A Healthcare Economic Policy for Non-Insulin-Dependent Diabetes Mellitus Type 2 Patients Monitoring in Ukraine

Doctoral Thesis / Dissertation , 2021 , 151 Pages , Grade: N/A

Economy - Health Economics

This research explores the cost, life expectancy and quality of life impact of a national quarterly monitoring program on type 2 diabetes for non-insulin-dependent patients. In Ukraine, many people suffer from diabetes and its complications. In this research we focus only on type 2 diabetes, as the most common type of diabetes. Among those we focus only on non-insulin-dependent patients, as these are the patients that would benefit the most from the improved monitoring. Diabetes leads to lower life expectancy, lower quality of life of an individual, and higher healthcare costs both for people and the healthcare system. This burden increases even more if diabetes is not managed. The research analyses the potential impact of a nationwide point of care based non-insulin-dependent diabetics monitoring program.

The research method used in the study is the combined cost-effectiveness analysis and budget impact analysis from the payer perspective. This is a special type of the summative evaluation research used to assess the impact of a healthcare program. With the research method, the author answers the question whether the proposed diabetes monitoring strategy is more cost-effective than the standard of care. The author also answers the question what the impact of a nation-wide diabetes monitoring program on the annual healthcare budget of the payer would be. He also analyses the average cost associated with diabetes during the lifetime of an average patient from the payer perspective; the impact on the quality of life of such a patient, and on her (his) life expectancy. All this provides important information to assess the impact of an alternative healthcare economic policy for diabetes. Two formal decision scientific models were developed. They model the situation of diabetics with quarterly point of care based HbA1c monitoring program and compare it with the standard of care. The main types of input data for the models are transition probabilities between different health states, cost and utility of each individual health state. The data used in the models were taken from the literature review of publications and discussions with healthcare professionals in Ukraine.

Table of Contents

DEDICATION

Statement of originality

Abstract

Table of Contents

List of Figures

List of Tables

List of Abbreviations

1 Introduction

2 Background
2.1 Diabetes
2.2 Type 2 diabetes mellitus – a largely preventable disease
2.3 Diabetes – burden of disease
2.4 Diabetes monitoring and treatment
2.5 Diabetes monitoring guidelines in Ukraine

3 Literature review on cost-effectiveness analysis and budget impact analysis
3.1 Budget Impact Analysis
3.2 Cost-effectiveness analysis
3.3 Markov modeling

4 Budget impact analysis of a nation-wide quarterly POC-based type 2 diabetes mellitus monitoring program
4.1 Research methodology
4.2 Research setting and data collection
4.3 Findings
4.4 Limitations

5 Cost-effectivness analysis of the nation-wide quarterly POC-based diabetes mellitus monotoring policy for type 2 diabetes
5.1 Methodology and research design
5.2 Research setting and data collection
5.3 Findings
5.4 Sensitivity Analysis
5.5 Value of Information

6 Conclusion
6.1 Limitations
6.2 Substantative conclusions and final recommendations
6.3 Practical contributions of the study
6.4 Suggestions for future research

References

DEDICATION

I dedicate this research to all people with diabetes in Ukraine. I wish all the best to people living in Ukraine and hope that with my research I can contribute to better and healthier future of people in Ukraine.

Statement of originality

This dissertation work contains no material that has been accepted for the award of another degree at a university or other educational institution. To the best of my knowledge it contains no material previously published or written by another person or persons except where due reference has been made.

Abstract

This research explores the cost, life expectancy and quality of life impact of a national quarterly monitoring program on type 2 diabetes for non-insulin-dependent patients. In Ukraine, many people suffer from diabetes and its complications. In this research we focus only on type 2 diabetes, as the most common type of diabetes. Among those we focus only on non-insulin-dependent patients, as these are the patients that would benefit the most from the improved monitoring. Diabetes leads to lower life expectancy, lower quality of life of an individual, and higher healthcare costs both for people and the healthcare system. This burden increases even more if diabetes is not managed. The research analyses the potential impact of a nation-wide point of care based non-insulin-dependent diabetics monitoring program.

The research method used in the study is the combined cost-effectiveness analysis and budget impact analysis from the payer perspective. This is a special type of the summative evaluation research used to assess the impact of a healthcare program. With the research method, the author answers the question whether the proposed diabetes monitoring strategy is more cost-effective than the standard of care. The author also answers the question what the impact of a nation-wide diabetes monitoring program on the annual healthcare budget of the payer would be. He also analyses the average cost associated with diabetes during the lifetime of an average patient from the payer perspective; the impact on the quality of life of such a patient, and on her (his) life expectancy. All this provides important information to assess the impact of an alternative healthcare economic policy for diabetes. Two formal decision scientific models were developed. They model the situation of diabetics with quarterly point of care based HbA1c¹ monitoring program and compare it with the standard of care. The main types of input data for the models are transition probabilities between different health states, cost and utility of each individual health state. The data used in the models were taken from the literature review of publications and discussions with healthcare professionals in Ukraine.

The first finding of the study is that nation-wide point of care based HbA1c diabetes monitoring program is cost-effective if we adopt the cost-effectiveness threshold according to World Health Organization (WHO) recommendation. We show that such a program provides positive impact on both length and quality of life of diabetics in Ukraine. The other important finding is that in all 5 years after introduction of the program the healthcare budget incurs additional costs, meaning decrease in cost of treatment of diabetes-related complications due to higher rate of controlled diabetes does not offset the added costs for diabetes monitoring and preventive therapy. Therefore, the question of cost-effectiveness of the national point of care based HbA1c diabetes monitoring program comes down to the cost-effectiveness threshold applicable for Ukraine. Added per-patient costs are low, suggesting that added costs are justified given the gains in quality of life and life expectancy.

