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Prof. Megahed Abo El Magd
Professor of Internal Medicine
Faculty of Medicine – Mansoura University
Diabetes & Ramadan
Practical Guidelines
Guidelines recommendations
during Ramadan
 This report provides an update for diabetes management recommendation during Ramadan.
 In order to minimize adverse events related to diabetes such as hypoglycaemia during fasting, patient
education, regular glucose monitoring and adjustment of treatment regimens should occur weeks prior to
Ramadan.
 Patients treated with sulfonylureas and insulin are at highest risk of hypoglycaemia, and such patients need
careful blood glucose monitoring and, if necessary such treatment regimens may be adjusted.
On behalf of the International Group for Diabetes and Ramadan (IGDR)
Agenda
Ramadan Fasting Overview
Physiology of Ramadan Fasting
Risk Stratification of Individuals with Diabetes before Ramadan
Fasting in Diabetic Special populations
Pre-Ramadan education
Diabetes and Ramadan Practical Guidlines4
Agenda
Ramadan Fasting Overview
Physiology of Ramadan Fasting
Risk Stratification of Individuals with Diabetes before Ramadan
Fasting in Diabetic Special populations
Pre-Ramadan education
Diabetes and Ramadan Practical Guidlines5
Global Distribution of the Muslim Community(1)
Ramadan Fasting Overview
North America
3.5 M
0.2%
Europe
43.5 M
2.7 %
Middle East-North Africa
317 M
19.8%
Sub-Sarahan Africa
248.4 M
15.5%
Asia-Pacific
986.4 M
61.7%
Global Muslims
2010 1.6 B
Latin America-Caribbean
0.8 M
<0.1%
Diabetic Muslims
148 Million
Diabetes and Ramadan Practical Guidlines6
Most of Diabetic Muslims have an intense desire to fast during Ramadan(1)
Ramadan Fasting Overview
Fasting
43%
Not
Fasting
57%
T1DM
Fasting Not Fasting
Fasting
79%
Not
Fasting
21%
T2DM
Fasting Not Fasting
According to EPIDIAR Study* in 2001
Up to 79% of Muslims with diabetes fast
for at least 15 days during Ramadan
Diabetes and Ramadan Practical Guidlines7
*The epidemiology of diabetes and Ramadan Study
Agenda
Ramadan Fasting Overview
Physiology of Ramadan Fasting
Risk Stratification of Individuals with Diabetes before Ramadan
Fasting in Diabetic Special populations
Pre-Ramadan education
Diabetes and Ramadan Practical Guidlines10
Physiology of feeding and fasting in healthy individuals(1)
11 Diabetes and Ramadan Practical Guidlines
Physiology of Ramadan Fasting
In a healthy individual,
fasting causes:
• The release of glucose
from glycogen stores
(glycogenolysis)
• The formation of glucose
from non-carbohydrate
substrates
(gluconeogenesis)
Physiology of fasting in patients with Diabetes(1)
12 Diabetes and Ramadan Practical Guidlines
Physiology of Ramadan Fasting
The EPIDIAR study:
4.7-fold and 7.5-fold increase
in the incidence of severe
hypoglycemic complications in
patients with T1DM & T2DM,
respectively, compared with
non-Ramadan periods
Without suitable
management, patients
with diabetes are more
likely to experience
severe hypoglycemia
during Ramadan than in
non- fasting periods
Other metabolic effects of Ramadan fasting in diabetics(1)
13 Diabetes and Ramadan Practical Guidlines
Physiology of Ramadan Fasting
Unchanged in the
majority of patients
with T1DM and T2DM
Both favorable and
unfavorable changes
in Lipid Profile have
been reported
Dehydration Thrombosis
According to The EPIDIAR study
Other metabolic effects of Ramadan fasting in diabetics(1)
14 Diabetes and Ramadan Practical Guidlines
Physiology of Ramadan Fasting
• Dehydration may be compounded in hot climates or in individuals who undertake intensive
physical labor, as well as by osmotic diuresis caused by hyperglycemia.
• Dehydration can lead to hypotension and subsequent falls or other injuries.
• According to a survey in Saudi Arabia, the incidence of retinal vein occlusion increased during
Ramadan when almost 30% of all cases occurred, significantly more than in other months of the
year. Dehydration was proposed to be a possible cause.
Conclusion(1)
15 Diabetes and Ramadan Practical Guidlines
Physiology of Ramadan Fasting
• In patients with diabetes, Ramadan fasting can be
associated with certain risks due to the
pathophysiology that disrupts normal glucose
homeostatic mechanisms.
• Therefore, patients with diabetes, and in particular
those with T1DM, should seek medical advice before
deciding to proceed with Ramadan fasting
Agenda
Ramadan Fasting Overview
Physiology of Ramadan Fasting
Risk Stratification of Individuals with Diabetes before Ramadan
Fasting in Diabetic Special populations
Pre-Ramadan education
Diabetes and Ramadan Practical Guidlines16
Key risks associated with fasting for patients with diabetes(1)
17 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
RisksDiabetic
ketoacidosis
Hyperglycemia
Hypoglycemia
Dehydration
&
Thrombosis
Healthcare professionals:
• Must be conscious of the
risks associated with fasting.
• Should quantify and stratify
the risks for every patient
individually.
in order to provide the best
possible care.
According to EPIDIAR Study(1)
18 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
Diabetic
ketoacidosis
Hyperglycemia
Hypoglycemia
Dehydration
&
Thrombosis
T1DM T2DM
The major risks associated with
fasting (hypoglycemia and
hyperglycemia) are the same
challenges that people with diabetes
face on a daily basis; however,
studies have shown that fasting
may increase the risk of these
events occurring
Meals during Ramadan(1)
19 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
• Meals eaten during Ramadan are often large and
contain fried and sugary food which can have an
impact on blood glucose control.
• Fluctuations in blood glucose levels, particularly
postprandial hyperglycemia, have been linked
with oxidative stress and platelet activation as
well as the development of cardiovascular
disease in people with diabetes.
Risk quantification(1)
20 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
Factors for risk quantification
Type of
diabetes
Patient
medications
Individual
hypoglycemic
risk
Presence of
complications
and/or
comorbidities
Individual
social and
work
circumstances
Previous
Ramadan
experience
Risk stratification(1)
21 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
The 2005 American Diabetes Association (ADA) recommendations for management of
diabetes during Ramadan and its 2010 update categorized people with diabetes into
four risk groups:
- Very high risk - High Risk - Moderate Risk - Low Risk
Surprisingly, the numbers of days fasted by the highest and the lowest risk group only
varied by 3 days, indicating that either:
• These risk categories are not efficiently applied by HCPs.
OR
• People with diabetes are ignoring these medical recommendations despite the fact
that they are recognized by religious leaders.
Risk stratification(1)
22 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
• Patients who are in the two highest categories of risk are advised not to fast; however, many
of these patients will choose to do so and this must be respected.
• Patients who insist on fasting need to be aware of the risks associated with fasting, and of
techniques to decrease this risk.
• It is also worth highlighting that the initial risk assessment could change in time according to
a number of factors.
• For example, a person with T2DM with poor glycemic control is considered to be at high risk.
If control improves pre-Ramadan and the choice of treatment does not include multiple insulin
injections, then such a person would be considered to be at moderate risk.
Key Points
Approaches to Minimize Hazards Risks(1)
23 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
Structured
Education
Regular self-
monitoring of
blood glucose
levels (SMBG)
Medication
Adjustments
Nutritional
and Exercise
Advice
Pre-Ramadan
Assessment
IDF-DAR risk categories for patients with diabetes in Ramadan(1)
24 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
Risk category Patient characteristics Comments
Category 1:
very high risk
Listen to
medical advice
MUST NOT fast
• One or more of the following:
• Severe hypoglycemia within the 3 months prior to
Ramadan.
• DKA within the 3 months prior to Ramadan.
• Hyperosmolar hyperglycemic coma within the 3 months
prior to Ramadan.
• History of recurrent hypoglycemia
• History of hypoglycemia 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 hyperglycemia.
• Be prepared to stop the fast in case of
frequent hypo- or hyperglycemia or
worsening of other related medical
conditions.
IDF-DAR risk categories for patients with diabetes in Ramadan(1)
25 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
Risk category Patient characteristics Comments
Category 2:
high risk
Listen to
medical advice
Should NOT fast
One or more of the following:
• T2DM with sustained poor glycemic 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
risk factors
• People with diabetes performing intense physical labor
• Treatment with drugs that may 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 hyperglycemia.
• Be prepared to stop the fast in case of
frequent hypo- or hyperglycemia or
worsening of other related medical
conditions
IDF-DAR risk categories for patients with diabetes in Ramadan(1)
26 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
Risk category Patient characteristics Comments
Category 3:
moderate/low
risk
Listen to medical
advice
Decision to use
license 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
– Thiazolidinedione's
– 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
IDF-DAR risk categories for patients with diabetes in Ramadan(1)
27 Diabetes and Ramadan Practical Guidlines
Risk Stratification of Individuals with Diabetes before Ramadan
It is important to have unification between HCPs and religious leaders on
which patients with diabetes should fast and who should seek exemption
The new diabetes and Ramadan fasting risk categorizations described in
IDF-DAR Practical Guidelines have been approved by the Mofty of Egypt
Key Points
Agenda
Ramadan Fasting Overview
Physiology of Ramadan Fasting
Risk Stratification of Individuals with Diabetes before Ramadan
Fasting in Diabetic Special populations
Pre-Ramadan education
Diabetes and Ramadan Practical Guidlines28
Type 1 Diabetes(1)
29 Diabetes and Ramadan Practical Guidlines
Fasting in Diabetic Special populations
• People with T1DM will be advised not to fast because of the risks of severe complications.
