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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
111
Fasting Algorithm for Singaporeans with Type 2 Diabetes
Standard of care
Tan Tock Seng Hospital
Singapore, Singapore
National Healthcare Group Polyclinic (Bukit Batok)
Singapore, Singapore
Change in HbA1c
Change in HbA1c during and after Ramadan from baseline
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
Incidence of minor and major hypoglycemia
Incidence of minor hypoglycemia which is defined as signs and symptoms with known precipitating causes such as irregular eating habits, increased daily activity or other attributes that can be modified. Major hypoglycemia is defined as any hypoglycemic symptoms that require the help from another person.
Time frame: During one month of Ramadan
Incidence of hyperglycemia
Incidence of hyperglycemia which is defined as signs and symptoms of frequent urination, increased thirst or fruity-smelling breath.
Time frame: During one month of Ramadan
Change in fasting blood glucose (FPG)
Change in FPG during and after Ramadan from baseline
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
Change in post-prandial blood glucose
Change in 2 hours post meal during and after Ramadan from baseline
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
Change in blood pressure
Change in BP during and after Ramadan from baseline
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
Change in lipid panel
including LDL, TG, TC, HDL
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and post Ramadan (3 months after Ramadan)
Change in general health status
EQ-5D-5L
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Change in diabetes-related distress
Problem Area in Diabetes (PAID)
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Change in diabetes-specific quality of life
Audit of Diabetes Dependent Quality of Life (ADDQoL)
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Change in diabetes treatment satisfaction
Diabetes Treatment Satisfaction Questionnaires (DTSQ)
Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
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