| Outcome Measures: |
Primary: HbA1c + weight loss, Double composite endpoint of a change in HbA1c (≥ 0.3%) and weight loss (≥1kg) between baseline and 3-4 weeks post-Ramadan., Baseline and 3-4 weeks post-Ramadan | Secondary: HbA1c + weight loss + Hypoglycaemic events, Triple composite endpoint of a reduction or maintenance of HbA1c, reduction in weight (≥ 1kg) and no hypoglycaemic events between baseline and 3-4 weeks post-Ramadan., Baseline and 3-4 weeks post-Ramadan|HbA1c, Mean change in HbA1c level (%), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Fructosamine, Mean change in Fructosamine, Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Body weight (kg), Mean change in body weight (kg), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Systolic blood pressure (mm Hg), Mean change in systolic blood pressure (mm Hg), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Diastolic blood pressure (mm Hg), Mean change in diastolic blood pressure (mm Hg), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Total cholesterol (mmol/L), Mean change in total cholesterol (mmol/L), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|HDL cholesterol (mmol/L), Mean change in HDL cholesterol (mmol/L), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|LDL cholesterol (mmol/L), Mean change in LDL cholesterol (mmol/L), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Triglycerides (mmol/L), Mean change in Triglycerides (mmol/L), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Diabetes Treatment Satisfaction, Mean change in Diabetes Treatment Satisfaction (DTSQ), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Physical Activity (self-reported), Mean change in self-reported physical activity levels (measured using the International Physical Activity Questionnaire; IPAQ), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Physical Activity (GENEActiv), Mean change in light, moderate, and vigorous intensity physical activity levels (measured using the GENEActiv device), Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Hypoglycaemic events (change) (self-measured), Mean change in frequency of self-measured and self-reported hypoglycaemic events, Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Severe hypoglycaemic events (change) (self-measured), Mean change in frequency of self-measured and self-reported severe hypoglycaemic events, Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Hypoglycaemic events (self-measured), Median (interquartile range; IQR) number of self-measured and self-reported hypoglycaemic events per patient, Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Severe hypoglycaemic events (self-measured), Median (interquartile range; IQR) number of self-measured and self-reported severe hypoglycaemic events per patient, Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Hypoglycaemic events (per person year) (self-measured), Incidence rate of self-measured and self-reported hypoglycaemic events per person year (incidence rate ration; IRR)., Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Severe hypoglycaemic events (per person year) (self-measured), Incidence rate of self-measured and self-reported severe hypoglycaemic events per person year (incidence rate ration; IRR)., Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Weight loss (kg) + severe hypoglycaemic events, Double composite endpoint of weight loss (kg) and no severe hypoglycaemic events., Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|No weight gain (kg) + reduction of hypoglycaemic events, Double composite endpoint of no weight gain (kg) and a reduction in the number of self-measured and self-reported hypoglycaemic events (+/- symptoms)., Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|HbA1c (%) + severe hypoglycaemic events, Double composite endpoint of improved HbA1c (%) and no self-measured and self-reported severe hypoglycaemic events., Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|HbA1c (%) + hypoglycaemic events, Double composite endpoint of improved HbA1c (%) and a reduction in the number of self-measured and self-reported hypoglycaemic events., Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|No weight gain (kg) + HbA1c (%), Double composite endpoint of no weight gain (kg) and improved HbA1c (%)., Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|No weight gain (kg) + severe hypoglycaemic events, Double composite endpoint of no weight gain (kg) and no self-measured and self-reported severe hypoglycaemic events., Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|No weight gain (kg) + no hypoglycaemic events, Double composite endpoint of no weight gain (kg) and no self-measured and self-reported hypoglycaemic events., Baseline and (a) 3-4 weeks post-Ramadan, (b) 12 weeks post-Ramadan and (c) 12 months post-Ramadan.|Hospital admissions, Comparison of the number of hospital admissions between groups for complications related to diabetes during Ramadan., Beginning and end of Ramadan (i.e., during the month of Ramadan)|Flash Glucose Monitoring - Time in glycaemic range, Change in proportion of time spent in each glycaemic range (measured using the Flash Glucose Monitoring (FGM) device) calculated between treatment groups., Baseline and (a) 3-4 weeks post-Ramadan, and (b) during Ramadan.|Flash Glucose Monitoring - Incidence, Incidence of hypoglycaemic events and severe hypoglycaemic events (measured using the Flash Glucose Monitoring (FGM) device)., Baseline and (a) 3-4 weeks post-Ramadan, and (b) during Ramadan.|Flash Glucose Monitoring - Change, Change in the frequency of hypoglycaemic events and severe hypoglycaemic events (measured using the Flash Glucose Monitoring (FGM) device)., Baseline and (a) 3-4 weeks post-Ramadan, and (b) during Ramadan.|Flash Glucose Monitoring - MAGE, Change in the mean average glucose excursion (MAGE; measured using the Flash Glucose Monitoring (FGM) device)., Baseline and (a) 3-4 weeks post-Ramadan, and (b) during Ramadan.
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