Insulin Devices
`
`957
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`Insulin Devices
`Addressing Barriers to Insulin Therapy
`With the Ideal Pen
`
`Geralyn Spollett, MSN
`
`From the Department of Internal Medicine, Yale
`University School of Medicine, New Haven,
`Connecticut.
`
`Correspondence to Geralyn Spollett, MSN,
`Department of Internal Medicine, Yale University
`School of Medicine, PO Box 208020, New Haven, CT
`06520-8020 (geralyn.spollett@yale.edu).
`
`Acknowledgments: Geralyn Spollett has received
`honoraria for advisory work for sanofi-aventis and
`has served on advisory boards for sanofi-aventis, Eli
`Lilly, and Amylin Pharmaceuticals. She is also a
`member of the speaker bureaus of Novo Nordisk and
`Pfizer Laboratories.
`
`DOI 10.1177/0145721708326763
`
`Purpose
`
`The purpose of this article was to identify and address
`barriers to initiating insulin therapy in patients with type
`2 diabetes.
`
`Results
`
`Insulin pen devices address many of the mechanical barri(cid:173)
`ers associated with a syringe and vial. In addition, pen
`devices are increasingly being improved, offering long(cid:173)
`term pen users benefits over earlier pen users. These
`devices can be tailored to address the specific needs of dif(cid:173)
`ferent patient populations, such as elderly patients or those
`with visual or manual dexterity disabilities. Although
`insulin devices offer benefits over the syringe and vial, fea(cid:173)
`tures desirable in the ideal pen have not been established.
`
`Conclusions
`
`Data suggest that currently available insulin pens pos(cid:173)
`sess various features that make them suitable for partic(cid:173)
`ular patients. Individual needs of each patient should be
`considered before an insulin pen device is prescribed.
`
`F or patients with type 1 or type 2 diabetes,
`
`achieving and maintaining tight glycemic con(cid:173)
`trol is paramount for reducing the risk of
`developing long-term complications. 1
`2 It is
`•
`increasingly apparent that patients with type 2
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`The Diabetes EDUCATOR
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`958
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`diabetes benefit from early addition of insulin to oral antidi(cid:173)
`abetic agents in their therapeutic regimen.3·4 However,
`numerous barriers prevent or delay the initiation of insulin.
`This article identifies key barriers to insulin administration
`and discusses the use of several insulin pen devices.
`
`Barriers Associated With Insulin
`Administration
`
`Fear of weight gain and hypoglycemia are 2 key fac(cid:173)
`tors that prevent or delay the initiation of insulin therapy
`in patients with type 2 diabetes.5·6 The introduction of
`insulin analogs, such as insulin glargine7 and insulin
`detemir,8 has lessened the risk of hypoglycemia and limit
`weight gain versus traditional insulins, such as neutral
`protamine Hagedorn (NPH) insulin.
`Also, a number of barriers to initiating insulin therapy are
`not caused by insulin therapy. The method by which insulin
`is administered has been shown to affect patient acceptabil(cid:173)
`ity of insulin therapy and quality of life and may serve as a
`key barrier to the initiation of insulin.9 The traditional way to
`administer insulin-using a syringe and vial-is associated
`with several disadvantages, making it unpopular and unsuit(cid:173)
`able for many patients with diabetes. Visual impairment and
`reduced manual dexterity are common symptoms associated
`with diabetes. Visual impairment is estimated to affect at
`least 16% of patients with type 2 diabetes older than age 65
`years and 27% of patients by age 75 years. 10 At least 50% of
`patients with type 2 diabetes have limited joint mobility in
`their hands, 11 and 25% have symptomatic peripheral neu(cid:173)
`ropathy.12 For patients with such disabilities, correctly hold(cid:173)
`ing a syringe or seeing sufficiently to accurately draw the
`required amount of insulin may be problematic.
