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Barriers toward insulin therapy
in T2DM
 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.
 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: 5:69.
 This phenomenon is called psychological insulin
resistance .
Polonsky WH.Diabetes Care 2005, 28:2543-2545.
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, 57:455-460.
 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, 9:19.
DCCT: Relationship of HbA1c to risk of
microvascular complications
Relative Risk
Retinopathy
15
13
11
9
7
5
3
1
Nephropathy
Neuropathy
Microalbuminuria
6
7
8
9
10
HbA1c (%)
Skyler JS. Endocrinol Metab Clin. 1996;25:243–254.
11
12
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.
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 glucoselowering.
 Insulin-naïve patients failing on OGLAs, which
collects records from general practices throughout
the UK.
 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 Dec;24(12):1412-8.
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, 206–211 (2011).
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 Sep;25(9):1108-11.
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 2004:22,147-150.
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.
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 .2007:30:2199–2204,
Scale 4 “Stigmatization by insulin injections
 Injections
in public are embarrassing to me. Pills
are more discreet.
 Feelings
 When
of dependence.
people inject insulin, it makes them feel like
drug addicts.
• The literatures showed that resistance to initiate insulin
may be impacted by patients’ beliefs and knowledge
about diabetes and insulin.
Qual Life Res (2009) 18:23–32.
• 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, 36–38.
• 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, 147–150.
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.
 Women have been found to be more unwilling
than men (P < 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 .
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
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, 36–38.
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 Care1994:17, 1178–1185.
•
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.
• 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 one’s health.
Polonsky, W. H. Diabetes Care1994:17, 1178–1185.
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 .
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.
• 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.
• 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 .
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 .
• 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 .
Physicians have also been shown to experience PIR
for their patients.

Doubts about a patient’s compliance with treatment,

Fears of hypoglycemia

Weight status,

Impressions based on previous physician experience
with insulin,

Concerns about the patient’s 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), 220–226.
Overcoming Barriers to the Initiation
of Insulin Therapy
Patient concerned with pain from injection
o Minimal with thinner, smaller needles
o
Use of insulin pens
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
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
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
Patient concerned that taking insulin will
upset daily routine
 Address specific concerns
 Taking insulin may be less intrusive than complicated
drug regimens
Patient believes that insulin will decrease
his/her quality of life
 Benefits from glucose control: more energy,
better sleep, overall well-being
Patient thinks insulin will lead to diabetic
complications
• Discuss role of insulin in reducing risk of diabetic
complications
Patient concerned that he/she will be treated
differently by friends and family
• Educate friends and family
Patient has heard insulin causes weight gain
• Role of diet and exercise
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; 54:445.
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.2005:p27(Suppl B), S89–S100.
• 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), 1712–1725. 1710–1711.
• 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.
• Modern insulin analogs and pen systems offer the
promise of novel insulin treatment with improved
technological features.
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), 2543–2545
• Appreciating and understanding the multifaceted and
complex nature of PIR and discussing the etiology of a
given patient’s PIR is an important first step.
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 .
• Tailoring modalities, such as the use of modern insulin
analogs and insulin pen devices, may greatly reduce
PIR.
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.
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.
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 patient’s fears and then
providing information about the provider’s
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?”
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.
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.
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
• 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.
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.
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
Iran Yazd
IRAN -YAZD
Glucose-lowering therapy use in
Europe – 2003
Proportion of glucose-lowering
therapy use (%)
Insulin
Sulfonylureas
10
90
0
80
70
60
50
4
030
20
10
0
Melander A et al. Diabetologia. 2006:49:2024-2029.
Metformin