Preventative foot care for people living with diabetes

Riaan Knight, a medical orthotist and prosthetist, explains why preventative foot care is so important for people living with diabetes.


Father’s loss of limb directs choice of career

As a medical orthotist and prosthetist, I frequently deal with the debilitating effects of foot ulcers and amputation caused by vascular disease. Sadly, in my practise, vascular disease is almost always directly linked to diabetes.

Speaking from personal experience, I can’t emphasise enough the importance of diabetic foot care. As a young man, I had to watch my dad, who was diabetic, deal with the devastating effects of a recurring foot ulcer.

At first, he lost his mobility, he had to walk with crutches. Later, he lost his ability to drive a vehicle and then eventually, as to stop infection from spreading, he had to undergo an amputation of his left lower limb.

Although the medical aspect was dealt with successfully, he now faced a new dilemma, he used up all available sick leave and had to deal with the loss of his income.

On the upside, his successful rehabilitation with a prosthetic limb left a huge impression on me. I immediately knew I wanted to study medical orthotics and prosthetics.

It was during my studies that I realised to my dismay that if only the medical team followed proper orthotic management protocols, he may have never had re-ulceration or limb amputation. Research proved the effectiveness of foot orthotic treatment to assist in recurring foot ulcers.

I have often asked myself could we have cured his foot ulcer? Could we have prevented the amputation of his limb? What I do know is that foot orthotic studies confirm positive results.

Study with astounding results

A well-known study, done on the effectiveness of orthotic treatment in patients with recurrent diabetic foot ulcers, by Fernandez ML, Et al, published in the American Journal of Podiatric Medicine showed astounding results:

  • “Before foot orthotic treatment, the re-ulceration rate in diabetic patients was 79% and the amputation rate was 54%. Two years after the start of orthotic therapy, the re-ulceration rate was 15% and the amputation rate was 6%.
  • Orthotic therapy reduced peak plantar pressures in patients with re-ulcerations and in those without.
  • Sick leave was reduced from 100% to 26%.”

The results are staggering. Yet, sadly the incidence of pressure ulcers in the diabetic community remains high and may very well increase.

Diabetes on the rise

The World Health Organisation (WHO) has predicted that there will be 380 million diagnosed diabetic patients worldwide by 2025. They further determined that Africa will face the second highest increase in prevalence of the disease.

A research study by the Non-Communicable Diseases Research Unit, based at Tygerberg Hospital, confirmed this “increase” prediction for South Africa. Their research found an above normal increase in persons diagnosed with diabetes in SA.

In fact, they state that the prevalence of diabetes increased amongst the female population from 8 to 14% and amongst male population from 5 to 10% for the period between 1980 and 2014.

Risk for foot ulcers

WHO further state that the lifetime risk for foot ulcers in people with diabetes is estimated to be as high as between 15 and 25%. Research further showed that 85% of all amputations done in diabetics are preceded by ulceration.

The at-risk diabetic would need to take cognisance of the fact that due to insufficient vascularity and neural dysfunction associated with diabetic neuropathy, he/she will always be at risk of developing a plantar foot ulcer. Preventative action should be high priority.

Preventative plantar pressure screening is essential

Unfortunately, an aspect that can greatly assist with the early detection of possible ulcer prone areas of the diabetic neuropathic foot has been ignored to a fair extend. Preventative plantar pressure screening is essential. Stop the ulcer before such can develop.

I am obviously aware of all other avenues of diabetic screening and complication prevention protocols. But, I do feel that it’s of paramount importance that diabetic foot care screening via specialised medical plantar pressure devices are developed and implemented in addition to those throughout South Africa.

Although such medical devices are available in the private sector, only a small handful is available to state patients. The conundrum is to convince government to invest in such fairly-expensive systems.

However, the money saved in long-term (unnecessarily used to fund wound treatment and limb prosthetics) would be astronomical and will far outweigh the initial set up cost.

Studies prove effectiveness of these systems

The effectiveness of these systems has been proved in many a medical research study. A study, by Joslin Beth Israel, Et al, at the Deaconess Foot Centre, Harvard Medical School, concluded that both the rearfoot and forefoot pressures are increased in the diabetic neuropathic foot, indicating an imbalance in pressure distribution with increasing degrees of neuropathy. The later stages of peripheral neuropathy play an important role in the aetiology of diabetic foot ulceration.

Another study, by the Department of Internal Medicine, Academic Medical Centre, University of Amsterdam, showed that claw/hammer toe deformity is associated with elevated plantar pressures at the metatarsal heads in neuropathic diabetic patients. This condition increases the risk for plantar ulceration.

The fact remains that even healthy tissue placed under abnormal pressure over a prolonged period will break down and ulcerate. Unfortunately, in the case of diabetic patients even more so.

How does a plantar pressure device work?

Planter pressure devices can predict areas of abnormal pressures by measuring pressure over time and relating such to normative values from healthy individuals.

Another plus point is the ability of specialised integrated software as to recommend areas and percentage of correction to be applied via a suitable foot orthotic.

I strongly advise all high-risk diabetics to seek referral from their diabetologist (or medical doctor) to undergo such preventative foot care (preventative plantar measurement) screening on an ongoing basis. Prevention is better than the cure.

MEET OUR EXPERT


Riaan Knight is a medical orthotist and prosthetist based in Port Elizabeth. He has been in private practise since 1994. He served as Chairperson to the South African Orthotic and Prosthetic Association for 10 years and is regarded as the forefather of plantar pressure measurement devices in SA. Riaan was the first person (2003) to import and train local orthotists on the use and advantages of plantar pressure measurement devices in SA.


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How to recover from an injury if you have diabetes

Saadia Jantjes shares advice to help you recover from an injury if you have diabetes.


Leading a healthy and active life is an essential aspect of managing diabetes. When a body injury occurs, it often presents challenges in maintaining fitness, preventing weight gain and could potentially have negative effects both physically and mentally. Recovering from an injury is tough, and even more so for someone living with diabetes.

When it comes to recovering from an injury while managing diabetes, you could be faced with thoughts and fears of gaining fat, losing muscle and how to adjust insulin doses now that you are relatively less active.

Being immobile increases the rate of muscle loss, thus making you more sensitive to insulin.

So, how do you manage an injury while still managing your diabetes?