`For children and adolescents with diabetes, there are many
`barriers to achieving optimal glycemic control with insulin
`therapy. A key issue is titrating insulin therapy to the tight rec(cid:173)
`ommended glycemic targets. In this age group, it is particu(cid:173)
`larly difficult to titrate insulin because of the increased risk and
`-15 In addition, for many children with
`fear of hypoglycemia. 13
`diabetes, doses of insulin required are lower than those for
`adults, with a higher rate of hypoglycemia observed in chil(cid:173)
`dren. In part, this may be caused by the increased percentage
`error in administering small quantities of insulin.16 Problems
`injecting small quantities of insulin and administering insulin
`accurately are identified when using a syringe and vial.17
`The specific needs of elderly patients with diabetes must
`also be considered when prescribing insulin. Nearly half of
`
`all patients with type 2 diabetes are older than age 65 years.18
`Therapeutic intervention in the elderly must not only
`accommodate comorbidities and psychosocial changes asso(cid:173)
`ciated with aging but must also consider that episodes of
`hypoglycemia can have particularly serious clinical conse(cid:173)
`quences in this age group.19 Administration of exogenous
`insulin with consistent reproducibility using a syringe and
`vial is difficult.17 Such a problem may be exacerbated by
`age-associated visual and manual dexterity disabilities.
`
`Pen Devices Address Many
`Barriers to Insulin Initiation
`
`The advent of pen devices addresses many of the
`mechanical barriers associated with administering insulin
`using a syringe and vial. Since the launch of the first
`insulin pen in the mid-198Os, the administration of insulin
`has become increasingly simplified. 20 The key advantages
`associated with the use of insulin pens include improved
`patient acceptability and compliance,21 reduced injection
`pain,22 increased convenience and lifestyle flexibility,
`greater reliability and accuracy of dosing,21·23·24 and sim(cid:173)
`plification of insulin administration. These benefits have
`been seen in previously insulin-
`(and pen-) naive
`patients,25 in children and elderly populations,23·26-28 and in
`those patients with visual29 or dexterity30 disabilities.
`
`What Features Are
`Important When Choosing
`an Ideal Insulin Pen?
`An insulin pen device suitable for a wide range of patient pop(cid:173)
`ulations with diabetes can be evaluated by several criteria: (1)
`ease of use, (2) ease of learning, (3) pen features, and (4) social
`factors that influence pen use (Table 1 ). A recently published
`study assessed the usability, specific pen features, and patient
`preference of 4 prefilled disposable insulin pens: Lilly
`Disposable pen (Humalog/Humulin pen; Eli Lilly and
`Company, Indianapolis, Indiana), Novolog FlexPen (Novo
`Nordisk, Bagsvaerd, Denmark), a prototype pen (Pen X), and
`SoloStar (sanofi-aventis, Paris, France).31 The FlexPen, SoloStar,
`and Lilly Disposable pen are shown side by side in Figure 1.
`
`Ease of Use
`
`Several studies have demonstrated that ease of use is
`an important criterion for the ideal pen user. A recent
`study assessed acceptability of the HumaPen Ergo (not
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`Insulin Devices
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`959
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`Table "1
`
`Subjective Criteria Used to Assess Prefilled Insulin Pen Devices31
`
`Design and esthetics
`
`Exterior design and styling
`Size and portability
`How well the cap fits onto the pen
`Tactile feel and features
`
`Features
`
`Usability
`
`Ease of use
`Ease of setting the dose
`Ease of reading the dose
`Ease of correcting the dose if overdialed
`Auditory feedback
`Number of turns to set dose
`How far the dose button sticks out
`The effort required to inject the dose
`Ease of determining whether the dose was delivered
`Ease of determining the amount of insulin left in the cartridge
`
`In a study by Haak et al,31 which investigated the
`usability of the new SoloStar device, FlexPen, and Lilly
`Disposable pen in 510 patients with type 1 or type 2 dia(cid:173)
`betes, patients were assessed on their ability to correctly
`complete a variety of tasks involved in using each pen,
`including the following:
`
`• Getting started and removing the cap
`
`• Attaching a needle
`
`• Setting (including activation of the dose knob with the Lilly
`Disposable pen) and delivering a safety dose
`
`• Dialing a 40-U dose and delivering that dose
`
`The assessed steps (excluding the safety step or attach
`needle step, which was deemed independent of the device)
`for the SoloStar and FlexPen devices were correctly com(cid:173)
`pleted by a similar proportion of patients: 94% for
`SoloStar and 90% for FlexPen; however, fewer patients
`correctly completed the same steps with the Lilly
`Disposable pen (61 % ). Patients were then asked to rate
`their preference for each pen based on various usability
`features. The feature "easy/intuitive to figure out how to
`use" was most frequently rated as best for SoloStar (55%
`of the time) and least frequently for the Lilly Disposable
`pen (13% ). The FlexPen was rated as best for "easy/intu(cid:173)
`itive to figure out how to use" 32% of the time.31
`In elderly patients, ease of use is an important considera(cid:173)
`tion when recommending an injection device; a complicated
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`Figure 1. The FlexPen, SoloStar, and Lilly Disposable pen.
