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  1. Hassanein M, Al Sifri S, Shaikh S, Raza SA, Akram J, Rudijanto A, et al.
    Diabetes Ther, 2021 Jun;12(6):1703-1719.
    PMID: 33974216 DOI: 10.1007/s13300-021-01067-1
    INTRODUCTION: To analyse the safety and effectiveness of gliclazide modified release (MR) in adults with type 2 diabetes mellitus participating in Ramadan from three geographically and culturally different regions of the world included in the DIA-RAMADAN study.

    METHODS: DIA-RAMADAN was a real-world, observational, international, non-comparative study. The global study population was divided into three regional subgroups, with data gathered at inclusion 6-8 weeks prior to Ramadan (V0), during Ramadan (4.5 weeks) and 4-6 weeks after Ramadan (V1). Primary endpoint was the proportion of patients reporting ≥ 1 symptomatic hypoglycaemic events (HE), which were collected using a patient diary along with other adverse events.

    RESULTS: Patient numbers from the three regions were n = 564 (46.5%; Indian sub-continent), n = 354 (29.1%; Middle East) and n = 296 (24.4%; South-East Asia). Patient baseline characteristics, demographics, fasting habits and antidiabetic treatments varied between regions. There were similar proportions of symptomatic HE between regions, with no severe HE. Significant weight reductions were observed in all regions following Ramadan, along with reductions in HbA1c and fasting plasma glucose.

    CONCLUSION: These real-world study data indicate that gliclazide MR is safe and effective for management of type 2 diabetes during Ramadan in all three regions studied as part of DIA-RAMADAN.

    TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT04132934. INFOGRAPHIC.

  2. Hassanein M, Al Sifri S, Shaikh S, Abbas Raza S, Akram J, Pranoto A, et al.
    Diabetes Res Clin Pract, 2020 May;163:108154.
    PMID: 32330510 DOI: 10.1016/j.diabres.2020.108154
    AIMS: To explore the real-world safety and effectiveness of gliclazide modified release (MR) in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan.

    METHODS: DIA-RAMADAN (NCT04132934) was a prospective, international, observational study conducted in nine countries. Patients >18 years of age with T2DM (N = 1244) were examined at an inclusion visit (V0) occurring 6-8 weeks before the start of Ramadan. Patients received a diary to report treatment changes, hypoglycaemic events (HEs), and other adverse events. Gliclazide MR was taken once daily for 14-18 weeks. A second visit (V1) was conducted 4-6 weeks after the end of Ramadan. The primary endpoint was the proportion of patients reporting ≥1 symptomatic HE. Changes in HbA1c, fasting plasma glucose (FPG), and body weight were secondary endpoints.

    RESULTS: The proportion of patients reporting ≥1 symptomatic HE during Ramadan was low (2.2%) with no reported severe HEs. There was a significant reduction in HbA1c (-0.3%), FPG (-9.7 mg/dL), body weight (-0.5 kg) and body mass index (-0.2 kg/m2) between V0 and V1 (p 

  3. Hassanein M, Alamoudi RM, Kallash MA, Aljohani NJ, Alfadhli EM, Tony LE, et al.
    Diabetes Res Clin Pract, 2021 Feb;172:108626.
    PMID: 33321160 DOI: 10.1016/j.diabres.2020.108626
    OBJECTIVES: The DaR Global survey was conducted to determine the impact of the COVID-19 pandemic on the intentions to fast and the outcomes of fasting in <18 years versus ≥18 years age groups with type 1 diabetes mellitus (T1DM).

    METHODS: Muslim people with T1DM were surveyed in 13 countries between June and August 2020, shortly after the end of Ramadan (23rd April-23rd May 2020) using a simple questionnaire.

