This prospective study was conducted at nine diabetes specialist centers in four provinces of Pakistan. The study was carried out in two phases; a pre-Ramadan recruitment interview (visit A) and a post-Ramadan follow up interview (visit B) of the same patients. Visit A commenced 15 days prior to Ramadan of 2011 (Hijri year, 1432) and continued until the first day of Ramadan, 2011. The second interview (visit B) was performed up to one month after the end of Ramadan, 2011. At each center; randomly selected health care providers (diabetologists or diabetes educators), involved in the care of patients with diabetes were assigned the task to enroll patients for the study after obtaining informed consent. Ethical approval for the study was obtained from the Institutional Review Board of Baqai Institute of Diabetology & Endocrinology (BIDE).
All subjects with type 1 or type 2 diabetes who gave history of fasting in the previous year and showed intention to fast in the coming Ramadan, were considered eligible to participate in the study.
Patients with type 1 or type 2 diabetes with serious complications, such as unstable angina, uncontrolled hypertension, severe liver or renal disease, newly diagnosed patients (< 3 month), pregnant women, patients with brittle type 1 diabetes, elderly patients with alertness problems, hospitalized individuals and patients with diabetes with hypoglycemia unawareness were excluded from the study.
The methodology of the study was explained and uniform recommendations and educational material regarding the information to be communicated to the patients at the time of recruitment in the study were presented to each health care provider (diabetologists or diabetes educators) before the start of the study. They were advised to assess the patient’s physical well-being and metabolic control at the time of recruitment in the study. An identical questionnaire was used at each center.
Pre-Ramadan individual counseling was given to each patient by the health care providers during visit A. The counseling session usually lasted for 15–20 min. Patients were educated regarding recognition of warning symptoms of possible complications such as hypoglycemia, hyperglycemia and dehydration. They were told to monitor blood glucose at home according to their usual routine and also when they experienced any hypo or hyperglycemic symptoms. Patients were advised to discontinue their fast immediately for the rest of the day in the case of any medical emergency and to seek medical care. Patients were also encouraged to continue their routine physical activities, although they were advised to avoid non routine heavy physical activity during fasting. Each patient was also provided written educational material regarding Ramadan-specific diabetes management recommendations.
The physicians (diabetologists) were recommended to adjust drug dosage and timing in fasting patients with diabetes. The advice to the patients was to take 75% of their full pre-Ramadan morning dose of oral hypoglycemic agents such as sulphonylureas, meglitinides as well as insulin, (alone or in combination) at Iftar (pre-dusk) and half of the pre-Ramadan evening dose at Sehar (pre-dawn). The rest of the oral hypoglycemic agents like metformin, thiazolidinedione and acarbose could be continued as their full pre-Ramadan morning dose of oral hypoglycemic agents taken at Iftar (pre-dusk) and half of the pre-Ramadan evening dose at Sehar (pre-dawn). However, the decision for altering the medication regimen was at the physician’s discretion, depending on the glycemic control of individual patients.
Two standardized questionnaire-based interviews were conducted by the physicians who enrolled the study subjects during face-to-face interviews.
Pre-Ramadan interview (visit A)
In the visit A, detailed history was taken from the patient. Information collected included socio-demographic and anthropometric data, diabetes type, duration of the disease, comorbidities, frequency and type of current treatment of diabetes, diet, physical activity level including type of exercise and routine blood glucose monitoring practices. Laboratory investigations including fasting blood glucose, HbA1c and fasting lipid profile were also collected from the patient’s record (if available within 3 months).
Post-Ramadan follow up interview (visit B)
In the visit B information collected included anthropometric data, number of days of fasting during Ramadan, development of symptoms of hypoglycemia and hyperglycemia and if developed, the frequency of the symptoms and the measures taken, hospital admission for any medical reason, frequency of blood glucose monitoring during Ramadan, frequency and type of treatment of diabetes during Ramadan and physical activity level including type of exercise during Ramadan.
Symptomatic hypoglycemia was defined as the occurrence of one or few of the hypoglycemic symptoms such as palpitation, shivering, cold sweating, feelings of weakness, excessive hunger, visual problems, drowsiness and unconsciousness .
Symptomatic hyperglycemia was defined as the occurrence of one or few of the hyperglycemic symptoms such as polyphagia, polydipsia, frequent urination, drowsiness and unconsciousness .
All the data was centralized into the computer data base of Baqai Institute of Diabetology & Endocrinology (BIDE). A total of 682 patients initially enrolled in the study (visit A). Of these 388 (56.89%) completed the follow up interview (visit B). Individuals with diabetes who did not attend the follow up interview (visit B) within the stipulated time period of one month after Ramadan were excluded from the final analysis.
Data analysis was conducted on Statistical Package for Social Sciences (SPSS), version 13.0. All the continuous variables, i.e. age, duration of diabetes, waist circumference, weight, height, body mass index (BMI), systolic and diastolic blood pressure, fasting blood sugar, HbA1c, cholesterol, HDL, LDL and triglycerides, were presented as Mean±SD. Categorical variables, such as gender, education level, occupation, physical activity level and treatment modality were presented in the form of number and percentage. A paired t-test was utilized to find the difference in mean values and chi square was used for categorical variables. P<0.05 was considered statistically significant.