Check your glucose levels

Often. Because most injuries require a period of rest and recovery, if you are injured and you were particularly active and fit, you will now face a period of relative inactivity.

You’ll need to check and test your glucose levels as often as you can to gain as much information as possible to understand how your body is reacting to a significant lack of exercise or movement.

Once you have collected this information, it’ll make it easier to see when and how you would need to adjust your insulin doses.

When you have recovered from your injury, the same strict management and regular testing will gradually get you back to your pre-injury fitness level without experiencing phases of hypoglycaemia.

Nutrition

Nutrition will become a key element in both diabetes and injury management. Now that your energy expenditure is relatively less due to being injured, you can’t expect to continue eating the same way without an effect on weight and blood glucose levels.

With a decreased energy expenditure, comes a decrease in caloric intake. Depending on the period of recovery and absolute rest, you will have to adjust your calorie intake.

A calorie and carb tracking app, like MyFitnessPal, will help you keep track of your daily consumption in relation to your activity levels.

Protein is a vital macronutrient when recovering from an injury, as are vitamins A, C and D, calcium and zinc.

Adopting a well-balanced diet of wholesome foods can meet your injury management needs as well as your diabetes needs.

Consult your dietitian if you are struggling to manage your blood glucose levels or start to experience weight gain after facing an injury.

Positive and optimistic

Staying positive and optimistic while recovering from an injury is challenging. Especially if it means forfeiting a race, competition or a goal which you had been working towards.

Keep motivated by putting as much effort into your rehabilitation and recovery as you would have if you were indeed training for that 10km race.

Have a solid support structure in your family, friends and those involved in your rehab, like your physiotherapist, biokineticist or trainer. Make sure these people are aware of your goals so that they are implemented into your recovery programme.

Alternate activities

Find alternate activities to keep your fitness levels up. Continuing to exercise while you have an injury ultimately depends on the severity of the injury as well as the location of the injury.

For example, if you have a broken wrist, you could still walk, do aqua aerobics or resistance training, or spinning. However, if you are recovering from a back operation, your activity options are significantly less and could be limited to only walking for a few minutes at a time.

Again, consult your healthcare professionals, like the operating surgeon or a physiotherapist, if you are worried that you’ll be causing more harm than good by doing some exercise.

Recovering from an injury is always a setback, both mentally and physically. Be patient. Allow your body to heal through rest and recovery, while still maintaining a positive outlook to your daily activities, and you’ll be back to your best in no time.

MEET OUR EXPERT


Saadia Kirsten Jantjes is a physiotherapist with a passion for health and wellness. With a second degree in Sport Science, exercise is one of her favourite rehabilitation tools, to not only rehab injuries but prevent injuries too. Saadia has her own private practice in Morningside, Johannesburg, while working at a Sub-Acute Clinic and furthering her studies in Pilates.


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Baqsimi – a nasal glucagon

Dr Louise Johnson explains why it’s good news that a nasal glucagon, sold under the name Baqsimi, was approved in July by the US FDA. The bad news is that it will be some time before it is available in South Africa. 


Baqsimi, manufactured by Eli Lilly, is the first nasal glucagon approved for the emergency treatment of severe hypoglycaemia that can be administered without an injection.

The risk of hypoglycaemia

Millions of people living with diabetes are on insulin to control their blood glucose levels and to prevent long-term complications of diabetes.

Insulin can cause hypoglycaemia (low blood glucose), potentially severe and even life-threatening complications that burdens insulin users each day1.

The risk is relevant to all Type 1 diabetes patients and 30% of Type 2 diabetes patients receiving insulin treatment.

Severe hypoglycaemia is defined as an episode of low blood glucose, wherein a person with diabetes requires assistance from a third party to treat the episode.

In the T1D Exchange Patient Registry, it was indicated that this occurs more frequently than previously thought2.

The fear of another hypoglycaemic episode often leads to reduced glucose control to allow glucose to remain higher than desired. This increases the risk of both microvascular and macrovascular complications3.

It’s acknowledged that, if it was not for the fear of hypoglycaemia, people with diabetes could have normal to near normal glucose levels and avoid the complications of hyperglycaemia (high blood glucose).

Challenges with management of severe hypoglycaemia

Glucagon hypo kit

Glucagon is the treatment of choice in severe hypoglycaemia. It is very unstable in the liquid form and is therefore available in a hypo kit.

This kit consists of a pre-filled liquid syringe and a vial of dry powder. It must be mixed by the third party who then administers the treatment during an episode of severe hypoglycaemia.

It can be very daunting for the third party, usually a non-medical person, to observe the person with diabetes having hypoglycaemic seizure or being in a hypoglycaemic coma.

Study

In a study, in which parents of children with Type 1 diabetes used a glucagon hypo kit in a simulated emergency hypoglycaemia, it showed that the parent took between two minutes and 12 minutes to get the solution ready and inject it into a piece of meat (to simulate a thigh muscle).

The study consisted of 136 parents who were all trained before the study. The data shows that despite the training, 69% of the parents had trouble with the hypo kit.

These were all handling difficulties, such as opening the pack, removing of the needle sheath, mixing the ingredients and bending needles4.

The great concern in this study was that 6% aborted the injection entirely and 4% injected only air or water from the prefilled syringe.

This data clearly indicates the need for a better, safer and easier way of giving glucagon in an emergency.

A unique and critical aspect of glucagon use is the intended user. Unlike insulin, a third party gives glucagon. This is the co-worker, teacher, friend, child, sport coach, etc. This is almost never a trained medical professional.

The previous study clearly shows that this leads to suboptimal use of otherwise effective medication, delays in treatment and costly use of emergency services and hospitalisation.

Nasal glucagon

In 1983, it was shown that glucagon administered with a carrier drug, such as sodium glycocholate, could raise blood glucose levels when administered as intranasal drops.

Despite promising data, research into nasal glucagon was minimal. Reasons are debatable. Some of the reasons given are the fact that the market is very small for this drug and new promising drugs, such as the SGLT2 inhibitors, came onto the market and many more.

In recent years though, there was renewed interest to address the unmet need for a glucagon delivery system that is easy for healthcare providers to teach and easy for caregivers and third parties to administer.

Introducing Baqsimi

Baqsimi is a dry powder glucagon formulation in a compact, highly portable, single-use nasal powder dosing device that allows for a single-step nasal administration.

