Neobook — clinical reference

SEMDSA 2017 Recommendations
Fasting during the month of Ramadan may pose a health risk to some patients with diabetes. The healthcare professional should assess this risk according to the risk categories defined by medical experts and Islamic jurists, that serve as a guidance as to who could or should not fast	C
For those patients who intend to fast despite medical advice to the contrary, the role of the healthcare professional is to advise the patient on how to fast as safely as possible	C
A pre-Ramadan medical assessment is essential to assess overall well being, define co-morbidities, provide Ramadan focused education on meal planning, adjustments to medication, planning of exercise and monitoring of blood glucose	C
Always enquire about the patient’s previous challenges and successes during Ramadan to guide treatment decisions	C
Patients must be educated that finger prick self-monitoring of glucose does not invalidate the fast	C
Patients must be educated to break their fast if they have any confirmed or suspected hypoglycaemia irrespective of the time of day	C
DPP-4 inhibitors are preferred to sulphonylureas as they have a lower potential to cause hypoglycaemia, although both may be used during Ramadan	B
GLP 1 analogues may be safely used provided they are started one to two months prior to Ramadan	B
Insulin doses, timing and regimens need to be modified during Ramadan	C
Patients must be educated about self-titration and adjustment of insulin during fasting to enable individuals to fast safely during Ramadan	C

INTRODUCTION

Fasting during the holy month of Ramadan constitutes one of the five fundamental pillars of Islam. Muslims abstain from food and drink from dawn (suhur) to dusk (iftaar). Despite ill individuals being exempted from this obligation, many Muslims with diabetes mellitus will still wish to fast. Individuals with diabetes that fast are at risk for hypoglycaemia, hyperglycaemia and dehydration.

It is increasingly important that healthcare professionals (HCP) are aware of potential risks associated with fasting in Ramadan, and adopt the necessary approach to mitigate those risks.

This section outlines defining criteria for diabetic subjects who may safely fast during Ramadan, emphasises the importance of planning and education before Ramadan, and provides guidelines on dietary advice and adjustments that need to be made at a therapeutic level to minimise the risks associated with fasting during Ramadan.

The terms suhur and iftaar are used throughout this guideline. Suhur refers to the pre-dawn meal at the start of the day’s fast and will be referred to as “pre-dawn meal” or “morning meal”. Iftaar refers to the meal at sunset and marks the end of the day’s fast; it will be referred to as “sunset meal” or “evening meal”. Individuals observing the fast are prohibited, inter-alia, from smoking and consuming any food or liquid orally.

RAMADAN AND FASTING

“O you who believe! Fasting is prescribed to you as it was prescribed to those before you so that you may attain self restraint”.¹

“Whoever witnesses the month (of Ramadan) then he/she should fast. But, if any of you is ill or travelling – then he or she is exempted from fasting”.²

Fasting in the month of Ramadan is one of the five pillars of Islam. It is incumbent on every Muslim upon attaining puberty and thereafter to fast during this month. However, certain categories of individuals are exempted from fasting e.g. an ill person, a traveller or a pregnant or lactating woman.¹ Missed fasting days need to be made up once an individual regains sound health.

FASTING EXEMPTIONS

The month of Ramadan involves greater expression of devotion in addition to fasting in order to achieve nearness to and seek the pleasure of God, with the result that many Muslims who are exempt from fasting because of diseases such as diabetes are reluctant to take advantage of this concession.

Islamic scholars and medical experts have made recommendations for “diabetes and fasting of Ramadan”,³ which may help individuals with diabetes make an informed decision. Patients with diabetes are classified into 3 categories: - very high risk, high risk and moderate to low risk (Table I below).