`
`available in the United States), a reusable injection pen
`launched in 1998 by Eli Lilly and Company, which con(cid:173)
`tains replaceable 3.0-mL (300-U) cartridges of insulin.
`The study showed that in 228 patients with type 1 or type 2
`diabetes and 13 health care professionals who were
`assessed on the acceptability of the HumaPen Ergo, ease of
`use was considered a reason for recommending the HumaPen
`Ergo to insulin-requiring patients by 55% of patients and
`52% of health care professionals. 32
`
`Spollett
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`

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`The Diabetes EDUCATOR
`
`960
`
`regimen that the patient does not find easy to use may
`reduce patient compliance and could lead to inaccurate
`dosing. In a 12-week study of patients aged older than 60
`years with diabetes, patients were assessed on their abil(cid:173)
`ity to use a syringe and vial versus an insulin pen.
`Patients were randomly assigned to administer insulin
`for 6 weeks using 1 of the 2 methods and then switched
`to the other method. In total, 90% of patients found the
`insulin pen easy to understand and preferred it for future
`treatment because it was faster and easier to use com(cid:173)
`pared with the conventional syringe and vial method. 27
`In the study by Haak et al,31 a high proportion of patients
`aged 60 years or older correctly completed the assessed
`steps with the SoloStar (90%) and FlexPen (83%) com(cid:173)
`pared with the Lilly Disposable pen, for which the assessed
`steps were correctly completed by only 47% of patients. A
`similarly high proportion of patients with dexterity (91 % )
`and visual (94%) impairments correctly completed all
`steps analyzed with SoloStar, which was similar to that
`observed with the FlexPen (84% of patients with dexterity
`and 89% of patients with manual impairment). In contrast,
`only half of all patients with either dexterity (52%) or
`visual (52%) impairments correctly completed all analyzed
`steps with the Lilly Disposable pen.
`
`Ease of Learning How to Use a Pen
`
`Ease of learning how to use a pen is an important cri(cid:173)
`terion for all patient populations and is particularly
`important for ensuring early acceptance of insulin ther(cid:173)
`apy in previously insulin-naive patients, elderly patients,
`and those patients with visual or manual dexterity dis(cid:173)
`abilities. Assessment of the HumaPen Ergo in patients
`with type 1 or type 2 diabetes and by health care profes(cid:173)
`sionals found that ease of learning was a key feature,
`making the pen superior to other devices. Indeed, 23% of
`patients and 18% of health care professionals rated ease
`of learning as a reason for recommending the pen to
`other patients requiring insulin. 32
`In another study, pen-naive patients with type 1 or
`type 2 diabetes who were experienced in administering
`insulin using a syringe and vial were randomly assigned
`to 4 weeks of insulin therapy using either a prefilled, dis(cid:173)
`posable pen device (FlexPen) or a syringe and vial, fol(cid:173)
`lowed by 4 weeks of using the other injection device.