Developing countries, like Ukraine, need to be careful with spending their resources as the budget is limited, while the demand for healthcare is high. With this research we show that smart allocation of some funds to a nation-wide quarterly point of care based HbA1c diabetes monitoring program for non-insulin-dependent patients, can have a large lasting positive impact on Ukrainian population with minor impact on the healthcare budget.

List of Figures

Figure 1: Process of absorption of glucose by human cells with the help of insulin

Figure 2: Adults who died from diabetes, HIV/AIDS, tuberculosis, and malaria worldwide

Figure 3: Diabetes complications

Figure 4: Rates of complications in diabetes mellitus type 2 patients

Figure 5: Risk factors of development of T2DM

Figure 6: Pre-diabetes and undiagnosed diabetes in Ukraine.

Figure 7: Interpreting measurement values of HbA1c

Figure 8: What is HbA1c

Figure 9: Majority of T2DM related costs are the costs of complications

Figure 10: Number of diabetics worldwide in different years

Figure 11: Estimated age-adjusted prevalence of diabetes in adults (20-79), 2015

Figure 12: Mean diabetes-related healthcare expenditure per person with diabetes (20-79 years) (International Dollars)

Figure 13: Global health spending to treat diabetes (in billion USD)

Figure 14: Algorithm of HbA1c monitoring decision making

Figure 15: Main components of diabetes therapy

Figure 16: Tissue-specific metabolic effects of exercise in patients with T2DM

Figure 17: Treatment algorithm for people with type 2 diabetes.

Figure 18: Treatment algorithm for people with type 2 diabetes

Figure 19: Near Patient Testing Reduces HbA1c levels faster

Figure 20: Budget impact schematic

Figure 21: Hierarchy of evidence pyramid

Figure 22: QALY calculation

Figure 23: Incremental Cost-Effectiveness Ratio

Figure 24: Incremental Cost-Effectiveness Ratio

Figure 25: Two scenarios for budget impact analysis

Figure 26: Markov model for non-insulin-dependent diabetics monitoring

Figure 27: Cost-effectiveness acceptability curves

Figure 28: Tornado analysis of all parameters of the model

Figure 29: One-way sensitivity analysis on preventive treatment costs with POC-based quarterly monitoring

Figure 30: One-way sensitivity analysis on preventive treatment costs lab-based semiannual monitoring

Figure 31: Two-way sensitivity analysis on preventive treatment costs with and without monitoring at WTP=€9,801.85

Figure 32: Two-way sensitivity analysis on preventive treatment costs quarterly POC-based and semiannual lab-based monitoring at WTP=€458.07

Figure 33: Monte-Carlo simulation of incremental cost-effectiveness of quartly POC-based HbA1c monitoring vs. semiannual lab-based monitoring at WTP=€9,801

Figure 34: Monte-Carlo simulation of incremental cost-effectiveness of quartly POC-based HbA1c monitoring vs. semiannual lab-based monitoring at WTP=€458.07

Figure 35: EVPI vs WTP values

Figure 36: EVPPI for model variables at WTP=€9,801.85

Figure 37: EVPPI for model variables at WTP=€456.97

Figure 38: EVPPI for health state utility of controlled diabetes at different WTP levels

Figure 39: EVPPI for preventive treatment costs with monitoring at different WTP levels

Figure 40: EVPPI for preventive treatment costs with semiannual lab-based monitoring at different WTP levels

List of Tables

Table 1: Guideline for monitoring T2DM and complications.

Table 2: Diabetes population in Ukraine

Table 3: Summary of transition probabilities

Table 4: Annual Transitions Between Health States

Table 5: Cost data adjusted to inflation to reflect 2019 US dollars

Table 6: Budget Impact Analysis results

Table 7: Per-patient Budget Impact Analysis results

Table 8: Health outcomes

Table 9: Health state utilities

Table 10: Discount rates for costs and outcomes

Table 11: Lifetime per-patient cost-effectiveness results

Table 12: Net Monetary Benefit

List of Abbreviations

ADA – American Diabetes Association

BIA – Budget Impact Analysis

CAD – Coronary Artery Disease

CEA – Cost Effectiveness Analysis

CGM – Continuous glucose monitoring

CV – Cardiovascular

CVD – Cardiovascular Disease

CVOT – Cardiovascular Outcome Trials

DPP – Diabetes Prevention Program

ESRD – End-stage renal disease

FPG – Fasting plasma glucose test

GDP – Gross Domestic Product

GFR – Glomerular filtration rate

HbA1c – Glycated hemoglobin A1c

ICER – Incremental Cost-Effectiveness Ratio

IDF – International Diabetes Federation

IFG – Impaired Fasting Glucose

IGT – Impaired Glucose Tolerance

ISPOR – International Society for Pharmacoeconomics and Outcomes Research

NHB – Net Health Benefit

NMB – Net Monetary Benefit

MI – Myocardial Infarction

MNT – Medical Nutrition Therapy

NICE – National Institute for Health and Clinical Effectiveness

OGTT – Oral glucose tolerance test

POC – Point Of Care

PSE – Probabilistic Sensitivity Analysis

QALY – Quality Adjusted Life Years

RCT – Randomized Controlled Trial

SCD – Sudden Cardiac Death

SMBG – Patient self-monitoring of blood glucose

STEMI – ST-Elevation Myocardial Infarction

TB – Tuberculosis

T1DM – Diabetes Mellitus Type 1

T2DM – Diabetes Mellitus Type 2

UK – United Kingdom of Great Britain and Northern Ireland

USA – United States of America

USD – United States Dollar

WHO – World Health Organization

WTP – Willingness To Pay

YLD – Years Lived with Disability

1 Introduction

Diabetes Mellitus (DM or diabetes) is a complex, chronic illness, which occurs when the body cannot produce enough insulin or cannot use insulin². The disease is characterized by elevated levels of blood glucose. Blood testing for raised levels of glucose is essential for diagnosis and management of diabetes. Poorly managed diabetes leads to serious complications and early death.

