Innovative College Of Pharmacy

Approved by AICTE, New Delhi and affiliated to UP Tech. Uni., Lucknow

Plot no. 6 knowledge Park -2 Greater Noida -201306

CERTIFICATE

This is to certify that the work contained in this project entitled “ Diabetes
mellitus” submitted
in partial fulfillment of the requirements for the Degree of Pharmacy of
Innovative College of
Pharmacy (AKTU UNIVERSITY) has been carried out during the academic
year
2014-2018(Mar-Apr) by Mr. ANIL KUMAR SAHDEV under our
supervision and
guidance at the M. M.G HOSPITAL GT ROAD GHAZIABAD.
It is further stated that no part of this work has been submitted either in part
or in full for any
Degree in Innovative College of pharmacy and is the original work of the
candidate .
Forwarded

By

Dr. (Mrs.) RENI KAPOOR

Principal
Faculty of Pharmacy
Innovative College Of Pharmacy

Mr. ANIL KUMAR SAHDEV

Assistant Professor
Department of Pharmacology
Innovative College Of Pharmacy
 ACKNOWLEDGEMENT

It gives me immense pleasure to express my gratitude and thanks to my respected and beloved
teacher and guide, Mr. ANIL KUMAR SAHDEV., Assistant Professor, Innovative college
of
pharmacy, Greater Noida for his priceless guidance, affection and constant encouragement in
preparing this dissertation .
The inspiration, enthusiasm and passion of attaining higher education is the outcome of the
massive contribution of my mentors who always remained inclined to erect my glimmering
future and beckoned the of mending an extremely scintillating career. And this dissertation is the
complete reflection of their efforts .
Of course, God helps those, who help themselves and I have tried my level best to perform my
work to the best of my abilities. In this I had the great fortune to work under auspicious guidance
of Mr. ANIL KUMAR SAHDEV, a symbol of versatile personalities and talented skills of
his
kind. He set me along the correct path and was always there at every turn with his wise
suggestion and guidance, which help me to complete this work within the stipulated time. A
heartfelt thanks to both of them .
I acknowledge with great gratitude and support of my Head of Department Asst. Prof. Mr.
ANIL KUMAR SAHDEV. He established the Department of Pharmacy Practice. He
provided
all the necessary facilities and guidance whenever & wherever required .
I am highly obliged to Dr. R. P. SINGH, Medical Superintendent, M. M. G Hospital,
GT Road
Ghaziabad (up) for their kind support, encouragement and providing necessary facilities to
carried out my work .
 ABREVIATION

BP - Blood Pressure

CI- Confidence Interval

DKK- Danish Crowns

Ghb- Glycated Hemoglobin

HbA1c- Glycated Hemoglobin

HTA- Health Technology Assessments

LDL- Low-density lipoprotein

LOCF- Last Observation Carried Forward

MINT- Motivational Interviewing Network of Trainers

MITI- Motivational Interviewing Treatment Integrity

OHA- Oral Hypoglycemic Agents

PAID- Problem Areas in Diabetes

PCDS-Perceived Competence for Diabetes Scale

QUOROM- Quality of Reporting of Meta-analyses

RCT- Randomized controlled trial

SD- Standard Deviation

SPSS- Statistical Package for the Social Sciences

WHO- World Health Organization

INTRODUCTION
DIABETES MELLITUS

Diabetes mellitus
Classification and external resources

Universal blue circle symbol for diabetes.

Diabetes mellitus , or simply diabetes , is a group of metabolic diseases in which a

person has
high blood sugar , either because the pancreas does not produce enough insulin , or because cells
do not respond to the insulin that is produced. This high blood sugar produces the classical
symptoms of polyuria (frequent urination), polydipsia (increased thirst)
and polyphagia (increased hunger).

There are three main types of diabetes mellitus (DM).

● Type 1 DM results from the body's failure to produce insulin, and currently requires the
person to inject insulin or wear an insulin pump. This form was previously referred to as
"insulin-dependent diabetes mellitus" (IDDM) or "juvenile diabetes".

● Type 2 DM results from insulin resistance , a condition in which cells fail to use insulin
properly, sometimes combined with an absolute insulin deficiency. This form was
previously referred to as non insulin-dependent diabetes mellitus (NIDDM) or
"adult-onset diabetes".

● The third main form, gestational diabetes occurs when pregnant women without a
previous diagnosis of diabetes develop a high blood glucose level. It may precede
development of type 2 DM.

Other forms of diabetes mellitus include congenital diabetes, which is due to genetic defects of
insulin secretion, cystic fibrosis -related diabetes, steroid diabetes induced by high doses of
glucocorticoids, and several forms of monogenic diabetes .
Untreated, diabetes can cause many complications. Acute complications include diabetic
ketoacidosis and nonketotic hyperosmolar coma . Serious long-term complications
include cardiovascular disease , chronic renal failure , and diabetic retinopathy (retinal damage).
Adequate treatment of diabetes is thus important, as well as blood pressure control and lifestyle
factors such as stopping smoking and maintaining a healthy body weight.

All forms of diabetes have been treatable since insulin became available in 1921, and type 2
diabetes may be controlled with medications. Insulin and some oral medications can
cause hypoglycemia (low blood sugars), which can be dangerous if severe. Both types 1 and 2
are chronic conditions that cannot be cured. Pancreas transplants have been tried with limited
success in type 1 DM; gastric bypass surgery has been successful in many with morbid
obesity and type 2 DM. Gestational diabetes usually resolves after delivery .

