CHALLENGING CLINICAL INERTIA AND

THE STEPWISE DIABETES TREATMENT

APPROACH (WITH INSULIN THERAPY)

NAME:
 Clinical Inertia: Could you describe what this
means?

Clinical inertia may be defined as a

failure to initiate or
intensify treatment in
a timely manner in people
with diabetes whose health is likely
to improve with this
intensificationm
Clinical inertia is not a new concept,
having gained attention in the early 2000s.
However, increased awareness of the potential for
this disconnect in clinical practice does not seem to
have translated into improved treatment outcomes.
TIMELY INITIATION OF INSULIN CAN CONTRIBUTE TO BETTER
GLYCEMIC CONTROL

Glycated hemoglobin levels for

patients who were originally
assigned to receive either
sulfonylurea–insulin or
conventional therapy (Panel A)
or metformin or conventional
therapy (Panel B) are shown.
Panels C and D show the
corresponding mean body
weights in the two groups

Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med
2008;359:1577-89
 TIMELY INITIATION OF INSULIN CAN CONTRIBUTE TO
PREVENTION OF FUTURE DIABETIC COMPLICATIONS

The proportions of patients in the United Kingdom Prospective Diabetes Study who had any diabetes related end point (Panels A and
B), myocardial infarction (Panels C and D) are shown for the sulfonylurea–insulin group versus the conventional-therapy group and for
the metformin group versus the conventional-therapy group
Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med
2008;359:1577-89
 TIMELY INITIATION OF INSULIN CAN CONTRIBUTE TO
PREVENTION OF FUTURE DIABETIC COMPLICATIONS

The proportions of patients in the United Kingdom Prospective Diabetes Study who had any diabetes related (Panels E and F) or
who died from any cause (Panels G and H) are shown for the sulfonylurea–insulin group versus the conventional-therapy group and
for the metformin group versus the conventional-therapy group
Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med
2008;359:1577-89
PSYCHOLOGICAL INSULIN RESISTANCE (PIR) AND DIABETES:
ATTITUDES ABOUT INSULIN THERAPY, UNWILLING VS.
WILLING SUBJECTS

Many patients have concerns, including misconceptions, about insulin therapy. PIR
includes the belief that insulin is ineffective and that starting insulin is a sign of
failure, and fear of injection pain and hypoglycemia

Polonsky WH, Fisher L, Guzman S, et al. psychological insulin resistance in patients with Type 2 Diabetes the scope of the problem. Diabetes
Care 2005;28:2543-5
 CLINICAL INERTIA IS A GLOBAL PROBLEM
USA An observational study, reported a delay of almost three years in patients with consistently
elevated HbA1c levels despite dual OAD therapy (metformin and sulphonylurea), (3891
patients). (Nichols GA, Koo YH, Shah SN. 2007)

A multinational, 26-week observational study reported an HbA1c level of 8.9% (74

mmol/ mol) at insulin initiation. (Home P, Naggar NE, Khamseh M, Gonzalez-Galvez G, Shen C,
Chakkarwar P, et al., 2011)
Japan A Japanese study also revealed that physicians are strongly resistant to initiating insulin in individuals
with type 2 diabetes, resulting in high levels of HbA1c (9.6%; 81 mmol/mol) at the
time of recommending insulin to patients. (Ishii H, Iwamoto Y, Tajima N. 2012)

The same study demonstrated that differences in physician and patient perceptions of diabetes
therapies could deter patients from accepting insulin therapy. (Yoshioka N, Ishii H,
Tajima N, Iwamoto Y, The DAWN Japan group. 2013)
Canada a Canadian study in adults with diabetes aged 65 years (n = 2502), which found that, although
diabetologists are more likely to initiate insulin based on poor glycaemic control [HbA1c >8.0% (64
mmol/mol)], only 45% intensified treatment overall. (Shah Br Hux JE, Laupacis A, Zinman B,
Van Walvaren C. 2005)
 What causes clinical inertia?
Physicians. In early-stage disease:
PCPs may not be aware that many patients will benefit from
combination therapy.
Physicians may be reluctant to move beyond monotherapy
in patients who are asymptomatic.
A lack of confidence with newer therapies and insulin
initiation amongst practitioners may be a barrier to better
care.
A lack of infrastructure to help physicians monitor and
achieve treatment goals.
The adoption of a ‘wait until next visit’ approach in response
to soft rationalisations by patients to avoid treatment
intensification
 What causes clinical inertia?