    RESULTS: 71.1% of muslims with T1DM fasted during Ramadan. Concerns about COVID-19 were higher in individuals ≥18 years (p = 0.002). The number of participants who decided not to fast plus those who received Ramadan-focused education were significantly higher in the ≥18-year group (p 

  4. Hassanein M, Hussein Z, Shaltout I, Wan Seman WJ, Tong CV, Mohd Noor N, et al.
    Diabetes Res Clin Pract, 2021 Mar;173:108674.
    PMID: 33493579 DOI: 10.1016/j.diabres.2021.108674
    OBJECTIVES: The DAR Global survey of Ramadan-fasting during the COVID-19 pandemic aimed to describe the characteristics and care in participants with type 2 diabetes (T2D) with a specific comparison between those <65 years and ≥65 years.

    METHODS: Participants were consented to answer a physician-administered questionnaire following Ramadan 2020. Impact of COVID-19 on the decision of fasting, intentions to fast and duration of Ramadan and Shawal fasting, hypoglycaemia and hyperglycaemia events were assessed. Specific analysis comparing age categories of <65 years and ≥65 years were performed.

    RESULTS: Among the 5865 participants, 22.5% were ≥65 years old. Concern for COVID-19 affected fasting decision for 7.6% (≥65 years) vs 5.4% (<65 years). More participants ≥65 years old did not fast (28.8% vs 12.7%, <65 years). Of the 83.6%, participants fulfilling Ramadan-fasting, 94.8% fasted ≥15 days and 12.6% had to break fast due to diabetes-related illness. The average number of days fasting within and post-Ramadan were 27 and 6 days respectively, regardless of age. Hypoglycaemia and hyperglycaemia occurred in 15.7% and 16.3% of participants respectively, with 6.5% and 7.4% requiring hospital care respectively. SMBG was performed in 73.8% of participants and 43.5% received Ramadan-focused education.

    CONCLUSION: During the COVID-19 pandemic, universally high rates of Ramadan-fasting were observed regardless of fasting risk level. Glycemic complications occurred frequently with older adults requiring higher rates of acute hospital care. Risk stratification is essential followed by pre-Ramadan interventions, Ramadan-focused diabetes education and self-monitoring to reduce and prevent complications, with particular emphasis in older adults.

  5. Hassanein M, Binte Zainudin S, Shaikh S, Shaltout I, Malek R, Buyukbese MA, et al.
    Curr Med Res Opin, 2024 Sep;40(9):1515-1523.
    PMID: 39076065 DOI: 10.1080/03007995.2024.2385057
    BACKGROUND: Managing diabetes during Ramadan fasting is a challenge due lifestyle changes. We described the characteristics and patterns of care for type 2 diabetes mellitus (T2DM) during Ramadan 2020 and 2022.

    METHODS: Our study included multinational Muslims with T2DM who were during routine consultation. We collected data on demographics, fasting characteristics, and complications. Descriptive statistics, chi-square test, and multiple testing were performed.

    RESULTS: 12,529 patients participated. Mean age was 55.2 ± 11.8 years; 52.4% were females. Mean diabetes duration was 9.9 ± 7.4 years; 27.7% were with HbA1c >9% (75 mmol/mol) and 70% had complications. Metformin was the most used medication followed by insulin. 85.1% fasted ≥1 day; fasting mean duration was 27.6 ± 5.6 days. Hypoglycemia occurred in 15.5% of whom 11.7% attended emergency department or were hospitalized; this was significantly associated with age and/or duration of diabetes. Hyperglycemia occurred in 14.9% of whom 6.1% attended emergency department or were hospitalized and was also associated with age or duration of diabetes. 74.2% performed SMBG during fasting. 59.2% were educated on Ramadan fasting, with 89.7% receiving it during routine consultation.

    CONCLUSIONS: Ramadan fasting in T2DM is high. Multidisciplinary approach is required to mitigate complications. Our findings support current recommendations for safe fasting.

