Preventative Heart Rhythm Monitoring for Diabetics

The incidence of diabetes mellitus is increasing rapidly. Diabetes is the leading cause of heart diseases and complications, as well as one of the strongest and independent risk factor for cardiovascular morbidity and mortality (Koektuerk, Aksoy, Horlitz, Bozdag-Turan & Turan, 2016). Moreover, diabetes is associated with heart rhythm disorders such as the two most common form of arrhythmias- atrial fibrillation (AF) and ventricular arrhythmias (VA). According to a meta-analysis published by Huxley, Filion, Konety & Alonso (2011), patients with diabetes have a 40% greater risk of developing atrial fibrillation compared to patients without diabetes. More studies have established that diabetes is a dominant and independent risk factor for the development of atrial fibrillation. Diabetes is a common risk for coronary artery disease which can lead to myocardial infraction, as well as ventricular arrhythmias-an arrhythmia that occurs in the lower chambers of the heart (Daubert, 2008).

The risk for irregular heartbeats rises even higher in people who have diabetes and uncontrolled blood sugar levels. Hyperglycaemia (raised blood sugar), Insulin resistance, glucose fluctuations and the cellular shift among the people with diabetes carry a high risk for development of cardiovascular risk factors such as hypertension, lipid disorders and the activation of coagulation. As a consequence, mortality from heart rhythm disorders is higher in individuals with diabetes. The extensive fibrosis in the atrial tissue is the anatomical hallmark of atrial fibrillation, and as the fibrosis expands and develops, it is more likely that the AF transforms into permanent arrhythmic condition (Corradi, 2014). Diabetes-related to atrial fibrosis has the potential role in starting AF. Moreover, the relationship between diabetes and ventricular arrhythmias is often based on the extent of coronary artery disease and glucose fluctuations among the people with diabetes.

For 2017, the International Diabetes Federation, estimates the total number of adult diabetics (aged between 20 and 79 years) globally at approximately 425 million (8.8%) ("International Diabetes Federation - What is diabetes", 2017). This figure is expected to rise to 629 million (9.9%) by the year 2045. The proportion of individuals with type 2 diabetes is increasing in most nations, and 79 percent of the adults with diabetes live in low-and-middle-income and developing countries. The highest number of people with diabetes are between 40 and 59 years of age, with 212 million (1 in 2) people with diabetes undiagnosed.

Moreover, diabetes caused 4 million deaths and at least $727 billion in health expenditure in the year 2017. More than 1,106,500 children are currently living with type 1 diabetes with a further 352 million people at a higher risk of developing diabetes. Individuals with diabetes have an increased risk of developing several serious health problems. High blood glucose levels can lead to serious heart complications with diabetes being the leading cause of cardiovascular diseases such as coronary disease, atrial fibrillation, and stroke. Over time, diabetes can damage the heart, blood vessels, eyes, kidneys and the nerves. With the increasing hospitalization and healthcare costs, diabetes has both economic and social burden to many families and nations at large.

Diabetes Mellitus affects many individuals globally, and the Type 2 diabetes is a leading cause of morbidity and mortality. Like most nations in Asia, the economic development in Malaysia has fuelled an increase in diabetes, which is related to lifestyle and diet. In the year 2015, approximately 3.5 million adults in Malaysia had diabetes, and it is fair to assume that the number has since increased tremendously. According to the National Health and Morbidity Surveys, the prevalence of diabetes has been rising from 11.6% in 2006 to 15.2% in 2011 in Malaysia, and further to 17.5% in 2015. In the meantime, based on the International Diabetes Federation Diabetes Atlas 2015, Malaysia had the highest prevalence of Type 2 Diabetes Mellitus at 16.6% in the Western-Pacific region. This was higher than neighbouring countries such as Philippines (6.1%), Indonesia (6.2%), Thailand (8.0%) and Singapore (12.8%); this is due to the migration, urbanization, and mechanization and economic development in Malaysia.

