throbber
P R A C T
`
`I C A L
`
` P O I N T E R S
`
`What’s So Tough About Taking Insulin?
`Addressing the Problem of Psychological Insulin
`Resistance in Type 2 Diabetes
`
`William H. Polonsky, PhD, CDE, and Richard A. Jackson, MD
`
`Patients with type 2 diabetes are
`
`often reluctant to begin insulin
`and, in many cases, delay the start
`of insulin therapy for quite lengthy peri-
`ods of time. Patients may refuse insulin
`outright (“Look, doc, there is just no
`way I could take the needle.”), bargain
`with their health care providers for more
`time (“Please, I just need a few more
`months to see if I can drop this
`weight.”), or even drop out of treatment
`altogether. Sadly, actions such as these
`can lead to chronically elevated blood
`glucose levels, possibly for considerable
`periods of time, raising the risk for long-
`term complications.
`But what do we really know about
`such cases of “psychological insulin
`resistance” (PIR)? How often do they
`occur, why do patients harbor such pow-
`erful misgivings, and how can busy cli-
`nicians respond most effectively?
`While clinical lore suggests that PIR
`is quite common, there has been little
`formal study in this area. In the United
`Kingdom Prospective Diabetes Study
`(UKPDS),1 of those type 2 patients ran-
`domized to insulin therapy, 27% initial-
`ly refused. Early reports from the inter-
`national Diabetes Attitudes, Wishes, and
`Needs (DAWN) study2 indicate that the
`majority (54.9%) of insulin-naive
`patients worry about the possibility of
`insulin therapy. Okazaki et al.3 reported
`that 73% of type 2 patients beginning a
`diabetes education program where
`insulin was to be started were reluctant
`to do so at first. Finally, in a recent sur-
`vey of insulin-naive type 2 patients,4
`24.7% of respondents reported being
`not willing to take insulin if it was pre-
`scribed. Furthermore, the survey
`
`showed that Hispanic patients were
`much more frequently unwilling than
`non-Hispanic whites (55.6 vs. 21.5%).
`Qualitative data from Hunt et al.5 also
`suggest that PIR may be common in the
`Hispanic population.
`Overall, these data suggest that PIR
`may be relatively common across multi-
`ple ethnic groups and across nations.
`However, although patients may express
`significant reluctance in the abstract, it is
`not yet known how often this leads to
`outright refusal or bargaining when the
`patient is alone with his or her provider
`and an actual recommendation to begin
`insulin is made.
`Why are so many insulin-naive
`patients averse to the possibility of
`insulin therapy? Six major factors are
`apparent.
`First, insulin is often associated with
`a perceived loss of control over one’s
`life. When asked to identify their reasons
`for insulin therapy reluctance, 61.4% of
`patients agreed that, “Once I start
`insulin, I can never stop,” and 50.6%
`believed that insulin therapy would
`restrict their lives.4 Recent data from the
`DAWN study point to similar concerns.6
`As one patient explained, “Taking
`insulin would mean no more sponta-
`neous adventures for me. It would make
`it too hard to travel, or eat out, or even
`have a life!” In the days before glargine,
`lispro, and aspart insulins became avail-
`able, it was certainly true that insulin
`therapy often required significant vigi-
`lance and changes to one’s lifestyle, but
`in the vast majority of cases, this no
`longer needs to occur.
`The second factor is poor self-efficacy
`about insulin therapy. Approximately
`
`40–50% of patients do not feel confident
`that they could handle the demands of
`insulin therapy, such as determining the
`proper timing and dosages.4,6 Without
`proper care and explanation, insulin ther-
`apy can at first seem much too complicat
`ed and overwhelming. And when patient
`do not have confidence in their ability to
`perform a particular self-care behavior, it
`is unlikely that they will follow recom-
`mendations to do so.7
`A third factor is that as many as 50%
`of patients associate insulin therapy with
`personal failure.4,6 In other words,
`insulin is viewed as a well-deserved pun
`ishment for one’s own gluttony, sloth, or
`negligence in some other area of diabete
`self-care. As one patient described it, “If
`I have to take insulin, it means that I hav
`messed up, that I haven’t done a good
`enough job taking care of my diabetes.”
