UKPDS: Study goals

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Barriers toward insulin therapy in T2DM
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• Poor glycaemic control is a risk factor for the
• development of diabetes-specific complications
  
• in diabetic patients.
• Many T2DM require insulin therapy after several
  
• years of disease duration in order to maintain
  
• good glycemic control and prevent
  complications.

• But many T2DM do not receive insulin therapy in
  a
• timely manner because of a negative
  appraisal of this
• treatment option.

Kulzer B. Diabetes. 2004 53 A438-A439.
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• Patients negative attitudes towards starting
  insulin
• therapy are based on their beliefs that
  the need for
• insulin therapy indicates a greater
  severity of the
• disease and proves their failure to
  self-manage
• the diabetes adequately.
• Snoek FJ. Health Qual Life Outcomes. 2007 569.

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• This phenomenon is called psychological insulin
  
• resistance .
• Polonsky WH.Diabetes Care 2005, 282543-2545.

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• Data from the UK have shown that patients may
• typically delay the initiation of insulin
  by around
• 8 years despite poor glycemic control .
• Calvert MJ, et.al. Br J Gen Pract 2007,
  57455-460.

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• There were also substantial reductions in
  cumulative
• incidence and time to onset of all
  diabetes-related
• complications with immediate versus delayed
  insulin
• initiation.

Gordon Goodall , et al . BMC Endocrine Disorders
2009, 919.
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DCCT Relationship of HbA1c to risk of
microvascular complications
Retinopathy
15
Nephropathy
13
11
9
Neuropathy
Relative Risk
7
5
Microalbuminuria
3
1
6
7
8
9
10
11
12
HbA1c ()
Skyler JS. Endocrinol Metab Clin. 199625243254.
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• To achieve tight glycemic control in T2DM, it
  may
• be advantageous to introduce insulin
  therapy much
• earlier in the disease course.

• Unfortunately, many patients are reluctant to
  begin
• insulin and may delay starting insulin
  therapy for
• significant periods of time.

Okazaki K, et.al. Diabetes 48 (Suppl.1)A319,
1999.
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Delayed initiation of subcutaneous insulin
therapy after failure of oral glucose-lowering
agents (OGLAs) in T2DM patients in the UK

• Retrospective cohort study

• Estimate the time to insulin initiation in
  patients with
• T2DM inadequately controlled on oral
  glucose-
• lowering.

• Insulin-naïve patients failing on OGLAs, which
  
• collects records from general practices
  throughout
• the UK.

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• 25 of patients had insulin initiation delayed
  for at
• least 1.8 years

• 50 of patients delayed starting insulin for 5
  years
• after failure of OGLA poly therapy, even
  in the
• presence of diabetes-related
  complications.

Diabet Med. 2007 Dec24(12)1412-8.
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prevalence of insulin refusal amongst Singaporean
patients with Type 2 diabetes mellitus

• Cross-sectional interviewer-administered survey
  ,
• 265 patients .

• Refuse to use insulin (70.6).

• A tertiary level of education was associated
  with
• willingness to use insulin .

Diabet. Med. 28, 206211 (2011).
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Prevalence and reasons for insulin refusal in
Bangladeshi patients with poorly controlled T2 DM

• 212 Bangladeshi with poor glycemic control on
  maximum OHA
• 57.5 commenced insulin immediately, 22.1
  started insulin within 6 months and 20.3 refused
  to commence insulin despite repeated counselling.
  

Diabet Med. 2008 Sep25(9)1108-11.
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• Most subjects reported several reasons for
  avoiding
• insulin, rather than just one.

• Patients may associate insulin therapy with a
  sense
• of personal failure due to common
  physician
• practice, where the possibility of insulin
  therapy
• may be used to motivate better glycemic
  control .

Polonsky WH.Clinical Diabetes 200422,147-150.
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• To overcome these psychological barriers to
• insulin treatment, first it is necessary
  to identify
• these barriers in specific patients in
  order to
• decide which interventions are
  appropriate.

• Thus, a well-validated diagnostic tool may be
  helpful
• to identify specific obstacles against the
  initiation of
• insulin treatment.

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Barriers to Insulin Treatment Questionnaire( BIT)

• Scale 1 Fear of injections and self-testing

• Scale 2 Expectations regarding negative
  insulin-related
• outcomes
• Insulin works worse than pills.
• People who get pills feel better.
• Insulin can cause long-term complications.

• Scale 3 Expected hardship from insulin therapy

• Scale 4 Stigmatization by insulin injections

• Scale 5 Fear of hypoglycemia and permanent
• damage to my health

FRANK PETRAK . Diabetes Care .20073021992204,
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Scale 4 Stigmatization by insulin injections

• Injections in public are embarrassing to me.
  Pills
• are more discreet.