Classification

1.1 Type 1 diabetes

1.2 Type 2 diabetes
1.3 Gestational diabetes
1.4 Other types

● 2 Signs and symptoms

2.1 Diabetic emergencies

2.2 Complications

● 3 Causes
● 4 Pathophysiology
● 5 Diagnosis
● 6 Management

o 6.1 Lifestyle
o 6.2 Medications
o 6.3 Support

● 7 Epidemiology

7.1 Australia
7.2 China
7.3 India
7.4 United Kingdom
7.5 United States

CLASSIFICATION
 Comparison of type 1 and 2 diabetes

Feature Type 1 diabetes Type 2 diabetes

Onset Sudden Gradual

Age at onset Mostly in children Mostly on adults

Body habitus Thin or normal

Ketoacidosis Common Rare

Autoantibodies Usually present Absent

Concordance
in identical twins 50% 90%

Prevalence 10% 90%

Diabetes mellitus is classified into four broad categories: type 1 , type 2 , gestational diabetes and
"other specific types". The "other specific types" are a collection of a few dozen individual
causes. The term "diabetes", without qualification, usually refers to diabetes mellitus. The rare
disease diabetes insipid us has similar symptoms as diabetes mellitus, but without disturbances in
the sugar metabolism ( insipid us means "without taste" in Latin) .
The term "type 1 diabetes" has replaced several former terms, including childhood-onset
diabetes, juvenile diabetes, and insulin-dependent diabetes mellitus (IDDM). Likewise, the term
"type 2 diabetes" has replaced several former terms, including adult-onset diabetes,
Obesity-related diabetes, and noninsulin-dependent diabetes mellitus (NIDDM). Beyond these
two types, there is no agreed-upon standard nomenclature.

Chapter 1
TYPE 1 DIABETES ( INSULIN
DEPENDENT)
Type 1 diabetes mellitus is characterized by loss of the insulin-producing beta cells of the islets
Of Langerhans in the pancreas, leading to insulin deficiency. This type can be further classified
as immune-mediated or idiopathic. The majority of type 1 diabetes is of the immune-mediated
nature, in which beta cell loss is a T-cell -mediated autoimmune attack. There is no known
preventive measure against type 1 diabetes, which causes approximately 10% of diabetes
mellitus cases in North America and Europe. Most affected people are otherwise healthy and of a
healthy weight when onset occurs. Sensitivity and responsiveness to insulin are usually normal,
especially in the early stages. Type 1 diabetes can affect children or adults, but was traditionally
termed "juvenile diabetes" because a majority of these diabetes cases were in children.

"Brittle" diabetes, also known as unstable diabetes or labile diabetes, is a term that was
traditionally used to describe to dramatic and recurrent swings in glucose levels, often occurring
for no apparent reason in insulin -dependent diabetes. This term, however, has no biologic basis
and should not be used. There are many reasons for type 1 diabetes to be accompanied by
irregular and unpredictable hyperglycaemia , frequently with ketosis , and sometimes
serious hypoglycaemia, including an impaired counter regulatory response to hypoglycemia,
occult infection, gastroparesis (which leads to erratic absorption of dietary carbohydrates), and
endocrinopathies (e.g., Addison's disease) These phenomena are believed to occur no more
frequently than in 1% to 2% of persons with type 1 diabetes.

TYPE 2 DIABETES

Type 2 diabetes mellitus is characterized by insulin resistance , which may be combined with
relatively reduced insulin secretion. The defective responsiveness of body tissues to insulin is
believed to involve the insulin receptor . However, the specific defects are not known. Diabetes
mellitus cases due to a known defect are classified separately. Type 2 diabetes is the most
common type.

In the early stage of type 2, the predominant abnormality is reduced insulin sensitivity. At this
stage, hyperglycemia can be reversed by a variety of measures and medications that improve
insulin sensitivity or reduce glucose production by the liver.

GESTATIONAL DIABETES

Gestational diabetes mellitus (GDM) resembles type 2 diabetes in several respects, involving a
combination of relatively inadequate insulin secretion and responsiveness. It occurs in about
2%–5% of all pregnancies and may improve or disappear after delivery. Gestational diabetes is
fully treatable, but requires careful medical supervision throughout the pregnancy. About
20%–50% of affected women develop type 2 diabetes later in life.

Though it may be transient, untreated gestational diabetes can damage the health of the fetus or
mother. Risks to the baby include macrosomia (high birth weight), congenital cardiac and central
nervous system anomalies, and skeletal muscle malformations. Increased fetal insulin may
inhibit fetal surfactant production and cause respiratory distress
syndrome . Hyperbilirubinemia may result from red blood cell destruction. In severe cases,
prenatal death may occur, most commonly as a result of poor placental perfusion due to vascular
impairment. Labor induction may be indicated with decreased placental function. A Caesarean
section may be performed if there is marked fetal distress or an increased risk of injury
associated with macrosomia, such as shoulder dystocia.

A 2008 study completed in the U.S. found the number of American women entering pregnancy
with pre-existing diabetes is increasing. In fact, the rate of diabetes in expectant mothers has
more than doubled in the past six years. This is particularly problematic as diabetes raises the
risk of complications during pregnancy, as well as increasing the potential for the children of
diabetic mothers to become diabetic in the future.

OTHER TYPES

Prediabetes indicates a condition that occurs when a person's blood glucose levels are higher
than normal but not high enough for a diagnosis of type 2 DM. Many people destined to develop
type 2 DM spend many years in a state of prediabetes which has been termed "America's largest
healthcare epidemic."

Latent autoimmune diabetes of adults (LADA) is a condition in which type 1 DM develops in

adults. Adults with LADA are frequently initially misdiagnosed as having type 2 DM, based on
age rather than etiology.
Some cases of diabetes are caused by the body's tissue receptors not responding to insulin (even
when insulin levels are normal, which is what separates it from type 2 diabetes); this form is very
uncommon. Genetic mutations ( autosomal or mitochondrial ) can lead to defects in beta
cell function. Abnormal insulin action may also have been genetically determined in some cases.
Any disease that causes extensive damage to the pancreas may lead to diabetes (for
example, chronic pancreatitis and cystic fibrosis ). Diseases associated with excessive secretion
of insulin-antagonistic hormones can cause diabetes (which is typically resolved once the
hormone excess is removed). Many drugs impair insulin secretion and some toxins damage
pancreatic beta cells.