The caregiver simple inserts the device into the nasal opening and fully depresses the plunger. This gently expels the powder into the nasal cavity.

The product has been designed that no breathing is necessary as it is absorbed from the nasal mucosa. The dosage is a fixed 3mg dosage for all people with diabetes from four years of age.

What are the side effects of Baqsimi?

  • Nasal irritation (runny nose, congestion, sneezing, cough, nasal bleed) – 12,4% people experienced these side effects. The nasal irritation in injectable glucagon was only 1,3%.
  • Nausea (26%), headache (18%), vomiting (15%). These last three side effects were also experienced in intramuscular injected glucagon preparations in 33,8%, 9,3%, and 13,9%.

Warnings and precautions

Intranasal glucagon should not be used in persons with hypoglycaemia of chronic nature due to starvation; low adrenal gland functioning (Addison’s disease); insulinoma (tumour of pancreas) or pheochromocytoma (tumour of adrenal gland tissue (which produces catecholamine and where glucagon can cause a dangerously high blood pressure)).

Previously allergic reaction to glucagon with injectable form should be avoided.

It also carries a warning that it should not be used in those that have been fasting for long periods. The reason for this is that it causes low levels of reusable glucose in the liver.

Drug interaction

Patients taking beta-blockers may have a transient increase in blood pressure and pulse rate when given nasal glucagon.

Patients taking indomethacin may have no response to nasal glucagon, or even lower glucose. In such situations, per mouth or IV or IM glucose should be given5.

In conclusion, we can at long last be excited about an easy-to-administer drug for people with diabetes on insulin that should need this in a hypoglycaemic emergency. It will, however, still take some time to arrive in South Africa.


References:

  1. Pontiroli A.E. “Intranasal glucagon: A promising approach for treatment of severe hypoglycaemia.”Journal of Diabetes Science and Technology,2015 :vol9(1) p38-43
  2. Beck R. et. al. ‘The T1D Exchange Clinic. Registry.’ J Clin endocrinol Metab ,2012;97 p4383-4389
  3. Cryer P. ‘Hypoglycemia in diabetes: Pathophysiology, Prevalence and Prevention. 2nd Alexandria V.A.: American Diabetes Association,2012
  4. Harris G et.al. ‘Glucagon administration –underevaluated and undertaught.’ Practical Diabetes Int 2001:18;22-25
  5. (GN HCP ISI 24Jul 2019 (Eli Lilly Baqsimi package insert)
Dr Louise Loot

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Dr Louise Johnson is a specialist physician passionate about diabetes and endocrinology. She enjoys helping people with diabetes live a full life with optimal quality. She is based in Pretoria in private practice.


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(Cost) effective blood glucose monitoring

Kevin Stead explains (cost) effective blood glucose monitoring.


With the rising cost of living in South Africa, it is imperative that we realise value in every rand spent. Especially when it comes to treatment and control of diabetes.

This becomes clear when reviewing the cost of healthy living and medication. It’s therefore important to understand why it is so essential to know and understand blood glucose control and why monitoring is so crucial to reduce cost, as well as prevent complications.

The situation in South Africa

Seven percent of South Africans, between the ages of 21 and 79, have diabetes. This means that 3,85 million South Africans in this age group may have diabetes.

The prevalence of diabetes in South Africa, in 2010, was estimated at 4,5% – a 155% increase in six years. The International Diabetes Federation (IDF) Diabetes Atlas indicates that the uncertainty range is between 3,6 and 14%. Data suggests that 630 000 to 2, 394 million people are undiagnosed in South Africa.

Financial implications

Cost per person per annum was approximately R5 000 in 2010 and R26 743,69 in 2015.

Sixty to 80% of people with diabetes in South Africa die before the age of 60 (loss of manpower).

The World Bank suggests that no more than 5% of a country’s gross domestic profit should be spent on health. In South Africa, 8,9% GDP is spent on health.

What is the solution?

What of glycaemic control? Complications? Education? Dr Shaukat Sadiko, IDF president, said, “Big talk and quoting statistics have little value if we do not do initiatives which improve the lives of all our people with diabetes.”

Testing in pairs

The average cost of a glucose strip is R3,76 (R188 medical aid reimbursement rate). So, testing can be expensive and seemingly worthless, especially in people living with diabetes who don’t understand how to use the information from their meter to control their glucose levels.

For example: A Type 2 diabetes patient will test their glucose level in the mornings only (fasting), only to discover six months later that their HbA1c levels are high (above 6,5%). So, where is the problem?

The blood glucose peaks are not being pinpointed, i.e. the after-meal glucose levels which only peak from 1,5 to 2 hours after meals.

If testing is performed in pairs, before and after meals, an accurate and immediate benefit is that the patient will see the effect that a meal has on their glucose levels. This in turn leads to an action to either reduce food intake, exercise, or increase medication to address the ‘spike’.

By alternating testing times (breakfast, lunch and supper), very soon a clear picture will emerge and a better understanding of the effect that testing with a purpose has on food and medication.

Yes, testing in the morning is important but testing in pairs on alternate days and alternate meals will provide a clear understandable picture of overall control.

A tin of 50 strips will be sufficient in most Type 2 diabetes patients to test 12 times a week. And, if utilised correctly, will result in the healthcare provider to easily access and manage diabetes patients effectively.

Education is the key. Many diabetes patients need to be educated on why monitoring is important as well as an understanding of the effects that food and medication has on blood glucose.

How does this make sense?

It seems nonsensical to cut down cost by testing in pairs. That means more glucose strips are used, right?

Yes, indeed. But, a random test means nothing to you, the patient, as well as your doctor. If random tests are done, they are a complete waste of money and strips.

Once your diabetes is controlled and you are on the correct dosage, etc. then and only then will testing protocol’s as per Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA) apply.

However, usually diabetes patients that get one tin of strips per month, on medical aid, never uses them. So, by the year end, they end up with lots of unused, expired strips that are a complete waste of money.

On the other hand, if all 50 strips are used in a month, a comprehensive trend pattern is formed allowing the patient and doctor to intervene much sooner.

In effect, the question really is: Do I only test once a week in the mornings (complete waste of a strip) or do I use what the medical aid is paying for to get as much data per month on my “actual” glucose control?

Regardless, if patients test in pairs, even minimally (three times a week) then at least test with a purpose (before meals and after meals and a fasting).

What is the real issue?

