Dr Angela Murphy helps us understand the recent changes in the guidelines for treating diabetes.

The purpose of treating diabetes is to improve the symptoms which result from high glucose levels and to prevent other complications in the future. Diabetes is a risk for heart disease, stroke, kidney failure, amputations and loss of vision. In fact, heart disease is the most common complication of diabetes, encompassing angina, heart attack and heart failure.

With good control, these conditions can be avoided. Achieving good control is the challenge for both patient and healthcare provider (HCP). We must never under estimate the benefit of a healthy lifestyle and this is always the building block in any treatment algorithm.

Controlled portions, choice of unrefined carbohydrates and good fats, as well as regular exercise are essential to have a holistic approach to managing diabetes.

When insulin was first discovered in 1922, it seemed the only feasible treatment for diabetes. It remains the cornerstone of treatment for Type 1 diabetes to this day. Although, there have been advances in types of insulin and ways to deliver it.

The initiation of treatment for Type 2 diabetes is generally straightforward in that most patients will be counselled regarding a healthy lifestyle and given metformin. Metformin reduces levels of blood glucose by decreasing the amount of glucose produced by the liver. It also improves the action of insulin, secreted by the pancreas, at the level of the muscle cell.

Many people, particularly those eating and exercising correctly, may control their blood glucose levels on metformin indefinitely. However, if the glucose levels and HbA1c start to rise, further treatment will need to be added.

At this point, the choice of medication becomes quite extensive. The critical question the HCP must now ask is: what is the right medication for the patient in front of me?

What is the right medication for the patient?

There are eight groups of diabetic medications with various types within each group. This means that the possible combinations of drug types and dosages can count into the hundreds. HCPs have for many years looked to clinical practice guidelines to assist in their choice.

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) are sentinel voices in the world of diabetes. Many experts over many years have come together to work out diabetes management guidelines.

Most countries, including South Africa, will consult the content of these guidelines when drawing up local recommendations. In recent years, the experts from ADA and EASD have come together on several occasions to issue a Combined Consensus Statement on the management of Type 2 diabetes. The latest one, published at the end of 2018, suggested some basic changes to our approach of diabetes management.

2018 guidelines

The reason for the new guidelines is that it recognises the excess risk of cardiovascular disease in diabetic patients and takes into consideration the evolution of diabetes drugs, particularly with the advent of the sodium-glucose transport protein 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists.

SGLT2 inhibitors

SGLT2 inhibitors (Forxiga; Jardiance), also known as the gliflozins, act by blocking the re-uptake of glucose that has been filtered through the kidney. This results in excess glucose being excreted in the urine. The advantage of this glucose loss from the body is that this translates into a calorie loss as well which helps with some weight loss in the patient.

As the name of the medication suggests, not only excess glucose but sodium is excreted. The lowering of sodium helps reduce blood pressure and has beneficial effects on the heart.

Jardiance is registered in America for the indication of cardiovascular death reduction in the patient with Type 2 diabetes and previous cardiovascular disease (angina, heart attack, need for stents).

Forxiga has recently been shown to improve heart function in patients with heart failure; in both diabetic and non-diabetic subjects.

GLP-1 receptor agonists

GLP-1 (Byetta; Victoza) is a hormone secreted by the cells in the wall of the small intestine in response to food. The GLP-1 then stimulates the pancreas to secrete insulin and, thus, lowers post-meal glucose levels. The GPL-1 receptor agonist drugs also delay the emptying of the stomach and increase the sense of fullness which results in weight loss.

In addition, Victoza has proven to reduce the risk of a heart attack, stroke or death from these causes in Type 2 diabetic patients who have already had an event. The Federal Drug Agency (FDA) in America have added this benefit to the indications for the use of Victoza.

Cardiac protection changes how Type 2 diabetes patients are managed

The incredible cardiac protection these new medications offer in addition to diabetes control is so important that it has initiated a change in how we mange Type 2 diabetes.

It is crucial that HCPs identify the patients who would benefit from these medications as soon as possible. For this reason, the 2018 guidelines now advise that after initiation of metformin, patients should be divided into two groups.

The first group is those patients with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD); i.e. patients who have already suffered from a heart attack or angina, had coronary stents, a stroke or have chronic decrease in kidney function.

