT200 with SoloSTAR. The study included

patients with either type 1 (n = 22) or type 2 diabetes (n = 42), nurses (n = 32)

and physicians (n = 32). Subjects were randomized to test each of the FT100,

FT200 and SoloSTAR pens in a crossover set up. Subjects performed injections

into a foam cushion at 4 -- 6 different doses per device (2, 20, 40, 80, 120 and

160 IU).

Results: Overall, a significantly higher proportion of subjects, including

dexterity-impaired and pen-naive patients, preferred to use FT100 (93.0%;

119/128) and FT200 (91.4%; 117/128) compared with 2.3% (3/128) and 3.9%

(5/128) who preferred SoloSTAR (p < 0.001), respectively.

Conclusion: FT100 and FT200 were preferred over SoloSTAR by nurses,

physicians and patients with diabetes. This may be due to the novel design

of FT, which improves ease of use, preference and confidence in delivering a

complete, accurate dose of insulin, even at high doses.

Keywords: FlexTouch, healthcare professionals, insulin degludec, insulin pen, patients,

preference

Expert Opin. Drug Deliv. (2014) 11(9):1381-1389

1. Introduction

Patients with type 1 diabetes (T1DM) have an absolute deficiency of insulin thattherefore necessitates insulin treatment in these patients [1]. Worldwide, theincidence and prevalence of type 2 diabetes (T2DM) are increasing, particularly indeveloping countries, as a result of increasing obesity and the westernization of life-styles [2]. Insulin therapy offers the most effective way to control plasma glucose levels,thereby contributing to the prevention of serious long-term complications of diabetesthat impact patient morbidity and mortality [2]. The evolution in insulin delivery

10.1517/17425247.2014.927438 © 2014 Informa UK, Ltd. ISSN 1742-5247, e-ISSN 1744-7593 1381All rights reserved: reproduction in whole or in part not permitted

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devices has progressed in parallel with insulin treatments, fromvial and syringe to insulin pumps and pen devices. The intro-duction of pen devices has overcome many of the psychologicaland social barriers associated with insulin self-injection; andpatients have been shown to prefer using pen devices to the ‘vialand syringe’ approach [3-5]. Moreover, dose accuracy is alsoimproved using prefilled insulin pens compared with insulinsyringes [5-7]. To date, the design of all insulin pens has beenbased on the principle of dialling the dose selector until therequired insulin dose is displayed by the dose counter on thebarrel of the pen. However, this produces an extension ofthe push-button (the length of the extension increases withthe size of the dose required); the patient then depresses thepush-button to deliver the insulin dose. The dose button exten-sion can be problematic, specifically at higher doses and amongpatients with reduced hand strength or impairedmanual dexter-ity, such as those with diabetic neuropathy. Consequently,advances in insulin pen technology have therefore focused onimproving ease of use, particularly to reduce the thumb pressurerequired to depress the push-button extension on prefilledinsulin syringes [8].FlexTouch (FT) (Novo Nordisk A/S, Bagsvaerd, Denmark)

is a novel prefilled insulin pen device with no push-buttonextension due to a unique torque spring design. Instead ofrequiring thumb pressure from the user to deliver the dose,the torque spring is loaded during dose setting and the energyrelease when the push-button is depressed produces the injec-tion force required. The only force required from the user isa light touch to activate the spring-loaded injection. Thedesign of FT reduces injection force, offering a significantlylower injection force at maximum dose size compared toSoloSTAR (Sanofi, Paris, France), KwikPen (Eli Lilly & Co,Indianapolis, IN, USA) and FlexPen� (Novo Nordisk A/S,Bagsvaerd, Denmark) [8,9]. In a study assessing accuracy andpreference of FT used by patients, physicians, nurses andcarers, it has also been shown that FT delivered insulin dosesmore accurately and consistently and was better acceptedthan vial and syringes [5]. Consistent dose accuracy of FT hasbeen demonstrated at low-, medium- and high-dose levels,comparable to the accuracy of other prefilled insulin pens,including SoloSTAR [10]. Moreover, in comparison studies,FT was rated significantly higher than SoloSTAR orKwikPen� for ease of use and confidence, and was preferred

overall by patients, nurses and physicians [11,12]. FT was alsopreferred to SoloSTAR or KwikPen by healthcare professionalsfor ease of teaching and learning to use [12].