The real issue is: do you, the diabetes patient, know what a Sunday lunch does to your glucose level? Do you know what effect the six beers you drank last night has on your glucose level? Or what the effect of exercising was? What happens to your glucose when you are sick?

Often than not, most don’t know and wonder why their HbA1c levels are so high, or suddenly get an abnormal high and don’t know why?

Another main issue is morbidity and the result of developing the complications. The cost of treatment is exorbitant so as the old adage goes, prevention is better than cure.

So, when we step back and look at the entire picture, isn’t it good sense to monitor effectively and prevent complications, or simply test at random, waste strips, be blissfully ignorant of glucose changes and hope for the best?

What it boils down to

It really boils down to the value you are spending on strips against the value of saving a few strips that would be better utilised. And, at the same time prevent a stroke, heart attack, kidney failure, blindness, amputations, etc.

SEMDSA guidelines

The diagnosis of diabetes is confirmed1

  1. In patients with symptoms of hyperglycaemia (excessive urination, rxcess thirst, blurred vision, weight loss) or metabolic decompensation (diabetic ketoacidosis or hyperosmolar non-ketotic state), when any one single test confirms that the:
  •  Random plasma glucose is ≥ 11,1 mmol/L
  •  Fasting plasma glucose is ≥ 7,0 mmol/L
  •  HbA1c is ≥ 6.5%
  • 2-hour post-load glucose is ≥ 11,1 mmol/L.

However, a glucose tolerance test is rarely needed in this category of patient.

  1. In an asymptomatic individual, when any one of the following tests, repeated on separate days within a two-week period confirms that the:
    •  Fasting plasma glucose is ≥ 7,0 mmol/L
    • 2 hr-post load glucose (OGTT) is ≥ 11, 1 mmol/L
    • HbA1c is ≥ 6,5%

If the diagnosis of diabetes is not confirmed with the repeated test, institute lifestyle modification and retest in three to six months.



References:

  1. SEMDSA guidelines 2018
  2. Centre for Diabetes and Endocrinology clinical guidelines 2018
  3. IDF IDF Diabetes Atlas. Seventh edition Brussels, IDF 2015, IDF Atlas Sixth edition, Brussels IDF. 2013
  4. Statistics South Africa. Midyear population estimates 2015 htpp://www.statssa.gov.za/publications/P0302/P03022015.pdf
  5. World Bank. Health expenditure, total (% GDP) 2016 htpp://data.worldbank.org/indicator/SH.XPD.TOTL.ZS 

MEET OUR EXPERT


Kevin Stead is a professional representative specialising in diabetes and diabetes management.


Header image credit by Freepik 

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Movement disorders associated with diabetes

People living with diabetes may suffer from an array of movement disorders that can cause pain and dysfunction. Physiotherapist, Saadia Jantjes, tells us more.


In the last issue, I discussed the importance of getting active and incorporating more movement into your daily life. But what if you’re experiencing joint or bone pain, discomfort or just have difficulty moving?

One of the barriers preventing people living with diabetes from implementing exercise into their daily routine is movement or musculoskeletal disorders that develop due to diabetes.

Diabetic patients may suffer from an array of musculoskeletal disorders that can cause pain and dysfunction. This could result in a negative effect on the management of their diabetes, stress and a decrease the quality of life.

Common examples of such movement disorders

Frozen shoulder

Frozen shoulder is frequently on both sides in diabetic patients. It’s characterised by severe pain, increased tightening, stiffness, and restricts the range of motions of the shoulder. It has an incidence of 10 – 20% in Type 1 diabetes patients and 7 – 32% in Type 2 diabetes patients. Other risk factors include past shoulder trauma, cardiac-, respiratory- and cerebral diseases. 

Carpal tunnel syndrome

This is a neuropathy that occurs frequently in the wrist and hand. Diabetes is the most common metabolic disease that causes carpal tunnel syndrome, found in 14 – 16% of patients. It is also seen more frequently in women than in men.

Symptoms include paresthesia (abnormal sensation) that worsens in the evenings in the thumb, index, and middle fingers of the hands, which wakes the person up from sleep.

Pain in the wrist and hand can cause clumsiness and poor control of hand movements. It can cause a decrease in work production as well as pain in manual workers, office workers and drivers.

Diabetic peripheral neuropathy (DPN)

Peripheral neuropathy is nerve damage which leads to numbness, loss of sensation, pain or impaired sensation in hands, feet and legs.

The dangers of having neuropathy include loss of balance and poor control of extremities which could result in falls and further injury.

The prevalence of numbness and poor sensation means that bruises, cuts and abrasions are usually gone unnoticed and untreated, leading to ulcers which could result in amputation if infected. It is the most common complication of diabetes; about 60 to 70% of people with diabetes will eventually develop peripheral neuropathy.

However, studies have shown that diabetic patients can reduce their risk of nerve damage by controlling their blood glucose levels through correct nutrition and exercise.

Charcot arthropathy

This is a result of diabetic peripheral neuropathy. It is a progressive and degenerative disease of the foot and ankle joints, which causes damage and deformities of the joint if left untreated. Charcot’s joints are typically seen in patients over the age of 50 who have had diabetes for many years and have existing neuropathic complications.

What to do if one of these sound familiar?

Consult your GP and he/she will point you in the right direction. You may need further tests done to get a proper diagnosis and a consult with a specialist, like a neurologist, orthopaedist, or rheumatologist.

It is important to note that I have only highlighted a few and more common disorders. If you are feeling any pain during exercise or at rest, whether it is constant pain or intermittent pain, the best thing would be to consult your GP and get it checked out. Exercise should not be painful.

I’ve been diagnosed with a diabetes associated movement disorder, now what?

This is where your multi-disciplinary team becomes involved. Not only will you need regular check-ups with your GP, nurse and dietitian, but this is where physiotherapy and occupational therapy become an integral part of your management of your condition as well.

It may all seem incredibly daunting and scary. But keeping yourself informed is one of the best tools when managing your diabetes. The management of your condition is critical in preventing movement complications.

When the control of diabetes is poor, higher levels of diabetic complications result. Pharmacotherapy, diet, and a regular physiotherapy programme should be the cornerstone of diabetes management.

It is imperative to have an appropriate exercise programme, overseen by a GP, as an integral part of diabetes management to reduce the frequency and severity of complications.