There are three main types of diabetes. Type 1 diabetes, type 2 diabetes and gestational diabetes. Type 1 diabetes mellitus (T1DM) is characterized by a lack of insulin³ production. Globally about 7-12% of cases of diabetes are of type 1. This type of diabetes cannot be prevented or delayed with the current knowledge. Due to this nature of T1DM it is out of scope of this research. Type 2 diabetes mellitus (T2DM) results from the body’s ineffective use of insulin. Globally about 87-91% of diabetes cases are of type 2. T2DM is largely preventable⁴. Due to this nature of T2DM it is included in the scope of this research. Gestatinal diabetes can appear during pregnancy. It can lead to severe health risks both to the mother and the child. Although gestational diabetes normally disappears after birth, there is an increased risk of developing a T2DM later for both the mother and the child. Gestatinal diabetes is out of scope of this research.

In 2015, the International Diabetes Federation estimated that there are around 415 million adults aged 20-79 worldwide with diabetes.⁵ In addition, there are further 318 million adults with pre-diabetes. People with pre-diabetes are at high risk of developing diabetes in the future. By 2040, the International Diabetes Federation estimates that there will be 642 million of people with diabetes worldwide.⁶

While there are many risk factors of diabetes, and various treatment options exist, with the proper management of diabetes, the development of the disease can be halted, and in some cases reversed.

“There is now extensive evidence that good management improves the immediate and long-term quality of life of those with type 2 diabetes”.⁷

With this research, we want to evaluate the impact of introducing a quarterly point of care based HbA1c diabetes monitoring program for non-insulin-dependent T2DM patients in Ukraine on the budget of the Ministry of Health, on the lifetime diabetes-related costs of an average Ukrainian with diabetes, on the lives saved and on the quality of life of an average Ukrainian with diabetes. We want to answer the question on healthcare economic policy: whether Ukraine should introduce a government-sponsored quarterly point of care based HbA1c diabetes monitoring program for non-insulin-dependent T2DM patients. Little research has been undertaken to determine optimal healthcare economic policy for T2DM in Ukraine. Current clinical guidelines in Ukraine⁸ are not consistent with the international consensus⁹ on optimal care for non-insulin-dependent T2DM patients. Quarterly point of care (POC) based HbA1c diabetes monitoring is more costly than the semiannual laboratory-based HbA1c monitoring currently recommended in the Ukrainian clinical guidelines. It is unclear if the added costs of quarterly POC-based monitoring of T2DM will outweigh the benefits of such a policy. With this research we answer this question and contribute to better diabetes care in Ukraine.

2 Background

2.1 Diabetes

Diabetes is one of the four major global non-communicable diseases identified by WHO along with cardiovascular disease, cancer and chronic respiratory disease. Besides, diabetes is a personal and social calamity. It imposes high burden on inviduals, their families and economies worldwide. It is a chronic condition, which occurs when the body either cannot produce or cannot use insulin.

Next, we give an overview on what is insulin. Insulin is a hormone produced in pancreas. Insulin helps the human body both to store and to tranform glucose into energy. In the human body the process starts after a human consumes food. After the food consumption, the surgar or carbohydrates from the food are converted into glucose by a human body and injected in the blood. When the human body detects high level of glucose in blood, it reacts by triggering the pancreas to release insulin into the bloodstream. The function of insulin is not to flight the glucose. The human body needs glucose as an energy source to support all its functions. The function of insulin is to travel to the cells and tell them to open up and let the glucose in. As a next step, the human cells process glucose and either directly convert it into energy or store it for later use. The Figure 1 shows the process of absorption of glucose by human cells with the help of insulin.

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Figure 1: Process of absorption of glucose by human cells with the help of insulin.¹⁰

It is very important for the human body to keep the glucose (also known as blood sugar) at a certain level, where it is neither too much nor too little glucose in the blood. If there is too much glucose, the human eyesight will become blurry, and the human will feel tired. If there is too little glucose, the human can experience confusion, pass out, or even go into a coma. Both situations are possible for the people with diabetes, as diabetes is an insulin-related dysfunction.

In patients with diabetes, either not enough insulin is produced, or the body cells cannot use insulin. If there is not enough insulin to reduce the glucose blood level, or insulin cannot be used by the body cells, the glucose remains in the blood, leading to a high level of blood sugar. This can cause damage to organs, tissue and human cells. This aspect of diabetes makes the disease so deadly and dangerous in terms of mortality and morbidity. People with unmanaged diabetes tend to develop various complications over time. Diabetes is an important cause of devastating, irreversible complications, disability and premature death.

In 2015, 5.0 million worldwide people died from diabetes.¹¹ To put this number in the perspective, it is more deaths than the combined number of deaths from such deadly diseases as HIV/AIDS, tuberculosis and malaria.

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Figure 2: Adults who died from diabetes, HIV/AIDS, tuberculosis, and malaria worldwide.¹²

In Ukraine, 42,920 people die from diabetes and its complications annualy¹³. To put this number in the perspective, this corresponds to 7.2% of all deaths in Ukraine every year.

In Poltava region of Ukraine, 47% of T2DM patients have complications.¹⁴ People with diabetes are at higher risk, than those without diabetes to develop various disabling and life-threatening complications. High level of glucose in the blood can cause inflamations and lead to diseases in various organs. The complications can lead to stroke, visual impairment and blindness, nerve damage, diabeteic foot and lower limb amputation, heart attack, kidney failure, arteriosclerosis, pregnancy complications, and erectile dysfunction. Diabetes also exacerbates major infectious diseases such as tuberculosis (TB), HIV/AIDS and malaria.