Among other insulin analogues, FT is used to deliver thebasal insulin, insulin degludec (IDeg) [13-16], a novel basalinsulin, characterized by an ultra-long duration of action,allowing for flexibility in dose timing of once daily injections.In the USA, ~ 80% of patients with T2DM are over-weight [17]. Obese patients often are less sensitive to exogenousinsulin and therefore require higher doses of insulin to main-tain good glycemic control [18]. While FT is used to deliver anumber of insulins, IDeg is the one product that is configuredfor use in two dose strengths, both administered with FT:100 IU/ml (FT100) and 200 IU/ml (FT200), to meet theincreasing insulin dosage needs of patients. The 200 IU/mlformulation allows larger insulin doses to be delivered usingFT in a single injection, up to 160 U (Figure 1). FT hasbeen developed with a dose counter that indicates the numberof units dialled, irrespective of formulation strength. This isan important safety feature, because it means thatconversion is not required when dialling a dose or when usingeither the FT100 or the FT200 formulation.

To evaluate whether the novel features of FT affect theoverall preferences of patient and healthcare professionals forthe pen device, a preference and ease of use study was con-ducted to compare FT100 and FT200 with the widely usedSoloSTAR containing insulin glargine (Lantus�). The studywas carried out in a sample comprising patients with diabetesand healthcare professionals involved in the management ofdiabetes. Patients experienced in using insulin pens as wellas pen-naive patients were included in the study.

2. Methods

2.1 Study population and settingThis was a multicenter, randomized, open-label, crossover pref-erence study conducted in two groups: outpatients with T1DMor T2DM, and healthcare professionals. The patient group(n = 64) was further subdivided into pen-naive patients orpen-experienced patients as well as into those with normal orimpaired manual dexterity. The healthcare professional groupconsisted of physicians (n = 32) and nurses (n = 32) all of

A.

B.

Figure 1. Images of the Tresiba FlexTouch pen, without cap (A) 80 units; (B) 160 units.

A. Pfutzner et al.

1382 Expert Opin. Drug Deliv. (2014) 11(9)

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whom had a minimum of 2 years’ experience in diabetesmanagement.

The study was conducted and managed in Germany andthe USA by an independent clinical research organization inaccordance with the principles of the Declaration of HelsinkiEthical Principles for Medical Research involving HumanSubjects 2000, with amendments 2002, 2004, 2008 andISO/IEC 62366:2008 ‘Medical Devices.’ The required insti-tutional review board approval was obtained for the study,and informed written consent was obtained from all subjectsprior to the start of any test-related procedures or activities.Subjects were not aware of the sponsor of the trial.

2.2 Inclusion of study participantsParticipants were included based on the following criteria:male or female adults (age ‡ 18 years) with a confirmeddiagnosis of either type 1 or 2 diabetes mellitus; patients whohad been using oral antidiabetic drugs for at least 2 years oran insulin pen for over 6 months. T2DM insulin-naive partic-ipants were included in this study. The ratio of patients whowere naive to using a pen and those who were current pen userswas ~ 50:50. Previous use of a pen was an inclusion criterion toensure that both pen-naive and pen-experienced patientswould be included. At least 10% of patients were left-handed,reflecting the global prevalence of left-handedness in the pop-ulation. Additionally, 25% of patients had a body mass indexover 30 kg/m2 and 25% of patients had impaired manualdexterity (based on patient self-assessment).

Participants were excluded from participation in the studyif they met one or more of the following criteria: any diseaseor condition that might interfere with their ability to com-plete the test activities (e.g., physical or mental incapacity,psychological disorders, dementia, cognitive function disor-ders), unwillingness or language barriers precluding adequateunderstanding and cooperation, any personal or family rela-tionship to a pharmaceutical or market research company orany prior participation in FT clinical trials. Of the patientswho were current pen users, a maximum of 50% were usingSoloSTAR and a maximum of 50% were using FlexPen.A maximum number of current pen users were set for bothSoloSTAR and FlexPen groups in order to avoid theintroduction of bias.