Atrial Fibrillation is the most common arrhythmia in clinical practice resulting in significant cardiovascular morbidity and mortality (Ball, Carrington, McMurray & Stewart, 2013). The risk of developing atrial fibrillation and other critical arrhythmias increases with age, diabetes, high blood pressure and other heart diseases such as coronary artery disease. One of the main complications of AF is a stroke. People with atrial fibrillation have a risk of stroke that is three to five times greater than those without the arrhythmia. More than 750,000 hospitalizations occur each year because of AFib, and the condition contributes to an estimated 130,000 deaths each year.

Atrial Fibrillation and ventricular arrhythmia exact a significant clinical burden to the health care system and policies. For example, AF is an independent predictor of mortality and is associated with more deaths, independent of other risk factors. Atrial Fibrillation costs the United States approximately $6 billion annually, with the medical costs for people who have the condition being $8,705 higher per year than those who do not have AFib. The number of patients with Atrial Fibrillation in 2030 in Europe is estimated to be 14-17 million. AF increases the development of heart failure and adversely affects the quality of life, including cognitive function.

Atrial fibrillation-related stroke impairs the survivors’ quality of life more than non-AF-related stroke. The permanent disability and other consequences of AF-related stroke place a heavy burden on the family members and caregivers, as well as health and social services. The healthcare cost associated with these arrhythmias is very high. The survivors of AF-related strokes have described their subsequent life as a fate worse than death (Daniel, Wolfe, Busch & McKevitt, 2009). Moreover, atrial fibrillation increases the risk of medical complications. Compared to those without AF, patients with AF suffer more frequently from pneumonia and pulmonary oedema (accumulation of fluid in the lungs).

The economic and social burden of atrial fibrillation and other arrhythmia are substantial because of high rates of hospitalization and additional health resource utilization. Hypertension, coronary heart disease, and systolic heart failure are the most critical risk factors for AF (Sanoski, 2009). Ischemic stroke is the most devastating complication of AF. Risk factors for stroke in patients with AF include recent congestive heart failure, hypertension, advanced age, diabetes mellitus, and a history of stroke or transient ischemic attack (Gladstone et al., 2008).

Self-monitoring of blood glucose (SMBG) is a crucial component of diabetes management; it provides information about current glycemic status-which is necessary to trigger immediate treatment adjustments to improve glucose control (Virdi, Daskiran, Nigam, Kozma & Raja, 2012). Its integration into daily practice has represented a significant step forward in diabetes care, since it helps to optimize treatment outcomes and promotes the active participation of patients in the control and treatment of their disease, the development of self-confidence, and motivation (Fisher et al., 2012).

However, self-monitoring blood glucose is under-utilized by patients and physicians within the Asia-Pacific region. This is because of barriers such as the cost of monitoring supplies, lack of diabetes self-management skills and concerns about the reliability of blood glucose readings (Chowdhury, Ji, Suwanwalaikorn, Yu & Tan, 2015). The prevailing practice of self-monitoring of blood glucose (SMBG) is low in the Asia region primarily because of lack of education and motivation. The most used SMBG devices globally include Glucose test strips, Glucose Meter, and lancets. North America has the most substantial number of people practicing SMBG while Asia Pacific is the fastest growing region with regards to the number of individuals who use SMBG. The uptake of SMBG still remains low in low-income and developing countries, including Malaysia. In Malaysia, only 6.9% and 26.8% of people with diabetes in private clinics and public hospitals, respectively practiced SMBG in the year 2010. (Kirk & Stegner, 2010). Despite SMBG being highly recommended in people with diabetes using insulin, its utilization remains low. Two Australian studies reported that 88.4% and 81.7% of those with diabetes using insulin practiced SMBG (Chubb, Van Minnen, Davis, Bruce & Davis, 2011). Such high prevalence of SMBG use may be attributed to the subsidies for test strips provided by the federal government. However, in high income nations few people utilize SMBG because they prefer visiting the hospitals or clinics.

The weaknesses of self-monitoring of glucose are mainly seen when only Blood Glucose levels alone is measured without other health vital signs. As Diabetic patients over a period of time tend to have more number of health vital signs like Heart rate, Heart Rhythm being affected as highlighted earlier, you need to visit the hospital or clinics for further and more elaborate testing. Medical professionals need to step in and conduct their tests. Therefore, individuals are encouraged to visit hospitals for further tests periodically. While SMBG is useful for measuring blood glucose levels only, for the patients who do not regularly check other health vital signs, SMBG does not enable them to manage blood glucose levels or capture marked and sustained hyperglycaemic excursions effectively (Walker, Fonda, Salkind & Vigersky, 2012). SMBG conducted in an unstructured manner is of limited value and can be a waste of money (Owens & Speight, 2007).