`The fourth factor concerns perceived
`disease severity. For many patients,
`insulin therapy signifies that their dia-
`betes is now suddenly more serious and
`more dangerous.4,6 As first reported by
`Hunt et al.,5 many patients are concerne
`that insulin therapy may cause further
`health problems. In some cases, such
`beliefs may be at least partially correct
`(e.g., a slightly increased hypoglycemia
`risk), while in other cases (e.g., “Insulin
`will cause me to go blind.”), they may be
`quite wrong. Not surprisingly, if people
`are convinced that insulin will worsen
`their health, they may be very resistant to
`begin insulin therapy.
`Of interest, Polonsky et al.4 noted a
`sizeable ethnic split on this latter issue.
`While the majority of Hispanics (72.2%)
`felt that insulin therapy could cause fur-
`ther health problems, very few non-His-
`
`CLINICAL DIABETES • Volume 22, Number 3, 2004
`
`147
`
`MPI EXHIBIT 1111 PAGE 1
`
`

`

`P R A C T
`
`I C A L
`
` P O I N T E R S
`
`panic whites (8.1%) believed this to be
`so.
`
`A fifth factor concerns injection-
`related anxiety. Approximately 50% of
`patients report being fearful of injec-
`tions.6 Although this is often presumed
`to be the single, or single largest, con-
`tributor to PIR, we suspect that this may
`be overstated. True injection phobia is
`rare, even among insulin-using patients
`with diabetes.8 Certainly, few people
`look forward to injections. But when
`patients report that they “could never
`take the needle,” this may often represent
`a broader reluctance to consider insulin
`therapy, reflecting their many negative
`beliefs about insulin or lack of knowl-
`edge about its use (e.g., the relative pain-
`lessness of insulin injections) rather than
`simply a fear of needles per se.
`A final factor contributing to PIR
`is the perceived lack of positive gain.
`Skovlund et al.6 found that few
`insulin-naive patients anticipated posi-
`tive benefits from insulin therapy. Less
`than 10% believed that insulin might
`help them achieve good glycemic con-
`trol, improve their energy level, or
`improve their health. In total, given the
`widespread appraisal of insulin thera-
`py as a negative and perhaps harmful
`intervention and the lack of recogni-
`tion that it might have positive bene-
`fits, it is no wonder that PIR appears
`to be so commonplace.
`What causes patients to develop such
`negative beliefs toward insulin? One
`contributor is likely to be patients’ per-
`sonal experiences. Consider the follow-
`ing story:
`“My mother had diabetes, and it was
`no big deal to her for over 20 years. She
`rarely saw a doctor and never paid much
`attention to it, and it never really both-
`ered her. But then her doctor finally con-
`vinced her to start insulin and—bam!
`Over the next year, she started having
`serious problems with her eyes, and then
`there were terrible pains in her legs. In
`fact, she eventually lost most of her left
`leg. No doubt about it, insulin was the
`culprit. And now you want me to start
`insulin? No way!”
`
`In cases like these, it is likely to be
`the many years of self-care neglect that
`is the major source of harm, not insulin.
`Still, such stories are not uncommon,
`and it is understandable—given the
`chronology—that patients may come to
`confuse cause and effect.
`Another contributor, and perhaps the
`major one, is the subtle and not-so-subtle
`messages that patients receive from their
`providers.9 For example, it is common
`for insulin-naive patients to be threat-
`ened with insulin, to be told that if they
`don’t work harder to manage diabetes,
`then there will be no choice but to start
`insulin, to “get the needle.” Clinicians
`may inadvertently influence patients’
`beliefs about insulin through the use of
`such unfortunate terms as “oral agent
`failure.”
`And clinicians’ own negative feel-
`ings about insulin therapy may also play
`a role. Many clinicians are, understand-
`ably, fearful of the extra time needed to
`start and manage insulin therapy, they
`may be loathe to handle the potentially
`unpleasant confrontations with patients
`who do not want to take insulin, and
`they may be concerned about the poten-
`tial for severe hypoglycemia, excessive
`weight gain, or other adverse effects.