SIGN AND SYMPTOMS

Chapter 1
Overview of the most significant symptoms of diabetes
The classic symptoms of untreated diabetes are loss of weight, polyuria (frequent
urination), polydipsia (increased thirst) and polyphagia (increased hunger).Symptoms may
develop rapidly (weeks or months) in type 1 diabetes, while they usually develop much more
slowly and may be subtle or absent in type 2 diabetes.

Prolonged high blood glucose can cause glucose absorption in the lens of the eye, which leads to
changes in its shape, resulting in vision changes. Blurred vision is a common complaint leading
to a diabetes diagnosis. A number of skin rashes that can occur in diabetes are collectively
known as diabetic dermadromes.

DIABETIC EMERGENCIES
People (usually with type 1 diabetes) may also present with diabetic ketoacidosis , a state of
metabolic dysregulation characterized by the smell of acetone , a rapid, deep breathing known
as Kussmaul breathing, nausea, vomiting and abdominal pain , and altered states of
consciousness.

A rare but equally severe possibility is hyperosmolar nonketotic state , which is more common in
type 2 diabetes and is mainly the result of dehydration.
COMPLICATIONS
Complications of diabetes mellitus

All forms of diabetes increase the risk of long-term complications. These typically develop after
many years (10–20), but may be the first symptom in those who have otherwise not received a
diagnosis before that time. The major long-term complications relate to damage to blood vessels
Diabetes doubles the risk of cardiovascular disease . The main "macrovascular" diseases (related
to atherosclerosis of larger arteries) are ischemic heart disease ( angina and myocardial
infarction ), stroke and peripheral vascular disease.

Diabetes also damages the capillaries (causes microangiopathy ). [13] Diabetic retinopathy , which
affects blood vessel formation in the retina of the eye, can lead to visual symptoms, reduced
vision, and potentially blindness . Diabetic nephropathy , the impact of diabetes on the kidneys,
can lead to scarring changes in the kidney tissue , loss of small or progressively larger amounts
of protein in the urine and eventually chronic kidney disease requiring dialysis diabetic
neuropathy is the impact of diabetes on the nervous system , most commonly causing numbness,
tingling and pain in the feet and also increasing the risk of skin damage due to altered sensation.
Together with vascular disease in the legs, neuropathy contributes to the risk of diabetes-related
foot problems (such as diabetic foot ulcers ) that can be difficult to treat and occasionally
require amputation.

CAUSES
The cause of diabetes depends on the type .

Type 1 diabetes is partly inherited, and then triggered by certain infections, with some evidence
pointing at Coxsackie B4 virus . A genetic element in individual susceptibility to some of these
triggers has been traced to particular HLA genotypes (i.e., the genetic "self" identifiers relied
upon by the immune system). However, even in those who have inherited the susceptibility,
type 1 DM seems to require an environmental trigger. The onset of type 1 diabetes is unrelated to
lifestyle .

Type 2 diabetes is due primarily to lifestyle factors and genetics.

The following is a comprehensive list of other causes of diabetes:

● Genetic defects of β-cell function

Maturity onset diabetes of the young
Mitochondrial DNA mutations
● Genetic defects in insulin processing or insulin action
o Defects in proinsulin conversion
o Insulin gene mutations
o Insulin receptor mutations
● Exocrine pancreatic defects
o Chronic pancreatitis
 o Pancreatectomy
o Pancreatic neoplasia
o Cystic fibrosis
● Endocrinopathies
o Growth hormone
o excess
o Cushing syndrome
o Hyperthyroidism
o Pheochromocytoma
o Glucagonoma
● Infections
o Cytomegalovirus
o Coxsackievirus B
● Drugs
o Glucocorticoids
o Hemochromatosis
o Fibrocalculous pancreatopathy
o Thyroid hormone
o β-adrenergic agonist
o Statins [16]

PATHOPHYSIOLOGY

This section does not cite any references or sources . Please help improve this
section
by adding citations to reliable sources. Unsourced material may be challenged
and removed .

The fluctuation of blood sugar (red) and the sugar-lowering hormone insulin (blue) in humans
during the course of a day with three meals - one of the effects of a sugar -rich a starch -rich
meal is highlighted.

Mechanism of insulin release in normal pancreatic beta cells - insulin production is more or less
constant within the beta cells. Its release is triggered by food, chiefly food containing absorbable
glucose .
Chapter 1
Insulin is the principal hormone that regulates uptake of glucose from the blood into most cells
(primarily muscle and fat cells, but not central nervous system cells). Therefore, deficiency of
insulin or the insensitivity of its receptors plays a central role in all forms of diabetes mellitus .
Humans are capable of digesting some carbohydrates , in particular those most common in food;
starch, and some disaccharides such as sucrose, are converted within a few hours to simpler
forms, most notably the monosaccharide glucose , the principal carbohydrate energy source used
by the body. The rest are passed on for processing by gut flora largely in the colon. Insulin is
released into the blood by beta cells (β-cells), found in the islets of Langerhans in the pancreas,
in response to rising levels of blood glucose, typically after eating. Insulin is used by about
two-thirds of the body's cells to absorb glucose from the blood for use as fuel, for conversion to
other needed molecules, or for storage .
Insulin is also the principal control signal for conversion of glucose to glycogen for internal
storage in liver and muscle cells. Lowered glucose levels result both in the reduced release of
insulin from the β-cells and in the reverse conversion of glycogen to glucose when glucose
levels
fall. This is mainly controlled by the hormone glucagon , which acts in the opposite manner to
insulin. Glucose thus forcibly produced from internal liver cell stores (as glycogen) re-enters the
bloodstream; muscle cells lack the necessary export mechanism. Normally, liver cells do this
when the level of insulin is low (which normally correlates with low levels of blood glucose).
Higher insulin levels increase some anabolic ("building up") processes, such as cell growth and
duplication, protein synthesis , and fat storage. Insulin (or its lack) is the principal signal in
converting many of the bidirectional processes of metabolism from a catabolic to an anabolic
direction, and vice versa . In particular, a low insulin level is the trigger for entering or leaving
ketosis (the fat-burning metabolic phase) .