For tracking Heart Rhythm and its variations due to atrial fibrillation, though Regular 12-lead ECG tests can be used but it could be challenging as it needs trained technicians / cardiologists to interpret and the 12-lead ECG do not one hundred percent qualify as the precise, validated and suitable screening test to determine atrial fibrillation. The 12-lead devices have limitations in the acute evaluation of chest pains associated with heart attacks at random or outside test labs. These devices could sometimes miss many real ischemic events, (Misra, 2013).

The widespread use the glucometer could be as a result of the increase in diabetic population. There is a close relationship between diabetes and AF. Prolonged or chronic diabetes increases higher the chances of an individual developing critical arrhythmias. Diabetes Mellitus increases the risk of atrial fibrillation, and it is not the other way around. Even with the increasing number of diabetic cases in South-East Asia, the availability of cardiologists and certified cardiology technicians is still low.

The signals from the portable single lead ECG devices would require a trained cardiologist or technician for interpretations. It is possible get the signals generated by the wearable devices using mobile app. The resulting several episodes of ECG signal data need to be inspected beat by beat for any indications of problematic arrhythmias. Unlike the glucometer that provides instant blood glucose reading, the signals from the wearable or portable single lead ECG requires precise, accurate and professional analysis by the cardiologists to determine any symptoms of AF. The signal generated by these wearable devices are used by the cardiologists to extract vital characteristics, information or symptoms regarding AF or other critical arrhythmias.

When the wearable devices are paired to a smart phone with an artificial intelligence-based app, they can detect severe and often symptomless heart arrhythmias including atrial fibrillation. This combination provides much more accuracy. Citta.AI based models developed based on Multi-layered neural networks and Deep Learning identifies 92.9% of patients with AF, while the remaining 7.1% of the times correctly identified for irregular rhythm (which is a pre-condition for AFib) with abnormal conditions. Atrial Fibrillation and Diabetes Mellitus have globally become a burden to most countries and their health care systems, as most patients remain symptomless and undiagnosed, thus leading to the raised mortality rate throughout the world. The AI-based diagnosis is a breakthrough in the health industry since it allows self-care thus leading to early detection of the cardiac disease and improving the quality of life thereby decreasing the overall burden on healthcare cost.
AI-based AF or other critical arrhythmias diagnosis can detect severe and often symptomless heart arrhythmia, atrial fibrillation and this can help the people with diabetes determine if they are at risk of developing AF. AI-based AF diagnosis presents an innovative opportunity to monitor, capture and prompt medical treatment for atrial fibrillation without any active effort from the diabetic patients. While AI- based Afib diagnosis technology screening has the potential to successfully screen diabetics- who are at an increased risk and thus lowers the number of undiagnosed cases of AF. If people with diabetes are to provide these AI-based interpretations to Cardiologists or certified cardiology technician, this will significantly increase their diagnostic accuracy and productivity as they are not only short supply but also overworked thereby reducing the cost associated with diabetes and AF.

Diabetic individuals are likely to have ongoing medical costs because of the regular visits with their diabetes care team, prescription medications, and testing supplies (Rapp, 2017). It cost $10, 000 or more per person to treat someone with diabetes than someone who does not have the chronic disease (Japsen, 2015). This is a great burden to both the insurance companies and the insured. The health insurance companies have much higher claims and the risks of diabetics with stroke is higher for the insurers.
With the high costs involved in managing diabetes, the health insurances should consider focusing on or extending subsidies for self-monitoring blood glucose and rhythm monitoring in order to lower the costs. As mentioned, diabetes self-management for Prolonged or chronic diabetic patients alone can be very expensive if they are not monitored for their heart rhythm and other underlying cardiac symptoms like Atrial fibrillation etc. It would be a relief for the health providers if the insurance companies extended the subsidies for heart rhythm monitoring. This move would reduce the burden on the lack of beds, limited resources and the shortages of healthcare professionals.