Table I: Pre-Ramadan Assessment and Risk Stratification

Risk category Religious opinion	Patient characteristics	Comments
Category 1: Very High Risk Listen to medical advice MUST NOT fast	One or more of the following: Severe hypoglycaemia within the three months prior to Ramadan DKA within the three months prior to Ramadan Hyperosmolar hyperglycaemic coma within the three months prior to Ramadan History of recurrent hypoglycaemia History of hypoglycaemia unawareness Poorly controlled T1DM Acute illness Pregnancy in pre-existing diabetes, or GDM treated with insulin or SUs Chronic dialysis or CKD stage 4 & 5 Advanced macrovascular complications Old age with ill health	If patients insist on fasting then they should: Receive structured education Be followed by a qualified diabetes team Check their blood glucose regularly (SMBG) Adjust medication dose as per recommendations Be prepared to break the fast in case of hypo or hyperglycaemia Be prepared to stop the fast in case of frequent hypo- or hyperglycaemia or worsening of other related medical conditions
Category 2: High Risk Listen to medical advice SHOULD NOT fast	One or more of the following: T2DM with sustained poor glycaemic control* Well-controlled T1DM Well-controlled T2DM on MDI or mixed insulin Pregnant T2DM or GDM controlled by diet only or metformin CKD stage 3 Stable macrovascular complications Patients with comorbid conditions that present additional factors People with diabetes performing intense physical labour Treatment with drugs that my affect cognitive function	If patients insist on fasting then they should: Receive structured education Be followed by a qualified diabetes team Check their blood glucose regularly (SMBG) Adjust medication dose as per recommendations Be prepared to break the fast in case of hypo or hyperglycaemia Be prepared to stop the fast in case of frequent hypo or hyperglycaemia or worsening of other related medical conditions
Category 3: Moderate/Low Risk Listen to medical advice Decision to use licence not to fast based on discretion of medical opinion and ability of the individual to tolerate fast	Well-controlled T2DM treated with one or more of the following: Lifestyle therapy Metformin Acarbose Thiazolidinediones Second-generation SUs Incretin-based therapy SGLT2 inhibitors Basal insulin	Patients who fast should: Receive structured education Check their blood glucose regularly (SMBG) Adjust medication dose as per recommendations

*Level of glycaemic control to be agreed between physician and patient, according to multiple factors`: CKD, chronic kidney disease; DKA, diabetic ketoacidosis; GDM, gestational diabetes mellitus; MDI, multiple dose insulin; SMBG, self-monitoring of blood glucose; SU; sulphonylurea; T1DM, type 1 diabetes; T2DM, type 2 diabetes

PRE-RAMADAN ASSESSMENT

Assessments for risk stratification and a focused education plan for all Muslim patients with diabetes should occur six to eight weeks prior to Ramadan. Based on the evaluation, the HCP should advise on fasting. Patients can be reassured that these stratified risk recommendations have been endorsed by religious leaders and scholars.

Those in the exempt category who insist on fasting should be reminded of the Quranic injunction: “Let not your own hands throw you into destruction”.⁴
For fasting individuals, it is essential for the HCP to assist with an individualised management plan, focusing on symptoms of hypoglycaemia or hyperglycaemia, the importance of self monitoring of blood glucose (SMBG), Ramadan nutrition, modification of therapy and management of comorbidities.

It should be emphasised that blood glucose monitoring via pinprick does not break the fast. For those individuals who are not fasting, the HCP should still provide education on appropriate Ramadan nutrition as dietary habits often change during the month.

RAMADAN NUTRITION PLAN

Meals must be planned to avoid hypoglycaemia, dehydration and postprandial hyperglycaemia. Dietary plans should be developed based on individual metabolic, nutritional and lifestyle requirements.

A balanced diet which differs little from the normal everyday diet is advised, limiting foods usually high in sugar and fat i.e. the fast should not be followed by feasting but rather by several smaller meals during the period between iftaar (evening) and suhur (morning). The pre-dawn meal should never be missed.

The daily calorie allowance can be split over two to three smaller meals during the non-fasting interval. Dates, the traditional food used to break the fast, are high in sugar and only two or three should be consumed. Adequate water and low calorie drinks should be consumed in the non-fasting period to reduce risk of dehydration, and caffeine-containing beverages should be limited or avoided.