If the amount of insulin available is insufficient, if cells respond poorly to the effects of insulin
(insulin insensitivity or resistance), or if the insulin itself is defective, then glucose will not have
its usual effect, so it will not be absorbed properly by those body cells that require it, nor will it
be stored appropriately in the liver and muscles. The net effect is persistent high levels of blood
glucose, poor protein synthesis, and other metabolic derangements, such as acidosis.

When the glucose concentration in the blood is raised to about 9-10 mmol/L (except certain
conditions, such as pregnancy), beyond its renal threshold (i.e. when glucose level surpasses
the transport maximum of glucose reabsorption), reabsorption of glucose in the proximal renal
tubule is incomplete, and part of the glucose remains in the urine ( glycosuria ). This increases
the osmotic pressure of the urine and inhibits reabsorption of water by the kidney, resulting in
increased urine production ( polyuria ) and increased fluid loss. Lost blood volume will be
replaced osmotically from water held in body cells and other body compartments, causing
dehydration and increased thirst.

DIAGNOSIS

Glycated hemoglobin and Glucose tolerance test

Diabetes diagnostic criteria
Condition 2 hour glucose Fasting glucose
HbA 1c
mmol/l(mg/dl) mmol/l(mg/dl) %
Normal <7.8 (<140) <6.1 (<110) <6.0
Impaired fasting glycaemia <7.8 (<140) ≥ 6.1(≥110) & <7.0(<126) 6.0–6.4
Impaired glucose tolerance ≥7.8 (≥140) <7.0 (<126) 6.0–6.4
Diabetes mellitus ≥11.1 (≥200) ≥7.0 (≥126)
≥6.5
Diabetes mellitus is characterized by recurrent or persistent hyperglycemia, and is diagnosed by
demonstrating any one of the following:

● Fasting plasma glucose level ≥ 7.0 mmol/l (126 mg/dl)

● Plasma glucose ≥ 11.1 mmol/l (200 mg/dL) two hours after a 75 g oral glucose load as in
a glucose tolerance test
● Symptoms of hyperglycemia and casual plasma glucose ≥ 11.1 mmol/l (200 mg/dl)
● Glycated hemoglobin (Hb 1C) ≥ 6.5% .

A positive result, in the absence of unequivocal hyperglycemia, should be confirmed by a repeat

of any of the above methods on a different day. It is preferable to measure a fasting glucose level
because of the ease of measurement and the considerable time commitment of formal glucose
tolerance testing, which takes two hours to complete and offers no prognostic advantage over the
fasting test. According to the current definition, two fasting glucose measurements above
126 mg/dl (7.0 mmol/l) is considered diagnostic for diabetes mellitus.

People with fasting glucose levels from 110 to 125 mg/dl (6.1 to 6.9 mmol/l) are considered to
have impaired fasting glucose . Patients with plasma glucose at or above 140 mg/dL
(7.8 mmol/L), but not over 200 mg/L (d11.1 mmol/L), two hours after a 75 g oral glucose load
are considered to have impaired glucose tolerance . Of these two prediabetic states, the latter in
particular is a major risk factor for progression to full-blown diabetes mellitus, as well as
cardiovascular disease .
Glycated hemoglobin is better than fasting glucose for determining risks of cardiovascular
disease and death from any cause.

DIABETES MANAGEMENT

Diabetes mellitus is a chronic disease which cannot be cured except in very specific situations.
Management concentrates on keeping blood sugar levels as close to normal ("euglycemia") as
possible, without causing hypoglycemia. This can usually be accomplished with diet, exercise,
and use of appropriate medications (insulin in the case of type 1 diabetes, oral medications, as
well as possibly insulin, in type 2 diabetes).

Patient education, understanding, and participation is vital, since the complications of diabetes
are far less common and less severe in people who have well-managed blood sugar levels. The
goal of treatment is an HbA1C level of 6.5%, but should not be lower than that, and may be set
higher. Attention is also paid to other health problems that may accelerate the deleterious effects
of diabetes. These include smoking , elevated cholesterol levels, obesity , high blood pressure ,
and
lack of regular exercise. Specialised footwear is widely used to reduce the risk of ulceration, or
re-ulceration, in at-risk diabetic feet. Evidence for the efficacy of this remains equivocal,
however.

Lifestyle

Diabetic diet

There are roles for patient education, dietetic support, sensible exercise, with the goal of keeping
both short-term and long-term blood glucose levels within acceptable bounds . In addition, given
the associated higher risks of cardiovascular disease, lifestyle modifications are recommended to
control blood pressure .
Medications

Oral medications- Anti-diabetic medication

Metformin is generally recommended as a first line treatment for type 2 diabetes, as there is good
evidence that it decreases mortality Routine use of aspirin , however, has not been found to
improve outcomes in uncomplicated diabetes .

Insulin

Insulin therapy

Type 1 diabetes is typically treated with a combinations of regular and NPH insulin , or
synthetic insulin analogs . When insulin is used in type 2 diabetes, a long-acting formulation is
usually added initially, while continuing oral medications . Doses of insulin are then increased to
effect .
Chapter 1
SUPPORT

In countries using a general practitioner system, such as the United Kingdom , care may take
place mainly outside hospitals, with hospital-based specialist care used only in case of
complications, difficult blood sugar control, or research projects. In other circumstances, general
practitioners and specialists share care of a patient in a team approach. Home telehealth support
can be an effective management technique.