• Recent studies involving young adults suggest that many of these patients can fast safely if:
 The patient is stable
 Healthy
 Has good hypoglycemic awareness
 Complies with their individualized management plan under medical supervision.
Key Points
Type 1 Diabetes(1)
30 Diabetes and Ramadan Practical Guidlines
Fasting in Diabetic Special populations
Study involving 33 adolescent children with
T1DM found that:
• 60.6% completed the fast without any serious
problems.
• These children and their caregivers were
given intensive training and education on
insulin adjustment, SMBG, and nutrition
before Ramadan and were closely monitored
during the month-long fast.
• In total, five cases of mild hypoglycemia and
no cases of DKA were recorded.
Study involving 21 adolescents with T1DM also
found that a majority (76%) could fast for at least
25 days.
However, the use of continuous glucose
monitoring equipment in this study
demonstrated that blood glucose levels
fluctuated and some episodes of hypoglycemia
went unrecognized, suggesting that regular
SMBG during fasting is vital.
The findings also highlighted the importance of
thorough attention to hypoglycemia
unawareness in these circumstance.
Type 1 Diabetes(1)
31 Diabetes and Ramadan Practical Guidlines
Fasting in Diabetic Special populations
Strategies to ensure safety of individuals with T1DM who choose to fast
include
Ramadan-
focused medical
education
Pre-Ramadan
medical
assessment
including robust
assessment of
hypoglycemia
awareness
Following a
healthy diet and
physical activity
pattern
Modification of
insulin regimen
Frequent SMBG
or continuous
Glucose
monitoring
The Elderly(1)
32 Diabetes and Ramadan Practical Guidlines
Fasting in Diabetic Special populations
• Many older people have enjoyed fasting during Ramadan for many years and they should not
be categorized as high risk based on a specific age but rather on health status and their social
circumstances.
• Many elderly people, especially those who have suffered with diabetes for a prolonged period,
will have comorbidities that impact on the safety of fasting and present additional challenges
to the HCPs managing them.
• Assessments of functional capacity and cognition need to be performed and the care
provided should be adapted accordingly.
• The current risk categorization considers those with old age combined with ill health as very
high risk, however, old age on its own is not considered as an additional risk factor for
fasting.
• The choice of anti-diabetic agents, which carry varying risks for hypoglycemia, should also be
considered.
Key Points
Pregnant women(1)
33 Diabetes and Ramadan Practical Guidlines
Fasting in Diabetic Special populations
Of Muslim pregnancies
overlap with Ramadan.
The risk to both the mother
and fetus mean that
pregnant women are exempt
from fasting
Many of these women will
choose to fast
Pregnant women(1)
34 Diabetes and Ramadan Practical Guidlines
Fasting in Diabetic Special populations
We should take into consideration the differences between pregnancy in pre-existing diabetes
and gestational diabetes mellitus (GDM). Some important factors to consider include:
• Pregnancy in pre-existing diabetes affects the pregnant woman throughout the duration of
pregnancy, compared to the relatively shorter duration of GDM which normally develops
during the second or third trimester.
• The type of diabetes medication the woman with diabetes uses pre-pregnancy: incretins or
thiazolidinediones are considered relatively low risk with regards to safety for fasting.
However, during pregnancy, the vast majority of women with T2DM would be treated with
insulin, metformin or glibenclamide. Insulin and glibenclamide carry a higher risk of
hypoglycemia if fasting.
Key Points
Pregnant women(1)
35 Diabetes and Ramadan Practical Guidlines
Fasting in Diabetic Special populations
• Many are concerned about hypoglycemia in Ramadan, however, for pregnant women
hyperglycemia is associated with increased risk for both mother and baby. For this reason
pregnant women with pre-existing diabetes or GDM are advised not to fast until further research
data are available to support any change in risk category
Key Points
Pregnant women are exempt from fasting
Agenda
Ramadan Fasting Overview
Physiology of Ramadan Fasting
Risk Stratification of Individuals with Diabetes before Ramadan
Fasting in Diabetic Special populations
Pre-Ramadan education
Diabetes and Ramadan Practical Guidlines36
Ramadan-Focused Diabetes Education in Brief(1)
37 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan EducationEducationObjectives
• To raise
awareness of the
risks associated
with diabetes
and fasting.
• To provide
strategies to
minimize the
risk.
EducationDesign
• Simple.
• Engaging.
• Delivered with
cultural
sensitivity.
• Delivered by well
informed
individuals.
EducationOutcome
• Enabling patients
with diabetes to
maintain and
improve glycemic
control during
and after fasting.
Targets of Ramadan-Focused Diabetes Education(1)
38 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan Education
TARGETS
Healthcare
professionals
Patients with
diabetes
General
public
Only 2/3 of patients with
diabetes received
recommendations from their
HCPs regarding
management of their
condition during Ramadan
EPIDIAR Study
• 96% of physicians provided
advice to fasting patients.
• Only 63% used guidelines or
recommendations to do so.
• Only 67% of physicians used
a Ramadan focused
educational programme
CREED Study*
*Multi-country retrospective observational study of the
management and outcomes of patients with Type 2
diabetes during Ramadan in 2010 (CREED)
HCPs as target for Ramadan-Focused Diabetes Education(1)
39 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan Education
HCPs should be trained to deliver Ramadan-focused diabetes education in
a culturally sensitive manner
HCPs should be knowledgeable
and adequately trained for the
provision of appropriate advice
and optimal diabetes care
HCPs should be trained to
recognize and understand the
different cultural and religious
aspects of fasting and how these
may impact on the management
of diabetes
For example, they should
understand the religious feelings
of patients who insist on fasting
despite having an illness that
could potentially exempt them
Patients as target for Ramadan-Focused Diabetes Education(1)
40 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan Education
Key
components of a
Ramadan-focused
educ. Prog.
Risk
quantitation
When to
break Fast
Medication
Adjustment
Blood
glucose
monitoring
Exercise
advice
Fluids and
dietary
advice
Patients as target for Ramadan-Focused Diabetes Education(1)
44 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan Education
Blood
glucose
monitoring
Dietary advice for patients with diabetes during Ramadan
Divide daily calories between suhoor and iftar, plus 1–2 snacks if necessary
Ensure meals are well balanced
• 45–50% carbohydrate • 20–30% protein • <35% fat (preferably mono and polyunsaturated)
Include low glycemic index, high fibre foods that release energy slowly before and after fasting
• E.g. granary bread, beans, rice
Include plenty of fruit, vegetables and salads
Minimize foods that are high in saturated fats
• E.g. ghee, samosas, pakoras
Avoid sugary desserts
Use small amounts of oil when cooking
• E.g. olive, rapeseed
Keep hydrated between sunset and sunrise by drinking water or other non sweetened beverages
Avoid caffeinated and sweetened drinks
Patients as target for Ramadan-Focused Diabetes Education(1)
48 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan Education
Blood
glucose
monitoring
Fluids and
dietary
advice
Exercise
advice
Medication
Adjustment
When to break the fast ?
• All patients should break their fast if:
 Blood glucose <70 mg/dL (3.9 mmol/L)
 re-check within 1 h if blood glucose 7090 mg/dL (3.95.0 mmol/L)
 Blood glucose >300 mg/dL (16.6 mmol/L)*
 Symptoms of hypoglycemia, hyperglycemia, dehydration or acute illness occur
* Consider individualization of care
Hypoglycemia
• Trembling
• Sweating/chills
• Palpitations
• Hunger
• Altered mental status
• Confusion
• Headache
Hyperglycemia
• Extreme thirst
• Hunger
• Frequent urination
• Fatigue
• Confusion
• Nausea/vomiting
• Abdominal pain
Ramadan Nutrition Plan (RNP)(1)
51 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan Education
Blood
glucose
monitoring
Fluids and
dietary
advice
Exercise
advice
Medication
Adjustment
The 10 principles of the RNP
Based on the goal of achieving optimal Medical Nutrition Therapy during Ramadan, the
principles of the RNP are defined as:
1. Consume an adequate amount of total daily calories and divide them between suhoor,
iftar and if necessary, 1–2 snacks.
2. Meals should be balanced, with carbohydrates (low GI preferred) comprising around
45–50%; protein (legumes, fish, poultry or lean meat) comprising 20–30%; and fat
(mono and polyunsaturated fat preferred) comprising <35% of the meal. Saturated fat
should be limited to <10% of the total daily caloric intake.
3. Use the “Ramadan plate” method for designing meals.
Ramadan Nutrition Plan (RNP)(1)
52 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan Education
Blood
glucose
monitoring
Fluids and
dietary
advice
Exercise
advice
Medication
Adjustment
The 10 principles of the RNP
4. Sugar-heavy desserts should be avoided after iftar and between meals. A moderate
amount of healthy dessert is permitted, for example a piece of fruit.
5. Select carbohydrates with low GI, particularly those high in fibre (preferably whole
grains). Consumption of carbohydrates from vegetables (cooked and raw), whole fruits,
yoghurt and dairy products is encouraged. Consumption of carbohydrates from sugar
and highly processed grains (wheat flour and starches like corn, white rice and potato)
should be avoided or significantly minimized.