“People with diabetes are three times more likely to develop TB¹⁵ when infected and approximately 15% of TB globally is thought to be due to diabetes. Diabetes and malaria frequently occur together in countries where malaria is endemic. These diseases are harder to treat together and there is a higher chance of death for people with both. HIV/AIDS can increase the risk of diabetes as some anti-retroviral treatments can cause diabetes.”¹⁶

Besides chronic conditions, diabetes can also lead to various short-term complications. An especially dangerous short-term complication is low blood glucose (also known as hypoglycaemia). This complication can lead to coma and death, if untreated. It is critical to detect and treat diabetes as early as possible. Diabetes is often asymptomatic. Many years may pass since the onset of the disease until complications start to occur. By this point, it is often too late to reverse the course of the disease.

Diabetes complications can be prevented by managing the blood glucose, blood pressure and cholesterol levels within the normal range. Earlier screening can help to identify complications at earlier stages. Diabetes monitoring requires education of people with diabetes on their condition, access to insulin, medications, and monitoring equipment. Healthcare systems should provide support with educated physicians, regular blood tests, eye and foot examinations.

Main complications associated with diabetes are the following¹⁷:

- visual impairment and blindness. Worldwide, diabetic retinopathy is the cause of 1.9% of moderate to severe visual impairment. In addition, it caused 2.6% of cases of blindness in 2010.
- kidney failure. Diabetes causes at least 80% of cases of end-stage renal disease (ESRD), hypertension or a combination of the two. Diabetes is the cause for 12–55% of ESRD cases worldwide. Adults with diabetes have a 10 times higher incidence of ESRD than adults without diabetes.
- heart attack. Cardiovascular disease (CVD) is two to three times more widespread among adults with diabetes, than those without it. The rising fasting plasma glucose levels lead to higher risk of CVD. This is the case even if levels sufficient for a diabetes diagnosis are not reached.
- stroke. The prevalence of stroke among diabetics is up to four times higher than in people without diabetes. Among stroke patients, the patients with diabetes have higher burden of mortality, recurrent events, and hospitalizations comparing to non-diabetic stroke patients.¹⁸
- nerve damage. The most common type is peripheral neuropathy. This disease affects the sensory nerves in the feet. The typical symptoms are pain, tingling, and loss of sensation. Patients with this disease can have injuries to go unnoticed, leading to ulceration (diabetic foot), serious infections and in some cases amputations.
- lower limb amputation. Over the past decade diabetics had from 1.5 to 3.5 amputations per 1000 persons per year. This is 10 to 20 times higher rate of amputation than what non-diabetics have.
- erectile dysfunction.
- pregnancy complications.

The most common result of uncontrolled diabetes is hyperglycemia. It is also known as high blood sugar. Over a period of time it can severely damage several systems in the body, including the nerves and blood vessels.¹⁹ Undiagnosed or poorly controlled diabetes can result in various complications listed above. All these complications caused by diabetes lead to higher risk of dying prematurely. Besides, uncontrolled diabetes is shown to increase health care utilization.²⁰ Thus, diabetes mellitus is one of the leading causes of death in the world.

However, diabetes complications are also very common. At the same time, there are no internationally agreed standard for diagnosing and assessing diabetes complications.

In Polatava region of Ukraine 61% of diabetics are women, 71% are 60 years old and younger, 85% are obese, 77% have high blood pressure. Besides, 29% are insulin-dependent.²¹ In Ukraine, 77% of T2DM patients reported to be admitted as in-patient at least once every 12 months.²²

Patients with T2DM are at high risk of CV death and adverse CV outcomes.²³ Unfortunately, in these patients, coronary artery disease (CAD) develops often asymptomatically until suddenly it causes a sudden cardiac death (SCD), or myocardial infarction (MI).²⁴ T2DM is a strong predictor of CAD, because in 26% of asymptomatic T2DM patients a silent cardiac ischemia can be detected.²⁵ Besides, diabetes increases mortality risk in ST-Elevation Myocardial Infarction (STEMI) patients. The risk is even more pronounced in insulin-dependent T2DM patients.²⁶

“…by using evidence-based therapies, physicians can improve both glucose control and, importantly, the CV outcome for patients with T2DM at high risk for or with established CVD. Uptake of these therapies in the majority of indicated patients has not yet been realized, despite rigorous evidence from CVOTs and guideline recommendations…”²⁷

One example of such evidence-based therapy is HbA1c monitoring along with Medical Nutrition Therapy (MNT) and other lifestyle changing therapies. Figure 3 below gives a graphical overview of diabetes complications.

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Figure 3: Diabetes complications.²⁸

Various literature suggests a connection between T2DM complications and glycemic control. There are strong regional differences in the prevalence of diabetes complications. For Eastern Europe Litwak (2013) finds especially high rate of macrovascular complications. In this region it is at the level of 72%, which is much higher than the global prevalence of 27%, or the prevalence in China of 21%. Although other studies report 38% level of macrovascular complications in Ukraine.²⁹ A similar picture with microvascular complications. Here again, Eastern Europe has the world highest rate of 89%, while South Asia reports only 39% prevalence of such complications. Likewise, Easter Europe has the prevalence of 83% for neuropathy comparing to 25% in South Asia. These world highest rates of diabetes complications for Eastern Europe, including Ukraine, underline the high impact of diabetes complications on morbidity of diabetics in Ukraine. Figure 4 illustrates the complications in the region to which Ukraine belongs.