Epidemiology

Prevalence of diabetes worldwide in 2000 (per 1,000 inhabitants) - world average was 2.8%.
no data
≤ 7.5
7.5–15
15–22.5
22.5–30
30–37.5
37.5–45
45–52.5
52.5–60
60–67.5
67.5–75
75–82.5
≥ 82.5

Disability-adjusted life year for diabetes mellitus per 100,000 inhabitants in 2004

No data
<100
100–200
200–300
300–400
400–500
500–600
600–700
700–800
800–900
900–1,000
1,000–1,500
>1,500

Globally, as of 2010 [update] , an estimated 285 million people had diabetes, with type 2 making up
about 90% of the cases. [3] Its incidence is increasing rapidly, and by 2030, this number is
estimated to almost double. [32] Diabetes mellitus occurs throughout the world, but is more
common (especially type 2) in the more developed countries. The greatest increase in prevalence
is, however, expected to occur in Asia and Africa, where most patients will probably be found by
2030. [32] The increase in incidence in developing countries follows the trend of urbanization and
lifestyle changes, perhaps most importantly a "Western-style" diet. This has suggested an
environmental (i.e., dietary) effect, but there is little understanding of the mechanism(s) at
present, though there is much speculation, some of it most compellingly presented. [32]

Australia

Indigenous populations in first world countries have a higher prevalence and increasing
incidence of diabetes than their corresponding nonindigenous populations. In Australia, the
age-standardised prevalence of self-reported diabetes in indigenous Australians is almost four
times that of nonindigenous Australians. [33] Preventative community health programs, such
as Sugar Man (diabetes education) , are showing some success in tackling this problem.

China

Almost one Chinese adult in ten has diabetes. A 2010 study estimated that more than 92 million
Chinese adults have the disease, with another 150 million showing early symptoms. [34] The
incidence of the disease is increasing rapidly; a 2009 study found a 30% increase in 7 years. [35]

India

India has more diabetics than any other country in the world, according to the International
Diabetes Foundation, [36] although more recent data suggest that China has even more. [34] The
disease affects more than 50 million Indians - 7.1% of the nation's adults - and kills about 1
million Indians a year. [36] The average age on onset is 42.5 years. [36] The high incidence is
attributed to a combination of genetic susceptibility plus adoption of a high-calorie, low-activity
lifestyle by India's growing middle class. [37]

United Kingdom
About 3.8 million people in the United Kingdom have diabetes mellitus, but the charity Diabetes
U.K. have made predictions that that could become high as 6.2 million by 2035/2036. Diabetes
U.K. have also predicted that the National Health Service could be spending as much as
16.9 billion pounds on diabetes mellitus by 2035, a figure that means the NHS could be spending
as much as 17% of its budget on diabetes treatment by 2035. [38] [39] [40]

United States

Diabetes rates at county levels 2004 - 2009.

13

For at least 20 years, diabetes rates in North America have been increasing substantially. In
2010, nearly 26 million people have diabetes in the United States, of whom 7 million people
remain undiagnosed. Another 57 million people are estimated to have prediabetes. [41] [42]
The Centers for Disease Control and Prevention (CDC) has termed the change
an epidemic . [43] The National Diabetes Information Clearinghouse estimates diabetes costs
$132 billion in the United States alone every year. About 5%–10% of diabetes cases in North
America are type 1, with the rest being type 2. The fraction of type 1 in other parts of the world
differs. Most of this difference is not currently understood. The American Diabetes
Association (ADA) cites the 2003 assessment of the National Center for Chronic Disease
Prevention and Health Promotion (Centers for Disease Control and Prevention) that one in three
Americans born after 2000 will develop diabetes in their lifetimes. [44] [45]
According to the ADA, about 18.3% (8.6 million) of Americans age 60 and older have
diabetes. [46] Diabetes mellitus prevalence increases with age, and the numbers of older persons
with diabetes are expected to grow as the elderly population increases in number. The National
Health and Nutrition Examination Survey (NHANES III) demonstrated, in the population over
65 years old, 18% to 20% have diabetes, with 40% having either diabetes or its precursor form
of impaired glucose tolerance .
 Review of Literature

Diabetes Mellitus

Diabetes mellitus is a group of metabolic diseases that result when the body fails
to use or produce insulin, a hormone essential for glucose uptake into body cells. The two
major forms of the disease are type 1 and type 2 diabetes.
Type 1 diabetes is
characterized by an inability to produce insulin (ADA, 2007a). Type 2 diabetes results as
cells become unresponsive to insulin and a progressive insulin secretary defect develops
(ADA, 2007b). Diabetes has been deemed the 5th leading cause of death in the United
States (CDC, 2005). The World Health Organization estimated that, in 2000, 171 million
people worldwide had diabetes and predicts that, by 2030, 366 million people worldwide
will have diabetes (WHO, 2005). For many years, diabetes has been viewed as a costly
and burdensome chronic disease with increasing prevalence at epidemic proportions in
the United States and throughout the world (King, Albert, & Herman, 1998).

Type 1 diabetes. Type 1 diabetes is an autoimmune disease in which the immune

system attacks and destroys the insulin-producing beta cells in the pancreas resulting in
little or no insulin production within the body (National Institute for Digestive and
Kidney Diseases, 2006). Insulin must be provided through injections or an insulin pump.
This form of diabetes is typically diagnosed in children and young adults and is a lifelong
condition that cannot be prevented (ADA, 2007a). The cause of type 1 diabetes is
unknown, but risk factors are associated with autoimmune, genetic, and environmental
factors. Type 1 diabetes accounts for 5-10% of all diagnosed cases of diabetes (National
Institute for Digestive and Kidney Diseases).