Patients: Understanding and engagement with treatment can be a crucial

determinant of how likely they are to adhere to it. Adherence may be
influenced by:

Exposure to negative media coverage of topics related to diabetes

Misperception of the disease may affect motivation and compliance.
The fear of hypoglycaemic episodes and insulin-associated weight gain.
Paradoxically, the dialogue prior to insulin initiation often vilifies the
therapy itself.
Statements such as ‘if you don’t comply with the exercise regimen you will
need to inject yourself’ serve to present the insulin as a punishment rather
than a necessary part of the management of this progressive condition. (In
making such statements, physicians can be the root cause of non-adherence to
their own prescriptions )
 What causes clinical inertia?

Others:
Non-adherence to lifestyle modification and prescribed
drug treatments
Socio-economic factors and environmental pressure
 Potential causes of clinical
inertia

Failure of clinicians to fully appreciate the progressive nature of type 2 diabetes mellitus
consequent to β-cell failure.
A clinician’s lack of understanding about the frequent failure of monotherapy and that
most patients will ultimately require combination therapy
A clinician’s and/or patient’s fear of hypoglycaemia and weight gain when intensifying
therapy particularly with sulphonylureas or insulin
A clinician’s lack of confidence, particularly when working in the primary care setting, in
using insulin
Poor recognition, by clinicians, of the evidence that demonstrates the benefits of early
glycaemic control
A clinician’s general reluctance to use combination therapy early after diagnosis
POTENTIAL CAUSES OF CLINICAL INERTIA

Future directions

Clinical trials that evaluate the effectiveness of

different combinations of antidiabetic therapies at
diabetes onset.
Guidelines for type 2 diabetes mellitus
recommending combination therapy at an early
stage
 ASSESSMENT OF BARRIERS
The first step is to determine the patient’s view of insulin therapy and
correctly identify barriers from the patient’s perspective.

To determine a patient’s concerns, ask questions such as:

1. What do you
need to know to 7. Can you tell me
consider more about that?
insulin therapy?

2. What problems
6. Why do you think
do you think you will
that is?
encounter?

3. What do you see 5. Are you willing to

as the biggest 4. What would help try insulin? If not,
negative of insulin? you overcome your what would cause
The greatest concerns? you to consider
benefit? insulin?

Funnell MM. Overcoming barriers to the initiation of insulin therapy. Clin Diabetes 2007;25:36-8
 Many patients have concerns,
including misconceptions,
about insulin therapy

PIR includes the belief

Psychological insulin that insulin is ineffective and that
resistance (PIR)
starting insulin is a sign
of failure, and fear of injection pain
and hypoglycemia

Physicians are likely to under-

estimate the prevalence
of such feelings

A better understanding of patients’ beliefs and attitudes by

those who care for them would allow targeted strategies to
address barriers and encourage insulin uptake when
needed
2014
 METHODE: ASSESSMENT OF PATIENT PIR AND ESTIMATION OF
THEIR PIR BY THEIR PHYSICIANS
Sixteen statements about insulin therapy on issues were generated to assess
patient PIR such as:
Lifestyle restrictions,
Fear of injections,
Fear of side effects,
Social stigma, and
Misconceptions about insulin therapy,
Patients were asked to rate their level of agreement using a 5-category ordinal
response scale such as:
1. Strongly disagree
2. Mostly disagree
3. Slightly agree
4. Mostly agree
5. Strongly agree

In order to assess physician perceptions, each patient’s physician was asked to

select the statements they believed were factors contributing to PIR.
To compare with physician response, responses of ‘slightly agree’, ‘mostly agree’,
and ‘strongly agree’ in the patient survey were combined and interpreted as
agreement with the statement. Responses were compared between patients and
physicians as a group.
CLINICAL CHARACTERISTICS OF THESE PATIENTS(N=148).

Overall, 149 patients were

advised to start insulin therapy by
68 physicians. Of these, 148
completed the questionnaires
which were used in the study
Mean HbA1c was 9.69, and
mean duration of diabetes was
143.3 months. Sulphonylureas
were used in all patients.
CHARACTERISTICS OF THEIR ATTENDING PHYSICIANS:
(N=68).

Overall, 67.6% were Japan Diabetes Society (JDS) certified

diabetes specialists. The mean number of type 2 diabetic
patients per month was 336.4
 PATIENTS ATTITUDE TOWARD INSULIN THERAPY AND
PHYSICIANS ESTIMATION OF PATIENTS PIR

The proportion of patients who agreed (the combination of responses of ‘slightly agree’, ‘mostly agree’, and
‘strongly agree’) with each of the statements regarding insulin therapy
GAPS IN PERCEPTIONS
ABOUT INSULIN
THERAPY BETWEEN
PATIENTS AND THEIR
PHYSICIANS

Physicians significantly
under-estimated the
importance of 12 of the
16 statements.