2.3 Study procedures and assessmentsThe study involved a single site visit; on arrival, trained staffexplained to subjects how to use each of the test devices usingthe standard instructions for use and demonstrated thehandling of FT and SoloSTAR. Subjects were randomizedto test FT100 and FT200 and SoloSTAR in a crossovermanner. Injecting into a foam cushion is the standard wayof simulating clinical use in order to assess usability and pref-erence; therefore, subjects performed injections into a foamcushion at four (with FT100) to six different dose settingsper device (2, 20, 40, 80, 120 and 160 IU). The larger doses,120 and 160 IU, could not be delivered in a single injection

with FT100, and were therefore only tested with FT200.For comparative purposes, 120 and 160 IU doses were alsotested with SoloSTAR and required two injections, as Solo-STAR can only deliver a maximum of 80 IU in a single injec-tion. Following testing of each device, subjects were asked tocomplete preference and confidence questionnaires 1 and2 about the device that was just used (see SupplementaryTables 1, 2, 3); the same procedure was repeated for the othertwo insulin pens. After all three pens had been tested, subjectscompleted two final overall preference questions (see Supple-mentary Table 2).

2.4 Statistical analysesThe primary end point of the study was overall devicepreference (FT vs SoloSTAR), which was assessed by a singlequestion in the overall device preference questionnaire:‘Overall, which pen do you prefer to use?’ This was evaluatedusing a one-sample binomial test with an exact method. Thenull hypothesis for the primary end point was no preference.

Secondary end points included subjects’ preference forone pen over another in terms of comfort/holding thepen, setting/correcting a dose, needle attachment, preparingthe pen for injection, ease of reaching push-button, lengthof push-button, injection, dose force and confidence of cor-rect dose delivery. These were assessed by several questionsusing a 5-point response scale based on questions developedby Niskanen et al. [19]. Subjects’ preference for one pen overthe other regarding ease of use, ease of learning to use andease of teaching use of the pen to others were also assessedusing a questionnaire based on a 5-point scale. Overall easeof use, learning to use and teaching others to use and con-fidence in correct dose delivery were assessed as overallquestions in a questionnaire. Any technical complaintsreported by any subject for any of the pens were recorded.

Descriptive summary statistics were used to evaluatecontinuous and categorical variables; categorical variableswere summarized as counts per category and percentages percategory, regarding the total number of observations. Inferen-tial statistics were used to determine the statistical significanceof differences in preference for FT and SoloSTAR. This studywas designed to compare FT100 and FT200 with SoloSTARprefilled with insulin glargine. As a consequence, no statisticalanalyses were performed comparing the FT100 andFT200 subgroups. Overall group results (patients and health-care providers) were analyzed for statistically significant differ-ences, and individual group results (patients, nurses anddoctors) were shown descriptively. The Wilcoxon signed-rank test was used to compare the 5-point scale responsesfor FT and SoloSTAR. The binomial test was used to analyzethe yes/no responses of the perception questions. The statisti-cal significance level was set to 5%, wherein p = 0.05 denotesa statistically significant difference (the Bonferroni adjustmentfor multiple testing was applied).

Assessment for ease of use and preference of a new prefilled insulin pen

Expert Opin. Drug Deliv. (2014) 11(9) 1383

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3. Results

3.1 Subject dispositionA total of 128 subjects took part in the study (Table 1) includ-ing 64 patients, 32 nurses and 32 physicians. The mean age ofthe patients was 54 years, and the mean healthcare providerage was 48 years; male (46.9%) and female (53.1%) patientswere almost equally represented, but the majority of health-care providers were female (71.9%). Of the 64 patients withdiabetes, 42 (65.6%) had T2DM and 22 (34.4%) hadT1DM. A total of 22 patients reported having impaired man-ual dexterity. Patients were evenly split with regard to previ-ous pen use, with 50% of patients being pen-naive. Of thepatients with previous pen experience, 25.8% had previouslyused SoloSTAR, whereas 16.1% had previously used FlexPen(the remaining patients had used various other pens; data notshown). Nearly all of the healthcare providers had previousexperience in training patients to use either SoloSTAR(97.8%) or FlexPen (80.4%).