Type 2 diabetes. Type 2 diabetes is the most prevalent form of diabetes,

accounting for 90-95% of all diagnosed cases (CDC, 2005). The twin epidemics of
diabetes and obesity are rising dramatically around the world and urgent action is needed
to avoid a global public health crisis (International Obesity Task Force, 2006). Type 2
diabetes used to be termed adult onset diabetes, but recently an increasing incidence of
type 2 diabetes among adolescents has accompanied the national rise in adolescent
obesity (Pashas et al., 1996; International Obesity Task Force; ADA, 2005b). It is
predicted that if the obesity rates continue to rise, prevalence of type 2 diabetes will also
increase rapidly. In 2000, there were an estimated 300 million obese adults worldwide, a
statistic which continues to grow (WHO, 2005).
Unlike type 1 diabetes, type 2 diabetes is potentially reversible before permanent
beta cell failure has occurred (Wing, 1995). Individuals with type 1 diabetes experience
immediate health impacts during times of mismanagement, but individuals with type 2
diabetes may not see immediate effects of neglect and poor control, which makes
adherence to a health regimen seem less compelling to those diagnosed with type 2
diabetes (Pashas et al., 1999).
Metabolic syndrome is a public health concern associated with type 2 diabetes. It
is characterized by elevated waist circumference, elevated triglycerides, reduced highdensity
lipoprotein cholesterol, elevated blood pressure, and elevated fasting blood
glucose (“Expert panel,” 2001). Although the abnormalities of metabolic syndrome are
not a direct cause of diabetes, they act as strong predictors of type 2 diabetes
development (Grundy, 2004). Effective management of the components of metabolic
syndrome through lifestyle modification is required to prevent progression to type 2
diabetes (Fonseca, 2005). Table 1 provides a comparison of type 1 and type 2 diabetes.

Table 1
Similarities and Differences of Type 1 and Type 2 Diabetes
Type 1 diabetes Type 2 diabetes

Cause • Autoimmune disease destroys beta cells.

• Insulin is not produced within the body.

• Typically diagnosed before the age of 25.

• Preventable disease.

• Body is unresponsive to insulin being produced.

• Onset is associated with obesity.

• Diet is very important to keep blood sugar levels under control.

• Insulin is not always needed.

• Diet modification and weight loss alone can manage the disease in the early stages.

• Complications can result due to poor management such as eye, kidney, heart, and nerve disease.

• Episodes of low blood sugar are common.

• Complications can result due to poor management such as eye, kidney, heart, and nerve disease.

• No episodes of low blood sugar unless taking insulin or oral diabetes medications.
Diabetes standards of medical care. Since diabetes is a disease that requires
continuing medical care, the American Diabetes Association has established standards of
care that include general care guidelines, treatment goals, and tools to evaluate the quality
of care. According to the guidelines, screening for type 2 diabetes should be performed
every 3 years in individuals older than 45 years of age, particularly those with body mass
indexes greater than 25 kg/m2 (ADA, 2006). Due to the acute onset of symptoms, type 1
diabetes is usually detected soon after symptoms develop (ADA, 2006). The preferred
diagnostic test for diabetes is fasting blood glucose, which measures blood glucose levels
after at least 8 hours of fasting, with levels higher than 126 mg/dl considered
classification for diabetes (ADA, 2006). After diagnosis, a medical evaluation should be
conducted to assess presence or absence of diabetes related complications.
Individuals diagnosed with diabetes should receive medical care from a
physician-coordinated team, including physicians, nurses, dietitians, pharmacists, and
mental health professionals (ADA, 2006). The interdisciplinary team approach promotes
multidimensional diabetes care by using shared leadership with common goals, shared
professional identity, and collaborative as opposed to consultative relationships among
members. To assess short-term glycaemic control, it is recommended that
individuals implement self-monitoring of blood glucose levels at least twice daily and
strive for blood sugar levels of 90-130 mg/dl before meals and less than 180 mg/dl after
meals (ADA, 2006). The hemoglobin A1c (HbA1c) test is used to assess long-term blood
glucose control as it measures the patient’s average glycemic levels over the past 2 to 3
months. Every percentage point decrease in HbA1c reduces the risk of diabetes
complications by 40% (CDC, 2005). The HbA1c goal for patients with diabetes is less
than 7% (ADA, 2006).

Diabetes medical nutrition therapy. Medical nutrition therapy aims to prevent and
treat diabetes as well as potential complications of the disease, such as cardiovascular
problems, nephropathy and retinopathy. Goals of diabetes medical nutrition therapy
include maintenance of blood glucose levels as close to normal as possible, establishment
of lipid profiles and blood pressure levels that reduce the risk for developing
macro vascular diseases, modification of dietary and lifestyle patterns to prevent and treat
obesity, and general health improvement through incorporation of healthy food choices
and physical activity (ADA, 2002). Learning how to obtain the medical nutrition therapy
goals established by the American Diabetes Association is an integral component of
diabetes self-management.

The focus of medical nutrition therapy varies slightly for type 1 and type 2
diabetes. Medical nutrition therapy of youth diagnosed with type 1 diabetes aims to
provide adequate energy to promote optimal development and to prevent hypoglycemic
episodes (ADA, 2002). Individuals diagnosed with type 2 diabetes typically require
changes in eating and physical activity habits to reduce insulin resistance and improve
metabolic status (ADA, 2002). Medical nutrition therapy for both types of diabetes
emphasizes the need for a healthy lifestyle and the control of blood sugar levels to
prevent diabetes related complication.
 AIMS AND OBJECTIVES

● To study about the patients with diabetes mellitus with regards to various
like age , sex and occupation.

● To study the mode of presentation of diabetes mellitus.

● To study various predisposing factors of diabetes mellitus

.
● To study the diabetes mellitus at M.M.G Hospital, GT Road Ghaziabad (UP).

● To study the analysis of the diabetes

 OBSERVATION AND RESULTS

During the period of my study, a total of 55 patients suffering from fever were selected for the
study in paediatric O.P.D. and I.P.D. of M M G Hospital over a period of 2 months.

GENDER DISTRIBUTION OF THE STUDY SUBJECTS

Among the 55 patients suffering from fever 65.89% were males and 34.11% were females,
indicating male population is more susceptible to various infections.