Ramadan Nutrition Plan (RNP)(1)
53 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan Education
Blood
glucose
monitoring
Fluids and
dietary
advice
Exercise
advice
Medication
Adjustment
The 10 principles of the RNP
6. Maintaining adequate hydration by drinking enough water and non-sweetened
beverages at or between the two main meals is important and should be encouraged
(diet beverages may be consumed). Sugary drinks, canned juices or fresh juices with
added sugar should be avoided. Consumption of caffeinated drinks (coffee, tea as well
as cola drinks) should be minimized as they are diuretics.
7. Take suhoor as late as possible, especially when fasting for >10 hours.
8. Consume an adequate amount of protein and fat at suhoor as foods with higher levels
of these macronutrients and lower levels of carbohydrate have a lower GI than
carbohydrate-rich foods, and do not have an immediate effect on postprandial blood
glucose. Protein and fat also induce satiety better than carbohydrates.
Ramadan Nutrition Plan (RNP)(1)
54 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan Education
Blood
glucose
monitoring
Fluids and
dietary
advice
Exercise
advice
Medication
Adjustment
The 10 principles of the RNP
9. Iftar should begin with plenty of water to overcome dehydration from fasting, and 1–2
dried or fresh dates to raise blood glucose levels.
10. If needed, a snack of one piece of fruit, a handful of nuts, or vegetables may be
consumed between meals. Generally, each snack should be 100–200 calories, but this
may be higher depending on the individual’s caloric requirement. Some individuals may
use a snack to break fasting and then eat iftar later in the evening.
Ramadan Nutrition Plan (RNP)(1)
55 Diabetes and Ramadan Practical Guidlines
Pre-Ramadan Education
Blood
glucose
monitoring
Fluids and
dietary
advice
Exercise
advice
Medication
Adjustment
Example of a Ramadan plate*
*Plate to be adapted according to the individual’s daily
caloric target
Agenda
Ramadan Fasting Overview
Physiology of Ramadan Fasting
Risk Stratification of Individuals with Diabetes before Ramadan
Fasting in Diabetic Special populations
Pre-Ramadan education
Diabetes and Ramadan Practical Guidlines56
It is safe for patients with T2DM treated with metformin monotherapy to fast during
Ramadan
No RCTs have been conducted on metformin monotherapy in fasting patients with diabetes
However, the risk of hypoglycaemia is low for this medication so fasting
is considered safe
RCT, randomised controlled trial; T2DM, type 2 diabetes
Patients with diabetes on
METFORMIN may need to
ADJUST THEIR
MEDICATION during
Ramadan
Changes to metformin dosing during Ramadan
No dose modification
usually required
Take at iftar
No dose modification
usually required
Take at iftar
and suhoor
Morning dose
to be taken before
suhoor
Combine afternoon
dose with dose
taken at iftar
No dose
modification
usually required
Take at iftar
Three times
daily dosing
Twice-daily
dosing
Once-daily
dosing
Prolonged-
release
metformin
It is safe for patients with T2DM treated with acarbose to fast during Ramadan
No RCTs have been conducted on acarbose monotherapy in fasting patients with diabetes
However, the risk of hypoglycaemia is low for this medication so fasting is considered safe
RCT, randomised controlled trial; T2DM, type 2 diabetes
NO DOSE ADJUSTMENTS are required for ACARBOSE during Ramadan
Pioglitazone, a TZD, is associated with a low risk of hypoglycaemia
One study has evaluated the effects of pioglitazone in fasting patients during Ramadan1
OAD, oral anti-diabetic drug; RCT, randomised controlled trial;
TZD, thiazolidinediones 1. Vasan S, Thomas N, Bharani AM, et al. 2006.
Study drug Comparator Study details Hypoglycaemia Glycaemic control
Additional
observations
Pioglitazone
(plus OADs)
Placebo
n=86,
double-blind RCT,
(India)
No significant difference in
hypoglycaemic events
between groups
Fructosamine levels
significantly lower on
pioglitazone throughout
Ramadan and after
Body weight
significantly increased
on pioglitazone
NO DOSE MODIFICATION of PIOGLITAZONE is required
during Ramadan and doses can be taken with iftar or suhoor
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Short-acting insulin secretagogues are taken before meals and carry a low risk
of hypoglycaemia
• The short duration of action makes the use of these drugs
(e.g. repaglinide, nateglinide) appealing during Ramadan
• Three observational studies and two RCTs have evaluated the use
of repaglinide during Ramadan
RCT, randomised controlled trial; SU, sulphonylurea
1. Bakiner O, Ertorer ME, Bozkirli, et al. 2009.
2. Sari R, Balci MK, Akbas SH, et al. 2004.
3. Cesur M, Corapcioglu D, Gursoy A, et al. 2007.
4. Anwar A, Aszmi K, Hamidon B, et al. 2006.
5. Mafauzy M. 2002.
The daily dose of SHORT-ACTING INSULIN SECRETAGOGUES
(based on a three-meal dosing) may be REDUCED or REDISTRIBUTED
to two doses during Ramadan according to meal size
Observational studies
• In two studies, no hypoglycaemic events were reported
for patients treated with repaglinide1,2
• In the third study, no significant difference in hypoglycaemic events was
observed on repaglinide treatment compared with insulin glargine or SU
therapy3
RCTs
• A low incidence of hypoglycaemic events was associated with repaglinide in
both studies4,5
• Hypoglycaemic events occurred in similar proportions of patients treated with
repaglinide and SU therapy4
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
The risk of hypoglycaemia decreases with second-generation SUs
• Studies have shown that the proportion of patients experiencing a hypoglycaemic event while
fasting is consistently lower for second-generation SUs
SU, sulphonylurea
Aravind S, Al Tayeb K, Ismail SB, et al. 2011.
Aravind SR, Ismail SB, Balamurugan R, et al. 2012.
Al-Arouj M, Hassoun A, Medlej R, et al. 2013.
Al Sifri S, Basiounny A, Echtay A, et al. 2011.
25.6
31.8
19.7
9.1
16.8
17.9
12.4
5.2
14.0
19.2
6.6
1.8
0
20
40
60
Aravind et al, 2011 (n=1,378) Al-Arouj et al, 2013 (n=1315) Al Sifri et al, 2011 (n=1066) Aravind et al, 2012 (n=870)
Patientsexperiencing≥1hypoglycaemicevent(%)
Glibenclamide Glimepiride Gliclazide
Proportion of patients (%) experiencing a hypoglycaemic event
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Sulphonylureas need dose adjustment if they are used by fasting
patients with diabetes
BG, blood glucose; OAD, oral anti-diabetic drug;
SU, sulphonylureas; T2DM, type 2 diabetes
The use of SUs should be individualised following clinician guidance and MEDICATIONS ADJUSTED as outlined
here
Changes to SU dosing during Ramadan
Iftar dose remains the same
In patients with well-controlled BG
levels, the suhoor dose should be
reduced
Twice-daily
dosing
Take at iftar
In patients with well-controlled BG levels
the dose may be reduced
Once-daily
dosing
Older drugs (e.g. glibenclamide)
with a higher risk of hypoglycaemia should
be avoided
Second-generation SUs
(glicazide,glimepiride) should be used in
preference
Older drugs
in the class
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
SGLT2 inhibitors are considered suitable and safe for some
patients during Ramadan1
SGLT2, sodium-glucose co-transporter-2; T2DM, type 2 diabetes 1. Beshyah SA, Chatterjee S, and Davies MJ. 2016.
Survey of doctors
regarding the management of patients with
T2DM
receiving SGLT2 inhibitors who intend to fast
during Ramadan
197 participants mainly from the Middle East
and North Africa responded to a web-based
questionnaire
• Majority (92.2%) would advise patients to take the SGLT2 inhibitor with iftar
• The importance of taking on extra clear fluids during the evening after a fast was highlighted
16.2 13.2
70.6
0
20
40
60
80
100
General use No use Selective use
Respondents(%)
Opinion on the use of SGLT2 inhibitors in patients with T2DM who
choose to fast during Ramadan
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Due to safety concerns, SGLT2 inhibitors are not recommended for
some patients during Ramadan
SGLT2, sodium-glucose co-transporter-2;
T2DM, type 2 diabetes .
SGLT2 inhibitors can be used with CAUTION in some patients.
NO DOSE ADJUSTMENTS are required. It is advised that the dose is taken with iftar
Patients with T2DM deemed more
at risk of complications should
not be treated with
SGLT2 inhibitors
The elderly
Patients with renal impairment
Hypotensive individuals
Those at risk of dehydration
Those taking diuretics
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Relative risk of hypoglycaemia is reduced with sitagliptin therapy
compared with SU treatment
*≥2 of glimepiride, gliclazide, glibenclamide or glipizide
CI, confidence interval; RR, risk ratio; SU, sulphonylurea
1. Al Sifri S, Basiounny A, Echtay A, et al. 2011.
2. Aravind SR, Ismail SB, Balamurugan R, et al. 2012.
Patients with T2DM treated with sitagliptin
or SU
Open-label, randomised, controlled
trial conducted in MENA
(n=1,066)1
Risk of hypoglycaemia significantly decreased on the
sitagliptin-based regimen
RR [95% CI] = 0.51 [0.34, 0.75] (p<0.001)
Patients with T2DM treated with sitagliptin
or SU
Open-label, randomised, controlled
trial conducted in India and Malaysia (n=870)2
Risk of hypoglycaemia significantly decreased on the
sitagliptin-based regimen
RR [95% CI] = 0.52 [0.29, 0.94] (p=0.028)
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
The advantages of vildagliptin and sitagliptin* therapy during
Ramadan
DPP-4, dipeptidyl peptidase
Low risk of
hypoglycaemia
Maintain good glycaemic
control*
Do not require dose
titration prior to Ramadan
Taken orally
Taken independently of
meals
Not associated with
weight gain
DPP-4 inhibitors DO NOT REQUIRE TREATMENT MODIFICATIONS during Ramadan
Vildagliptin/sitag
liptin
Other drugs in this
class may also
present with these
advantages but
evidence during
Ramadan is lacking
*No Glycaemic control data in Ramadan for Sitagliptin
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Summary
• Newer anti-diabetic drugs are associated with a lower risk of hypoglycaemia
• Incretin-based therapies, such as DPP-4 inhibitors and GLP-1 RAs,
do not require dose modifications during Ramadan
• These factors may make the use of these drugs preferable during Ramadan
• SGLT2 inhibitors are probably safe but should be used with caution
in some patients
• More data regarding the use of SGLT2 inhibitors during Ramadan
are required
DPP-4, dipeptidyl peptidase-4;
GLP-1 RA, glucagon-like peptide-1 receptor agonist;
SGLT2, sodium-glucose co-transporter-2
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
The use of insulin analogues is recommended over regular human
insulin during Ramadan
BG, blood glucose; IS, insulin secretagogue;
NPH, neutral protamine Hagedorn; OAD, oral anti-diabetic drug;
RCT, randomised controlled trial; Ref, reference; SU, sulphonylurea;
T2DM, type 2 diabetes
Cesur M, Corapcioglu D, Gursoy A, et al. 2007.