The second big group is the patients who have not had heart or kidney disease to date. The latter group then gets subdivided into three main groups aiming for treatment that addresses a patient’s most pressing concern.

The groups identify those patients struggling with hypoglycaemia (low blood glucose), obesity, and those patients who need to keep costs of treatment down.

It makes sense that those patients with established ASCVD and CKD be given one of the classes of medication which have been proven to protect the heart from further events or a deterioration in heart function. As one would expect with a ‘designer drug’, the cost is significant and reimbursement from medical aids is not guaranteed.

SGLT2 inhibitors and GLP-1 receptor agonists do not cause hypoglycaemia. So, they would be possible choices in patients who need to avoid hypoglycaemia.

Dipeptidyl peptidase-4 inhibitors

Another group of medications, called dipeptidyl peptidase-4 inhibitors, also increase the natural GLP-1 levels and do not cause hypoglycaemia. The class of drugs most effective with weight loss is the GLP-1 receptor agonists, especially Victoza. However, much higher doses need to be used for weight loss management than just for diabetes management. A higher dose pushes up the cost.

South African setting

In South Africa, where most of the diabetes patients receive healthcare from the state and, in the current climate of escalating costs in the private healthcare system, cost effective medicine is essential.

The oldest group of oral medications used in Type 2 diabetes are the sulphonylureas (SUs) which increase insulin secretion from the pancreas.

The South African diabetes guidelines, drawn up by Society of Endocrinology and Metabolism of South Africa (SEMDSA), advocate the use of the newer generation SUs, such as gliclazide MR (Diamicron MR, Diaglucide MR and other generic formulations), as acceptable second-line treatment for Type 2 diabetes.

More than two million South Africans are living with diabetes. To improve their present and future health aiming for good glucose control is important. However, with increasing types of medication available to manage Type 2 diabetes, choosing the right drug for the right patient is becoming ever more important.

The newer agents have made it possible to improve long-term complications from the outset, by mechanisms other than just glucose lowering. It may not be necessary, or possible, for everyone to access these medications at present but the guidelines from both local and international societies will continue to guide the diabetes community to make the correct choice.

Diabetes Awareness in Happy Valley, Port Elizabeth on 30 September 2019

Martin and Elizabeth Prinsloo were invited to attend  a gathering of more than 100 senior citizens who were treated by the South African National Zakah Fund to an outing in our beautiful Happy Valley to enjoy the fresh air and the beauty of nature and, at the same, be encouraged and informed about living a healthy and happy lifestyle. Many of those who attended either had diabetes or had a friend or family member with diabetes. Some refreshing Spring showers greeted us early the morning, but the sun soon appeared to brighten the day. Soraya Boomgaard, a fitness coach, who is associated with our Springdale Diabetes Wellness Group demonstrated easy exercises everyone can do and then invited the more active people present to join her on the lawns for some fun exercises.

Did you know the earliest changes in the body caused by diabetes can be seen in the eye? Dr Stephen Cook advocates early screening of diabetic retinopathy.

Diabetes epidemic

According to reports on World Diabetes Day 2018, about 3,5 million South Africans suffer from diabetes, and a further 5 million are estimated to have pre-diabetes.

The diabetic epidemic presents a massive burden to healthcare services. Type 2 diabetes mellitus is said to be the fastest growing chronic disease in the world. South Africa, in particular, is badly affected.

South Africa faces a plethora of healthcare needs, and specialist services are few and far between. More so in the field of preventable blindness. According to Orbis Africa, there are only six ophthalmologists for every million South Africans.

One of the biggest challenges currently facing South Africa is the diabetic epidemic. Examination of the eye can provide important information regarding the state of health of the nerves and small vessels of the body. These changes can be observed in the retina of the eye. The changes are referred to as diabetic retinopathy.

Diabetic retinopathy

Diabetic retinopathy (DR) refers to damage and loss of function of the retina (back of the eye) due to uncontrolled diabetes, and without a healthy, functioning retina, the eye cannot see.

Having uncontrolled elevated blood glucose levels causes the blood vessels in the retina to ‘leak’ or close off, leading to damage, which, in some cases, can be permanent.

When diabetic retinopathy is detected the person is said to be retinopathy positive. This status provides extremely important information regarding the risk of future events, particularly heart attack.