MEET OUR EXPERT


Saadia Kirsten Jantjes is a physiotherapist with a passion for health and wellness. With a second degree in Sport Science, exercise is one of her favourite rehabilitation tools, to not only rehab injuries but prevent injuries too. Saadia has her own private practice in Morningside, Johannesburg, while working at a Sub-Acute Clinic and furthering her studies in Pilates.


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Informing the uninformed – doctors and patients

Lisa Swaine gives us legal insight as to why doctors need to have a record of informed consent, and highlights that good clear communication is key.


1 April 2019 was certainly not a day for fools. The Supreme Court of Appeal gave judgment in the case of Beukes v Smith ((211/2018) [2019] ZASCA 48) for a surgeon whose information to his patient was called into question.

The decision highlights the value of keeping proper written records of explanations, discussions and advice leading to the informed consent to avoid protracted legal proceedings for both doctors and patients.

What is informed consent?

The introduction to the ethical guidelines published by the Health Professions Council of South Africa succinctly describes informed consent in this statement: “Successful relationships between healthcare practitioners and patients depend upon mutual trust. To establish that trust, practitioners must respect patients’ autonomy – their right to decide whether or not to undergo any medical intervention, even where a refusal may result in harm to themselves or in their own death. Patients must be given sufficient information in a way that they can understand, to enable them to exercise their right to make informed decisions about their care. This is what is meant by informed consent.”

Medical treatment cannot be provided in the absence of consent. Our courts have held that, to give proper informed consent, a patient must be informed of all material risks associated with the treatment.

What is material? If a reasonable person in the position of the patient, warned of the risk, would attach significance to the risk, it is material. To give proper informed consent, the patient must know, appreciate and understand the nature and extent of the harm or risk.

The claim in the proverbial nutshell

Dr Smith performed a laparoscopic (using multiple small incisions with ports to perform surgery with specialised instruments) hernia repair on Mrs Beukes. She sued him for damages alleging that he had negligently failed to provide her with sufficient information to enable her to give informed consent for the surgery.

Dr Smith’s alleged failure was to inform her that the hernia repair could have been done by way of a laparotomy procedure (older technique that relies on a single large incision, through which a surgeon uses his or her hands to directly perform the procedure).

His failure caused her to give uninformed consent to the laparoscopy during which her colon was perforated, resulting in her suffering complications and damages.

Mrs Beukes lost in the Gauteng Division of the High Court in Pretoria. The appeal was against that judgment.

Consultation, motivation, operation, complication

Against the backdrop of the surgery lay Mrs Beukes’ medical risk. She was a high-risk patient which meant that because of her health, lifestyle and medical history, the risk of her suffering complications related to surgery was high.

Mrs Beukes was referred to Dr Smith who consulted with her on 21 February 2012. He admitted her to the hospital as surgery was inevitable if she did not respond to conservative treatment. The issue would then be which surgery to perform.

After having consulted the referring doctor’s report and radiological reports, Dr Smith’s recommendation was that the laparoscopy would be the best option for Mrs Beukes in the circumstances.

Dr Smith wrote a detailed motivation for approval for the laparoscopy to Mrs Beukes’ medical aid in which the reason for his recommendation for the laparoscopy was stated and the general and specific advantages of the surgery were listed.

The laparoscopy was performed by Dr Smith on 23 February 2012. Mrs Beukes was discharged from hospital on 28 February 2012.

Three days’ post-discharge, Mrs Beukes was re-admitted to hospital with various complications associated with a perforation of her colon which included sepsis. She underwent three further surgical procedures and remained in hospital until 19 April 2012.

Trial and tribulation

The doctor’s version

According to Dr Smith, Mrs Beukes gave him informed consent orally on 22 February 2012, after he had consulted with her and explained the nature of each of the two options available, being the contemplated laparoscopic surgery and the laparotomy, and the material benefits and risks associated with both.

He had informed her that, in his opinion, the laparoscopy was the better option in the circumstances. He also testified that she had signed a written consent shortly before the operation on 23 February 2012, which formed part of the record and was a confirmation of the oral consent given the previous day following his explanation of both procedures.

The patient’s version

Mrs Beukes, on the other hand, denied that Dr Smith had explained both procedures to her. She insisted that, in her first consultation with Dr Smith on 21 February 2012, he told her that he would first consult with the radiologists on her scans and thereafter perform a “quick 15 to 20-minute operation” to repair her hernia with a mesh and in “two or three days” she would be home.

In her version, Dr Smith made the decision to do the laparoscopic hernia repair during the first consultation on 21 February 2012 before having consulted the radiologists. She also denied having signed the written consent. She testified that had she been informed that the hernia could also have been repaired through a laparotomy, she would have discussed her options with her family and would have opted for the less risky of the two procedures. But, she trusted Dr Smith and believed him when he told her that the laparoscopy was a simple procedure that would take 15 to 20 minutes and that she would be discharged from hospital in three days.

Expert opinions

The specialist surgeons who gave expert testimony on behalf of Mrs Beukes and Dr Smith agreed that Mrs Beukes was a high-risk patient, that under the circumstances, the laparoscopy was the better option; the procedure had been performed by Dr Smith without negligence; and that Dr Smith’s post-operative management of Mrs Beukes was acceptable.

Was informed consent obtained?

The only issue was whether informed consent had been obtained.

At the heart of Mrs Beukes’ contentions was the fact that there was no written record of the details of the informed consent discussion.

It was not disputed that no record had been made of the content of Dr Smith’s explanation to Mrs Beukes.

Mrs Beukes’ version was that, in the absence of evidence on the detail of her consultation with Dr Smith, the court had to conclude that Dr Smith had not given Mrs Beukes the necessary information as he alleged and further, even if he had given her some information, it was not sufficient to enable her to make an informed decision

Dr Smith’s evidence was entirely reliant on his memory of what had transpired over the relevant period. However, as found by the trial court, several aspects supported his version, such as his demeanour and diligence which were more consistent with his version that all had been sufficiently explained.

Added to this were the medical records which also supported his version as opposed to that tendered by Mrs Beukes. Mrs Beukes’ version was inconsistent with Dr Smith’s undisputed caring and diligent nature.