Table 1
Gender No. of Patients % of Patients
Male 30 65.89%
Female 25 34.11%
Total 55 100%

Graph 1

DISTRIBUTION OF PAEDIATRIC PATIE

DISTRIBUTION OF PAEDIATRIC PATIENTS IN OPD AND IPD

Amongst 302 paediatric patients, the distribution of patients in OPD and IPD was 292 (96.68%)
and 10(3.32%) respectively.

Table 2
Department No. of patients % of patients
OPD 292 96.68%
IPD 10 3.32%
Total 302 100%
Graph 2
AGE DISTRIBUTION OF THE STUDY SUBJECTS

In paediatric O.P.D., it was observed that maximum number (90, 29.80%) of patients comes
under the age group of > 1month-1 year, followed by (71, 23.50%) patients in the age group of
>2 years- 4 years. The maximum number of male patients (64, 32.00%) belonged to the age
group > 1month-1 year whereas number of female patients (29, 28.43%) were the highest in age
group >2 years- 4 years.

Table 4
Age (yrs) Male Female Total patients

No. % No. % No. %

0 -1 month 6 3 2 1.96 8 2.64

>1 month-1 year 64 32 26 25.49 90 29.80

>1 year- 2 year 42 21 17 16.66 59 19.53

>2 year- 4 year 42 21 29 28.43 71 23.50

>4 year- 6 year 21 10.5 12 11.76 33 10.92

>6 year- 8 year 12 6 9 8.82 21 6.95

>8 year- 10 year 8 4 5 4.91 13 4.30

>10 year- 12 year 5 2.5 2 1.96 7 2.31

Total 200 100 102 100 302 100

Graph 4
Graph 4
AVERAGE NO. OF DRUGS PER PRESCRIPTION

Among the 55 patients that was included in the study, maximum number of patients (30)
received 3 drugs per prescription followed by 4 drugs per prescription received by (25) patients.
Average no. of drugs per prescription was found to be 5.61.

Table 5

No. of drugs per prescription

1 2 3 4 5 6 7 8 9

Total no. of Patients

10 30 78 65 62 34 9 2 1

Graph 5

AVERAGE NUMBER OF ANTIPYRETIC DRUGS PER

PRESCRIPTION

Among the 302 paediatric patients suffering from fever, average number of antipyretic drugs
prescribed is 1.086 per prescription.
MOST COMMON PHARMACOLOGICAL GROUP OF DRUGS
PRESCRIBED

The drug groups most often prescribed were Anti-infective that was found to be
245(81.12%). It was followed by Cold and cough preparations.

Table 6
Drug Category No. of patients %
Antipyretics 302 100.00
Anti-infectives 245 81.12
Cough And cold preparations 235 77.81
Vitamins 88 29.13
Anti-diarrhoeals 39 12.91
Anti-emetics 29 09.60
Anti-asthmatics 21 06.95
Anti-helmintics 18 05.96
Anti-malarials 11 03.64
Antiepileptics 5 01.65
GRAPH 6
MOST COMMONLY PRESCRIBED INDIVIDUAL DRUGS

Out of 74 drugs prescribed in Paediatric O.P.D. paracetamol, chlorpheniramine, ambroxol, and

co-amoxiclav was most frequently prescribed drugs.

Table 7
Drugs No. of prescriptions Percentage
PCM 302 21.66
Chlorpheniramine 162 11.62
Ambroxol 113 8.1
Co-amoxiclav 93 6.67
Phenyl propanolamine 66 4.73
L.sporogenes 63 4.51
Cefaclor 50 3.58
Pseudoephedrine 38 2.72
Cefpodoxime 28 2
Others 479 33.36

Graph 7
MOST COMMON DIAGNOSIS OF THE PATIENTS
Among the 55 patient that included in the study, major number 242(80.13%) of patients were
suffering from diabetes mellitus followed by Acute gastroenteritis in 28 (9.27%) patients.

Table 8
Diagnosis No. of patients %

Diabetes mellitus 41 80.13

Acute gastroenteritis 5 9.27

Typhoid 3 3.29

Malaria 2 2.98

Lower respiratory tract infection 2 1.32

Urinary tract infection 1 1.66

Neurocysticircosis 1 1.33
Graph 8

AVERAGE COST OF DRUGS PER PRESCRIPTION

In O.P.D., average cost of drugs per prescription was found to be Rs. 215.33. Most of the patient
comes under the range of 201-300 followed by 0-100.
The total cost of the drugs was mainly affected by cost of antibiotics.

Cost analysis:
Table 9
Costs (INR) No. of prescriptions Percentage
0-100 71 24.32
101-200 56 19.18
201-300 88 30.14
301-400 59 20.21
401-500 11 03.76
>500 7 02.39

Graph 9
RESIDENCE ENVIRONMENT OF THE PATIENT

Most of the patients enrolled in my study were from nearby localities and belonged to the low
socioeconomic status region. The infectious diseases were more prevalent in children due to poor
hygienic conditions.

Table 10
Residential Total no. 1st No. of 2nd No. of 3rd No. of
Area of Prevalen patients Prevalent patient Prevalen patients
patients t disease disease t disease
Sopra city 108 diabetes 90 Acute 8 Typhoid 4
gastroenteriti (28.57%) (25%)
indrapuram (35.76%) (37.81%
s
)
Mumura sec- 16 diabetes 14 Acute 1 Typhoid 1
gastroenteriti (3.57%) (6.25%)
61 noida (5.29%) (5.88%)
s
Beta1 gr. 20 diabetes 6 Acute 1 Typhoid 1
gastroenteriti (3.57%) (6.25%)
Noida (6.62%) (2.52%)
s
Manglam 19(6.29% diabetes 22 Acute 5 Typhoid 2
gastroenteriti (17.85%) (12.50%
apartment ) (9.24%)
s )
indrapuram
c-20 A27 56 diabetes 45 Acute 8 Typhoid 3
gastroenteriti ((28.57% (18.75%
indrapuram (18.54%) (18.90%
s ) )
)
Govindpuru 8 diabetes 9 Acute 0 Typhoid 0
gastroenteriti (0.00%) (0.00%)
m (2.64%) (3.78%)
s
Alpha-2 gr. 14 diabetes 10 Acute 1 Typhoid 0
gastroenteriti (3.57%) (0.00%)
Noida (4.63%) (4.20%)
s
Alpha-3 11 diabetes 10 Acute 0 Typhoid 0
gastroenteriti (0.00%) (0.00%)
gr.noida (3.64%) (4.20%)
s
Badarpur 27 diabetes 27 Acute 4 Typhoid 3
gastroenteriti (14.28%) (18.75%
Border (8.94%) (11.34%)
s )
Others 23 diabetes 5 Acute 0 Typhoid 2
gastroenteriti (0.00%) (12.50%
(7.61%) (2.10%)
s )
Total 302 238 28 16
(100%) (100%) (100%) (100%)