3.2 PreferenceOverall, 93.0% (n = 119) of subjects (patients and healthcareproviders) preferred to use FT100 compared with 2.3%(n = 3) who preferred to use SoloSTAR and 4.7% (n = 6)

who answered neither/either (Figure 2A). Similarly, 91.4%(n = 117) of subjects preferred to use FT200 compared to3.9% (n = 5) for SoloSTAR and 4.7% (n = 6) who answeredeither/neither (Figure 2B). Both comparisons showed a statis-tically significant preference for FT versus SoloSTAR(p < 0.001), the primary end point of the study. Similarresults were observed in each subgroup. More than 95% ofpatients in the dexterity-impaired subgroup preferred to useeither FT100 or FT200 compared to SoloSTAR.Similarly, > 96% of patients who were pen-naive preferredto use either FT100 or FT200 compared to SoloSTAR. Thefull results for all preference questions are shown inSupplementary Table 2.

3.3 Ease of useOverall, 93.8% (n = 120) of subjects in this study (patientsand healthcare providers) rated FT100 as easier to use, com-pared with 3.1% (n = 4) who found SoloSTAR easier to use(p < 0.001) (Figure 2; Supplementary Table 3). Similarly,89.8% (n = 115) found FT200 easier to use, compared with3.9% (n = 5) for SoloSTAR (p < 0.001). When asked torate which was easiest to learn how to use and which was eas-iest to teach others to use, more subjects favored FT100 andFT200 compared with SoloSTAR (p = ns) (Figure 2). Further-more, in the healthcare provider subgroup, more foundFT100 easier to teach others to use compared with SoloSTAR(51.6% [n = 33] vs 1.6% [n = 1], respectively) and, similarly,more found FT200 easier to teach others to use comparedwith SoloSTAR (45.3% [n = 29] vs 3.1% [n = 2],respectively).

In the overall population of (patients and healthcareproviders), significantly more subjects said they would recom-mend both FT100 (93.8%, n = 120) and FT200 (90.6%,n = 116) versus SoloSTAR (3.1% [n = 4] would recommendSoloSTAR vs FT100; 5.5% [n = 7] would recommend Solo-STAR vs FT200, p < 0.001 for comparisons with FT100 andFT200) (Figure 2).

Ratings for the key steps in preparing and injecting the penswere all higher for FT100 and FT200 compared with Solo-STAR (Figure 3A). The greatest difference in ratings forFT100 or FT200 and SoloSTAR was noted in the numberof subjects who found it easy to depress the push-down injec-tion button; over 96% of responders indicated that it waseither ‘very’ or ‘fairly easy’ to push down the injector buttonon FT compared with 25.8% of those who tested SoloSTAR.Knowing that the push-button had been depressed completelywas also rated as easy by more subjects for FT100 andFT200 (> 90%) compared with SoloSTAR (69.5%). Ques-tions related to pushing the injector button and injecting at dif-ferent dose levels showed that FT100 and FT200 both scoredmore highly than SoloSTAR in the proportion of subjects find-ing FT100 and FT200 either ‘very easy’ or ‘fairly easy’ to use athigher insulin doses (Figure 3B). When injecting a dose of80 IU, more than 96% of subjects found it ‘very easy’ or ‘fairlyeasy’ to push the injector button with FT100 and

Table 1. Characteristics of respondents.