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Figure 4: Rates of complications in diabetes mellitus type 2 patients.³⁰

The UK Prospective Diabetes Study (UKPDS 35) found that every 1% reduction in glycated hemoglobin (HbA1c) was associated with a 37% decrease in microvascular disease and a 14% reduction in myocardial infarction.³¹ In this study a patient cohort following the policy of intensive control of blood glucose after diagnosis of T2DM was compared with patient cohort following the conventional treatment. We advocate in this research for Ukraine to establish a quarterly point of care based HbA1c diabetes monitoring and control for non-insulin-dependent T2DM patients. The UKPDS 23 study reported an average HbA1c level of 7.0% in the intervention comparing to 7.9% in the control group over a median 10 years of follow up. This is consistent with the previous comparable prospective studies.³² The study concludes that there is a strong association between the risk of diabetic complications and previous hyperglycaemia.

“Any reduction in HbA1c is likely to reduce the risk of complications, with the lowest risk being in those with HbA1c values in the normal range (<6.0%).”³³

Increased HbA1c monitoring and treatment intensification for T2DM patients leads to improved HbA1c levels.³⁴ Results of a 10-year follow-up study found that people with T2DM, who maintain good glycemic control, experience benefit many years later, including lower rates of MI and diabetes-related death.³⁵ With this large follow-up study the benefits of blood glucose level control were shown to persist for long period of time.

“Our results highlight the added importance of glucose lowering in reducing the risk of coronary events and death from any cause. The findings strengthen the rationale for attaining optimal glycemic control and indicate emergent long-term benefits on cardiovascular risk.”³⁶

2.2 Type 2 diabetes mellitus – a largely preventable disease

There are number of risk factors associated with the development of T2DM. These are obesity, history of gestational diabetes, race/ethnicity, high blood pressure, family history of diabetes, poor nutrition and higher age.

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Figure 5: Risk factors of development of T2DM.³⁷

Ukrainian population gets older due to low birth rate. Besides, obesity rate raises as diets of many poor Ukrainians is not healthy. All these factors contribute to the growth in T2DM prevalence and incidence in Ukraine. Many people remain undiagnosed because there are often few symptoms during the early years of T2DM. Alternatively, the symptoms that do occur may not be recognized as being related to diabetes.³⁸ There is a high proportion of pre-diabetic and undiagnosed diabetic patients.

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Figure 6: Pre-diabetes and undiagnosed diabetes in Ukraine.³⁹

The earlier a person is diagnosed with diabetes, and the earlier the diabetes management is initiated, the better are the chances of preventing harmful and costly complications. Effective approaches are available to prevent T2DM and to prevent the complications and premature death that can result from all types of diabetes. Globally 318 million people are estimated to have impaired glucose tolerance. Among them, in Ukraine, these are 1 million 654 thousand people with impaired glucose tolerance.⁴⁰ Besides, there are 1.2 million people with undiagnosed diabetes in Ukraine.

There are many ways to test for diabetes:

- Oral glucose tolerance test (OGTT) is performed by ingesting a standard dose of glucose by mouth and measuring the blood glucose level two hours later.
- Fasting plasma glucose test (FPG) measures a person’s blood glucose level after fasting or not eating for at least 8 hours.
- Hemoglobin A1c (HbA1c) measures average blood glucose level for the past 3 months.⁴¹

Unless there is a a clear clinical diagnosis (e.g. clear symptoms of hyperglycemia), a second test is required for confirmation. Typically, the same test is required to be repeated to minimize test errors.⁴²

“For example, if the A1C is 7.0% (53 mmol/mol) and a repeat result is 6.8% (51 mmol/mol), the diagnosis of diabetes is confirmed. If two different tests (such as A1C and FPG) are both above the diagnostic threshold, this also confirms the diagnosis. On the other hand, if a patient has discordant results from two different tests, then the test result that is above the diagnostic cut point should be repeated.”⁴³

Although the official criteria for diabetes in HbA1c testing is 6.5%, people with HbA1c levels of 5.7-6.4% are considered as having “pre-diabetes”.⁴⁴ Please note, that as noted earlier, the focus of this research is the most frequent type of diabetes – T2DM. Therefore, measurement of HbA1c is highly relevant, as this is relevant for T2DM. On the contrast, T1DM requires different methods of diagnosis, glucose test in cases of an acute onset with symptoms of hyperglycemia, or a panel of antibodies in other cases.

Once the disease is diagnosed, it is important for diabetics to make sure they meet their glycemic targets to prevent or slow-down development of complications. ADA recommends⁴⁵ to perform HbA1c testing:

- At least two times a year in patients, who are meeting their treatment goals.
- Quarterly, in patients whose therapy has changed, or who are not meating glycemic goals.
- Point-of-care testing for HbA1c is appropriate to ensure timely treatment changes.

Progression to diabetes may be prevented if these individuals were provided with achievable lifestyle intervention. It may take years for the transition from the early metabolic abnormalities that precede diabetes to diabetes itself. These pre-diabetic abnormalities are impaired fasting glucose (IFG) and impaired glucose tolerance (IGT).

IFG is associated with an impaired insulin secretion and impaired suppression of hepatic glucose output, while IGT is associated with muscle insulin resistance and defective insulin secretion. The main difference between IFG and IGT is that in the former the insulin resistance is primarily in the liver, while muscles show normal values of insulin resistance.⁴⁶ In IGT, the insulin resistance in the liver is close to normal, while being abnormally high in the muscles.⁴⁷ Glucose tolerance normally worsens from normal levels to IFG, then from IFG to IGT, and from IGT to T2DM.⁴⁸ Some pre-diabetic people have both abnormalities at the same time. Up to 70% of people with these pre-diabetic abnormalities eventually develop diabetes.⁴⁹ As diabetes develops, the risk of CVD, and other complications related to eyes, kidneys, and nervous system inceases. Duration and level of glycemia influence the development of complications.