Determining the person’s retinopathy status is the most important part of screening, as this provides the person and their healthcare team with their “score” in the struggle against the disease.

Screen for Life

The Ophthalmological Society of South Africa (OSSA) has developed a diabetic retinal screening programme, called Screen for Life (S4L). The programme aims to raise awareness and expand screening capacity.

The S4L programme trains optometrists and interested GPs in retinal screening. In addition, artificial intelligence (AI) software is also proving beneficial in some centres.

Screen for Life has several components, including the patient-held record, quality assurance and suggested management plans. A basic screening for diabetic retinopathy entails having a retinal photograph taken with a fundus camera. It is quick and painless. This photograph is then graded by an accredited grader who makes a recommendation on further management.

Every person living with diabetes needs to know their retinopathy status. This informs them, their family and carers, as to their risk of serious systemic illness, such as heart attack and stroke. The earliest changes in the body caused by diabetes can be seen in the eye.

The OSSA diabetic retinopathy screening programme has been developed to get the most out of every screening opportunity. The programme follows the outline of the Scottish (NHS) diabetic retinopathy screening system.

This system has a track record of being evidence-based and cost-effective. In addition, our programme incorporates innovative risk calculation and co-screening for glaucoma.

Apples and red flag communication

Screen for Life uses the #redflag communication strategy. The patient held record is used to document the communication. Apples and red flags are used as images to convey the communication.

There are three distinct prompt points that help motivate for lifestyle changes. Lifestyle changes, particularly diet, exercise and stopping smoking can prevent suffering and save lives. The first prompt is communicating the diabetic status.

Retinopathy negative persons are congratulated and an apple sticker given or drawn onto the record. They are encouraged to stay negative to keep the apple.

Retinopathy positive persons receive a red flag indicating increased risk of systemic complications, particularly heart attack. They are encouraged to make changes to reverse the disease process. A follow-up appointment is set up to establish the trend of change.

Progression shows that whatever steps have been taken, have not been enough to stabilise the disease. This prompts a second red flag communication.

Where sight-threatening diabetic retinopathy or other disease (glaucoma, age-related macular degeneration, etc.) is detected, a third red flag is given and the person is referred to an ophthalmologist.

The patient-held record serves as a score card which helps practitioners know which stage of disease their patients are at. The programme uses a quality assurance and education system for graders.

Use of AI

The system is also artificial intelligence (AI) ready. AI is an enabling technology. In the short-term, this will enable safer high-quality, high volume grading.

In the long-term, AI is expected to provide powerful predictive information regarding other conditions, such as cardiovascular and dementia risk.

Challenges facing SA

I am extremely concerned that in general, medical doctors are not using diabetic retinopathy screening to modify the medical management of our patients.

We are failing to provide DR screening as part of our primary healthcare. This means that valuable medical information regarding the current micro-vascular state and future risk is not being taken into consideration.

People living with diabetes are unaware of their retinopathy status. Our experience is, sadly, that by the time the person consults a doctor for decreased vision, the eye disease is already advanced.

Awareness of the need for screening is the main problem. Communication about the significance of any retinopathy is the second, and a lack of access to fundus cameras is the third problem.

The threat of blindness, heart attack, stroke and other end-organ failures help motivate for better lifestyle choices to control and manage the disease.

Research has shown that diabetic retinopathy is a powerful indicator of the future risk of these things happening. The complexity of the disease and the socio-economic situation of the person living with diabetes make it very difficult to make changes. Communication needs to be supportive and ongoing if it is to contribute positively to making changes last.

End-organ failure causing blindness

Ophthalmology is a specialist field. As such, it is easy to feel overwhelmed by the scale of the disease and isolate our inputs to managing the current tsunami of end-organ failure causing blindness.

In doing this, we may be ignoring the opportunity to contribute to the primary care of people living with diabetes. Diabetic retinopathy may be the first sign of diabetic disease. This may predate the onset of end-organ failure by many years.

Lifestyle changes early in the disease process have powerful and long-lasting beneficial effects. Our communicating the significance of the discovery of any retinopathy early in the disease may just provide the necessary prompt for someone to change on time to prevent suffering and loss of life.

Better control of risk factors is the best means of preventing end-organ failure. Diabetic Retinopathy is an important biomarker for the systemic disease burden.

For more information, visit www.screenforlife.co.za