People with diabetes n = 64

Subjects with type 1 diabetes, n (%)Duration of diabetes, years (SD)

22 (34)18 (12)

Subjects with type 2 diabetes, n (%)Duration of diabetes, years (SD)

42 (66)11 (8)

Male/female, n (%) 30/34 (47/53)Mean age, years (SD) 54 (16)Mean height, m (SD) 1.7 (0.1)Mean weight, kg (SD) 88.3 (20.3)Mean BMI, kg/m2 (SD) 30.9 (7.2)Pen-naive, n (%) 32 (50)Dexterity impaired, n (%) 22 (34.4)

Healthcare professionals n = 64

Male/female, n (%) 18/46 (28/72)Age, years 48 (11)Injection devices that healthcareprofessionals train devices on, n (%)FlexPen 37 (80)HumaPen/KwikPen 34 (74)SoloSTAR 45 (99)NovoPen 38 (83)InnoLet 28 (61)OptiPen 30 (65)OptiClik 25 (54)OptiSet 24 (52.2)Autopen 15 (33)Other 6 (13)

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FT200 compared with the 20.3% with SoloSTAR. Similar rat-ing scores were obtained for the FT200 compared with theSoloSTAR for doses of 120 and 160 IU (Figure 3B). The differ-ence in rating between FT100 or FT200 and SoloSTARincreased markedly with higher dose.

All subjects were also asked to rate how suitable/convenient/comfortable they were with aspects of usingFT on a 5-point scale. More subjects reported that FT100and FT200 were ‘very’ or ‘rather’ suitable/convenient/comfortable for use in public, convenience of pen size andhandling of pen, compared to SoloSTAR. All results fromthe perception questionnaire are shown in the SupplementaryTable 4. No technical complaints were reported by any of thestudy participants for any of the pen devices used inthis study.

3.4 ConfidenceA significantly higher proportion of subjects had moreconfidence in correct and complete dose delivery with

FT100 (68.8% of subjects) and FT200 (71.9% of subjects)than the SoloSTAR device (< 6% of subjects) (p < 0.001 vsSoloSTAR). The better rating for FT100 or FT200 versusSoloSTAR in this question was reflected in both of thesubgroups -- patients and healthcare providers. In addition, asignificantly greater proportion of subjects reported moreconfidence in managing daily injections with FT100 orFT200 versus SoloSTAR (p < 0.001), with more subjectsresponded they were ‘very confident’ or ‘rather confident’ inmanaging daily injections with FT100 (92.2%, n = 59) orFT200 (90.6%, n = 58) than with SoloSTAR (71.9%,n = 46). For FT100, 92.2% (n = 59) of patients and 98.4%(n = 63) of healthcare providers reported this level of confi-dence in dose setting. For FT200, 90.6% (n = 58) of patientsand 92.2% (n = 59) of healthcare providers reported feeling‘very confident’ or ‘rather confident’ in managing daily injec-tions. By comparison, for SoloSTAR 71.9% (n = 46) ofpatients and 71.9% (n = 46) of healthcare providers reportedthat they were ‘very confident’ or ‘rather confident’ in

A.

B.

Figure 2. Subjects’ preference for one pen ([FT100] or [FT200] vs [SS]) with regard to their overall preference to use, ease to

use, ease of learning to use, easy of teaching others to use and recommendation to others in (A) FT100 and (B) FT200 groups.n = 128; *p < 0.001 for comparison between FT100/FT200 and SS.

FT100: FlexTouch� 100 IU/ml; FT200: FlexTouch 200 IU/ml; SS: SoloSTAR�.

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managing daily injections (Figure 4). All results on confidenceare shown in Supplementary Table 3.

4. Discussion

Overall, a significantly higher proportion of the patients andhealthcare providers in this study preferred FT100 andFT200 to SoloSTAR, and perceived that the FT deviceswere significantly easier to use and gave greater confidencein correct and complete insulin injections. In addition, agreater proportion of study participants found FT easier tolearn to use and to teach others to use, compared with Solo-STAR. Notably, a greater proportion of the healthcare pro-vider subgroup also found FT easier to teach others to useand to recommend compared with SoloSTAR.Latest recommendations from the American Diabetes

Association and the European Association for the Study ofDiabetes stress the importance of a patient-centered approach

to the treatment of diabetes [2], part of which is choosing themost appropriate insulin delivery device for a particularpatient. Initiating insulin treatment can be a particularly diffi-cult period for patients as it is often associated with the feelingof having failed on oral therapies and exercise alone and canbe perceived as a reminder of disease progression and mayimpose constraints on patients’ daily routines [20]. These fac-tors may reduce patient acceptance and adherence to insulintherapy, which may impact their ability to achieve glycemictargets and reduce the risk of long-term diabetic complica-tions. As a result, it is important that insulin delivery devicesare easy to use and improve the self-injection experience forpatients. This may be of particular importance when initiatinginsulin therapy in insulin-naive patients.