• Feelings of dependence.

• When people inject insulin, it makes them feel
  like
• drug addicts.

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• The literatures showed that resistance to
  initiate insulin
• may be impacted by patients beliefs and
  knowledge
• about diabetes and insulin.

Qual Life Res (2009) 182332.
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• Lack of knowledge about diabetes and insulin
• therapy or erroneous beliefs and
  misconceptions
• about the disease and treatment contribute
  to PIR.

• Some patients believe that insulin, rather than
  diabetes,
• causes serious health problems and severe or
  chronic
• complications, such as amputation, heart
  attack, or
• possibly blindness and even death .

Funnell, M. M. Clinical Diabetes. 2007 25,
3638.
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• Patients may also perceive that insulin is for
  more
• severe disease and/or that insulin
  initiation means
• that they are becoming more ill, their
  disease
• has dramatically progressed and become more
  
• serious, or that they are at the end of
  the road.

Polonsky, W. H, et.al. Clinical Diabetes. 2004
22, 147150.
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Negative self-perceptions and attitudinal barriers

• Feelings of guilt

• Unable to control the disease in the future

• Insulin is a threat, resulting in anger ,
• because patients may feel unfairly
  punished for
• poor self-care.

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• Women have been found to be more unwilling
• than men (P lt 0.001) to initiate insulin
  therapy .

• It was shown that women are also more likely to
  perceive insulin as punishment, whereas men view
  insulin more as a form of treatment that may
  help them .

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Fear of injections consists of multiple
components

• Technical concerns

• Fear that injections will be painful

• Fear of inflicting self-harm

• Fear of self-injecting

• General anxiety

• Needle phobia

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Lifestyle adaptations and restrictions

• Patients may have concerns that insulin adds to
  the burden
• and stress that they already experience
  from managing
• diabetes on a daily basis ,and do not feel
  confident that
• they can handle the day-to-day demands of
  insulin therapy.

• It cause a loss of personal freedom that will
  severely
• restrict their lives and be too
  inconvenient, time-
• consuming, and complex to manage may also
  facilitate
• PIR. It adversely affecting independence and
  lifestyle .

Funnell, M. MClinical Diabetes . 2007 25, 3638.
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Fear of side effects/complications

• Patients may experience PIR as the result of
• misconceptions regarding their disease, so
  that they
• attribute complications of diabetes to
  insulin use rather
• than insufficient glycemic control .

• patients also worry about potential side
  effects and
• complications, such as weight gain,
  hypoglycemia,
• which may be due to insulin use.

Polonsky, W. H. Diabetes Care199417, 11781185.
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• Hypoglycemia and weight gain are the most
  common
• side effects leading to PIR.

• For those who are already overweight the
  prospect of
• further weight gain can, therefore, be a
  major barrier
• to both the initiation and the
  intensification of insulin
• for both patients and health care
  providers.

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• Insulin omission was found in 1/3 women of all
  ages
• with T1DM, with approximately half of the
  them
• reporting omitting insulin for
  weight-management
• purposes .

• Increased weight in T2DM is associated with
• increased insulin resistance, so may
  compromise the
• efficacy of treatment ,thus reinforcing the
  belief that
• insulin is not good for ones health.

Polonsky, W. H. Diabetes Care199417, 11781185.
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• Fear of hypoglycemia can also be a major
  barrier to
• achieving optimal glycemic control.

• Hypoglycemia can give rise to high insecurity
  the
• thought of future episodes can cause
  fearful and
• disturbed feelings.

• In the attempt to avoid episodes, people with
  diabetes
• may modify their maintenance of glycemic
  levels
• especially during work or school hours .

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Social stigma

• It is not surprising that social stigma plays
  a key
• role in PIR because vials and syringes
  carry a
• strong negative connotation and are
  usually
• identified with either IV drug addicts or
  severe
• illness . It cause social embarrassment
  and social
• rejection.

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• Persons with DM often hide their injections to
• avoid disturbing other people.

• Fears that use of syringes would damage their
• relationships with others or that taking
  insulin
• will result in family members and friends
  treating
• them differently .

• Thus, the fear of social stigma when injecting in
  public may impact adherence to treatment, as the
  absence of a private area in which to inject may
  result in either injecting too early or, in some
  cases, the omission of an injection.

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• This may lead to a lack of motivation due to the
• inconvenience and embarrassment related to
• injections, patients selecting suboptimal
  locations
• to inject themselves while away from home,
  such
• as in public toilets, and may also cause
  some patients
• to delay injections and avoid social
  activities .