`Results indicated that more patients expressed a prefer(cid:173)
`ence for the pen versus the syringe and vial. Among the
`criteria that contributed to patient preference was ease of
`use: 74% of patients found the pen device easier to use
`
`overall compared with 21 % of patients who preferred the
`syringe and vial. 25
`The recent Haak et al31 study investigated the propor(cid:173)
`tion of insulin-naive patients (n = 232) who were able to
`correctly use 3 pens without tuition (although instruction
`manuals were available). A similar proportion of patients
`correctly used SoloStar and FlexPen for the first time
`(90% and 83%, respectively); however, a lower propor(cid:173)
`tion correctly used the Lilly Disposable pen for the first
`time (52% ). The ease of teaching and ease of use of
`SoloStar have also been evaluated in a 3-month observa(cid:173)
`tional survey of clinical practice, in which physicians
`and people with type 1 or type 2 diabetes reported that
`SoloStar was easy to teach33 and easy to use.34
`
`Dial Features: Dialing Specific
`Doses, Reading Dial Numbers,
`and Dialing Back
`
`The literature suggests that ease and accuracy with
`which patients can dial specific doses are important crite(cid:173)
`ria for a good injection device. As pen devices are more
`accurate than insulin syringes for the measurement of low
`insulin doses ( <5 U), they are preferred when dialing
`small doses accurately. This is an important criterion,
`particularly for children. 23 Accuracy and reliability of the
`dose setting are also important criteria for patients with
`visual impairment. Fox and colleagues 35 tested 86
`insulin-naive visually impaired patients with type 2 dia(cid:173)
`betes for their ability to handle 3 different insulin deliv(cid:173)
`ery devices; patient preference for each device was also
`assessed. Results indicated that a device with a clear
`dose scale, audible clicks accompanying the dialing of
`each dose, a large dose delivery button, and comfortable
`to handle device are important features for patients with
`visual disabilities. The study concluded that a device that
`is designed to simplify the accuracy and reliability of
`insulin delivery can improve patient ability to set and
`deliver correct doses on a repeated basis.
`Another randomized, multicenter, crossover trial compar(cid:173)
`ing the FlexPen and HumaLog pen (Eli Lilly and Company)
`in patients with type 2 diabetes found that 96% of patients
`believed it was very or rather important that the dose scale
`was easy to read.36 The 2 most common reasons why the
`HumaLog pen was rated as worth recommending to an
`insulin-requiring patient by patients with diabetes or health
`care professionals were "ease of reading numbers in the dose
`window" (68% and 74%, respectively) and "easy to dial back
`without wasting insulin" (77% and 80%, respectively).32
`
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`

`Insulin Devices
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`963
`
`An evaluation of specific pen features for SoloStar,
`FlexPen, and the Lilly Disposable pen showed that the
`proportion of times each pen was rated best for "easy to
`set dose" was much higher for SoloStar (51 % ) compared
`with either FlexPen (29%) or the Lilly Disposable pen
`(11 % ). 31 Similar trends were observed with "ease of cor(cid:173)
`recting dose if overdialed," for which SoloStar was rated
`best 50% of the time, compared with 33% for FlexPen
`and 16% for the Lilly Disposable pen.
`
`Social Issues: Flexibility, Convenience,
`and Quality of Life
`
`To improve patient acceptance of their treatment and
`consequently improve patient compliance, the literature
`suggests that a key criterion for an insulin pen is its
`impact on quality of life, including flexibility and con(cid:173)
`venience.
`A recent survey carried out in patients with type 1 or
`type 2 diabetes in the United States assessed patient pref(cid:173)
`erences for the syringe and vial or an insulin pen device.
`Forty-one percent of patients were insulin experienced,
`and 59% were insulin naive. 37 Results suggested that
`patients preferred the insulin pen device, regardless of
`previous insulin experience, with social acceptability the
`strongest predictor of preference for the device.
`Another study investigated patient acceptability of
`FlexPen based on previous treatment experience in
`patients with type 2 diabetes (including insulin-naive
`patients; insulin-experienced, pen-naive patients; and
`pen-experienced patients). Investigators found that
`respondents rated FlexPen significantly more positively
`than their prior treatment strategy, regardless of previous
`treatment or pen experience; the FlexPen was associated
`with improved convenience, flexibility, and perceived
`clinical efficacy and quality of life compared with previ(cid:173)
`ous regimens. 38
`In the study by Haak et al,31 patients were asked to
`evaluate the pens for size and portability. SoloStar and
`FlexPen were rated as best for these features by 42% and
`40% of patients, respectively, whereas
`the Lilly
`Disposable pen was rated best for these features by only
`22% of patients.
`
`Conclusions
`
`Insulin delivery devices provide a simple and more
`convenient method to administer insulin compared with
`
`use of a syringe and vial. Use of insulin delivery devices
`also addresses many of the barriers to insulin therapy in
`patients with diabetes. A number of criteria should be
`considered when identifying the ideal pen. Ease of learn(cid:173)
`ing how to use an insulin pen, dialing specific doses, and
`issues of flexibility and convenience are several criteria
`that must be considered with individual patients before
`prescribing a particular device.
`
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