According to the authors of the Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA) guidelines, diabetes has a heterogeneous aetiology and therefore the response to treatment will vary. Thus, it would seem intuitive that a single uniform approach to the management of such a heterogeneous disorder is unlikely to be successful, state the authors.²

What is personalised care?

There are different definitions of what personalised or patient-centred care means. Godfrey et al describes it as: ‘respect, acknowledging people’s essential human dignity, treating people as individuals, and finding out what is important to them relevant to their treatment and care’.³

The SEMDSA guidelines authors view personalised care as incorporating patients as partners in their healthcare. In practice, this means providing care that is ‘respectful of and responsive to individual patient preferences, needs and values, and ensures that patient values guide all clinical decisions’.²

Why personalised care is important in patients with diabetes

Studies have shown that patients living with diabetes have a lower quality of life (QoL) and shorter lifespan compared to their non-diabetics counterparts. Diabetes is associated with a number of complications and comorbidities such as peripheral neuropathy, retinopathy, nephropathy, skin and wound infections and cardiovascular disease (CVD). CVD is the leading cause of mortality in these patients.⁴

Furthermore, diabetes often causes emotional stress, which can lead to psychiatric comorbidities such as depression (twice as frequently in patients living with diabetes compared to the general population).⁴

Personalised care addresses patient needs

As mentioned above, diabetes is a heterogenous disease. Not every patient with diabetes who are the same age, have the same duration of disease, the same body mass index, and the same HbA1_c will respond in the same way to a given treatment.^2,6

The reason may be a genetic propensity to respond or not respond to a drug. The physician must assess every patient and then attempt to guess which treatment will work best. If the physician could be armed with specific personalised information about that patient, including information about their genetic makeup, then treatments could be tailored for each individual patient. This approach would lead to better outcomes without wasting time on ineffective therapy.⁶

The definition of personalised medicine for diabetes (PMFD) is the use of information about the genetic makeup of a person with diabetes to tailor strategies for preventing, detecting, treating, or monitoring their diabetes. The practice of PMFD involves four processes.⁶

1. Identification of genes and biomarkers for diabetes as well as for obesity, which is the greatest risk factor for type 2 diabetes.
2. After these predictors of diabetes are identified, is allocation of resources to prevent or detect the diabetes and/or obesity phenotype in high-risk individuals, whose risk is based on their genotype.
3. Selection of individualised therapies for affected individuals. The selection process involves deciding which drug to prescribe, what dose of drug to use, and which diet to prescribe. The selection process also accounts for which drug is least likely to cause side effects or toxicity.
4. Measurement of circulating biomarkers of diabetes to monitor the response to prevention or therapy.

The potential benefit of a personalised medicine approach to diabetes is the possibility of earlier interventions to prevent or treat the disease by using screening genetic tests. Patients who are at high risk for diabetes – as well as other chronic diseases - usually experience a prolonged asymptomatic period before the onset of the disease. Patients who are identified by genetic testing to be at high risk for diabetes can be directed to preventative measures, such as lifestyle modifications or medications, in order to delay or prevent the disease.⁶

Personalised medicine allows for personalised drug prescribing with less trial and error and less time wasted with an inadequate response or with side effects. The result of such a personalised medicine approach would be a better outcome for the disease being treated.⁶

A key component to a personalised approach is compounded medicine. Compounded medicine is not meant to replace medicine approved for the treatment of diseases such as diabetes such as antidiabetic drugs, rather it is aimed at patients when an approved drug is not medically appropriate to treat them.^7,15

According to the American Food and Drug Administration, a drug may be compounded for a patient who cannot be treated with an approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.¹⁵

What is compounding and how can it benefit patients with diabetes?

The concept of compounding dates back centuries and was used up to the late 1960s when the mass production of medicines became more common. Simply put, compounding is the ‘combining, mixing, or altering of ingredients to create a medication tailored to the needs of a patient’.  For decades, drug compounding has played a crucial role in effective healthcare delivery. Compounding pharmacists can tailor drugs to a specific patient’s needs by altering dosage concentrations or routes of administration.^8,9,10

According to Matt Poteet, Chief Operating Officer, The Compounding Pharmacy of America, there are numerous benefits to using compounded medicine in patients with diabetes, which can be used to enhance the efficacy of their prescribed anti-diabetic therapies. These include:¹⁰

Peripheral neuropathy: between 60% and 80% of patients experience pain in the hands, feet and extremities caused by nerve damage as a result of glucose variability. Topically applied compounded medications provide relief of diabetic paraesthesia and dysesthesia via multiple mechanisms of action. Since they affect multiple receptor sites and can simultaneously inhibit the production of substances that initiate pain, topical compounded medications provide an increased ability to resolve pain. Topical compounded medications can simultaneously provide an anti-inflammatory medication, a tricyclic antidepressant, or an anticonvulsant. They offer the opportunity to provide direct anti-inflammatory and antinociceptive relief with marked reduction in the potential adverse reactions associated with oral medications. Therefore, the utilisation of a topical compounded medication can reduce the production of proinflammatory cytokines and affect opioid receptors, calcium channel blockers, sodium channel blockers, glutamate receptors and other receptor sites involved in the transmission or production of pain.¹¹