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PIR and diabetes management

• For any treatment to be optimally efficacious, it
  must
• be initiated, be properly dose-adjusted
  over time,
• and treatment compliance must be achieved.
  PIR
• may be one of the major etiologies
  explaining both
• the reluctance of patients to initiate and
  to intensify
• treatment .

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• All components of PIR can interfere not only with
  
• the initiation of insulin treatment, but
  also with
• attempts to intensify and increase
  compliance with
• insulin therapy in individuals who are
  already
• using insulin .

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Physicians have also been shown to experience PIR
for their patients.

• Doubts about a patients compliance with
  treatment,

• Fears of hypoglycemia

• Weight status,

• Impressions based on previous physician
  experience
• with insulin,

• Concerns about the patients age,

• Perception that the disease is so severe that
  even
• insulin would not help the patient

Nakar, S., et.al. Journal of Diabetes and its
Complications.2007 21(4), 220226.
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• Overcoming Barriers to the Initiation
• of Insulin Therapy

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Patient concerned with pain from injection

• Minimal with thinner, smaller needles

• Use of insulin pens

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Patient worried that starting insulin signifies
worsening diabetes

• Diabetes is a progressive disease

• Taking insulin will control blood glucose and
  help prevent complications

• Taking insulin may slow down the rate of beta
• cell failure

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Patient believes that need for insulin signifies
patient failure to follow treatment regimen

• Diabetes is a progressive disease

• beta cell activity declines over time Not
  related to
• patient compliance

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Patient fears low blood sugar reactions

• Explain that severe hypoglycemia is rare in
  type 2
• diabetes

• Self-monitoring glucose levels

• Explain how to avoid and how to treat
  hypoglycemia

• Use of insulin pens

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Patient concerned that taking insulin will upset
daily routine

• Address specific concerns

• Taking insulin may be less intrusive than
  complicated
• drug regimens

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Patient believes that insulin will decrease
his/her quality of life

• Benefits from glucose control more energy,
  better sleep, overall well-being

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Patient thinks insulin will lead to diabetic
complications

• Discuss role of insulin in reducing risk of
  diabetic
• complications

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Patient concerned that he/she will be treated
differently by friends and family

• Educate friends and family

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Patient has heard insulin causes weight gain

• Role of diet and exercise

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Patient wants a more natural alternative therapy

• Insulin is the most natural therapy for diabetes.
  It
• is replacing the hormone that the patient
  does
• not make enough of.

Brunton, S.J Fam Pract 2005 54445.
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Implications of new insulin TX for PIR

• There are new modern insulin analogs and more
• discreet delivery systems (pen, inhaled,
  pump) available
• which have the potential to decrease PIR
  and improve
• treatment outcomes.

• These treatment advances may help to eliminate
  or
• reduce many of the key factors that
  contribute to
• PIR, namely, social stigma, and fear of
  side effects.

• The use of a new pen system may help patients
  to
• overcome the embarrassment issues that are
  commonly
• associated with using a vial and syringe in
  public.

Korytkowski, M.2005p27(Suppl B), S89S100.
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• These pen overcome issues of needle anxiety and
  the
• social embarrassment associated with
  self-injection .

• Overcome problems with insulin dosing errors
  and
• low adherence. This was recently
  demonstrated in
• a study of patients with type 2 diabetes
  treated in a
• managed care setting who switched from the
• administration of insulin by vial/syringe to
  a prefilled
• insulin pen device .

• Following the switch, the patients demonstrated
  
• improved medication adherence, fewer
  hypoglycemic
• events, reduced emergency department and
  physician
• visits, and lower annual treatment costs .

Lee, W. C., et.al.Clinical Therapeutics,
2006, 28(10), 17121725. 17101711.
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• Incidence of hypoglycemia is reduced using
  modern
• long-acting insulin analogs (detemir and
  insulin
• glargine) compared with human
  intermediate-acting
• insulin (NPH insulin).

Hermansen, K., et.al. Diabetes Care. 2006
29(6).1269-1274.
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• Modern insulin analogs and pen systems offer the
• promise of novel insulin treatment with
  improved
• technological features.

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• Limited reimbursement for pharmacy costs or
  
• difficulty with access to health care may
  negatively
• impact patients ability to care for
  themselves and
• their diabetes appropriately .

Polonsky, W. H., Diabetes Care, 28(10), 25432545
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Conclusion
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• Appreciating and understanding the multifaceted
  and complex nature of PIR and discussing the
  etiology of a
• given patients PIR is an important first
  step.

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• Clinicians can help patients overcome their PIR
  
• by working together to increase patients
  sense of
• control over their lives .

• Clinicians should emphasize the simplicity of
  the
• treatment in order to decrease their
  patients fear
• of dependency .