The natural history of pre-diabetes (IFG and IGT) is variable, with about 25% progressing to diabetes, 50% remaining in the pre-diabetes stage, and 25% reverting back to normal over the period of 3-5 years.⁵⁰ Annually, around 5-10% of people with pre-diabetes progress to diabetes, while a similar proportion convers back to normoglycaemia.⁵¹ Nevertheless with longer observation time, 70% of people with pre-diabetes develop diabetes. Most likely to progress are older, overweight individuals and those having other risk factors.

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Figure 7: Interpreting measurement values of HbA1c.⁵²

HbA1c is one of the top-ranked parameters, which primary care physicians use⁵³. Majority of newly diagnosed patients have had an undiagnosed diabetes. HbA1c testing provides an opportunity for early intervention to take place before the onset of complications.⁵⁴ HbA1c is a good predictor of an individual’s risk of developing long-term complications of diabetes.⁵⁵ This test needs to be performed at least twice a year in patients with T2DM. It does not require patient to fast prior to the test.

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Figure 8: What is HbA1c.⁵⁶

As described on the Figure 8 above, HbA1c is a composite phenomenon. It consists of a glucose and hemoglobin. Level of glucose fluctuates throughout a day. Hemoglobin cells have 2 to 3 months half-life. Glucose binds to hemoglobin to form HbA1c, which reflects the average glucose over 2 to 3 months and has a strong predictive power for diabetes complications.⁵⁷

HbA1c test is available in public sector, including the hospitals in Ukraine.⁵⁸ Benefits of blood glucose control, particularly early in the disease trajectory, are well documented.⁵⁹ In Ukraine only 33%⁶⁰ (2015-2016) of T2DM patients reached target levels of glycemic control, i.e. HbA1c<7%. In comparison, about 44% (1999-2002) and 57% (2003-2006) of the diabetes in the United States reached HbA1c<7%⁶¹. The role of blood glucose control in preventing the development and progression of complications has been proven both in T1DM and T2DM.⁶² Poor glycemic control is associated with a greater care cost of diabetes and with long-term adverse clinical and economic consequences.⁶³ Poor glycemic control is associated with a greater care cost of diabetes, thus highlighting the importance of achieving target HbA1c values to curtail the economic impact on healthcare resources.⁶⁴

2.3 Diabetes – burden of disease

Diabetes is one of the largest health emergencies of the 21st century, and one of four priority non-communicable diseases targeted for action by world leaders.⁶⁵ The first WHO’s Global Report on Diabetes underscores the enormous scale of the diabetes problem, and also the potential to reverse current trends. The global prevalence of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5%, with a steadily increasing tendency. Moreover, the prevalence of diabetes mellitus continues to increase globally. Nowadays, diabetes mellitus is a growing common chronic disease. This disease adversely affects the lives of millions of individuals around the world. Besides, it is among the major causes of death in most developed countries. The prevalence of both T1DM and T2DM is increasing, despite the fact that many causes of T2DM can be delayed or prevented.⁶⁶

“The International Diabetes Federation (IDF) has estimated the total number of persons with DM across the world will rise from 171 million in 2000 to 366 million by 2030⁶⁷. Unfortunately, the prevalence of DM world-wide has already reached 366 million by 2011.”⁶⁸

In Europe 56 million people are affected by T2DM.⁶⁹ This shows that prevalence of diabetes grows faster than previously expected.

“The other major fear is that there are still about 175 million undiagnosed cases, a mind-boggling number, and who are blissfully unaware that they are progressing towards diabetes-related complications.”⁷⁰

In 2016 annual spend on oral hypoglycemic therapy in Ukraine was $56.1 million. Total annual spend on diabetes in Ukraine is $460 million.⁷¹ Mean diabetes expenditure per person with diabetes in Ukraine was $355.7 in the same year. Most of the countries worldwide spend 5%-20% of their total health expenditure on diabetes. Diabetes causes not only direct losses in terms of money used to diagnose, manage, and treat diabetes and its complications. There is also a significant indirect loss caused by diabetes. The indirect costs of diabetes include increased absenteeism and reduced productivity at work for the employed people. In addition, those not in the labor force might be unable to work as a result of a diabetes-related disability. In addition, early mortality of patients with diabetes also causes indirect economic loss. Total losses in GDP worldwide (2011-2030) will total $1.7 trillion.

Figure 9 below shows that the major component of T2DM-related costs is the cost of drugs and treatment for diabetes complications. Drugs and treatment costs used directly to treat diabetes for T2DM patients comprise only a small part of the total T2DM-related costs, and this part of the costs decreases every year as a percentage of total T2DM-related costs. This shows the importance of T2DM early diagnosis, treatment and prevention to avoid the high costs of T2DM-related complications.

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Figure 9: Majority of T2DM related costs are the costs of complications .⁷²

IDF estimates 415 million adults aged 20-79 with diabetes worldwide, including 193 million people, who are undiagnosed. Further 318 million adults are estimated to have impaired glucose tolerance, which puts them at high risk of developing the disease. If the current trend continues by 2040 IDF estimates 642 million people living with diabetes.⁷³

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Figure 10: Number of diabetics worldwide in different years.⁷⁴

IDF Diabetes Atlas (2015) shows varying diabetes prevalence in different countries worldwide.