Dietary macronurient composition must be individualised with a nutritional approach that limits energy from fat (< 30%) and saturated fat (<10%), increases fibre (>15g/1000 kcal) and promotes whole grain, unrefined carbohydrates instead of refined carbohydrates. Simple carbohydrate consumption should be limited to small quantities at iftaar (sunset meal), if at all. Country-specific meal plans have been developed for different regions based on the caloric requirements and specific habits of a region. Ramadan Dietary Recommendations and Meal Plans provides country-specific meal plans appropriate for South Africa.

MONITORING OF BLOOD GLUCOSE

SMBG is important to enable safe fasting as both hyperglycaemia and hypoglycaemia are risks associated with fasting. It must be emphasised that the finger prick glucose testing does not invalidate the fast. The low risk patient may test the glucose once or twice daily, either at iftaar or midday.

The high risk patient is usually on insulin and it is recommended that glucose levels are monitored prior to suhur and iftaar, as well as mid-morning and mid afternoon. In addition, testing is done whenever hypoglycaemia is suspected. A two hour post iftaar test may be useful to detect hyperglycaemia. Patients must receive an adequate supply of test-strips before and during Ramadan.

NON-INSULIN THERAPIES

There is a paucity of well designed, randomised controlled trials assessing the efficacy, tolerability and safety of the various oral glucose lowering drugs (GLDs) when used in Ramadan.
The emergence of DPP 4 inhibitors has led to several studies assessing the role of these agents during the Ramadan fast, especially comparing them to sulphonylureas.

METFORMIN

Metformin is the preferred agent for managing patients with type 2 diabetes mellitus. Metformin carries a very low risk of hypoglycaemia⁴, making it an attractive option for individuals who fast. There are no RCTs looking specifically at the safety and efficacy of metformin as monotherapy during Ramadan.

However, most trials of other GLDs have used metformin as background medication, and no safety issues have been identified.

As metformin appears to be safe, dose modification is probably unnecessary. Some suggestions, if individuals choose to make dose adjustments, include dividing the total daily dose as follows: -

Two thirds at iftaar (evening meal), one third at suhur (morning meal)
Once daily metformin extended-release should be taken at iftaar (evening meal) rather than at suhur

ACARBOSE

No data is available for the use of acarbose as monotherapy in prolonged fasting, although one study comparing it to vildagliptin as monotherapy showed similar glycaemic reduction but poorer tolerability.⁶ Dose adjustment is not required.

ORAL SHORT ACTING INSULIN SECRETAGOGUES (MEGLINIDES)

Studies comparing the use of these agents with sulphonylureas showed either no difference⁷ or improved⁸ glycaemic control, and no difference⁹ or lower risk⁷^,¹⁰ of hypoglycaemia. The glinides (e.g. repaglinide) are short acting but are more expensive and, like sulphonylureas, are associated with weight gain. They can be taken twice daily with meals.

THIAZOLIDINEDIONES

A study comparing pioglitazone use to placebo in Ramadan showed improved glycaemic control, significantly greater weight gain and no increase in hypoglycaemia.⁹ No adjustments of thiazolidinedione dose is necessary, but consider administering the drug at iftaar (evening). Peak onset of action is 10-12 weeks, so therapy should be initiated in advance.

SULPHONYLUREAS

Sulphonylureas vary in their propensity to cause hypoglycaemia, with much lower rates seen with some second generation agents. The use of gliclazide is associated with comparably lower rates of hypoglycaemia, although the modified release preparation has been less well studied in Ramadan.

Switching a once daily dose of glimepiride or gliclazide to iftaar, (evening) as opposed to suhur, (morning) showed no change in glycaemic control¹¹^,¹² or weight,¹² and either no change¹¹ or fewer¹² hypoglycaemic episodes compared to pre-Ramadan.