`Therefore, they may collude with their
`patients to delay the initiation of insulin
`(e.g., “Why don’t you take a few more
`months and try to get more serious about
`exercise and weight loss. Maybe you
`can get those numbers down by the time
`we meet again.”). As patients witness
`such actions and hear such messages
`repeatedly over the years, the lessons
`absorbed are 1) insulin is a bad thing
`and should be avoided at all costs; 2) if
`insulin therapy is necessary, it is because
`you have failed to take adequate care of
`yourself; and 3) insulin therapy is how
`you will be punished for your lack of
`personal success.
`Patients, therefore, should not be
`blamed for harboring such inaccurate
`views of insulin. In many cases, they
`may be merely drawing the best conclu-
`sions possible from what they have
`learned from their providers.
`
`How should PIR be addressed? To
`date, there are no published intervention
`studies, but it seems evident that the
`most powerful solution is, of course, pre-
`vention. Type 2 diabetes is a progressive
`disease, and it is recognized that as many
`as one-third of type 2 patients are likely
`to require insulin at some point. There-
`fore, rather than threatening patients
`with insulin, patients should be fore-
`warned early in treatment that the need
`for insulin is quite likely to arise at some
`point in the future—not because of any-
`thing they have done wrong, but because
`of the nature of the disease.
`Long before insulin is actually pre-
`scribed, explain to patients that the even
`tual need for insulin is linked to the fact
`that they are currently healthy, not
`because they are sick. For example,
`“Diabetes gets tougher to handle as the
`years go by. The longer you live with it,
`the more likely it is that you will need
`powerful medications like insulin to con
`trol it. And because you are relatively
`young and healthy, you’re probably
`going to live a long time. So it is fairly
`likely that you’ll need insulin at some
`point, just because you’re so darned
`healthy.”
`When clinicians are faced with PIR,
`there are eight possible intervention
`strategies to consider:
`1. Identify the patient’s personal
`obstacles. When patients profess an
`unwillingness to start insulin therapy
`there is a natural tendency to imme-
`diately respond with helpful com-
`ments (e.g., “Injections aren’t so
`bad,” “Taking insulin doesn’t mean
`your diabetes is getting worse,” or
`“Trust me, you’re going to have so
`much more energy.”) or, perhaps, to
`jump to one of the strategies
`described below. But few of these are
`likely to be beneficial unless the
`intervention matches the patient’s
`perceived reasons for resisting
`insulin.
`Indeed, patients may be unable to
`appreciate any reassurances or addi-
`tional information until their person-
`al beliefs about insulin are recog-
`
`148
`
`Volume 22, Number 3, 2004 • CLINICAL DIABETES
`
`MPI EXHIBIT 1111 PAGE 2
`
`

`

`P R A C T
`
`I C A L
`
` P O I N T E R S
`
`nized and discussed. Consider a sim-
`ple, respectful, open-ended question
`such as, “Could you tell some of the
`reasons why you feel so strongly
`about not taking insulin?”
`Alternatively, to prompt patients’
`thinking and to engender a more
`detailed conversation, administering
`a brief, self-report PIR questionnaire
`might be advantageous.4,6
`2. Restore the patient’s sense of per-
`sonal control. When necessary,
`introduce insulin as a brief, tempo-
`rary experiment only (e.g., “I’d like
`you to try insulin for just a month. At
`the end of the month, if you don’t
`think it has been worthwhile, or if it
`still seems as awful as you’re imagin-
`ing it might be, I promise to help you
`stop.”). Of course, patients always
`retain this choice whether it is
`offered or not, but by putting this for-
`ward as a viable alternative that is
`supported by their clinician, it serves
`as an important reminder that insulin
`does not mean they will lose control
`of their lives.
`3. Enhance self-efficacy as quickly as
`possible. When insulin is first intro-
`duced, the process of insulin use
`should be demonstrated for patients
`while they are in the clinician’s
`office, and they should be encour-
`aged to practice before returning
`home. With the support and encour-
`agement of a caring clinician, the
`hands-on discovery that injections
`are easily accomplished and that
`insulin therapy is not difficult to mas-
`ter can be an enormous boost to con-
`fidence. This is enhanced even fur-
`ther as patients first observe the sur-
`prisingly small size of insulin needles
`and realize firsthand that injections
`are all but painless.