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Figure 11: Estimated age-adjusted prevalence of diabetes in adults (20-79), 2015.⁷⁵

As one can see on the map, diabetes prevalence varies between countries from lower than 4% to higher than 12%. In Ukraine, diabetes national prevalence among adults (20-79) was 8.0% in 2015.⁷⁶ Others estimate it to be 8.4%.⁷⁷ This corresponds to 2 million 756 thousand seven hundred adult residents of Ukraine suffering from diabetes. Of them approximately 1 million 196 thousand six hundred people have an undiagnosed diabetes.⁷⁸ People with undiagnosed diabetes will not be taking steps to manage their blood glucose level or lifestyle. This means these people are at higher risk of developing dangerous complications. Indeed, many of the people with undiagnosed diabetes already have complications such as chronic kidney disease, heart failure, retinopathy and neuropathy. Many of such people will find out of their diabetes only once the symptoms of complications occur, they are presented to a general practitioner, a specialist physician or a hospital, and a blood glucose test is ordered on them. In many cases by then diabetes and complications are already at advanced stages.

Various studies estimate the global health spending to treat diabetes and prevent complications was in the range of $673 billion to $1,197 billion in 2015. Based on the cost estimates from a recent systematic review, the direct annual cost of diabetes to the world is more than $827 billion.⁷⁹ IDF estimates that the total global health care spending on diabetes more than tripled over the period 2003 to 2013. By 2040 this spending is expected to grow to $802 billion to $1,452 billion. Generally, health care expenditures for people with diabetes are two- to three-fold higher than for people without diabetes.⁸⁰

In 2015 the average worldwide annual spending on diabetes was $1,622-$2,886 per person.⁸¹ Mean diabetes expenditure per person with diabetes in Ukraine was $781.2 in the same year.⁸² Most of the countries worldwide spend 5%-20% of their total health expenditure on diabetes. DM imposes a large economic burden on national healthcare systems. With such a high cost, the goal to decrease diabetes-related healthcare spending is a significant challenge to the healthcare systems, and an obstacle for sustainable economic development. DM causes direct losses in terms of money used to diagnose, manage, and treat diabetes and its complications.

There is also a significant indirect loss caused by diabetes. Total losses in GDP worldwide (2011-2030) will total $1.7 trillion. This is caused by the increased use of health services, loss of productivity, and the long-term support needed to overcome diabetes related complications, such as kidney failure, blindness and cardiac problems. The majority of countries spend between 5% and 20% of their total health expenditure on diabetes.⁸³

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Figure 12: Mean diabetes-related healthcare expenditure per person with diabetes (20-79 years) (International Dollars⁸⁴ ).⁸⁵

Below is the expected growth in spending to treat diabetes. It is projected to increase by 19% from 2015 till 2040.

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Figure 13: Global health spending to treat diabetes (in billion USD).⁸⁶

Fortunately, there are ways to improve outcomes and reduce costs. The earlier a person is diagnosed, and management is initiated, the better the chances are of preventing harmful and costly complications. Therefore, there is a strong case for screening, early detection and state-of-the-art therapy guidance to improve outcomes and reduce costs. Around 90% of those diagnosed with diabetes have T2DM, which is largely preventable when detected early. Currently, the prevalence of pre-diabetes is approximately 7% worldwide and one in two adults with diabetes is undiagnosed.

Numerous technological and societal trends will contribute to the effort to care for patients with T2DM and prevent its onset in the coming years.⁸⁷ Conversely, some trends will also pose increasing challenges for health care systems in managing patients with T2DM. A higher prevalence of obesity will trigger increasing T2DM incidence rates, especially among socially disadvantaged people. Rising childhood obesity is a matter of concern as it correlates with higher T2DM rates and an early onset of the disease. Fortunately, an increasing number of innovations and trends are emerging to enable and support the prevention and treatment of T2DM. For example, screening of patients with pre-diabetes offers tremendous potential for preventing progression of the disease and the serious complications associated with diabetes. This can be accomplished using various methods, including population health management, big data analytics, artificial intelligence, health economics, and HbA1c testing.

2.4 Diabetes monitoring and treatment

The longer a person lives with undiagnosed and untreated diabetes, the worse his/her outcomes are likely to be.⁸⁸ Current treatment of diabetes does not prevent all complications, but the progress of complications can be slowed down by early intervention.⁸⁹ Therefore easy access to basic diagnostics for diabetes is essential. Diagnosis should be available in primary healthcare setting.⁹⁰ 80% of T2DM can be prevented by simple cost-effective interventions.⁹¹ Studies suggest that screening and management of diabetes should be the role of primary care clinics.⁹² The current guidelines for T2DM monitoring in Germany can be described by the following charts.

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¹ Glycated hemoglobin A1c is a form of hemoglobin that is covalently bound to glucose. It is measured primarily to identify the three-month average plasma glucose concentration and thus can be used as a diagnostic test for diabetes and as an assessment test for glycaemic control in people with diabetes

² Alberti et al., 1997.

³ A hormone produced in pancreas, that regulates blood sugar, or glucose. It does so by transporting glucose from the bloodstream into the body’s cells. In the body’s cells glucose is used to produce energy. In patients with diabetes glucose remains in blood. Over time high levels of glucose in blood damage tissues in the body, leading the development of diabetes complications.

⁴ https://www.hsph.harvard.edu/nutritionsource/diabetes-prevention/preventing-diabetes-full-story/.

⁵ IDF Diabetes Atlas, 2015.

⁶ IDF Diabetes Atlas, 2015.

⁷ IDF Diabetes Atlas, 2015.

⁸ Ministry of Health of Ukraine, 2012.

⁹ American Diabetes Association, 2019; https://www.g-ba.de/downloads/62-492-1273/DMP-A-RL_2016-07-21_iK-2017-01-01.pdf.

¹⁰ Illustration created by my son, Aigar Boltyenkov.

¹¹ IDF Diabetes Atlas 2015.

¹² IDF Diabetes Atlas 2015, page 13.

¹³ IDF Diabetes Atlas 2015.

¹⁴ The World Bank, 2018.

¹⁵ Tuberculosis.

¹⁶ IDF Global Diabetes Plan 2011-2021, p. 7.