Akram J and De Verga V. 1999.
Bakiner O, Ertorer ME, Bozkirli E, et al. 2009.
Cesur et al, 2007
Observational
n=65
No significant increases in hypoglycaemia observed with insulin glargine
treatment during Ramadan compared with repaglinide or glimepiride
Akram et al, 1999
Open-label, crossover, randomised study
n=68
Compared the effects of rapid-acting analogue insulin
lispro and short-acting soluble human insulin, taken before iftar during
Ramadan
Postprandial rise in blood glucose levels after iftar and the rate of
hypoglycaemia were both significantly lower in the lispro group
Bakiner et al, 2009
Observational
n=19
No significant increases in hypoglycaemia observed with insulin glargine
treatment during Ramadan compared with non-fasting group
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Premixed insulins may provide better glycaemic control during
Ramadan than soluble insulin
BL, baseline; HbA1c, glycated haemoglobin; NR, not reported;
NS, not significant; OAD, oral anti-diabetic drug;
RCT, randomised controlled trial; Ref, reference; SU, sulphonylurea
1. Hui E, Bravis V, Salih S, et al. 2010.
2. Mattoo V, Milicevic Z, Malone JK, et al. 2003.
3. Shehadeh N and Maor Y. 2015.
4. Soewondo P, Adam JM, Sanusi H, et al. 2009.
Study
drug
Comparator
Additional
medication
Study details Hypoglycaemia
Glycaemic
control
Ref
Lispro Mix50
(evening)/ human
insulin Mix30
(morning)
Human insulin
Mix30 (twice
daily)
NR
n=52
Observational
No significant difference in
events between groups
HbA1c change:
Lispro Mix50/human insulin
Mix30 ↓0.48%, Human insulin
mix30 ↑0.28% (p=0.0004)
1
Lispro Mix25
Soluble insulin
30/70
NR
n=151
Open-label
crossover RCT
Similar for both groups
Daily glycaemia: Lispro
Mix25<soluble insulin
(p=0.004)
2
Insulin detemir/
biphasic insulin
aspart
Standard care
Metformin, SU
in some patients
n=245
Open-label RCT
Patients experiencing events:
Intervention
<standard care (p<0.001)
Intervention was non-inferior to
standard care
3
Biphasic insulin
aspart
None
OADs in some
patients
n=152
Observational
Events: End of study<BL (NS)
Biphasic insulin aspart
significantly reduced all
glycaemic indices
4
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Patients are advised to monitor their blood glucose several times
during the day1
Recommended timings to check blood glucose levels during Ramadan fasting
Levels should be checked at any time when
symptoms of hypoglycaemia are
recognised
Midday/Noon
12 Midday 12:00
3
Morning
Suhoor/dawn
Afternoon
Iftar/sunset
Morning Evening
12 Midnight 00:00
Midnight
2
1
4
5
6
7
pm
am
DAY
NIGHT
1. Pre-dawn meal (suhoor)
2. Morning
3. Midday
4. Mid-afternoon
5. Pre-sunset meal (iftar)
6. 2-hours after iftar
7. At any time when there are symptoms
of hypoglycaemia/hyperglycaemia or feeling unwell
1. Hassanein M, Belhadj M, Abdallah K, et al. 2014.
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Dose adjustments for long- or short-acting insulins are
recommended during Ramadan
* Adjust the insulin dose taken before suhoor
**Adjust the insulin dose taken before iftar
BG, blood glucose; NPH, neutral protamine Hagedorn; T1DM, type 1 diabetes; T2DM, type 2 diabetes .
Fasting/pre-iftar/ pre-suhoor BG
Pre-iftar* Post-iftar*/ post-suhoor**
Basal insulin Short-acting insulin
<70 mg/dL (3.9 mmol/L) or symptoms Reduce by 4 units Reduce by 4 units
70–90 mg/dL (3.9–5.0 mmol/L) Reduce by 2 units Reduce by 2 units
90–130 mg/dL (5.0–7.2 mmol/L) No change required No change required
130–200 mg/dL (7.2–11.1 mmol/L) Increase by 2 units Increase by 2 units
>200 mg/dL (11.1 mmol/L) Increase by 4 units Increase by 4 units
Changes to long- and short-acting insulin dosing during Ramadan
Long/intermediate-acting (basal) insulin Short-acting insulin
Normal dose at iftar
Omit lunch-time dose
Reduce suhoor dose
by 25–50%
NPH/determir/glargine/degludec once-daily
Reduce dose by 15–30% Take at iftar
NPH/determir/glargine twice-daily
Take usual morning dose at iftar
Reduce evening dose by 50% and take at suhoor
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
BG, blood glucose; T1DM, type 1 diabetes; T2DM, type 2 diabetes 1. Hassanein M, Belhadj B, Abdallah, et al. 2014.
Dose adjustments for premixed insulins are recommended during
Ramadan1
Fasting/pre-iftar/pre-suhoor BG Premixed insulin modification
<70 mg/dL (3.9 mmol/L) or symptoms Reduce by 4 units
70–90 mg/dL (3.9–5.0 mmol/L) Reduce by 2 units
90–126 mg/dL (5.0–7.0 mmol/L) No change required
126–200 mg/dL (7.0–11.1 mmol/L) Increase by 2 units
>200 mg/dL (11.1 mmol/L) Increase by 4 units
Changes to premixed insulin dosing during Ramadan
Once-daily dosing
Take normal dose at iftar
Three times daily dosingTwice-daily dosing
Take normal dose at iftar
Reduce suhoor dose by 25–50%
Omit afternoon dose
Adjust iftar and suhoor doses
Carry out dose-titration every 3
days (see below)
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Patients treated with insulin pumps should adjust the dosing
during Ramadan fasting
T1DM, type 1 diabetes; T2DM type 2 diabetes
1. Benbarka MM, Khalil AB, Beshyah SA, et al. 2010.
2. Khalil AB, Beshyah SA, Abu Awad SM, et al. 2012.
3. Bin-Abbas BS. 2008.
Patients with T2DM and poor glycaemic control
despite multiple daily injections may benefit from an
insulin
pump system
There are no data for insulin
pump use during Ramadan for
patients with T2DM
Studies in adults and
adolescents with T1DM suggest it may be possible to
fast safely using insulin pumps1–3
Changes to insulin pump use during Ramadan
Bolus rate
Normal carbohydrate counting
and insulin sensitivity
principles apply
Basal rate
Reduce dose by
20–40% in the last 3–4 hours of
fasting
Increase dose by
0–30% early after iftar
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Adolescents with T1DM should not fast
• A small number of studies have investigated fasting in adolescents with T1DM but patient numbers are very
low1–5
• The general consensus is that some can fast safely if they fulfil the following criteria:
MDI, multiple daily injections; SMBG, self-monitoring of blood glucose; T1DM, type 1 diabetes
1. AlAlwan I and Banyan AA. 2010.
2. Al-Khawari M, Al-Ruwayeh A, Al-Doub K, et al. 2010.
3. Zabeen B, Tayyeb S, Benarjee B, et al. 2014.
4. Bin-Abbas BS. 2008.
5. Kaplan W and Afandi B. 2015.
Good hypoglycaemic awareness
Good pre-Ramadan
glycaemic control
Knowledge and willingness
to SMBG levels
Ability to adjust medication
as needed
Changes to MDI dosing for adolescents
during Ramadan
Short-acting
insulin
Long/intermediate-acting insulin
Normal dose at iftar
Reduce suhoor
dose by 25–50%
Reduce dose by 30–40%
Take at iftar
IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines
Pregnant women are stratified as very high risk and are advised
not to fast
BG, blood glucose; SU, sulphonylurea
1. Almond D and Mazumder B. 2011.
2. Alwasel SH, Abotalib Z, Aljarallah JS, et al. 2010.
• Although studies have demonstrated that fasting in pregnancy is associated with foetal and long-
term health implications, many pregnant women will observe the fast during Ramadan1,2
Fasting during pregnancy is an important personal decision
Patients should receive focused education relating to
self-management skills including modifications to diet and insulin regimens
and frequent BG monitoring to ensure good pregnancy outcomes
Those who insist on fasting should be managed by an expert team
Those on SU and/or insulin treatments should be
strongly discouraged due to a higher risk of hypoglycaemia
The potential effects on mother and foetus should be fully explained
Thank You
References
1) Diabetes and Ramadan: Practical Guidelines. International Diabetes Federation (IDF), in collaboration with the Diabetes and Ramadan
(DAR) International Alliance. April 2016. Published by the International Diabetes Federation.
78 Diabetes and Ramadan Practical Guidlines

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Prof. megahed abo el magd presentation

  • 1. Prof. Megahed Abo El Magd Professor of Internal Medicine Faculty of Medicine – Mansoura University Diabetes & Ramadan Practical Guidelines
  • 3.  This report provides an update for diabetes management recommendation during Ramadan.  In order to minimize adverse events related to diabetes such as hypoglycaemia during fasting, patient education, regular glucose monitoring and adjustment of treatment regimens should occur weeks prior to Ramadan.  Patients treated with sulfonylureas and insulin are at highest risk of hypoglycaemia, and such patients need careful blood glucose monitoring and, if necessary such treatment regimens may be adjusted. On behalf of the International Group for Diabetes and Ramadan (IGDR)
  • 4. Agenda Ramadan Fasting Overview Physiology of Ramadan Fasting Risk Stratification of Individuals with Diabetes before Ramadan Fasting in Diabetic Special populations Pre-Ramadan education Diabetes and Ramadan Practical Guidlines4
  • 5. Agenda Ramadan Fasting Overview Physiology of Ramadan Fasting Risk Stratification of Individuals with Diabetes before Ramadan Fasting in Diabetic Special populations Pre-Ramadan education Diabetes and Ramadan Practical Guidlines5
  • 6. Global Distribution of the Muslim Community(1) Ramadan Fasting Overview North America 3.5 M 0.2% Europe 43.5 M 2.7 % Middle East-North Africa 317 M 19.8% Sub-Sarahan Africa 248.4 M 15.5% Asia-Pacific 986.4 M 61.7% Global Muslims 2010 1.6 B Latin America-Caribbean 0.8 M <0.1% Diabetic Muslims 148 Million Diabetes and Ramadan Practical Guidlines6
  • 7. Most of Diabetic Muslims have an intense desire to fast during Ramadan(1) Ramadan Fasting Overview Fasting 43% Not Fasting 57% T1DM Fasting Not Fasting Fasting 79% Not Fasting 21% T2DM Fasting Not Fasting According to EPIDIAR Study* in 2001 Up to 79% of Muslims with diabetes fast for at least 15 days during Ramadan Diabetes and Ramadan Practical Guidlines7 *The epidemiology of diabetes and Ramadan Study
  • 8. Agenda Ramadan Fasting Overview Physiology of Ramadan Fasting Risk Stratification of Individuals with Diabetes before Ramadan Fasting in Diabetic Special populations Pre-Ramadan education Diabetes and Ramadan Practical Guidlines10
  • 9. Physiology of feeding and fasting in healthy individuals(1) 11 Diabetes and Ramadan Practical Guidlines Physiology of Ramadan Fasting In a healthy individual, fasting causes: • The release of glucose from glycogen stores (glycogenolysis) • The formation of glucose from non-carbohydrate substrates (gluconeogenesis)
  • 10. Physiology of fasting in patients with Diabetes(1) 12 Diabetes and Ramadan Practical Guidlines Physiology of Ramadan Fasting The EPIDIAR study: 4.7-fold and 7.5-fold increase in the incidence of severe hypoglycemic complications in patients with T1DM & T2DM, respectively, compared with non-Ramadan periods Without suitable management, patients with diabetes are more likely to experience severe hypoglycemia during Ramadan than in non- fasting periods
  • 11. Other metabolic effects of Ramadan fasting in diabetics(1) 13 Diabetes and Ramadan Practical Guidlines Physiology of Ramadan Fasting Unchanged in the majority of patients with T1DM and T2DM Both favorable and unfavorable changes in Lipid Profile have been reported Dehydration Thrombosis According to The EPIDIAR study
  • 12. Other metabolic effects of Ramadan fasting in diabetics(1) 14 Diabetes and Ramadan Practical Guidlines Physiology of Ramadan Fasting • Dehydration may be compounded in hot climates or in individuals who undertake intensive physical labor, as well as by osmotic diuresis caused by hyperglycemia. • Dehydration can lead to hypotension and subsequent falls or other injuries. • According to a survey in Saudi Arabia, the incidence of retinal vein occlusion increased during Ramadan when almost 30% of all cases occurred, significantly more than in other months of the year. Dehydration was proposed to be a possible cause.
  • 13. Conclusion(1) 15 Diabetes and Ramadan Practical Guidlines Physiology of Ramadan Fasting • In patients with diabetes, Ramadan fasting can be associated with certain risks due to the pathophysiology that disrupts normal glucose homeostatic mechanisms. • Therefore, patients with diabetes, and in particular those with T1DM, should seek medical advice before deciding to proceed with Ramadan fasting
  • 14. Agenda Ramadan Fasting Overview Physiology of Ramadan Fasting Risk Stratification of Individuals with Diabetes before Ramadan Fasting in Diabetic Special populations Pre-Ramadan education Diabetes and Ramadan Practical Guidlines16
  • 15. Key risks associated with fasting for patients with diabetes(1) 17 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan RisksDiabetic ketoacidosis Hyperglycemia Hypoglycemia Dehydration & Thrombosis Healthcare professionals: • Must be conscious of the risks associated with fasting. • Should quantify and stratify the risks for every patient individually. in order to provide the best possible care.
  • 16. According to EPIDIAR Study(1) 18 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan Diabetic ketoacidosis Hyperglycemia Hypoglycemia Dehydration & Thrombosis T1DM T2DM The major risks associated with fasting (hypoglycemia and hyperglycemia) are the same challenges that people with diabetes face on a daily basis; however, studies have shown that fasting may increase the risk of these events occurring
  • 17. Meals during Ramadan(1) 19 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan • Meals eaten during Ramadan are often large and contain fried and sugary food which can have an impact on blood glucose control. • Fluctuations in blood glucose levels, particularly postprandial hyperglycemia, have been linked with oxidative stress and platelet activation as well as the development of cardiovascular disease in people with diabetes.
  • 18. Risk quantification(1) 20 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan Factors for risk quantification Type of diabetes Patient medications Individual hypoglycemic risk Presence of complications and/or comorbidities Individual social and work circumstances Previous Ramadan experience
  • 19. Risk stratification(1) 21 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan The 2005 American Diabetes Association (ADA) recommendations for management of diabetes during Ramadan and its 2010 update categorized people with diabetes into four risk groups: - Very high risk - High Risk - Moderate Risk - Low Risk Surprisingly, the numbers of days fasted by the highest and the lowest risk group only varied by 3 days, indicating that either: • These risk categories are not efficiently applied by HCPs. OR • People with diabetes are ignoring these medical recommendations despite the fact that they are recognized by religious leaders.
  • 20. Risk stratification(1) 22 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan • Patients who are in the two highest categories of risk are advised not to fast; however, many of these patients will choose to do so and this must be respected. • Patients who insist on fasting need to be aware of the risks associated with fasting, and of techniques to decrease this risk. • It is also worth highlighting that the initial risk assessment could change in time according to a number of factors. • For example, a person with T2DM with poor glycemic control is considered to be at high risk. If control improves pre-Ramadan and the choice of treatment does not include multiple insulin injections, then such a person would be considered to be at moderate risk. Key Points
  • 21. Approaches to Minimize Hazards Risks(1) 23 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan Structured Education Regular self- monitoring of blood glucose levels (SMBG) Medication Adjustments Nutritional and Exercise Advice Pre-Ramadan Assessment
  • 22. IDF-DAR risk categories for patients with diabetes in Ramadan(1) 24 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan Risk category Patient characteristics Comments Category 1: very high risk Listen to medical advice MUST NOT fast • One or more of the following: • Severe hypoglycemia within the 3 months prior to Ramadan. • DKA within the 3 months prior to Ramadan. • Hyperosmolar hyperglycemic coma within the 3 months prior to Ramadan. • History of recurrent hypoglycemia • History of hypoglycemia 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 hyperglycemia. • Be prepared to stop the fast in case of frequent hypo- or hyperglycemia or worsening of other related medical conditions.
  • 23. IDF-DAR risk categories for patients with diabetes in Ramadan(1) 25 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan Risk category Patient characteristics Comments Category 2: high risk Listen to medical advice Should NOT fast One or more of the following: • T2DM with sustained poor glycemic 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 risk factors • People with diabetes performing intense physical labor • Treatment with drugs that may 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 hyperglycemia. • Be prepared to stop the fast in case of frequent hypo- or hyperglycemia or worsening of other related medical conditions
  • 24. IDF-DAR risk categories for patients with diabetes in Ramadan(1) 26 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan Risk category Patient characteristics Comments Category 3: moderate/low risk Listen to medical advice Decision to use license 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 – Thiazolidinedione's – 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
  • 25. IDF-DAR risk categories for patients with diabetes in Ramadan(1) 27 Diabetes and Ramadan Practical Guidlines Risk Stratification of Individuals with Diabetes before Ramadan It is important to have unification between HCPs and religious leaders on which patients with diabetes should fast and who should seek exemption The new diabetes and Ramadan fasting risk categorizations described in IDF-DAR Practical Guidelines have been approved by the Mofty of Egypt Key Points
  • 26. Agenda Ramadan Fasting Overview Physiology of Ramadan Fasting Risk Stratification of Individuals with Diabetes before Ramadan Fasting in Diabetic Special populations Pre-Ramadan education Diabetes and Ramadan Practical Guidlines28
  • 27. Type 1 Diabetes(1) 29 Diabetes and Ramadan Practical Guidlines Fasting in Diabetic Special populations • People with T1DM will be advised not to fast because of the risks of severe complications. • Recent studies involving young adults suggest that many of these patients can fast safely if:  The patient is stable  Healthy  Has good hypoglycemic awareness  Complies with their individualized management plan under medical supervision. Key Points
  • 28. Type 1 Diabetes(1) 30 Diabetes and Ramadan Practical Guidlines Fasting in Diabetic Special populations Study involving 33 adolescent children with T1DM found that: • 60.6% completed the fast without any serious problems. • These children and their caregivers were given intensive training and education on insulin adjustment, SMBG, and nutrition before Ramadan and were closely monitored during the month-long fast. • In total, five cases of mild hypoglycemia and no cases of DKA were recorded. Study involving 21 adolescents with T1DM also found that a majority (76%) could fast for at least 25 days. However, the use of continuous glucose monitoring equipment in this study demonstrated that blood glucose levels fluctuated and some episodes of hypoglycemia went unrecognized, suggesting that regular SMBG during fasting is vital. The findings also highlighted the importance of thorough attention to hypoglycemia unawareness in these circumstance.
  • 29. Type 1 Diabetes(1) 31 Diabetes and Ramadan Practical Guidlines Fasting in Diabetic Special populations Strategies to ensure safety of individuals with T1DM who choose to fast include Ramadan- focused medical education Pre-Ramadan medical assessment including robust assessment of hypoglycemia awareness Following a healthy diet and physical activity pattern Modification of insulin regimen Frequent SMBG or continuous Glucose monitoring
  • 30. The Elderly(1) 32 Diabetes and Ramadan Practical Guidlines Fasting in Diabetic Special populations • Many older people have enjoyed fasting during Ramadan for many years and they should not be categorized as high risk based on a specific age but rather on health status and their social circumstances. • Many elderly people, especially those who have suffered with diabetes for a prolonged period, will have comorbidities that impact on the safety of fasting and present additional challenges to the HCPs managing them. • Assessments of functional capacity and cognition need to be performed and the care provided should be adapted accordingly. • The current risk categorization considers those with old age combined with ill health as very high risk, however, old age on its own is not considered as an additional risk factor for fasting. • The choice of anti-diabetic agents, which carry varying risks for hypoglycemia, should also be considered. Key Points
  • 31. Pregnant women(1) 33 Diabetes and Ramadan Practical Guidlines Fasting in Diabetic Special populations Of Muslim pregnancies overlap with Ramadan. The risk to both the mother and fetus mean that pregnant women are exempt from fasting Many of these women will choose to fast
  • 32. Pregnant women(1) 34 Diabetes and Ramadan Practical Guidlines Fasting in Diabetic Special populations We should take into consideration the differences between pregnancy in pre-existing diabetes and gestational diabetes mellitus (GDM). Some important factors to consider include: • Pregnancy in pre-existing diabetes affects the pregnant woman throughout the duration of pregnancy, compared to the relatively shorter duration of GDM which normally develops during the second or third trimester. • The type of diabetes medication the woman with diabetes uses pre-pregnancy: incretins or thiazolidinediones are considered relatively low risk with regards to safety for fasting. However, during pregnancy, the vast majority of women with T2DM would be treated with insulin, metformin or glibenclamide. Insulin and glibenclamide carry a higher risk of hypoglycemia if fasting. Key Points
  • 33. Pregnant women(1) 35 Diabetes and Ramadan Practical Guidlines Fasting in Diabetic Special populations • Many are concerned about hypoglycemia in Ramadan, however, for pregnant women hyperglycemia is associated with increased risk for both mother and baby. For this reason pregnant women with pre-existing diabetes or GDM are advised not to fast until further research data are available to support any change in risk category Key Points Pregnant women are exempt from fasting
  • 34. Agenda Ramadan Fasting Overview Physiology of Ramadan Fasting Risk Stratification of Individuals with Diabetes before Ramadan Fasting in Diabetic Special populations Pre-Ramadan education Diabetes and Ramadan Practical Guidlines36
  • 35. Ramadan-Focused Diabetes Education in Brief(1) 37 Diabetes and Ramadan Practical Guidlines Pre-Ramadan EducationEducationObjectives • To raise awareness of the risks associated with diabetes and fasting. • To provide strategies to minimize the risk. EducationDesign • Simple. • Engaging. • Delivered with cultural sensitivity. • Delivered by well informed individuals. EducationOutcome • Enabling patients with diabetes to maintain and improve glycemic control during and after fasting.
  • 36. Targets of Ramadan-Focused Diabetes Education(1) 38 Diabetes and Ramadan Practical Guidlines Pre-Ramadan Education TARGETS Healthcare professionals Patients with diabetes General public Only 2/3 of patients with diabetes received recommendations from their HCPs regarding management of their condition during Ramadan EPIDIAR Study • 96% of physicians provided advice to fasting patients. • Only 63% used guidelines or recommendations to do so. • Only 67% of physicians used a Ramadan focused educational programme CREED Study* *Multi-country retrospective observational study of the management and outcomes of patients with Type 2 diabetes during Ramadan in 2010 (CREED)
  • 37. HCPs as target for Ramadan-Focused Diabetes Education(1) 39 Diabetes and Ramadan Practical Guidlines Pre-Ramadan Education HCPs should be trained to deliver Ramadan-focused diabetes education in a culturally sensitive manner HCPs should be knowledgeable and adequately trained for the provision of appropriate advice and optimal diabetes care HCPs should be trained to recognize and understand the different cultural and religious aspects of fasting and how these may impact on the management of diabetes For example, they should understand the religious feelings of patients who insist on fasting despite having an illness that could potentially exempt them
  • 38. Patients as target for Ramadan-Focused Diabetes Education(1) 40 Diabetes and Ramadan Practical Guidlines Pre-Ramadan Education Key components of a Ramadan-focused educ. Prog. Risk quantitation When to break Fast Medication Adjustment Blood glucose monitoring Exercise advice Fluids and dietary advice
  • 39. Patients as target for Ramadan-Focused Diabetes Education(1) 44 Diabetes and Ramadan Practical Guidlines Pre-Ramadan Education Blood glucose monitoring Dietary advice for patients with diabetes during Ramadan Divide daily calories between suhoor and iftar, plus 1–2 snacks if necessary Ensure meals are well balanced • 45–50% carbohydrate • 20–30% protein • <35% fat (preferably mono and polyunsaturated) Include low glycemic index, high fibre foods that release energy slowly before and after fasting • E.g. granary bread, beans, rice Include plenty of fruit, vegetables and salads Minimize foods that are high in saturated fats • E.g. ghee, samosas, pakoras Avoid sugary desserts Use small amounts of oil when cooking • E.g. olive, rapeseed Keep hydrated between sunset and sunrise by drinking water or other non sweetened beverages Avoid caffeinated and sweetened drinks
  • 40. Patients as target for Ramadan-Focused Diabetes Education(1) 48 Diabetes and Ramadan Practical Guidlines Pre-Ramadan Education Blood glucose monitoring Fluids and dietary advice Exercise advice Medication Adjustment When to break the fast ? • All patients should break their fast if:  Blood glucose <70 mg/dL (3.9 mmol/L)  re-check within 1 h if blood glucose 7090 mg/dL (3.95.0 mmol/L)  Blood glucose >300 mg/dL (16.6 mmol/L)*  Symptoms of hypoglycemia, hyperglycemia, dehydration or acute illness occur * Consider individualization of care Hypoglycemia • Trembling • Sweating/chills • Palpitations • Hunger • Altered mental status • Confusion • Headache Hyperglycemia • Extreme thirst • Hunger • Frequent urination • Fatigue • Confusion • Nausea/vomiting • Abdominal pain
  • 41. Ramadan Nutrition Plan (RNP)(1) 51 Diabetes and Ramadan Practical Guidlines Pre-Ramadan Education Blood glucose monitoring Fluids and dietary advice Exercise advice Medication Adjustment The 10 principles of the RNP Based on the goal of achieving optimal Medical Nutrition Therapy during Ramadan, the principles of the RNP are defined as: 1. Consume an adequate amount of total daily calories and divide them between suhoor, iftar and if necessary, 1–2 snacks. 2. Meals should be balanced, with carbohydrates (low GI preferred) comprising around 45–50%; protein (legumes, fish, poultry or lean meat) comprising 20–30%; and fat (mono and polyunsaturated fat preferred) comprising <35% of the meal. Saturated fat should be limited to <10% of the total daily caloric intake. 3. Use the “Ramadan plate” method for designing meals.
  • 42. Ramadan Nutrition Plan (RNP)(1) 52 Diabetes and Ramadan Practical Guidlines Pre-Ramadan Education Blood glucose monitoring Fluids and dietary advice Exercise advice Medication Adjustment The 10 principles of the RNP 4. Sugar-heavy desserts should be avoided after iftar and between meals. A moderate amount of healthy dessert is permitted, for example a piece of fruit. 5. Select carbohydrates with low GI, particularly those high in fibre (preferably whole grains). Consumption of carbohydrates from vegetables (cooked and raw), whole fruits, yoghurt and dairy products is encouraged. Consumption of carbohydrates from sugar and highly processed grains (wheat flour and starches like corn, white rice and potato) should be avoided or significantly minimized.
  • 43. Ramadan Nutrition Plan (RNP)(1) 53 Diabetes and Ramadan Practical Guidlines Pre-Ramadan Education Blood glucose monitoring Fluids and dietary advice Exercise advice Medication Adjustment The 10 principles of the RNP 6. Maintaining adequate hydration by drinking enough water and non-sweetened beverages at or between the two main meals is important and should be encouraged (diet beverages may be consumed). Sugary drinks, canned juices or fresh juices with added sugar should be avoided. Consumption of caffeinated drinks (coffee, tea as well as cola drinks) should be minimized as they are diuretics. 7. Take suhoor as late as possible, especially when fasting for >10 hours. 8. Consume an adequate amount of protein and fat at suhoor as foods with higher levels of these macronutrients and lower levels of carbohydrate have a lower GI than carbohydrate-rich foods, and do not have an immediate effect on postprandial blood glucose. Protein and fat also induce satiety better than carbohydrates.
  • 44. Ramadan Nutrition Plan (RNP)(1) 54 Diabetes and Ramadan Practical Guidlines Pre-Ramadan Education Blood glucose monitoring Fluids and dietary advice Exercise advice Medication Adjustment The 10 principles of the RNP 9. Iftar should begin with plenty of water to overcome dehydration from fasting, and 1–2 dried or fresh dates to raise blood glucose levels. 10. If needed, a snack of one piece of fruit, a handful of nuts, or vegetables may be consumed between meals. Generally, each snack should be 100–200 calories, but this may be higher depending on the individual’s caloric requirement. Some individuals may use a snack to break fasting and then eat iftar later in the evening.
  • 45. Ramadan Nutrition Plan (RNP)(1) 55 Diabetes and Ramadan Practical Guidlines Pre-Ramadan Education Blood glucose monitoring Fluids and dietary advice Exercise advice Medication Adjustment Example of a Ramadan plate* *Plate to be adapted according to the individual’s daily caloric target
  • 46. Agenda Ramadan Fasting Overview Physiology of Ramadan Fasting Risk Stratification of Individuals with Diabetes before Ramadan Fasting in Diabetic Special populations Pre-Ramadan education Diabetes and Ramadan Practical Guidlines56
  • 47. It is safe for patients with T2DM treated with metformin monotherapy to fast during Ramadan No RCTs have been conducted on metformin monotherapy in fasting patients with diabetes However, the risk of hypoglycaemia is low for this medication so fasting is considered safe RCT, randomised controlled trial; T2DM, type 2 diabetes Patients with diabetes on METFORMIN may need to ADJUST THEIR MEDICATION during Ramadan Changes to metformin dosing during Ramadan No dose modification usually required Take at iftar No dose modification usually required Take at iftar and suhoor Morning dose to be taken before suhoor Combine afternoon dose with dose taken at iftar No dose modification usually required Take at iftar Three times daily dosing Twice-daily dosing Once-daily dosing Prolonged- release metformin
  • 48. It is safe for patients with T2DM treated with acarbose to fast during Ramadan No RCTs have been conducted on acarbose monotherapy in fasting patients with diabetes However, the risk of hypoglycaemia is low for this medication so fasting is considered safe RCT, randomised controlled trial; T2DM, type 2 diabetes NO DOSE ADJUSTMENTS are required for ACARBOSE during Ramadan
  • 49. Pioglitazone, a TZD, is associated with a low risk of hypoglycaemia One study has evaluated the effects of pioglitazone in fasting patients during Ramadan1 OAD, oral anti-diabetic drug; RCT, randomised controlled trial; TZD, thiazolidinediones 1. Vasan S, Thomas N, Bharani AM, et al. 2006. Study drug Comparator Study details Hypoglycaemia Glycaemic control Additional observations Pioglitazone (plus OADs) Placebo n=86, double-blind RCT, (India) No significant difference in hypoglycaemic events between groups Fructosamine levels significantly lower on pioglitazone throughout Ramadan and after Body weight significantly increased on pioglitazone NO DOSE MODIFICATION of PIOGLITAZONE is required during Ramadan and doses can be taken with iftar or suhoor
  • 50. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Short-acting insulin secretagogues are taken before meals and carry a low risk of hypoglycaemia • The short duration of action makes the use of these drugs (e.g. repaglinide, nateglinide) appealing during Ramadan • Three observational studies and two RCTs have evaluated the use of repaglinide during Ramadan RCT, randomised controlled trial; SU, sulphonylurea 1. Bakiner O, Ertorer ME, Bozkirli, et al. 2009. 2. Sari R, Balci MK, Akbas SH, et al. 2004. 3. Cesur M, Corapcioglu D, Gursoy A, et al. 2007. 4. Anwar A, Aszmi K, Hamidon B, et al. 2006. 5. Mafauzy M. 2002. The daily dose of SHORT-ACTING INSULIN SECRETAGOGUES (based on a three-meal dosing) may be REDUCED or REDISTRIBUTED to two doses during Ramadan according to meal size Observational studies • In two studies, no hypoglycaemic events were reported for patients treated with repaglinide1,2 • In the third study, no significant difference in hypoglycaemic events was observed on repaglinide treatment compared with insulin glargine or SU therapy3 RCTs • A low incidence of hypoglycaemic events was associated with repaglinide in both studies4,5 • Hypoglycaemic events occurred in similar proportions of patients treated with repaglinide and SU therapy4
  • 51. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines The risk of hypoglycaemia decreases with second-generation SUs • Studies have shown that the proportion of patients experiencing a hypoglycaemic event while fasting is consistently lower for second-generation SUs SU, sulphonylurea Aravind S, Al Tayeb K, Ismail SB, et al. 2011. Aravind SR, Ismail SB, Balamurugan R, et al. 2012. Al-Arouj M, Hassoun A, Medlej R, et al. 2013. Al Sifri S, Basiounny A, Echtay A, et al. 2011. 25.6 31.8 19.7 9.1 16.8 17.9 12.4 5.2 14.0 19.2 6.6 1.8 0 20 40 60 Aravind et al, 2011 (n=1,378) Al-Arouj et al, 2013 (n=1315) Al Sifri et al, 2011 (n=1066) Aravind et al, 2012 (n=870) Patientsexperiencing≥1hypoglycaemicevent(%) Glibenclamide Glimepiride Gliclazide Proportion of patients (%) experiencing a hypoglycaemic event
  • 52. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Sulphonylureas need dose adjustment if they are used by fasting patients with diabetes BG, blood glucose; OAD, oral anti-diabetic drug; SU, sulphonylureas; T2DM, type 2 diabetes The use of SUs should be individualised following clinician guidance and MEDICATIONS ADJUSTED as outlined here Changes to SU dosing during Ramadan Iftar dose remains the same In patients with well-controlled BG levels, the suhoor dose should be reduced Twice-daily dosing Take at iftar In patients with well-controlled BG levels the dose may be reduced Once-daily dosing Older drugs (e.g. glibenclamide) with a higher risk of hypoglycaemia should be avoided Second-generation SUs (glicazide,glimepiride) should be used in preference Older drugs in the class
  • 53. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines SGLT2 inhibitors are considered suitable and safe for some patients during Ramadan1 SGLT2, sodium-glucose co-transporter-2; T2DM, type 2 diabetes 1. Beshyah SA, Chatterjee S, and Davies MJ. 2016. Survey of doctors regarding the management of patients with T2DM receiving SGLT2 inhibitors who intend to fast during Ramadan 197 participants mainly from the Middle East and North Africa responded to a web-based questionnaire • Majority (92.2%) would advise patients to take the SGLT2 inhibitor with iftar • The importance of taking on extra clear fluids during the evening after a fast was highlighted 16.2 13.2 70.6 0 20 40 60 80 100 General use No use Selective use Respondents(%) Opinion on the use of SGLT2 inhibitors in patients with T2DM who choose to fast during Ramadan
  • 54. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Due to safety concerns, SGLT2 inhibitors are not recommended for some patients during Ramadan SGLT2, sodium-glucose co-transporter-2; T2DM, type 2 diabetes . SGLT2 inhibitors can be used with CAUTION in some patients. NO DOSE ADJUSTMENTS are required. It is advised that the dose is taken with iftar Patients with T2DM deemed more at risk of complications should not be treated with SGLT2 inhibitors The elderly Patients with renal impairment Hypotensive individuals Those at risk of dehydration Those taking diuretics
  • 55. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Relative risk of hypoglycaemia is reduced with sitagliptin therapy compared with SU treatment *≥2 of glimepiride, gliclazide, glibenclamide or glipizide CI, confidence interval; RR, risk ratio; SU, sulphonylurea 1. Al Sifri S, Basiounny A, Echtay A, et al. 2011. 2. Aravind SR, Ismail SB, Balamurugan R, et al. 2012. Patients with T2DM treated with sitagliptin or SU Open-label, randomised, controlled trial conducted in MENA (n=1,066)1 Risk of hypoglycaemia significantly decreased on the sitagliptin-based regimen RR [95% CI] = 0.51 [0.34, 0.75] (p<0.001) Patients with T2DM treated with sitagliptin or SU Open-label, randomised, controlled trial conducted in India and Malaysia (n=870)2 Risk of hypoglycaemia significantly decreased on the sitagliptin-based regimen RR [95% CI] = 0.52 [0.29, 0.94] (p=0.028)
  • 56. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines The advantages of vildagliptin and sitagliptin* therapy during Ramadan DPP-4, dipeptidyl peptidase Low risk of hypoglycaemia Maintain good glycaemic control* Do not require dose titration prior to Ramadan Taken orally Taken independently of meals Not associated with weight gain DPP-4 inhibitors DO NOT REQUIRE TREATMENT MODIFICATIONS during Ramadan Vildagliptin/sitag liptin Other drugs in this class may also present with these advantages but evidence during Ramadan is lacking *No Glycaemic control data in Ramadan for Sitagliptin
  • 57. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Summary • Newer anti-diabetic drugs are associated with a lower risk of hypoglycaemia • Incretin-based therapies, such as DPP-4 inhibitors and GLP-1 RAs, do not require dose modifications during Ramadan • These factors may make the use of these drugs preferable during Ramadan • SGLT2 inhibitors are probably safe but should be used with caution in some patients • More data regarding the use of SGLT2 inhibitors during Ramadan are required DPP-4, dipeptidyl peptidase-4; GLP-1 RA, glucagon-like peptide-1 receptor agonist; SGLT2, sodium-glucose co-transporter-2
  • 58. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines The use of insulin analogues is recommended over regular human insulin during Ramadan BG, blood glucose; IS, insulin secretagogue; NPH, neutral protamine Hagedorn; OAD, oral anti-diabetic drug; RCT, randomised controlled trial; Ref, reference; SU, sulphonylurea; T2DM, type 2 diabetes Cesur M, Corapcioglu D, Gursoy A, et al. 2007. Akram J and De Verga V. 1999. Bakiner O, Ertorer ME, Bozkirli E, et al. 2009. Cesur et al, 2007 Observational n=65 No significant increases in hypoglycaemia observed with insulin glargine treatment during Ramadan compared with repaglinide or glimepiride Akram et al, 1999 Open-label, crossover, randomised study n=68 Compared the effects of rapid-acting analogue insulin lispro and short-acting soluble human insulin, taken before iftar during Ramadan Postprandial rise in blood glucose levels after iftar and the rate of hypoglycaemia were both significantly lower in the lispro group Bakiner et al, 2009 Observational n=19 No significant increases in hypoglycaemia observed with insulin glargine treatment during Ramadan compared with non-fasting group
  • 59. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Premixed insulins may provide better glycaemic control during Ramadan than soluble insulin BL, baseline; HbA1c, glycated haemoglobin; NR, not reported; NS, not significant; OAD, oral anti-diabetic drug; RCT, randomised controlled trial; Ref, reference; SU, sulphonylurea 1. Hui E, Bravis V, Salih S, et al. 2010. 2. Mattoo V, Milicevic Z, Malone JK, et al. 2003. 3. Shehadeh N and Maor Y. 2015. 4. Soewondo P, Adam JM, Sanusi H, et al. 2009. Study drug Comparator Additional medication Study details Hypoglycaemia Glycaemic control Ref Lispro Mix50 (evening)/ human insulin Mix30 (morning) Human insulin Mix30 (twice daily) NR n=52 Observational No significant difference in events between groups HbA1c change: Lispro Mix50/human insulin Mix30 ↓0.48%, Human insulin mix30 ↑0.28% (p=0.0004) 1 Lispro Mix25 Soluble insulin 30/70 NR n=151 Open-label crossover RCT Similar for both groups Daily glycaemia: Lispro Mix25<soluble insulin (p=0.004) 2 Insulin detemir/ biphasic insulin aspart Standard care Metformin, SU in some patients n=245 Open-label RCT Patients experiencing events: Intervention <standard care (p<0.001) Intervention was non-inferior to standard care 3 Biphasic insulin aspart None OADs in some patients n=152 Observational Events: End of study<BL (NS) Biphasic insulin aspart significantly reduced all glycaemic indices 4
  • 60. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Patients are advised to monitor their blood glucose several times during the day1 Recommended timings to check blood glucose levels during Ramadan fasting Levels should be checked at any time when symptoms of hypoglycaemia are recognised Midday/Noon 12 Midday 12:00 3 Morning Suhoor/dawn Afternoon Iftar/sunset Morning Evening 12 Midnight 00:00 Midnight 2 1 4 5 6 7 pm am DAY NIGHT 1. Pre-dawn meal (suhoor) 2. Morning 3. Midday 4. Mid-afternoon 5. Pre-sunset meal (iftar) 6. 2-hours after iftar 7. At any time when there are symptoms of hypoglycaemia/hyperglycaemia or feeling unwell 1. Hassanein M, Belhadj M, Abdallah K, et al. 2014.
  • 61. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Dose adjustments for long- or short-acting insulins are recommended during Ramadan * Adjust the insulin dose taken before suhoor **Adjust the insulin dose taken before iftar BG, blood glucose; NPH, neutral protamine Hagedorn; T1DM, type 1 diabetes; T2DM, type 2 diabetes . Fasting/pre-iftar/ pre-suhoor BG Pre-iftar* Post-iftar*/ post-suhoor** Basal insulin Short-acting insulin <70 mg/dL (3.9 mmol/L) or symptoms Reduce by 4 units Reduce by 4 units 70–90 mg/dL (3.9–5.0 mmol/L) Reduce by 2 units Reduce by 2 units 90–130 mg/dL (5.0–7.2 mmol/L) No change required No change required 130–200 mg/dL (7.2–11.1 mmol/L) Increase by 2 units Increase by 2 units >200 mg/dL (11.1 mmol/L) Increase by 4 units Increase by 4 units Changes to long- and short-acting insulin dosing during Ramadan Long/intermediate-acting (basal) insulin Short-acting insulin Normal dose at iftar Omit lunch-time dose Reduce suhoor dose by 25–50% NPH/determir/glargine/degludec once-daily Reduce dose by 15–30% Take at iftar NPH/determir/glargine twice-daily Take usual morning dose at iftar Reduce evening dose by 50% and take at suhoor
  • 62. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines BG, blood glucose; T1DM, type 1 diabetes; T2DM, type 2 diabetes 1. Hassanein M, Belhadj B, Abdallah, et al. 2014. Dose adjustments for premixed insulins are recommended during Ramadan1 Fasting/pre-iftar/pre-suhoor BG Premixed insulin modification <70 mg/dL (3.9 mmol/L) or symptoms Reduce by 4 units 70–90 mg/dL (3.9–5.0 mmol/L) Reduce by 2 units 90–126 mg/dL (5.0–7.0 mmol/L) No change required 126–200 mg/dL (7.0–11.1 mmol/L) Increase by 2 units >200 mg/dL (11.1 mmol/L) Increase by 4 units Changes to premixed insulin dosing during Ramadan Once-daily dosing Take normal dose at iftar Three times daily dosingTwice-daily dosing Take normal dose at iftar Reduce suhoor dose by 25–50% Omit afternoon dose Adjust iftar and suhoor doses Carry out dose-titration every 3 days (see below)
  • 63. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Patients treated with insulin pumps should adjust the dosing during Ramadan fasting T1DM, type 1 diabetes; T2DM type 2 diabetes 1. Benbarka MM, Khalil AB, Beshyah SA, et al. 2010. 2. Khalil AB, Beshyah SA, Abu Awad SM, et al. 2012. 3. Bin-Abbas BS. 2008. Patients with T2DM and poor glycaemic control despite multiple daily injections may benefit from an insulin pump system There are no data for insulin pump use during Ramadan for patients with T2DM Studies in adults and adolescents with T1DM suggest it may be possible to fast safely using insulin pumps1–3 Changes to insulin pump use during Ramadan Bolus rate Normal carbohydrate counting and insulin sensitivity principles apply Basal rate Reduce dose by 20–40% in the last 3–4 hours of fasting Increase dose by 0–30% early after iftar
  • 64. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Adolescents with T1DM should not fast • A small number of studies have investigated fasting in adolescents with T1DM but patient numbers are very low1–5 • The general consensus is that some can fast safely if they fulfil the following criteria: MDI, multiple daily injections; SMBG, self-monitoring of blood glucose; T1DM, type 1 diabetes 1. AlAlwan I and Banyan AA. 2010. 2. Al-Khawari M, Al-Ruwayeh A, Al-Doub K, et al. 2010. 3. Zabeen B, Tayyeb S, Benarjee B, et al. 2014. 4. Bin-Abbas BS. 2008. 5. Kaplan W and Afandi B. 2015. Good hypoglycaemic awareness Good pre-Ramadan glycaemic control Knowledge and willingness to SMBG levels Ability to adjust medication as needed Changes to MDI dosing for adolescents during Ramadan Short-acting insulin Long/intermediate-acting insulin Normal dose at iftar Reduce suhoor dose by 25–50% Reduce dose by 30–40% Take at iftar
  • 65. IDF-DAR Practical GuidelinesIDF-DAR Practical Guidelines Pregnant women are stratified as very high risk and are advised not to fast BG, blood glucose; SU, sulphonylurea 1. Almond D and Mazumder B. 2011. 2. Alwasel SH, Abotalib Z, Aljarallah JS, et al. 2010. • Although studies have demonstrated that fasting in pregnancy is associated with foetal and long- term health implications, many pregnant women will observe the fast during Ramadan1,2 Fasting during pregnancy is an important personal decision Patients should receive focused education relating to self-management skills including modifications to diet and insulin regimens and frequent BG monitoring to ensure good pregnancy outcomes Those who insist on fasting should be managed by an expert team Those on SU and/or insulin treatments should be strongly discouraged due to a higher risk of hypoglycaemia The potential effects on mother and foetus should be fully explained
  • 67. References 1) Diabetes and Ramadan: Practical Guidelines. International Diabetes Federation (IDF), in collaboration with the Diabetes and Ramadan (DAR) International Alliance. April 2016. Published by the International Diabetes Federation. 78 Diabetes and Ramadan Practical Guidlines