Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Development and Implementation of Ramadan "Fasting Algorithm for Singaporeans With Type 2 Diabetes" (FAST): A Prospective Randomized Controlled Intervention Study
Background: Ramadan fasting is a religious observance carried out by Muslims all over the
world. During Ramadan, Muslims abstain from eating, drinking, and smoking during daylight
hours. Although Muslims who are ill, including patients with diabetes, are exempted from
fasting, many devoted Muslim patients still insist on fasting despite being advised not to by
their healthcare providers. Concerns have been raised over how the practice of fasting may
affect the metabolic control of Muslim patients with diabetes. Furthermore, it has also been
postulated that the act of fasting may increase the risk of hypoglycemia or glucose toxicity.
Although practice algorithms and suggestions on the use of glycemic therapies during fasting
have been discussed internationally. they are not generalizable as the observances of
Ramadan, duration of fasting and the food ingested differ from one country to another.
Aims: This study aims to develop and implement a clinical practice dose-adjustment algorithm
dedicated to the care of Singaporean patients with diabetes who fast during Ramadan.
Hypothesis: The use of clinical practice dose-adjustment algorithm can improve both clinical
and humanistic outcomes of patients with type 2 diabetes who wish to fast during Ramadan.
Methods: This is a prospective, randomized, interventional study involving patients with type
2 diabetes who wish to fast for at least 10 days during Ramadan. Eligible patient attending a
primary care institution or an outpatient specialist clinic of a tertiary institution will be
approached to participate in the study. Consented patients will be randomized to either
intervention arm or control arm. Patients in the control arm will receive usual care while
patients in the intervention arm will be given additional education session on Ramadan
fasting related diabetic management advice and an algorithm that was developed by the study
team members based on international guidelines, to guide them on self-management during
Ramadan. The primary outcomes will be change in HbA1c. Secondary outcomes include change in
fasting blood glucose, post prandial blood glucose, medication adherence and humanistic
outcomes. The safety outcomes include self reported incidence of major and minor hypoglycemia
as well as hyperglycemia during Ramadan month. All outcomes will be measured at baseline,
during Ramadan and at 3 month post Ramadan.
Significance: The validation of the algorithm through this study will ensure effective and
safe fasting of patients with type 2 diabetes during Ramadan.
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