Comparison of a DPP-4 inhibitor sitagliptin to sulphonylurea use in Ramadan showed more hypoglycaemia with sulphonylureas in general, but similar rates with gliclazide.¹³ A meta-analysis of three randomised controlled trials comparing gliclazide to DPP-4 inhibitors showed no statistical difference in the rates of symptomatic hypoglycaemia.¹⁴

Consider the following dose adjustments:

If taking a single daily dose, consider a switch to iftaar (evening)
If taking the drug twice daily, reduce the morning dose by 50%. e.g. change a twice daily dose of gliclazide 80 mg to 40 mg at suhur (morning), and 80 mg after Iftaar (evening). If taking a higher dose in the morning, take the morning dose at iftaar (evening), and take half the evening dose at suhur (morning)

Gliclazide modified-release is the sulphonylurea of choice because of its consistently better safety profile (Refer to: Glucose Control : Non-Insulin Therapies). Glibenclamide must not be used.

DPP-4 INHIBITORS

A meta-analysis of DPP-4 inhibitor use compared to sulphonylureas as a group showed similar glycaemic efficacy but lower rates of hypoglycaemia in Ramadan.¹⁵ Studies using vildagliptin compared to gliclazide show comparable glycaemic efficacy,¹⁶^,17no difference in weight¹⁷^,18and less hypoglycaemia¹⁶^,17,¹⁸ which was not always significant.

DPP-4 inhibitors are an alternative to sulphonylureas if the risk of hypoglycaemia is high.

If appropriate, consider switching to this class prior to Ramadan.

No dosage adjustments are necessary but if taking a once daily dose, switch to iftaar (evening)

SGLT-2 INHIBITORS

There is little data available for use of these drugs in Ramadan. These agents are associated with a low risk of hypoglycaemia when used as monotherapy in non-fasting individuals. Concerns have been raised about ketoacidosis, and it is important to recognise the potential risk for dehydration, particularly in the elderly, with concomitant diuretic use and also with prolonged fasting in warm or humid climates.

Consider switching daily dose to iftaar (evening).

GLUCAGON-LIKE PEPTIDE-1 AGONISTS

A glucagon-like peptide-1 (GLP-1) agonist can be used safely during Ramadan in combination with metformin^19,20 as well as with sulphonylureas and insulin.²¹ Although there are no studies with exenatide, liraglutide has been safely used in Ramadan with stable glycaemic control, weight loss and a trend to lower rates of hypoglycaemia when compared to sulphonylureas.^1,2

The GLP-1 agonist can be administered at the usual dose and at the usual time although dosing at iftaar (evening) may be preferable.
Patients wishing to fast and requiring the addition of a GLP-1 agonist should be initiated on the drug at least four to six weeks prior to Ramadan to allow dose titration and management of side effects (nausea) before they start fasting.

INSULIN THERAPY
COMMON REGIMENS

Many patients with type 2 diabetes require insulin to control their diabetes and a variety of insulin regimens are used. These include intermediate or long acting basal insulin only (usually combined with oral agents); premix insulin; and basal-bolus insulin, and these can either be human insulin or analogue insulin or a combination. It must be emphasised that the administration of insulin via the subcutaneous, intramuscular or intravenous route does not break the fast.

While in an ideal setting, overnight intermediate acting insulin should be injected with a rapid-acting insulin before meals.²² This is not always easy to implement. Asking patients to change their regimen for Ramadan only may lead to errors, non-adherence and require additional education that is not readily available due to time and resource constraints. The dosing regimen of the insulins used prior to Ramadan may therefore be adjusted to enable safe fasting.

If this is unsuccessful, then a new regimen may be considered. In addition to modification of the insulin regimens, monitoring of blood glucose levels and self-titration of insulin doses while fasting needs to be emphasised to enable safe fasting.