`The number of recommended
`behavioral changes also should be
`minimized, at least at first. If reluc-
`tant patients are introduced to insulin
`with a dizzying array of additional
`self-care procedures (e.g., much
`more frequent self-monitoring of
`blood glucose and recommendations
`
`to make major changes in the timing
`and composition of meals), it should
`not be surprising if they become even
`more concerned that they will not be
`capable of managing the demands of
`insulin therapy successfully (and,
`thus, even more resistant to insulin
`therapy).
`Luckily, it is increasingly common
`for type 2 patients to be first intro-
`duced to insulin as combination ther-
`apy. In this manner, when a single
`shot of insulin (often nighttime
`glargine or NPH insulin) is typically
`added to the existing or somewhat
`modified regimen of oral agents, few
`additional self-care steps are needed,
`and there is little further disruption to
`the person’s lifestyle.
`Clinicians need to follow-up
`quickly with initial insulin dose
`adjustments to ensure that patients
`will quickly see improvements in
`their glucose numbers following this
`new treatment. If a suboptimal dose
`is started and no changes are made in
`this dose until the next visit, the per-
`ceived efficacy of insulin may be
`undermined.
`4. Consider insulin pens. Because
`pens are easier to operate and appear
`less forbidding than the traditional
`bottle and syringe, they may be more
`acceptable to insulin-naive patients
`struggling with PIR. To date, there is
`only anecdotal evidence to support
`this observation. Many providers
`have commented that PIR in their
`practices has dramatically lessened
`since they begin initiating insulin
`therapy with pens. Not uncommonly,
`the response from patients has been,
`“You mean that’s all there is to it?!”
`5. Frame the insulin message properly.
`When talking about the need for
`insulin, stay focused on glycemic
`outcomes, sharing hemoglobin A1c
`(A1C) results with patients and
`explaining that the critical goal is to
`protect their health through the
`achievement of glycemic targets.
`Ideally, clinicians and patients should
`come to an agreement on specific
`
`A1C targets. When those targets are
`then not being met by a regimen of
`oral agents and lifestyle changes,
`insulin becomes a natural choice,
`providing patients with the additional
`tool they need to meet their goals.
`It should be stressed to patients
`that they have not “failed” with their
`diabetes, that they have done nothing
`wrong, and that insulin therapy does
`not indicate that their diabetes is get-
`ting worse. As mentioned earlier, it
`should be explained that diabetes is
`now understood to be a progressive
`disease—not that the disease is get-
`ting worse, but that more or stronger
`medications may be needed over
`time to achieve glycemic targets.
`And when such medications, includ-
`ing insulin, are needed, this is a func
`tion of the underlying disease, not
`the person’s failure at proper diabete
`self-care. Removing patients’ sense
`of personal guilt is critical.
`Finally, when patients worry abou
`untoward side effects, it may be use-
`ful to remind them that insulin is on
`of our most “natural” drugs; indeed,
`it is far more natural than any of the
`oral agents with which they may be
`familiar.
`6. Discuss the real risks of hypo-
`glycemia. Type 2 patients’ worries
`about hypoglycemia can often be
`traced to the dramatic tales told by
`type 1 patients or to hypoglycemic
`episodes as portrayed in films.
`Patients should be told that while
`severe hypoglycemia (an episode
`where help from another is required)
`may occur frequently in type 1 dia-
`betes, it is quite rare in type 2, even
`among patients on insulin. In the
`UKPDS, for example, the annual
`incidence of severe hypoglycemia in
`insulin-treated patients was < 3.0%.10
`Still, events do occur. Patients
`should be reassured that a modicum
`of vigilance on their part and on the
`part of their provider (e.g., through
`more frequent blood glucose moni-
`toring and a careful review of
`results), as well as further diabetes
`
`CLINICAL DIABETES • Volume 22, Number 3, 2004
`
`149
`
`MPI EXHIBIT 1111 PAGE 3
`
`

`

`P R A C T
`
`I C A L
`
` P O I N T E R S
`
`education (so that patients become
`more skilled regarding recognition
`and treatment of hypoglycemia), can
`reduce the risk of any potential prob-
`lems even further.