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• Tailoring modalities, such as the use of modern
  insulin
• analogs and insulin pen devices, may
  greatly reduce
• PIR.

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THANK YOU
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Insulin as a personal failure

• Explaining type 2 diabetes as a progressive
  disease of insulin resistance and b-cell failure
  from the onset will help to diminish or even
  prevent this erroneous belief.
• Point out to patients that they have not failed
  but that the other treatment options have failed
  them.
• Instead, describe insulin as a logical step in
  the continuum of treatment.

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Insulin is not effective

• This barrier could stem from personal experiences
  in which friends were prescribed insulin in doses
  insufficient to lower blood glucose levels, but
  still resulting in side effects such as weight
  gain or hypoglycemia.
• Although most patients think of diabetes as a
  sugar problem, pointing out to them that
  diabetes is actually an insulin problem and that
  the insulins used in therapy today are very
  similar to the insulin that the body naturally
  makes may be helpful.

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Insulin causes complications or death

• It stems from friends experiences.
• Insulin might have delayed or prevented these
  complications.
• It is generally more helpful to respond by
  acknowledging the patients fears and then
  providing information about the providers
  experiences.
• For example, I have cared for many patients with
  T2DM, and I have never known anyone who became
  impotent as a result of insulin therapy?

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Insulin injections are painful

• Many patients equate insulin injections with
  inoculations or injections of antibiotics that
  they have experienced in the past. Insulin
  needles are smaller and thinner and that most
  patients find it less painful than testing their
  blood glucose levels.
• Educators ask patients to give a dry injection to
  themselves at the time of the initial education.
  Insulin pens can also be helpful. True needle
  phobias. For those who do, psychological
  counseling is often needed and effective.

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Fear of hypoglycemia

• The fear of hypoglycemia often stems from
  observing people with diabetes who take insulin.
• Point out that with the use of newer rapid-acting
  andlong-acting insulins, hypoglycemia is less
  likely to occur and that very few patients with
  type 2 diabetes actually have severe
  hypoglycemia.
• Reassure patients that you can teach them
  strategies so that they can prevent, recognize,
  and treat hypoglycemia and thus avoid severe
  events.

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Change in lifestyle

• A concern among older adults or patients who live
  alone is that once they begin insulin therapy, it
  will adversely affect their independence, either
  because of hypoglycemia or because they fear they
  will not be able to draw up or administer their
  own injections.
• Providing information about insulin pens or other
  devices to increase accuracy and ease of
  administration may help to diminish these
  barriers.
• Teaching patients to correctly identify symptoms
  of hypoglycemia and strategies to facilitate
  insulin use is also often helpful.

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• Other lifestyle concerns are related to timing,
  difficulty in traveling, and loss of flexibility.
• Provide information about insulin regimens that
  offer maximum flexibility, strategies for
  traveling with insulin, or other identified
  lifestyle barriers.
• Some of these barriers result from concerns about
  injecting insulin away from home, for example in
  public places or at work.
• Some patients worry that if they inject in public
  places they will be perceived as injecting
  illegal drugs. Insulin pens can be very helpful
  for overcoming this barrier by increasing
  patients ability to inject discretely.
• Using only morning and/or bedtime insulin
  regimens can also eliminate this barrier for some
  patients.
• Some patients have concerns about the loss of
  their jobs if they need to begin insulin therapy.
  Regimen may be adjusted to allow for insulin
  injections to be given while patients are at home
  instead of at work.

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Insulin causes weight gain

• It is true that many patients who begin insulin
  therapy gain weight with improved glycemia and
  greater meal plan flexibility.
• If this is a barrier, offer to arrange a meeting
  with a dietitian before the initiation of insulin
  to identify strategies to prevent weight gain.

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Insulin is too expensive

• There is no question that diabetes is expensive,
  particularly for patients who have limited drug
  coverage or no insurance at all.
• Generally, however, insulin is less expensive
  than using multiple oral medications to produce
  the same glycemic outcomes. The regimen may also
  be adjusted to decrease this barrier by using
  premixed insulins if co-pays are a concern or
  less expensive insulins for patients with no or
  limited drug coverage.
• Other strategies to reduce this barrier include
  teaching patients to reuse insulin syringes,
  providing information about the least expensive
  sources for insulin and other supplies in your
  area, prescribing less expensive insulins.

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Iran Yazd
IRAN -YAZD
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Glucose-lowering therapy use in Europe 2003
Sulfonylureas
Insulin
Metformin
100
90
80
70
60
Proportion of glucose-lowering therapy use ()
50
40
30
20
10
0
Italy
Spain
Norway
Sweden
Finland
Germany
England
Belgium
Denmark
Portugal
Melander A et al. Diabetologia. 2006492024-2029.