In our study, insulin pen-naive patients indicated a greaterpreference for FT100 and FT200 compared with the prefilledSoloSTAR. These results suggest that the new FT device mayoffer further advantages for insulin-naive patients starting

A.

B.

Dose

Figure 3. Percentage of subjects (both patients and health care professionals) giving scores of 5 (‘very easy’) or 4 (‘fairly easy’)

regarding (A) handling all three devices; and (B) dosing at different levels.n = 128.

FT100: FlexTouch� 100 IU/ml; FT200: FlexTouch 200 IU/ml; SS: SoloSTAR�.

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insulin treatment, such as increased control over managingtheir disease and greater adherence to insulin treatment, whichcould facilitate improved glycemic control. Patients andhealthcare professionals in this study also found that FT waseasy both to teach others to use and to learn to use, suggestingthat FT may help in initiating therapy and managing dailyinjections. The study also included 22 patients who indicatedthat they had impaired manual dexterity. Dexterityimpairment is a common comorbidity in patients withboth T1DM and T2DM of all ages [21]. Polyneuropathy is aleading cause of impaired dexterity and has been shown toaffect ~ 40% of patients with diabetes [22,23], although deterio-ration in manual dexterity can occur independently of diabeticneuropathy [21]. When asked to compare the FT withSoloSTAR, nearly all the dexterity-impaired patients in thisstudy preferred FT100 and FT200 over SoloSTAR. Theobserved differences in preference and usability in patientswith impaired dexterity in this study favoring FT100 andFT200 over SoloSTAR may relate to no push-button exten-sion for FT, which has an impact on the whole dose handlingprocess. In this context, it is important to note that manypatients with diabetes are not aware of their dexterityimpairment [24], although this is a factor likely to influencetheir device preference [25].

The feature of no push-button extension with FT, incombination with the ability to deliver up to 160 IU in a sin-gle injection with the IDeg 200 IU/ml formulation, could beparticularly relevant in the administration of larger insulindoses. Globally, it has been estimated that a large proportionof patients with T2DM require in excess of 60 units of insulindaily [26]. These large doses often necessitate the use of multi-ple, large, daily injections [27]. Results from our study indicatethat more patients and healthcare professionals found

injecting with FT100 and FT200 easy compared with Solo-STAR. Ratings for the injection of larger doses showed aneven more pronounced preference for FT100 and FT200while ratings for SoloSTAR decreased markedly with higherdoses. These results may indicate that the lack of push-buttonextension with FT could help to overcome the barrier of injec-tion of high doses of insulin, and improve concordance withinsulin therapy in this subgroup of patients. This is consistentwith the findings of a separate preference trial that comparedFT with another widely available prefilled insulin pen withpush-button extension, KwikPen, in which the difference inusability ratings in favor of FT grew with increasing dosesize from 20 to 60 IU [12].

Although the clinical implications of the above findingsremain to be determined, the significantly greater number ofpatients favoring FT versus SoloSTAR with regard to confi-dence in correct and complete insulin injections, as well as thehigher ratings for FT in terms of confidence in setting dose,injecting the correct amount of insulin, managing dailyinjections and controlling blood sugar levels, could all have ben-efits in encouraging patients both to initiate and to adhere toinsulin treatment. This is especially relevant considering thecurrent emphasis on the importance of joint treatment decisionsbetween physician and patients in order to maximize patientcompliance with their diabetes management strategy [2].