The medical records suggested that there had been a more substantive discussion between her and Dr Smith than she was willing to admit. The written representations made by Dr Smith to Mrs Beukes’ medical aid, after his consultation with her the morning before the laparoscopy, were consistent with his version and revealed that the material risks and benefits of the medical procedures occupied his mind. Nothing in the medical records contradicted Dr Smith’s evidence.

Judgment day

Fortunately for Dr Smith, the Appeal Court found no basis upon which to overturn the factual finding by the trial court that Dr Smith’s version was probable and that of Mrs Beukes was not.

The cost of not recording what is said

Unfortunately for Dr Smith, as it would appear from what was stated in the judgment, he was subjected to lengthy cross-examination from which he might have been spared had there been a written record or other record of his explanation, discussion and advice leading to the informed consent.

That is aside from the cost of the litigation to Dr Smith and by cost, I don’t just mean legal costs. Litigation is stressful and takes one out of one’s day-to-day professional practice. It comes with a high personal and economic price tag.

Keeping record not only protects the patient which is primary. It also protects the practitioner and may well avoid the risk of becoming embroiled in costly and lengthy ‘he said – she said’ debates.

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Lisa Swaine is a partner at Webber Wentzel. She is a dispute resolution and litigation specialist.


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Vaccines – pneumococcal and influenza

Dr Louise Johnson educates us on winter vaccines pneumococcal and influenza – for people living with diabetes.


What is pneumococcal disease?

Pneumococcal disease is caused by the bacterium Streptococcus pneumonia (S. pneumonia). This can cause infection in the respiratory tract i.e. lung, sinus or ears.

In vulnerable people, such as children, the elderly, and people living with diabetes, these bacteria can invade the bloodstream and cause meningitis and septicaemia. This may lead to deafness, mental disability and even death. People at extreme ages (younger than two years or older than 65 years) are particularly susceptible to the complications because of their underdeveloped immune system or aging immune system.

Pneumococcal bacteria are spread from person to person through close contact with respiratory secretions (sputum or saliva).

Why immunise?

It is estimated that immunisation approximately prevents 2,5 million deaths a year due to infections. It is also cost-effective to the health system and has saved more lives than the development of antibiotics.1

Antibiotic-resistance is a reality, and resistance to commonly used antibiotics is becoming a serious threat to medical treatment of infections.

In the age of antibiotic-resistant bugs, the prevention of disease through vaccines has become essential. It not only helps prevent infections in vaccinated people, but also prevents a “herd immunity” by helping to prevent transmission of the bug to close contacts of the sick patient.

Types of vaccines:

There are two different types of pneumococcal vaccines available:

  1. PPV23 (Pneumovax 23)

Pneumococcal polysaccharide vaccine is made from polysaccharide (sugar like) capsule of 23 different strains of S. pneumonia.

This capsule is the main target of the body’s immune response during pneumococcal infection. The body produces antibodies when exposed to the capsule (acts like an antigen).

The next time the immune system is exposed to the same antigen, the immune system is prepared and can rapidly produce killing-antibodies. This is due to the body having a “memory” of the antigen via specially produced immune memory B-cells.

Children younger than two years of age have an immature immune system and cannot produce memory cells to the capsule. Therefore, they should not get this vaccine.

  1. PCV13 (Prevenar 13)

Pneumococcal conjugate vaccine is like PPSV23. Though, a protein that induces memory cells, even in young children, joins the capsular polysaccharide.

Who should be vaccinated with which vaccines?

Pneumovax 23:

Persons older than 65 years.

People older than two years with chronic heart and lung disorders, diabetes, chronic liver disease, COPD, alcoholism, spleen dysfunction, asplenia (spleen removed), cancer, organ transplantation, HIV infection and smokers.

Prevenar 13:

Children aged: six weeks, four months, and 12 months.

Children with underlying medical conditions should get an extra dose at six months. This is part of the South African Immunisation Programme.

How to vaccinate?

South African guidelines to CAP (community acquired pneumonia)2

Vaccination is the key pillar of antibiotic stewardship.

  • All patients older than 50 years who are vaccine naïve should receive a single-dose of PCV13.
  • Every adult older than 50 years who have received PPV23 should receive a single-dose of PCV13 one year later.
  • All adults older than 65 years of age who are vaccine naïve should receive a single-dose of PCV13, followed a year later by PPV23.
  • Every adult older than 65 years of age who have received PPV23, should receive a single-dose of PCV13 at least one year later.
  • Younger adults (>18 year) who are vaccine naïve with severe underlying comorbid or immunocompromising conditions, including HIV infection, should receive a single-dose of PCV13, followed at least two months later by PPV23.
  • Younger adults (> 18 years) who have previously received PPV23 and have severe underlying comorbid or immunocompromising conditions, including HIV infection should receive a single-dose of PCV13 one year later.
  • All women who are pregnant in the period of influenza vaccine availability, should be offered vaccination with influenza vaccination of that year.
  • Adults older than 65 years of age should receive the annual vaccination for influenza.
  • Individuals with chronic diseases (diabetes, lung disease, heart disease, HIV infected individuals and morbidly obese (BMI>40kg/m2) are at high risk and should be vaccinated.
  • All healthcare workers should be offered annual influenza vaccination.

Who should not be vaccinated?

Pneumovax 23 should not be given to children younger than two years. Hypersensitivity to the products in the vaccine.

What are the side effects of the pneumococcal vaccine?

Side effects are very uncommon. Local side effects to the injected area: redness, soreness, or rash. Also fatigue, headache, chills and diffuse achiness.

What is influenza?

Influenza (also known as flu) kills between 6 000 and 11 000 South Africans per year. These deaths are 50% in the elderly and 30% in HIV infected people.

The highest rate of hospitalisation is in people older than 65 years of age, HIV-infected people, and children less than five years of age.

Patients with chronic diseases, such as diabetes, heart and lung disease and tuberculosis are also at higher risk of contracting influenza.3

Flu is a virus and is spread from person to person. It causes many different symptoms from headache, fatigue, muscle pain, shivers, vomiting and diarrhoea.

It spreads mainly by droplets when people cough, sneeze, or talk. You can also get flu by touching a surface or object that has flu virus on it and then touching your mouth, eyes or nose.

What is in the flu vaccine?