Whilst hypoglycaemia risk may be higher with insulin therapy during Ramadan, there is some evidence that insulin analogues, if used in preference to human insulin, minimises this risk.^23,24 In addition, insulin analogues are associated with less post-prandial hyperglycaemia when compared to human insulin.²⁴

From a practical point, since insulin analogues are injected just before a meal unlike regular insulin; this property is advantageous in that it enables the patient to administer the injection at the time of breaking the fast. It is therefore recommended that patients wishing to fast be switched to insulin analogues for the month of Ramadan if hypoglycaemia, patient convenience and postprandial hyperglycaemia are concerns.²⁵ The starting dose of analogue insulin should be 20-30% less than the dose of regular insulin.²⁵

As with all diabetic therapies, the insulin regimen must be individualised according to the patient’s needs, taking into account their education, preference, diet and lifestyle. If a patient is well controlled prior to Ramadan, it is recommended that the total daily dose be decreased by 20-30% at the start of Ramadan and titrated according to the algorithm below (Table II).

The following serves as a guide on how to initiate some of the common insulin regimens.

Table II: Initiation of some common insulin regimens

Basal Insulin	Consider decreasing dose by 20% in well controlled patients
Once daily dose	Take dose either at Iftaar or bedtime
Twice daily dose	Keep full dose at Iftaar. Half dose at Suhur
Low ratio Premix insulin²⁴
Once daily dose	Same dose given at Iftaar. Titrate doses as per algorithm If still uncontrolled, change to twice daily premix insulin
Twice daily dose	Prescribe the usual morning dose at Iftaar Half the usual evening dose at Suhur Titrate doses as per algorithm
Thrice daily dose	Omit lunch dose. Adjust other doses as twice daily

Table III: Titration of basal/premix insulin doses (adapted from Hassaneinet al²⁵)

Fasting/pre-iftaar/pre-suhur BG	Basal/Premix insulin units*
<3.9 mmol/L or symptoms	Break the fast and down titrate by 2 units
4.0-5.0 mmol/L	−2 IU
5.1-7.0 mmol/L	No change
7.1-16.5 mmol/L	+2 IU
> 16.6 mmol/L	Break the fast and check for ketones Increase dose by 4 units

*Pre-iftaar dose to be adjusted based on pre-suhur BG and pre-suhur dose to be adjusted based on pre-iftaar BG levels

OTHER INSULIN REGIMENS

If evening post-prandial hyperglycaemia persists despite adequate pre-prandial blood glucose levels, then a premixed insulin in a 50:50 ratio of a rapid acting insulin analogue and a neutral protaminated insulin analogue may be used for the iftaar (evening) meal.²⁶

A regimen with pre-suhur (morning) detemir and iftaar (evening) insulin aspart/protamine-crystallised insulin aspart in the ratio 70/30 has also been shown to control glucose levels with a suggestion of less hypoglycaemia.²⁷ However, this will require a significant change for most patients and may lead to errors if education is inadequate.

When basal bolus insulin is used, the basal dose is adjusted as above. The prandial doses are given prior to Iftaar and suhur (morning). These doses should be decreased by 20-30% as well and then titrated to a two hour post-prandial glucose level < 10mmol/L without hypoglycaemia. The lunch time dose is omitted.

INSULIN TITRATION DURING RAMADAN

It is advisable to titrate the insulin dose every three to four days.²⁵ The lowest of the three readings on three consecutive days should be used to up titrate the insulin dose.²⁵

Hypoglycaemia is defined as blood glucose level below 3.9 mmol/L or symptoms of hypoglycaemia. If hypoglycaemia is noted at any time of the day (even close to Iftaar) in any patient on insulin therapy, the fast must be broken and the insulin dose down titrated the following day.²⁵

Authors: Hoosen A Randeree, Mohamed AK Omar and Nazeer A Mohamed
Editors: Tanya E Kinvig and Aslam Amod

References

This guideline was adapted from: International Diabetes Federation and the DAR International Alliance. Diabetes and Ramadan: Practical Guidelines. Brussels, Belgium: International Diabetes Federation, 2016. www.idf.org/guidelines/diabetesin- ramadan and www.daralliance.org. Accessed 22 February 2017.

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Management of Diabetes during Ramadan

Drugs mentioned