`7. Tackle injection phobias. In cases
`where patients are truly too fearful of
`needles to begin insulin therapy, cli-
`nicians may want to consider referral
`to a mental health provider familiar
`with cognitive behavioral therapy,
`especially the well-documented
`approach to phobias known as “sys-
`tematic desensitization.” Needle pho-
`bias can usually be resolved quite
`rapidly.11
`8. Pass along the good news. Once
`patients’ personal obstacles have
`been addressed, it may be worth-
`while to review the positive benefits
`associated with insulin (to be more
`precise, with better glycemic con-
`trol). Patients need to know that they
`may soon notice improvements in
`their mood, sleep, and energy level
`and that better glycemic control
`means that they are making a size-
`able investment in the protection of
`their long-term health.
`
`Summary
`In insulin-nai ve patients with type 2
`diabetes, PIR is not uncommon. It is
`likely that PIR contributes to unneces-
`sarily long delays for initiating insulin
`
`and, consequently, to extended periods
`of hyperglycemia.
`Patients’ reasons for avoiding insulin
`extend far beyond a simple fear of nee-
`dles and often involve deeply held
`beliefs about insulin and the nature of
`diabetes. It appears that clinicians’ stan-
`dard method for talking about insulin, in
`which insulin therapy is used to frighten
`patients toward taking better care, may
`be a major contributor to PIR.
`The good news is that PIR can be
`overcome when patients’ personal obsta-
`cles to insulin therapy are recognized
`and addressed. Most importantly, it
`seems likely that the majority of PIR
`cases could be prevented if clinicians
`began to introduce the possible need for
`insulin early in treatment, refrained from
`using insulin as a means for threatening
`or blaming patients, and helped patients
`see insulin as a possible friend rather
`than a foe.
`
`REFERENCES
`
`1United Kingdom Prospective Diabetes Study
`Group: Relative efficacy of randomly allocated
`diet, sulphonylurea, insulin, or metformin in
`patients with newly diagnosed non-insulin
`dependent diabetes followed for three years. BMJ
`14:83–88, 1995
`
`2Korytkowski M: When oral agents fail: prac-
`tical barriers to starting insulin. Int J Obes Relat
`Metab Disord 26:S18–S24, 2002
`
`3Okazaki K, Goto M, Yamamoto T, Tsujii S,
`Ishii H: Barriers and facilitators in relation to
`starting insulin therapy in type 2 diabetes
`
`(Abstract). Diabetes 48:A1319, 1999
`
`4Polonsky WH, Fisher L, Dowe S, Edelman
`S: Why do patients resist insulin therapy?
`(Abstract) Diabetes 52:A417, 2003
`
`5Hunt LM, Valenzuela MA, Pugh JA: NIDDM
`patients’ fears and hopes about insulin therapy:
`the basis of patient reluctance. Diabetes Care
`20:292–298, 1997
`
`6Skovlund SE, van der Ven N, Pouwer F,
`Snoek F: Appraisal of insulin treatment in type 2
`diabetes patients with and without previous expe-
`rience of insulin therapy (Abstract). Diabetes 52:
`A419, 2003
`
`7Bandura A: Self-efficacy: toward a unifying
`theory of behavioral change. Psychol Rev
`84:191–215, 1977
`
`8Zambanini A, Newson RB, Malsey M, Fehe
`MD: Injection related anxiety in insulin-treated
`diabetes. Diabetes Res Clin Pract 46:239–246,
`1999
`
`9Wallace TM, Matthews DR: Poor glycaemic
`control in type 2 diabetes: a conspiracy of dis-
`ease, suboptimal therapy and attitude. QJM
`93:369–374, 2000
`
`10United Kingdom Prospective Diabetes
`Study Group: Intensive blood glucose control
`with sulphonylureas or insulin compared with
`conventional treatment and risk of complications
`in patients with type 2 diabetes. Lancet
`352:837–854, 1998
`
`11Zarate R, Agras WS: Psychosocial treatmen
`of phobia and panic disorders. Psychiatry
`57:133–141, 1994
`
`William H. Polonsky, PhD, CDE, is an
`assistant clinical professor in psychiatry
`at the University of California, San
`Diego. Richard A. Jackson, MD, is a sen
`ior physician at the Joslin Diabetes Cen
`ter and assistant professor at Harvard
`Medical School in Boston, Mass.
`
`150
`
`Volume 22, Number 3, 2004 • CLINICAL DIABETES
`
`MPI EXHIBIT 1111 PAGE 4
`
`

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