AVERAGE CONSULTATION TIME

During the study, the average consultation time was found to be 7 minutes.
 SUMMARY AND CONCLUSION

Analyzing and describing the prescribing patterns of drugs allow for a measurement of
rationality of a pharmacological therapy. Several studies have documented prescribing
practices but there are fewer such studies available in cardiology. Since antipyretics play
an important role in daily practice, we studied the drug utilization pattern in patients with
special reference to antidiabetic drugs in patients attending OPD & IPD of Kailash
Hospital, Greater Noida.The duration of study was 2 months. All the patients between 30-
90 years of age, irrespective of sex, attending the OPD or hospitalized in IPD ward and
also who were prescribed at least one antihypertensive drug were selected. The study was
prospective. The parameters for evaluation included some of the WHO/INRUD
prescribing and patient care indicators in addition to some other indicators added by us.
The sources of data were physician’s prescribing records & patient’s medication profile.

A total of 40 patients suffering from Diabetes were studied. The results can be summarized as
below:

1. A higher no. of male patients (55%) as compared to female (45%) patients.

2. A much lesser IPD cases (3.32%) as compared to OPD (96.68).

3. Maximum patients (41.66%) belonged to the age group of 50 – 60 years.

4. Average number of drugs per prescription was 2.1

5. Insulin(50%), Biguanides / Metformin(32.50%), Sulphonylureas(16%) constituted the

commonest category of drugs prescribed.

6. Sufficient time was given to the patients with the average consultation time as 6 minutes.

The clinical project comprises three originals papers based on research work carried out from
April 2013 to March 2013 at the Department of Endocrinology, Kailash Hospital, and consisted
of a meta-analysis regarding the existing evidence on self-management intervention in diabetes,
a clinical randomized controlled trial regarding the effect of a self-management program and an
explorative study regarding patients’ understanding and experience of diabetes self-management
following the self-management program. The aim of the meta-analysis was to assess the
effectiveness of self-care behavior all interventions in improving glycaemic control in type 2
diabetes by analyzing the impact of different study characteristics on the effect size. The
literature searched in 8 scientific databases up to included original study articles of randomized
controlled trials that evaluated a self-care behavioral intervention in adult patients diagnosed
with type 2 diabetes. The 47 included studies yielded 7677 participants. The analysis showed a
0.36 % (95% CI 0.21 to 0.51) improvement in glycaemic control in people who received self-
care behavior treatment. In the univariate meta-regression sample size (effect size 0.42 %,
p=0.007) and follow-up period (effect size 0.49%, p=0.017) were identified to have significant
effect on
the effect size in favor of small studies and short follow-up. For type of intervention and duration
of intervention there was a nonsignificant effect on effect size in favor of educational techniques
and short intervention.

The aim of the explorative study was to explore how living with diabetes in everyday life is
experienced following a self-management intervention program based on motivational
interviewing.

We conducted group interviews, each comprising 3 to 5 participants diagnosed with type 1 or

type 2 diabetes. Data analysis based on a phenomenological method revealed three main themes
concerning diabetes self-management: 1) Becoming a self-regulating practitioner concerning
how patients handled the regimes of self-management in different daily situations and routines,
2)Managing the rules of self-management concerning how patients used self-management to get
control in their lives and 3) Creating a supportive social network concerning how the patients
were able to get support from family, friends and colleagues on their own terms. A narrative
analysis revealed a divergence in patients’ self-perceived competence in handling diabetes.

No effect was found on lipid profile, blood pressure, medication, and weight or waist
circumference. The motivational interviewing group maintained perceived competence for
diabetes (PCDS scores; 6.3 to 6.3 vs. 6.2 to 5.8, p=0.011) post intervention, but no effect was
found on problems areas in diabetes (PAID scores).

With this we have shown that self-care behavior interventions have an effect of glycaemic
control which is especially true under conditions which imply a compact program with sessions
closely grouped together. However, the effect might vanish over time. We did not find evidence
for the motivational interviewing program to improve glycemic control, though patients with
poor diabetes control might profit by the program. The motivational interviewing program
enhanced perceived competence in self-management among patients with type1 or type 2
diabetes mellitus. The study findings indicated that people with diabetes had specific needs for
support in the daily responsibility of managing diet, exercise, medication and blood glucose
monitoring. A meaningful treatment from the patient’s perspective would appear to be one that
aims at overcoming problems that the patient experiences in self-management of diabetes.
Further research is needed to establish knowledge about the long-term effect of interventions
sustaining self-care activities in patients with diabetes. Future research is also recommended to
focus on the implementing process of self-management intervention in clinical care.
 DECLARATION

I hereby declare that the project work entitled “ CLINICAL STUDY ON DIABETES ”

submitted. It is a record of an original work done by me “ AJAY PRATAP SINGH ”

under the guidance of Mr. ANIL KUMAR SAHDEV, Faculty Member of Innovative
College of Pharmacy, Greater Noida.

This project work has not performed the basis for the award of any Degree /

associate ship/fellowship and similar project if any.

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