¹⁷ World Health Organization Global Report on Diabetes, 2016.

¹⁸ Echouffo-Tcheugui, 2018.

¹⁹ Al Dawish et al., 2016.

²⁰ Gil et al., 2018.

²¹ The World Bank, 2018.

²² The World Bank, 2018.

²³ Cosentino et al., 2018.

²⁴ Upchurch et al., 2012.

²⁵ Zhang et al., 2014.

²⁶ Fröbert et al., 2013.

²⁷ Cosentino et al., 2018, p. 10.

²⁸ Illustration created by my son, Aigar Boltyenkov.

²⁹ The World Bank, 2018.

³⁰ Own illustration using MS PowerPoint based on the data from Litwak et al. 2013. Microvascular complications include damage to eyes (retinopathy) leading to blindness, to kidneys (nephropathy) leading to renal failure and to nerves (neuropathy) leading to impotence and diabetic foot disorders (which include severe infections leading to amputation). Macrovascular complications include cardiovascular diseases such as heart attacks, strokes and insufficiency in blood flow to legs.

³¹ Stratton et al., 2000.

³² Klein, 1995; Pirart, 1978; Adler et al., 1997; UKPDS 23, 1998; Kuusisto et al., 1994; Lehto et al., 1996; Standl et al., 1996; Groeneveld et al., 1999; Uusitupa et al., 1993; Wei et al., 1998; Hanfeld et al., 1996; Knuiman et al., 1992; Sasaki A., 1983.

³³ Stratton et al., 2000.

³⁴ Sussell et al., 2017.

³⁵ Holman et al., 2008.

³⁶ Holman et al., 2008.

³⁷ Illustration created by my son, Aigar Boltyenkov.

³⁸ IDF Diabetes Atlas, 2015.

³⁹ Own illustration using MS PowerPoint, based on IDF Diabetes Atlas, 2015.

⁴⁰ IDF Diabetes Atlas, 2015.

⁴¹ Albers, 2010.

⁴² American Diabetes Association, 2019.

⁴³ American Diabetes Association, 2019.

⁴⁴ American Diabetes Association, 2019.

⁴⁵ American Diabetes Association, 2019.

⁴⁶ DeFronzo, 2011.

⁴⁷ Abdul-Ghani et al., 2006.

⁴⁸ Ferrannini, 2007.

⁴⁹ Nathan et al., 2007.

⁵⁰ Nathan et al., 2007.

⁵¹ Nathan et al., 2007.

⁵² Illustration created by my son, Aigar Boltyenkov.

⁵³ Howick et al., 2014.

⁵⁴ Hng et al., 2016.

⁵⁵ World Health Organization Global Report on Diabetes, 2016.

⁵⁶ Illustration created by my son, Aigar Boltyenkov.

⁵⁷ Albers, 2010.

⁵⁸ World Health Organization Global Report on Diabetes, 2016.

⁵⁹ Bonafede et al., 2016.

⁶⁰ Broz et al., 2016.

⁶¹ Center for Disease Control and Prevention.

⁶² World Health Organization Global Report on Diabetes, 2016.

⁶³ Bonafede et al., 2016.

⁶⁴ Almutairi et al., 2013.

⁶⁵ World Health Organization Global Report on Diabetes, 2016.

⁶⁶ IDF Diabetes Atlas, 2015.

⁶⁷ Wild et al., 2004.

⁶⁸ Al Dawish et al., 2016.

⁶⁹ Nagy et al., 2016.

⁷⁰ Al Dawish et al., 2016.

⁷¹ The World Bank, 2018.

⁷² Figure 4, Page 4 of “innovating diabetes care in Turkey” report https://www.novonordisk.com/content/dam/Denmark/HQ/sustainablebusiness/performance-on-tbl/more-about-how-we-work/Creating%20shared%20value/PDF/blueprint-innovating-diabetes-care-in-turkey-uk.pdf.

⁷³ IDF Diabetes Atlas, 2015.

⁷⁴ Own illustration following IDF Diabetes Atlas (2015), p. 50.

⁷⁵ IDF Diabetes Atlas, 2015, p. 53, map 3.1.

⁷⁶ IDF Diabetes Atlas, 2015.

⁷⁷ The World Bank, 2018.

⁷⁸ IDF Diabetes Atlas, 2015.

⁷⁹ World Health Organization Global Report on Diabetes, 2016.

⁸⁰ IDF Diabetes Atlas, 2015.

⁸¹ IDF Diabetes Atlas, 2015.

⁸² IDF Diabetes Atlas, 2015.

⁸³ IDF Diabetes Atlas, 2015.

⁸⁴ International Dollar is a hypothetical unit of currency adjusted for purchasing power for every country. It is calculated from United States Dollar values adjusting them using the tables of purchasing power parities. For Ukraine $355.7 of actual annual expenditures per person with diabetes corresponds to $781.2 Internation Dollars after purchasing power adjustment.

⁸⁵ IDF Diabetes Atlas, 2015.

⁸⁶ Own illustration following IDF Diabetes Atlas (2015), p. 16.

⁸⁷ Biermann & Lachner, 2016.

⁸⁸ World Health Organization Global Report on Diabetes, 2016.

⁸⁹ World Health Organization Global Report on Diabetes, 2016.

⁹⁰ World Health Organization Global Report on Diabetes, 2016.

⁹¹ IDF Global Diabetes Plan 2011-2021.

⁹² Al-Nozha et al., 2004.

• Grade: N/A
• Author: Artem Boltyenkov (Author)
• Publication Year: 2021
• Pages: 151
• Catalog Number: V1239366
• ISBN (PDF): 9783346658630
• ISBN (Book): 9783346658647
• Language: English
• Tags: Diabetes, healthcare economic policy, cost-effectiveness, budget impact.