The flu vaccine contains three different types of inactivated flu viruses. This mean the virus is dead and can’t make you sick. The viruses in the flu injection are named for the year they were found and the place they were found. This year’s vaccine (2019) was updated with two new viruses. The current vaccine contains:

  1. A/California/7/2009(H1N1) pdm09 like virus
  2. A/HongKong/4801/2014(H3N2) like virus
  3. B/Brisbane/60/2008 like virus

Who should get the flu vaccine?

  • Pregnant and post-partum women (anytime during pregnancy).
  • People who are infected with HIV.
  • Healthcare workers.
  • People with chronic diseases (diabetes, lung, heart, kidney, liver, etc.)
  • People older than 65 years of age.
  • Residents of old age homes, chronic care and rehabilitation centres.
  • Children older than six months.
  • Adults and children in close contact with high-risk individuals.
  • Anyone wishing to reduce the risk of getting flu or spreading flu to others.

Who should not get the vaccine?

Anyone who had a severe allergic reaction to the vaccine, such as drop in blood pressure and difficulty in breathing.

Can I get the flu vaccine when I am sick?

Yes. You are safe to get the vaccine with mild cold or flu-like symptoms even if you have a fever. Though, if you are very ill (need to be admitted to a hospital) you should rather wait.

How effective is the flu vaccine?

The flu vaccine prevents only influenza and no other viruses. It is 60% effective in healthy individuals. The elderly and children younger than two years may not respond as well due to weaker immune system.4

Therefore, when looking at the bigger picture of population and personal health: be wise and vaccinate.


References:

  1. Plotkin SA, Mortimer E.A, Vaccines 2ndedition, Philadelphia:Wb Saunders, 1994
  2. J Thorac Dis 2017; 9 (6):1469-1502
  3. (nicd.ac.za) (www.cdc.gov/flu)
Dr Louise Loot

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Dr Louise Loot is a specialist physician passionate about diabetes and endocrinology. She enjoys helping people with diabetes live a full life with optimal quality. She is based in Pretoria in private practice.


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Understanding the Somogyi effect and dawn phenomenon

Diabetes nurse educator, Christine Manga, explains the causes behind elevated fasting blood glucose readings in the morning: Somogyi effect and dawn phenomenon.


Both the Somogyi effect and dawn phenomenon will lead to elevated fasting blood glucose (glucose level after an overnight fast) readings in the morning. The target for fasting blood glucose levels is <= 7mmol/L. This said, the causes are very different.

Dawn phenomenon

The dawn phenomenon occurs in everyone. However, people without diabetes will not notice it because their body is able to counteract the effects. It is caused by natural body changes during sleep.

During the night, less insulin is produced and in the early hours of the morning, hormones, such as cortisol, growth hormone, epinephrine and glucagon, are all released. These hormones all act in the opposite way to insulin, resulting in elevated blood glucose levels.

Towards the early hours of the morning, the body releases stored glucose from the liver into the bloodstream to provide energy for the coming day. This will cause a further rise in blood glucose levels. According to the American Diabetes Association, the dawn phenomenon occurs between 5:00am – 8:00am. The dawn phenomenon is a natural phenomenon.

Somogyi effect

The Somogyi effect is usually management related and is a rebound hyperglycaemia (high blood glucose). It happens in response to a nocturnal hypoglycaemia (low blood glucose).

This hypoglycaemia can be caused by giving too much insulin at night, not having an evening snack, or from doing vigorous exercise in the evening hours. In response to the hypo, the body releases hormones to raise the blood glucose levels. These include cortisol, growth hormone, glucagon and adrenaline. When you wake, you will have elevated fasting blood glucose level.

So, which one do you have: Somogyi effect and dawn phenomenon?

Due to the causes being different, the management will also differ. To establish what is causing your elevated fasting reading, you will need to do some extra blood glucose testing.

Testing your blood glucose levels between 2:00am – 3:00am on a few consecutive nights will give you an answer. If you are experiencing hypos at this time of night, then you are experiencing the Somogyi effect.

If on the other hand, your blood glucose levels are normal at this time, then you are experiencing the dawn phenomenon.

The use of continuous glucose monitoring (CGM) would be extremely useful in detecting the cause of your elevated blood glucose readings. CGM is now becoming more affordable, but definitely is still not cheap. Speak to your doctor about wearing a sensor to assist you in making management decisions.

Prevention

Dawn phenomenon

To prevent the dawn phenomenon, you could:

  • Increase the amount of vigorous physical exercise in the evening hours.
  • Wear an insulin pump to administer extra insulin in the early morning hours. This would work well.
  • Reduce the amount of carbs and evening snacks.
  • Change insulin formulations to more concentrated ones. This can lead to improved fasting blood glucose levels.
  • Administer insulin later at night. This may also be beneficial.
  • There may be a need to change some of your diabetes medications, or possibly even add more.

Somogyi effect

Here are ways to prevent the Somogyi effect from occurring:

  • Reduce the amount of insulin given in the evening.
  • Once again, changing your insulin to a stronger concentration can prevent nocturnal hypos.
  • Giving the insulin earlier may also prove helpful.
  • Getting assistance with carb counting will help you to match the amount of insulin to the amount of carbs you eat, preventing overdosing of insulin.
  • Your doctor may need to assess your medication and reduce, or discontinue some.
  • Try to reduce the amount of vigorous physical activity in the evening.
  • It may also be necessary to have an evening snack before bedtime. The down side to this is that it may cause long-term weight gain.

The most important thing is that you know which one, the dawn phenomenon or the Somogyi effect, is causing your elevated fasting readings. You can only manage what you know.

eating time budget

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Christine Manga (Post Grad Dip Diabetes and Msc Diabetes) is a professional nurse and a diabetes nurse educator. She has worked with Dr Angela Murphy at CDE Centre, Sunward Park since 2012.


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Depression and diabetes

Daniel Sher explores how diabetes and depression are linked, and gives some pointers for managing diabetes and depression together.


If you have diabetes, your chance of developing depression is two to three times higher than that of other people. As if we didn’t have enough to worry about already.

Why is this a problem?

Depression can make it harder for you to manage your glucose levels, often leading to diabetes burnout. Before you know it, you’re stuck in a vicious cycle of sadness, mood swings and poor blood glucose control.

What is depression?

Depression usually involves feelings of sadness, but depression and sadness are not the same thing. Rather, depression is a psychological disorder that affects a person not just emotionally, but also in terms of their thoughts and bodily functions.