Diabetic retinopathy: advanced or proliferative diabetic retinopathy can lead to loss of central and peripheral sight. What starts as blurry vision is caused by leakage from the tiny blood vessels in the eye. The retina swells, in response, and leads to diabetic macular oedema (DME). While there are treatments for DME and diabetic retinopathy, prevention is truly the best measure. It is important to keep blood sugars as stable as possible to reduce the damage to blood vessels and the eyes. Because certain medications can cause blood sugars to fluctuate even more, or can directly cause irritation, inflammation, swelling and damage to the eyes. In the United States, ophthalmologists make use of traditional compounding pharmacies to provide small-quantity orders of compounded and repackaged drugs for patients who do not improve using traditional therapies.¹²

Diabetic skin conditions: patients living with diabetes have a high risk of skin infections and conditions, because their immune system is already impaired or working under added pressure. Common diabetic skin conditions include:

• Bacterial skin infections
• Fungal skin infections
• Acanthosis nigricans
• Diabetic dermopathy
• Necrobiosis lipoidica diabeticorum
• Allergic reactions
• Bullosis diabeticorum
• Eruptive xanthomatosis
• Digital sclerosis
• Disseminated granuloma annulare

Bacterial infections that effect the skin include:

• Styes
• Boils
• Folliculitis
• Carbuncles
• Infections of the cuticles and around the fingernails
• Impetigo

Fungal infections that effect the skin include:

• Jock itch
• Athlete’s foot
• Ringworm
• Yeast infections

Compounding pharmacists can compound creams and treatments from scratch, utilising only the ingredients that are safe, while leaving out any ingredients that will cause a negative interaction.

• Cardiovascular disease: according to Centers for Disease Control and Prevention statistics, adults with diabetes are twice as likely to die from heart disease or stroke as those without diabetes. Because diabetic patients are at higher risk of other conditions, complications, and at risk of drug interactions and medication complications. Numerous studies have shown the benefits of compounding medicine in CVDs.^14,15

REFERENCES:

1. American Diabetes Association. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2022. Diabetes Care, 2022; 45(Supplement_1):S125–S143.
2. SEMDSA Type 2 Diabetes Guidelines Expert Committee. The 2017 SEMDSA guideline for the management of type 2 diabetes. JEMDSA. 2017;22(1)(Suppl. 1): S1–S196.
3. Godfrey M, Young J, Shannon R, et al. The Person, Interactions and Environment Programme to improve care of people with dementia in hospital: a multisite study. Southampton (UK): NIHR Journals Library; 2018 Jun. (Health Services and Delivery Research, No. 6.23.) Chapter 4, Person-centred care: meaning and practice.Available from: https://www.ncbi.nlm.nih.gov/books/NBK508103/
4. Muhlbacher AC, Sadler A and Juhnke C. Personalized diabetes management: what do patients with diabetes mellitus prefer? A discrete choice experiment. The European Journal of Health Economics, 2021.
5. Edelman SV, Wood R, Roberts M and Shubrook JH. Patients With Type 2 Diabetes Are Willing to Do More to Overcome Therapeutic Inertia: Results From a Double-Blind Survey. Clin Diabetes, 2020.
6. Klonoff DC. Personalized medicine for diabetes. J Diabetes Sci Technol. 2008 May;2(3):335-41. doi: 10.1177/193229680800200301. PMID: 19885196; PMCID: PMC2769744.
7. The Compounding Pharmacy of South Africa. What is compounding? https://compounding.co.za/what-is-compounding/
8. Batha RF. Why compounding pharmacies have a critical role to play in the future of personalised medicine. Journal of Anaesthesia Practice, 2022. https://japractice.co.uk/2022/03/why-compounding-pharmacies-have-a-critical-role-to-play-in-the-future-of-personalised-medicine/14180
9. National Academies of Sciences, Engineering, and Medicine. Health and Medicine Division, Board on Health Sciences Policy, Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy; Jackson LM, Parker RM, Mattison DR, editors. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington (DC): National Academies Press (US); 2020 Jul 1. 2, An Overview of Compounding.Available from: https://www.ncbi.nlm.nih.gov/books/NBK562881/
10. Poteet M. Compounding Pharmacies for Diabetic Patients.https://compoundingrxusa.com/blog/compounding-pharmacies-for-diabetic-patients/#:~:text=Compounding%20can%20help%20you%20with,related%20disorders%20and%20their%20symptoms
11. Jacobs A. Compounding Meds For Diabetic Neuropathic Pain: Can They Have An Impact? Podiatry Today, 2015.
12. Repka MX. Changing regulatory burdens in drug compounding. https://retinatoday.com/articles/2018-apr/news
13. Wang N, Woodward M, Huffman MD, and Rogers A. Compounding Benefits of Cholesterol-Lowering Therapy for the Reduction of Major Cardiovascular Events: Systematic Review and Meta-Analysis. Circulation: Cardiovascular Quality and Outcomes, 2022.
14. Bert’s Medicine. Managing Heart Medications: How A Compounding Pharmacy Can Help. https://burtsrx.com/heart-medications-pharmacy-help/
15. Compounding and the FDA: Questions and Answers. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers