Ueda2016 recommendations for management of diabetes during ramadan

1. Recommendations for Management of
Diabetes during Ramadan - Update 2015
International Group for Diabetes and Ramadan
IGDR

4.  Most people take two meals (Iftar and Suhur).
 Sick people are exempted from the duty of fasting.
 Diabetic patients fall in this category because of both acute and chronic
complications.
 This is not a simple permission but the prophet Mohammad (POH) said
“God likes his permission to be fulfilled, as he likes his will to be executed”.
 Many patients insist on fasting putting a real challenge to the medical system.
Introduction
‫أخر‬ ‫ايام‬ ‫من‬ ‫فعدة‬ ‫سفر‬ ‫على‬ ‫او‬ ‫مريضا‬ ‫منكم‬ ‫كان‬ ‫فمن‬

5. 1. Individual decision.
2. Religious practice.
3. Medical opinion.
To fast or not to fast
Religion Medicine
Person

6. Magnitude of the problem
Prevalence of diabetes: 6.9%
Type 1 diabetes ~ 43% Type 2 diabetes ~ 79%
More than 55 million people with diabetes worldwide fast
during Ramadan.
Results of the epidemiology of diabetes and Ramadan 1422/2001( EPIDIAR) study. Diabetes care 2004;27:2306-2311

7. RISKS ASSOCIATED WITH
FASTING IN PATIENTS
WITH DIABETES
During Ramadan
 Hypoglycemia
 Hyperglycemia
 Ketoacidosis
 Dehydration & Thrombosis
After Ramadan
 Glycemic Control A1C
 Body Weight

8. HYPOGLYCEMIA
 The EPIDIAR study
Fasting during Ramadan increased the risk of severe hypoglycemia:
4.7-fold in patients with type 1 diabetes
7.5-fold in patients with type 2 diabetes
 Severe hypoglycemia was more frequent in:
1. Patients in whom the dosage and timing of oral hypoglycemic
agents or insulin were not adjusted.
2. Patients who reported a significant change in their lifestyle.
Results of the epidemiology of diabetes and Ramadan 1422/2001( EPIDIAR) study. Diabetes care 2004;27:2306-2311

9. HYPERGLYCEMIA
 EPIDIAR study
1. Due to excessive
reduction in
dosages of
medications to
prevent
hypoglycemia.
2. Increase
food/sugar
intake.
Results of the epidemiology of diabetes and Ramadan 1422/2001( EPIDIAR) study. Diabetes care 2004;27:2306-2311
5x
3x

10. DIABETIC KETOACIDOSIS
 Pre-Ramadan poorly controlled type 1 diabetic patients, are at
increased risk for development of diabetic ketoacidosis during
fasting.
 The risk may be further increased due to excessive reduction of
insulin dosages based on the assumption that food intake is
reduced during Ramadan.

11. DEHYDRATION& THROMBOSIS
 Diabetic patients exhibit a hypercoagulable state due to:
1. Increase in clotting factors.
2. Decrease in endogenous anticoagulants.
3. Impaired fibrinolysis.
 Increased blood viscosity secondary to dehydration may enhance
the risk of thrombosis and stroke.
 Some medications may cause dehydration e.g SGLT2 .
 However, no strong evidence for increased hospitalizations due to
coronary events or stroke during Ramadan.

12. Safer Fasting
 Pre Ramadan Assessment and Education
 Self Monitoring
 Nutrition
 Physical activity
 Breaking the Fast
 Medication adjustment

13. PRE-RAMADAN ASSESSMENT
 1–2 months before Ramadan.
 Medical assessment and engagement in a structured education
program to undertake the fast as safely as possible.
 Appropriate blood studies should be ordered and evaluated.
 Necessary changes in their diet or medication regimen should be
made.
 Assessment should also extend to those who do not wish to fast,
as they are exposed to the risk of hypo- and hyperglycemia during
Ramadan as a reflection of social habits encountered during the
month.

14. RAMADAN-FOCUSED STRUCTURED
DIABETES EDUCATION
 The program should ideally include three components:
* An awareness campaign aimed at people with diabetes, health care
professionals, the religious and community leaders as well as
the general public.
* Ramadan-focused structured education for health care
professionals
* Ramadan- focused structured education for people with diabetes.

15. HEALTH CARE PROFESSIONALS
EDUCATION
 This program also includes:
* The appropriate meal choices to avoid postprandial
hyperglycemia.
* Advice on the timing and intensity of physical activity during
fasting.
* The use of diabetes-related medications and their potential risk
during fasting.

16. Self Monitoring
 Confirm that blood glucose testing does not
constitute breaking fast
 Teaching patients who fast how to test their
blood sugar
 Encouraging people with diabetes to test their
blood sugar especially if they feel any symptoms
related to hypoglycemia or hyperglycemia

17. Self Monitoring
 At the last two hours prior to breaking the fast.
 3 hours following breaking the fast ( after the main
meal )
 3 hours after the pre-dawn meal: To monitor the
pre-dawn meal and the treatment given at that
time.
 Every 2 - 3 hours during the fast for those on
Insulin and/or SU
 Any time the patient feels there is possibility of
hypoglycemia

18. Nutrition
During Ramadan, the diet should not differ significantly from a
healthy and balanced diet.
In most studies, 50–60% of individuals who fast maintain their body
weight during the month, while 20–25% either gain or lose weight.

19. Nutrition
 Avoid large amounts of foods rich in
carbohydrate and fat, especially at the
sunset meal, because of the delay in
digestion and absorption.
 Ingestion of foods containing
“complex” carbohydrates may be
advisable at the predawn meal, which
should be eaten as late as possible
before the start of the daily fast.
 Fluid intake be increased during non
fasting hours.
 MA-Pi 2 Diet

20. Exercise
 Normal physical activity may be
maintained.
 Excessive physical activity may lead to
higher risk of hypoglycemia and should
be avoided, particularly during the few
hours before the sunset meal.
 Repeated cycles of rising, kneeling,
and bowing during praying (Taraweeh)
should be considered a part of the daily
exercise program.

21. Breaking the fast
1. Hypoglycemia (blood glucose of <60 mg/dl [3.3
mmol /l]) occurs because their blood glucose
may drop further if they delay treatment.
2. Blood glucose reaches <70 mg/dl (3.9 mmol/l) in
the first few hours after the start of the fast,
especially if insulin, sulfonylurea drugs, or
meglitinide are taken at predawn.
3. Blood glucose exceeds 300 mg/dl (16.7 mmol/l).

22. MANAGEMENT OF TYPE 1 DIABETES
 Fasting at Ramadan carries a very high risk for
type 1 diabetic patients.
 This risk is particularly exacerbated in:
1. Poorly controlled patients.
2. Those with limited access to medical care.
3. Hypoglycemic unawareness, unstable glycemic
control, or recurrent hospitalizations.
4. Unwilling or unable to monitor their blood glucose
levels several times daily.

23. MANAGEMENT OF TYPE 1 DIABETES
 Basal-bolus regimen is the preferred protocol of
management: safer, with fewer episodes of hyper-
and hypoglycemia.
 A frequently used option is once- or twice-daily
injections of intermediate or long-acting insulin
along with pre meal rapid-acting insulin.
 It is unlikely that other regimens, including one
or two injections of intermediate-,long-acting, or
premixed insulin, would provide adequate insulin
therapy.

24. Antihyperglycemic Therapy in
Type 2 Diabetes
ADA. 7. Approaches to Glycemic Treatment. Diabetes Care 2015;38(suppl 1):S43. Figure 7.1;
adapted with permission from Inzucchi SE, et al. Diabetes Care, 2015;38:140-149

26. 28

27. METFORMIN
 Patients treated with
metformin alone may
safely fast because the
possibility of
hypoglycemia is minimal.
 The timing of the doses
be modified to provide
two thirds of the total
daily dose with the sunset
meal and the other third
before the predawn meal.

28. GLITAZONES
 The TZDs are not independently
associated with hypoglycemia, though
they can amplify the hypoglycemic
effects of sulfonylureas, glinides and
insulin.
 They are associated with:
1. Weight gain
2. Increased appetite.
 They require 2-4 weeks to exert
substantial antihyperglycemic effects.
 They cannot be quickly substituted for
agents associated with hypoglycemia
during periods of fasting .

29. -GLUCOSIDASE INHIBITORS
 Modest effect on fasting glucose.
 Usually used in combination with other agents.
 Associated with frequent mild to moderate gastrointestinal effects

30. SULFONYLUREAS
 Chlorpropamide is contraindicated during Ramadan because of the
possibility of prolonged and unpredictable hypoglycemia.
 Glyburide/Glibenclamide may be associated with a higher risk of
hypoglycemia than other second-generation SUs e.g. gliclazide,
glimepiride and glipizide.
 May NOT be used as a first choice during Ramadan
 Because of their worldwide use and relatively low cost, these agents if used
in Ramadan, extreme caution should be enfoced .
Grimaldi A. GUIDE study.Eur J Clin Invet 2004;34:535-542
RendellM.The role of sulfonylureas in the management of type 2 diabetesmellitus. Drugs 2004;64:1339-1358

31. SHORT-ACTING INSULIN
SECRETAGOGUES
 They are better than regular SUs because of their short duration
of action.
 They may be taken twice daily before the sunset and predawn
meals.
 However , these drugs may not be the first choice during
Ramadan

32. INCRETIN-BASED THERAY
 Exenatide can be dosed before meals to minimize appetite &
promote weight loss, it is not associated with a substantial effect
on fasting glucose.
 Liraglutide is dosed once a day, independent of meals, and is
more effective in controlling FBG.
 Both require titration to effective doses over a period of 2–4 weeks
 DPP-4 inhibitors are among the good tolerated drugs for the
treatment of diabetes in Ramadan.
 Moderately less effective in A1C lowering than GLP-1
 They do not require titration.

33. Saxagliptin Sitagliptin Linagliptin
Usage and
Indications
• Use with diet and exercise to improve glycemic control in T2DM
• Combination with SFU, MET, TZD
• Combination with insulin
Dosage
Administration
• Once daily, with or
without food
• Tablets:5mg & 2.5mg
(CrCI <50)
• Once daily, with or
without food
• Tablets:100mg, 50mg
(CrCI <50), & 25mg
(CrCI <30)
• Once daily, with or
without food
• Tablets:5mg
• No does adjustment
needed for renal
function
Contraindications • None • Hypersensitivity (i.e.,
anaphylaxis or
angioedema)
• Hypersensitivity (i.e.,
urticaria, angioedema,
or bronchial
hyperreactivity)
Warnings and
Precautions
• When used with a SFU or insulin, a lower dose may be needed to
reduce the risk of hypoglycemia
• Post-marketing reports of pancreatitis (D/C if suspect pancreatitis; Use
with caution in patients with h/o pancreatitis)
FDA Approved DPP-4
Inhibitors
Trajenta® (linagliptin) tablets, Prescribing Information, 2012
Onglyza® (saxagliptin) tablets, Prescribing Information, 2011
Januvia® (sitagliptin) tablets, Prescribing Information, 2012

34. Exenatide BID Liraglutide Exenatide ER
Usage and
Indications
• Use with diet and exercise to improve glycemic control in T2DM
• Combination with SFUs, MET, TZD
• Exenatide BID and liraglutide: Combination with insulin
Dosage
Administration
• Twice daily before
morning and evening
meals
• 5-10 mcg SC BID
• Once daily at any time
of day (independent of
meals)
• 1.2-1.8 mg SC Q day
• Once weekly
• 2 mg SC Q week
Contraindications • Hypersensitivity to
exenatide or any
product components
• Personal of family
history of medullary
thyroid ca. or MEN2
• Personal of family
history of medullary
thyroid ca. or MEN2
Warnings and
Precautions
• Post-marketing reports of pancreatitis (D/C if suspect pancreatitis;
Consider other therapies in patients with h/o pancreatitis)
• Medullary thyroid cancer (liraglutide and exenatide extended-release)
• Do not use in patients with severe renal impairment or ESRD
• Not recommended for patients with gastroparesis
• Consider reducing does of insulin when used in combination to reduce
risk of hypoglycemia
FDA Approved
GLP-1 Receptor Agonists
Bydureon® (exenatide extended-release for injectable suspension), Prescribing Information, 2012
Victoza® (liraglutide [rDNA origin] injection), Prescribing Information, 2012
Byetta® (exenatide) injection, Prescribing Information, 2011

35. SGLT2 Inhibitors
(canagliflozin, dapagliflozin)
Physicians’ desk reference (68th ed.). (2014). Montvale, NJ: Physicians’ Desk Reference.
Mechanism
of Action
Reduce renal glucose reabsorption and increases urinary glucose excretion (mechanism of
action is independent of insulin)
Benefits  No hypoglycemia
 Mean A1C reduction approximately 1% (starting from a baseline A1c of ~8.0%)
 Weight loss (2-5%) and systolic BP reduction (2-6mmHg)
Concerns  Genital mycotic infections
 Hypotension secondary to volume contracture especially in the elderly using loop diuretics
 Dehydration especially in hot seasons without adequate fluid intake
 Assess renal function before initiating and during therap. Do not initiate if e-GFR
is below 45 mL/min (cana-) or <60 mL/min (dapa-)
 Increased LDL-C
 Bladder cancer: Dapagliflozin should not be used in pts with active bladder cancer and
used with caution in pts with h/o bladder cancer.
Dosing Canagliflozin (INVOKANA®
)
 Starting dose: 100 mg daily before first meal of
day
 Increase to 300 mg daily if tolerating 100 mg daily
and eGFR > 60 mL/min
Dapagliflozin (FARXIGA®
)
 Starting dose: 5mg daily in morning with or
without food
 Increase to 10 mg daily if tolerating and need
additional glycemic control

36. Recent FDA warning !
Posted on May 15th 2015
 FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin,
and empagliflozin may lead to ketoacidosis
 Health care professionals should evaluate for the presence of acidosis,
including ketoacidosis, in patients experiencing these signs or symptoms
 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedic
alProducts/ucm446994.htm

37. INSULIN
 Problems facing type 2 diabetic patients who administer insulin are similar
to those with type 1 diabetes, except that the incidence of hypoglycemia is
less.
 The aim is to maintain necessary levels of basal insulin to prevent fasting
hyperglycemia.
 Effective strategy: use of intermediate- or long acting insulin preparations
plus a short acting insulin administered before meals.
 Hypoglycemia remains a risk, especially in patients:
1. Who have required insulin therapy for a number of years.
2. Where insulin deficiency predominates in the pathophysiology.
 Very elderly patients with type 2 diabetes may be at especially high risk.

38. INSULIN
 One injection of a long-acting or intermediate-acting insulin can
provide adequate coverage in some patients as long as the dosage
is appropriately individualized.
 Most patients will require rapid- or short-acting insulin in
combination with the basal insulin at meals, particularly at the
evening meal, which typically contains a larger caloric load.
 Evidence suggests that the use of a rapid acting insulin analog
instead of regular human insulin before meals in patients with
type 2 diabetes who fast during Ramadan is associated with less
hypoglycemia and smaller postprandial glucose excursions.

39. 41

40. Before Ramadan treatment During Ramadan treatment
Patients on diet and exercise control Consider modifying the time and intensity of
physical activity and ensure adequate fluid
intake
Patients on oral hypoglycemic agents Ensure adequate fluid intake
Biguanide, metforming 500 mg 3x daily Metformin, 1000 mg at the sunset meal
Metformin, 500 mg at the predawn meal
TZDs, AGIs , incretin-based therapies or
SGLT2
No change needed
Sulfonylurea 1x daily Dose should be given before the sunset meal
Adjust dose based on glycemic control and
risk of hypoglycemia
Sulfonylurea 2x daily Half the usual morning does at the predawn
meal
Usual dose at the sunset meal
Patients on insulin Ensure adequate fluid intake
Premixed or intermediates acting insulin 2x
daily
Consider changing to long-acting or
intermediate insulin in the evening and short
or rapid-acting insulin with meals
Take usual dose at sunset meal

41. PREGNANCY AND FASTING
 Elevated blood glucose and A1C levels in pregnancy are
associated with increased risk for major congenital
malformations.
 Fasting during pregnancy would be expected to carry a high risk
of morbidity and mortality to the fetus and mother, although
controversy exists.
 While pregnant Muslim women are exempted from fasting during
Ramadan, some with known diabetes (type 1, type 2, or
gestational) insist on fasting during Ramadan.
 They constitute a high-risk group, and their management requires
intensive care.
 Women with pre gestational or gestational diabetes should be
strongly advised to not fast during Ramadan.

42. Thank you