  6. Alamoudi RM, Aljohani NJ, Alfadhli EM, Alzaman N, Alfadhly AF, Kallash MA, et al.
    Diabetes Metab Syndr, 2023 Jan;17(1):102676.
    PMID: 36463695 DOI: 10.1016/j.dsx.2022.102676
    BACKGROUND AND AIMS: To compare Saudi Arabia with other countries regarding patient attitudes towards fasting Ramadan and complications related to fasting during the COVID-19 pandemic.

    METHODS: Data collected from Saudi Arabia and 12 other mostly Muslim majority countries, via physician administered questionnaire within post Ramadan 2020.

    RESULTS: 1485 Type1 diabetes (T1DM) patients analyzed; 705 (47.5%) from Saudi Arabia vs. 780 (52.5%) from other countries. 1056 (71.1%) fasted Ramadan; 636 (90.2%) of Saudi patients vs. 420 (53.8%) of other countries. Experiencing Ramadan during the COVID-19 pandemic did not affect the Saudi T1DM patients' decision to fast while it significantly influenced their decision in other countries (1.4 vs 9.9%, P 

  7. Hassanein M, Yousuf S, Ahmedani MY, Albashier A, Shaltout I, Yong A, et al.
    Diabetes Metab Syndr, 2023 Jul;17(7):102799.
    PMID: 37301008 DOI: 10.1016/j.dsx.2023.102799
    BACKGROUND AND AIMS: The DaR Global survey was conducted to observe the impact of the COVID-19 pandemic on the intentions to fast and the outcomes of fasting in people with diabetes and chronic kidney disease (CKD).

    METHODS: Muslim people with diabetes and CKD were surveyed in 13 countries shortly after the end of Ramadan 2020, using a simple Survey Monkey questionnaire.

    RESULTS: This survey recruited 6736 people with diabetes, of which 707 (10.49%) had CKD. There were 118 (16.69%) people with type1 diabetes (T1D), and 589 (83.31%) were with type2 diabetes (T2D). 62 (65.24%) people with T1D and 448 (76.06%) people with T2D had fasted with CKD. Episodes of hypoglycaemia and hyperglycaemia were more frequent among people with T1D compared to T2D, 64.52% and 43.54% vs 25.22% and 22.32% respectively. Visits to the emergency department and hospitalization were more frequent among people with CKD, however no significant difference was found between people with T1D and T2D.

    CONCLUSION: The COVID-19 pandemic had only a minor effect on the intention to fast during Ramadan in people with diabetes and CKD. However, hypoglycaemia and hyperglycaemia were found to be more frequent, as well as emergency visits and hospital admissions among people with diabetic kidney disease. Prospective studies are needed in future to evaluate the risk indicators of hypoglycaemia and hyperglycaemia among fasting people with CKD, especially in the context of different stages of kidney disease.

  8. Hassanein M, Afandi B, Yakoob Ahmedani M, Mohammad Alamoudi R, Alawadi F, Bajaj HS, et al.
    PMID: 35016991 DOI: 10.1016/j.diabres.2021.109185
    Fasting during Ramadan is one of the five pillars of Islam and is obligatory for all healthy Muslims from the age of puberty. Though individuals with some illness and serious medical conditions, including some people with diabetes, can be exempted from fasting, many will fast anyway. It is of paramount importance that people with diabetes that fast are given the appropriate guidance and receive proper care. The International Diabetes Federation (IDF) and Diabetes and Ramadan (DaR) International Alliance have come together to provide a substantial update to the previous guidelines. This update includes key information on fasting during Ramadan with type 1 diabetes, the management of diabetes in people of elderly ages and pregnant women, the effects of Ramadan on one's mental wellbeing, changes to the risk of macrovascular and microvascular complications, and areas of future research. The IDF-DAR Diabetes and Ramadan Practical Guidelines 2021 seek to improve upon the awareness, knowledge and management of diabetes during Ramadan, and to provide real-world recommendations to health professionals and the people with diabetes who choose to fast.
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