There were several limitations in the design of this usabilityand preference study that should be considered. Firstly, thequestionnaires did not attempt to assess any of the factorsthat influenced patient and healthcare provider preferences,and further evaluations are required to examine these factors.Secondly, the study was not carried out under conditionsmatching normal clinical use, and involved responses to injec-tions into foam cushions rather than normal subcutaneous

Figure 4. Percentage of patients and health care professionals giving scores of 5 (‘very confident’) or 4 (‘rather confident’) on

the 5-point scale after handling and injecting with each of the three pens.*Responses comprise scores 5 (‘very comfortable’) or 4 (‘rather comfortable’).

FT100 (n = 128); FT200 (n = 128); SS (n = 127).

FT100: FlexTouch� 100 IU/ml; FT200: FlexTouch 200 IU/ml; SS: SoloSTAR�.

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administration. These findings should be complemented byfurther observational studies examining the use of theFT100 and FT200 insulin delivery devices in clinical practice.However, the authors note that the conditions were identicalfor all three devices and the consistency of findings providesreasonable confidence that the reported preferences and confi-dence scores reflect the preference of patients and healthcareprofessionals for the insulin pens. Finally, manual dexteritywas identified through patients’ self-reported assessment ofphysical ability, which may not have accounted for patientswho were unaware of their dexterity impairment [24].In conclusion, patients with diabetes, including pen-naive

patients and those with impaired manual dexterity, nursesand physicians, preferred using FT100 and FT200 pens toSoloSTAR, finding them easier to use and associating FTwith greater confidence in correctly delivering insulin therapycompared to the SoloSTAR. The possibility of choosingbetween FT100 and FT200 combined with the feature ofno push-button extension, consistent dose accuracy and alower injection force compared with other prefilled insulinpens [8-10], should enhance ease of use and improve confidencein the injection process. Ultimately, these benefits of FT maylead to improved adherence to insulin treatment in patientswith diabetes, particularly among the increasing proportionof insulin-resistant patients requiring large daily doses of basalinsulin.

Declaration of interest

A Pfutzner has received research grants, consultancy fees andspeaker fees from Novo Nordisk, Eli Lilly, Insuline Medical,AstraZeneca, Bristol Myers Squibb, Pfizer, Boehringer Ingel-heim, Johnson & Johnson and Sanofi. T Forst has servedon advisory panels for Eli Lilly, BMS, Sanofi and Boehringer,and speaker bureaux for Eli Lilly, Novo Nordisk, Sanofi,BMS, Berlin Chemie, Novartis and Boehringer. He hasreceived research support from Novartis, Boehringer andSanofi. M Niemeyer is an employee of Novo Nordisk A/S.T Bailey has received research support from Abbott,ACON, Alere, Animas, Bayer, BD, Cebix, Bristol MyersSquibb, Dexcom, GlaxoSmithKline, Halozyme, Insulet, Life-scan, Lilly, Mannkind, Medtronic, Merck, Novo Nordisk,Orexigen, Sanofi and Tandem, and consultancy honorariafrom Bayer, BD, Medtronic, Novo Nordisk and Sanofi, andspeaking honoraria from Novo Nordisk. The authors haveno other relevant affiliations or financial involvement withany organization or entity with a financial interest in orfinancial conflict with the subject matter or materials dis-cussed in the manuscript apart from those disclosed. Thisstudy was funded by Novo Nordisk A/S. Writing assistancewas utilized in the production of this manuscript; it wasprovided by apothecom scopemedical and funded by NovoNordisk A/S.

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AffiliationAndreas Pfutzner†1, Thomas Forst2,

Marcus Niemeyer3 & Timothy Bailey4

†Author for correspondence1Diabetes Center and Practice, Parcusstr 8,

D-55116 Mainz, Germany

Tel: +49 6131 5763615;

Fax: +49 6131 5763611;

E-mail: AndreasP@ikfe.de2Profil Mainz GmbH, Rheinstrasse 4C,

55116 Mainz, Germany3Novo Nordisk A/S, Vandtarnsvej 114,

2860 Søborg, Denmark4AMCR Institute, Suite 201, 700 West El Norte

Parkway, Escondido, CA 92026, USA

Supplementary material available online

Supplementary Tables 1 -- 4.

Assessment for ease of use and preference of a new prefilled insulin pen

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