Development and Implementation of Ramadan Fasting Algorithm for Singaporeans With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): FAST; Standard of care
Intervention type(s): Other; Other
Intervention description(s): Fasting Algorithm for Singaporeans with Type 2 Diabetes; Standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes Mellitus, Type 2; Ramadan Fasting; Randomized controlled trial