Over-estimated the
importance of 1 of them
(‘Injections are painful’).

There was agreement

between patients and
physicians on ‘Injections
are scary’, ‘I don’t want
to inject myself for the
rest of my life’, and ‘My
pancreas will stop
functioning if I use
insulin’.
 STUDY SUMMARY
This study has shown that what physicians believe are
patient concerns regarding insulin initiation may not be
the same with what actually concerns patients in
relation to insulin.

To facilitate insulin use, healthcare providers therefore

need to be educated regarding potential social and
interpersonal fears surrounding insulin use, and
provided with tools and training to help identify and
tackle barriers that prevent individual patients from
benefitting from timely insulin initiation.
2014
METHODE: UNDERSTANDING CLINICAL INERTIA:
A SURVEY MAPPING ITS DIMENSIONS

Individuals
from six
countries
Brazil USA

India UK
Japan Spain

2500 physicians and 118,000 patients

Objective
To identify barriers in improving the treatment of T2DM and understand the ways in
which these can be overcome.
To understand clinical inertia and to what extent it constitutes a barrier to
improving care in T2DM
To explore perceptions on treating earlier and more aggressively.
To identify areas of unmet need.
THE DISTRIBUTION OF PARTICIPANTS BY NATIONALITY
 The majority of patients (68%) perceived having
understood the importance of lifestyle changes and diet

Overview of topics most and least easily understood by patients (N = 652) at the
diagnosis consultation. Score*, score 1 means ‘did not understand at all’ and 7
means ‘understood very well’.
 ATTITUDES TOWARDS COMPLICATIONS

(a) Physician and patient recall of explanation of the risks at

diagnosis;
(b) Complications patients were most concerned with at the
time of diagnosis;
(c) Patients feelings about complications at diagnosis.

a) Physicians placed similar or greater importance on cardiovascular and renal complications, with one-third of
physicians even explaining the potential risk of early death.
b)
Level of concern about risk of developing complications did not decrease from
The risk of retinopathy and blindness was of greatest concern to patients.
c) diagnosis
Only to thereported
25% of patients time ofthat
the survey.
they were worried about developing T2DM complications, while the rest were
either not concerned or thought the risk was remote
 HYPOGLYCAEMIA AWARENESS

Patient responses to a six-item hypoglycaemia quiz. N, all patients (N = 652); mean

number of incorrect answers was 3.2, with 97% of patients giving at least one
incorrect answer.
 STUDY SUMMARY
The principal findings of this survey suggest that impairments in
communication are at the heart of clinical inertia.
This manuscript lays out four key principles that believe are
achievable in all environments and can improve the lives of people with
diabetes.
Key principle 1: The health outcomes for people with
diabetes are a function of the communication between
the HCPs and people with diabetes acting as a team.
Key Principle 2: It is the duty of that team to establish
realistic shared goals and a contract in order to achieve
these objectives.
Key Principle 3: Individualising care needs to be
personalised to all aspects of the needs of the person with
diabetes, not simply chasing glycaemic, blood pressure, or
lipid targets.
Key Principle 4: Purchasers and providers should
incentivise good management in early disease in order
to optimise quality of life for those people with diabetes.
Both physicians and patients need to recognize that the natural history of T2DM is
progressive deterioration in glycaemic control.
In this context, the conventional stepwise approach for management of T2DM should
perhaps be re-examined.
Clinical practice guidelines for T2DM from major diabetes organizations
worldwide nearly universally suggest a graded treatment approach.
 CONCLUSION
Clinical inertia is, at least in part, responsible for delays in the initiation and escalation of
therapy in the treatment of type 2 diabetes.

There is impairment in communication between physicians and people with diabetes plays
a significant modifiable part in this clinical inertia.

This insightful study provides evidence that in routine diabetes care, the traditional
stepwise approach is failing to achieve the acceptable glycaemic targets that are
necessary for the optimal prevention of complications associated with T2DM.

In T2DM, more studies are needed to evaluate the efficacy of different early combination
therapies in comparison with a traditional stepwise approach.

As clinicians, we owe our patients the best care not only at diagnosis of T2DM but for the
whole duration of this progressive disease.