Some of the symptoms of clinical depression include:

  • Ongoing sadness that doesn’t seem to ease up.
  • An inability to enjoy activities that previously brought you happiness.
  • Sleep disturbances.
  • Mood swings at home or at work are interfering with your relationships.
  • Concentration difficulties.
  • Suicidal thoughts and behaviours.
  • Inappropriate guilt and poor self-esteem.
  • Social withdrawal.
  • Changes in weight and appetite.
  • Low energy.
  • Less motivation to test your blood glucose, exercise and take insulin (diabetes burnout).

How common is depression in people with diabetes?

Time and time again, research studies have shown that having diabetes puts one at risk of developing depression. For example, a 2012 study showed that people with Type 1 diabetes are three times more likely to have depression; while people with Type 2 diabetes are twice as likely to be depressed.

Another 2019 study confirmed these numbers, leading the authors to say that reducing diabetes by 25% could stop 2,34 million cases of depression from happening. But, believe it or not, research shows that the relationship goes both ways. Having depression can also make a person more likely to develop (Type 2) diabetes.

Clearly, then, a close link between the two conditions exists. But why does this link exist? Why do depression and diabetes occur together so often?

Explaining the link between diabetes and depression

Injections. Finger pricks. Doctor’s visits. Lows. Highs. Dietary restrictions. Worry and fear. Yes, as people living with diabetes, we deal with a whole lot of stress. Is it really that surprising that we’re more likely to end up with depression?

Of course, living with diabetes comes with a psychological burden which in and of itself can trigger depression. But, the stress of diabetes alone doesn’t completely account for this link. This is where things get interesting.

Diabetes, depression and the brain

Recent research suggests that high blood glucose levels have a direct impact on the parts of the brain that affect mood and thinking. The researchers used a (fMRI) brain scanner to compare the brains of people living with diabetes versus people without the illness. The people living with diabetes were given some glucose to raise their sugars.

The scanners showed that when blood glucose levels went up, a certain brain chemical (glutamate) was released in parts of the brain that control thinking and emotions. Glutamate is closely linked to depression. The researchers also showed that people with worse glucose control over time had patterns of electrical activity in the brain that are linked to depression.

So, in other words, this study tells us that the link between diabetes and depression is not just a matter of increased life-stress: the two disorders are linked on a biological level. People living with diabetes experience changes in the brain that make depression more likely; and this is especially the case when blood glucose levels are high.

A vicious cycle

Many clients who approach me for help are stuck in a vicious cycle. They struggle to control their diabetes as well as they would like; and they soon start to develop signs of depression. The depression makes it harder for them to stay motivated and hopeful. They start to slack-off in terms of self-monitoring, diet and exercise. Their glucose control suffers as a result. This leads them to become even more depressed.

Why is this important?

For starters, if you are one of millions of people living with diabetes who is struggling with depression, know this: it’s not all in your head. The stress and strains of living with diabetes are very real. But, the illness also predisposes you to depression because of altered brain chemistry.

Now that we know this, it’s absolutely vital for doctors, patients and family members of people living with diabetes to know how to recognise the signs of diabetes and get help where needed. Treating both diabetes and depression together is vital.

How to get help

The good news is that this cycle can be broken. In most people, depression responds well to treatment. Let’s look at the two most common treatment options:

  1. Psychotherapy

Also known as talk therapy, counselling or just therapy. Speaking with a licensed mental health professional can help you to change the thoughts and behaviours that make depression more likely.

Cognitive behavioural therapy (CBT) is one of the most popular forms of therapy for treating depression. If possible, try to find a therapist who is experienced in working with people living with diabetes. It can really help to speak with someone who understands the struggles and nuances of living with a chronic illness.

  1. Medication

One of the most common forms of antidepressant medications is called a selective serotonin reuptake inhibitor (SSRI). Examples include Celexa, Lexapro, Zoloft and Zytomil. A 2006 research paper suggests that medication and therapy are equally effective in managing depression; and that the best outcomes usually occur when the two are combined.

  1. Lifestyle interventions

Therapists often include ‘behavioural modification’ to their treatment. This means empowering the client to make healthier choices when it comes to their diet, diabetes management and exercise patterns. Making positive choices in this regard can help you manage your depression and diabetes at the same time.

How to get help

If you are concerned that you may be developing depression on top of your diabetes, speak to your endocrinologist or general practitioner. Alternatively, you may want to make direct contact with a clinical psychologist or psychiatrist in your area. If possible, try to consult with a mental health professional who has experience in working with diabetes.

If you or a family member are suicidal, contact the South African Depression and Anxiety Group on their 24-hour suicide hotline: 0800 567 567.

Final thought

So, we now know that people living with diabetes are more likely to experience depression. Not just because their lives are a whole lot more stressful, but because diabetes, depression and the brain are all linked on a biological level. For those of us with diabetes, this means that we need to remain vigilant for signs of depression.

By getting the mental health treatment that you deserve, it’s possible to improve your overall quality of life and your blood-sugar control at the same time.


References

Bădescu, S. V., Tătaru, C., Kobylinska, L., Georgescu, E. L., Zahiu, D. M., Zăgrean, A. M., & Zăgrean, L. (2016). The association between Diabetes mellitus and Depression. Journal of medicine and life, 9(2), 120-125.

Chireh, B., Li, M., & D’Arcy, C. (2019). Diabetes increases the risk of depression: A systematic review, meta-analysis and estimates of population attributable fractions based on prospective studies. Preventive medicine reports, 100822.

Dimidjian, S., Hollon, S. D., Dobson, K. S., Schmaling, K. B., Kohlenberg, R. J., Addis, M. E., … & Atkins, D. C. (2006). Randomized trial of behavioural activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. Journal of consulting and clinical psychology, 74(4), 658-670.

Endocrine Society. (2014, June 23). High blood sugar causes brain changes that raise depression risk. ScienceDaily. Retrieved June 19, 2019 from www.sciencedaily.com/releases/2014/06/140623092011.htm

Roy, T., & Lloyd, C. E. (2012). Epidemiology of depression and diabetes: a systematic review. Journal of affective disorders, 142, S8-S21.

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Daniel Sher is a registered clinical psychologist who has lived with Type 1 diabetes for over 28 years. He practices from Life Vincent Pallotti Hospital in Cape Town where he works with Type 1 and Type 2 diabetes patients to help them thrive. Visit www.danielshertherapy.com


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