Efficacy and Safety of Use of the Fasting Algorithm for Singaporeans With Type 2 Diabetes (FAST) During Ramadan: A Prospective, Multicenter, Randomized Controlled Trial.

PURPOSE: We aimed to evaluate the efficacy and safety of use of the Fasting Algorithm for Singaporeans with Type 2 Diabetes (FAST) during Ramadan. METHODS: We performed a prospective, multicenter, randomized controlled trial. The inclusion criteria were age ≥21 years, baseline glycated hemoglobin (HbA1c) level ≤9.5%, and intention to fast for ≥10 days during Ramadan. Exclusion criteria included baseline estimated glomerular filtration rate <30 mL/min, diabetes-related hospitalization, and short-term corticosteroid therapy. Participants were randomized to intervention (use of FAST) or control (usual care without FAST) groups. Efficacy outcomes were HbA1c level and fasting blood glucose and postprandial glucose changes, and the safety outcome was incidence of major or minor hypoglycemia during the Ramadan period. Glycemic variability and diabetes distress were also investigated. Linear mixed models were constructed to assess changes. RESULTS: A total of 97 participants were randomized (intervention: n = 46, control: n = 51). The HbA1c improvement during Ramadan was 4 times greater in the intervention group (-0.4%) than in the control group (-0.1%) (P = .049). The mean fasting blood glucose level decreased in the intervention group (-3.6 mg/dL) and increased in the control group (+20.9 mg/dL) (P = .034). The mean postprandial glucose level showed greater improvement in the intervention group (-16.4 mg/dL) compared to the control group (-2.3 mg/dL). There were more minor hypoglycemic events based on self-monitered blood glucose readings in the control group (intervention: 4, control: 6; P = .744). Glycemic variability was not significantly different between the 2 groups (P = .284). No between-group differences in diabetes distress were observed (P = .479). CONCLUSIONS: Our findings emphasize the importance of efficacious, safe, and culturally tailored epistemic tools for diabetes management.

Development of a Collaborative Algorithm for the Management of Type 2 Diabetes during Ramadan: An Anchor on Empowerment.

Empowerment plays significant roles in the complex management of type 2 diabetes. International guidelines have provided recommendations on management of Muslims who fast during Ramadan. However, there remains a lack of patient-centered epistemic tool to empower healthcare providers and patients in managing diabetes during Ramadan. This study discussed the development and evaluation of such tool. The collaborative algorithm was developed with reference to the nominal group technique by a board-certified clinical pharmacist and discussed with endocrinologists, nurses, and family physicians. The empowerment component of the algorithm was developed based on the Basic Psychological Needs Theory. The algorithm was evaluated through a randomized controlled trial. Glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial glucose (PPG) levels and safety profiles in terms of hypoglycemic events were assessed. The collaborative algorithm was developed with four components: screening, education, dose modification by healthcare provider, and dose adjustment by patient. A total of 62 individuals were recruited, with 30 and 32 randomized into the intervention and control groups, respectively. The mean age was 58.4 years, with majority being females (67.7%). There was a reduction in mean HbA1c from 7.9% ± 0.9% to 7.5% ± 0.8% (P < 0.001) in the intervention group, while no significant difference was observed in the control group (P = 0.270). FPG (P < 0.001) and PPG (P = 0.002) also improved significantly in the intervention group. There were no major hypoglycemic events and minor hypoglycemia comparable between both groups (P = 0.465). The collaborative algorithm incorporated empowerment and promoted shared decision-making in diabetes management, hence promoting safe and effective fasting.