DAR-MENA is the first prospective, large study investigating diabetes before and during Ramadan. The type 1 diabetes DAR-MENA analysis provides in-depth information on the characteristics and pattern of care of relatively young and healthy people with type 1 diabetes before and during Ramadan fasting. Importantly, it provides the reasons (outlined below) that prompted people to choose whether to fast during Ramadan. The study found that the majority of people (72.3%) fasted for at least 15 days, and nearly half (48.5%) fasted for the full 30 days of Ramadan without a significant increase in confirmed and severe hypoglycemia events.
The DAR-MENA type 1 diabetes population was young, with a mean age of 32 years and a low number of comorbidities at baseline. The mean duration of type 1 diabetes was 14 years and glycemic control was relatively poor with a mean HbA1c of 8.3% (67 mmol/mol). As expected, all participants were taking insulin; 49.3% were receiving basal insulin analogues.
The role of structured education for patients is well established in the management of diabetes, and guidelines state that this should be extended to Ramadan-focused diabetes education so that people can make informed decisions [3, 4]. In this study, only 45.6% of participants had access to diabetes education, of whom 45.2% received face-to-face educational sessions. Considering that Ramadan-focused education can enable individuals to reduce their risk of acute complications during fasts [3], the present study showed that this is an essential tool in patient management that is not yet being accessed by all patients. Healthcare professionals also seem to need more education on managing diabetes during Ramadan. One study in Pakistan found that almost one-third of general practitioners lacked knowledge of basic principles needed [11].
Of the 100 participants with type 1 diabetes who chose to fast, 63.0% reported that their reason was due to a personal decision, whereas 24.0% fasted to cope with pressure from their family and community. Of those people who did not fast, 60.0% reported a fear of diabetic complications as a reason for not fasting, and 50.0% had had previous experience of acute diabetic complications during fasting. Only 6.7% did not fast on the advice of their healthcare professional. Working conditions prompted 3.3% of participants to not fast during Ramadan.
The mean duration of fasting was 27 days with a daily duration of 16 h; during this time, most people reported lifestyle changes. The majority of participants reported changes in working hours (67.5%) and sleep duration (67.2%), whereas changes in physical activity (45.0%) and smoking (7.8%) were less common. For those with changes in working hours, most (84.3%) reported a decrease; however, changes were more balanced for those who reported a change in sleep duration, with 54.5% reporting a decrease and 45.5% reporting an increase. Food intake was also altered during Ramadan for 62.3% of participants. In those reporting changes, the proportions with increases and decreases were approximately equal for carbohydrates and sugars, whereas the majority of participants reported increases in protein (92.6%) and vegetables (91.8%) and decreases in fats (60.5%). Of the 63.1% reporting changes in fluid intake, most (80.5%) reported an increase. This change in food and fluid intake was accompanied by a change in insulin regimen in 84.6% of participants, and 72.1% modified their insulin dose.
It was anticipated that a greater proportion of participants (close to 100%) would make a change to their insulin dose, but this was not observed in this study. In practice, 27.9% of participants did not change their insulin dose (regardless of type: rapid, short, intermediate, basal, or premix). Of these, 60.5% were on rapid-acting insulin. A high proportion of participants did not modify their insulin dose, which may have been due to inadequate glycemic control before Ramadan.
During Ramadan, not only do participants abstain from eating and drinking during daylight hours but they also drastically change aspects of their lifestyle and habits, which can affect glycemic control. In this study, there was a significant improvement in mean glycemic profile (based on HbA1c and FPG) after Ramadan fasting compared with before Ramadan. This occurred with no significant change in the incidence of confirmed hypoglycemia or number of confirmed hypoglycemic events during Ramadan compared with the previous 4 weeks. The lack of a significant increase in hypoglycemia in people with type 1 diabetes during Ramadan is clinically important as previous studies suggest an increase during Ramadan [5], and diabetes guidelines highlight the increased risk of hypoglycemia with fasting [3, 4].
In DAR-MENA participants with type 1 diabetes, lipid levels remained constant throughout Ramadan, except for total cholesterol, which was significantly increased (P = 0.021). In addition, there was no significant weight gain. While those who did not fast said that they were fearful of developing diabetic complications related to fasting, this did not appear to have happened in this study. Indeed, the incidence and number of AEs for severe hypoglycemia, confirmed hyperglycemia, and severe hyperglycemia did not change significantly during Ramadan compared with before. This is supported by a recent survey of 526 people with diabetes in Tunisia, of whom 51 had type 1 diabetes, who had fasted during Ramadan, which found that more than half of people had been treated with insulin and most were able to fast without interruption [12]. A recent literature review also found that Ramadan fasting in people with diabetes using insulin is feasible, with negligible major complications reported [13]. In DAR-MENA, diabetes education and the diabetic medication/dosing adjustments (primarily dose reductions) may have contributed to the low rates of hypoglycemia observed.
The results of the DAR-MENA type 1 diabetes analysis provide new up-to-date information on fasting during Ramadan, in comparison with previous studies, such as the EPIDIAR study, which had used the older insulins [5]. In EPIDIAR, fasting lasted for at least 15 days during Ramadan in 43% of people, and the mean number of fasting days was 23 days, which is shorter than the 27 days reported in this study [5]. A higher proportion of people with type 1 diabetes in the EPIDIAR study (68%) received recommendations from their healthcare providers about fasting and diabetes during Ramadan than those who received education in DAR-MENA type 1 diabetes [5]. However, 57% of participants had the same food intake as before, and 65% maintained their insulin dose during Ramadan [5]. The incidences of severe hypoglycemic episodes in participants with type 1 diabetes prior to Ramadan were similar in the DAR-MENA and EPIDIAR studies (0.05 vs 0.03 events/month/participant, respectively).
In EPIDIAR, the significant increase (P = 0.0174) in the mean ± SD number of severe hypoglycemic episodes per month per person during Ramadan (0.14 ± 0.6 events/month) compared with the preceding year (0.03 ± 0.1 events/month) in the overall type 1 diabetes population may reflect the lack of dose change [5]. It should be noted that this significant increase roughly equates to only one more severe hypoglycemic event for each 5 months of fasting (+0.02 events/month/participant). Furthermore, the EPIDIAR study did not find a statistically significant increase in the mean ± SD number of severe hypoglycemic episodes per month per person during Ramadan (0.12 ± 0.48 events/month) compared with the preceding year (0.02 ± 0.05 events/month) in patients who fasted for at least 15 days [5].
New technologies for continuous glucose monitoring, such as glucose sensors and flash glucometers, can make fasting safer for people with type 1 diabetes who fast during Ramadan. Several studies have already shown the potential benefits of using an insulin pump during Ramadan [14]. In one study, those using an insulin pump performed self-monitoring of blood glucose more frequently than those on multiple daily insulin injections [7]. Unfortunately, the current high cost of an insulin pump restricts its use.
Our analysis has some limitations. Firstly, the DAR-MENA study enrolled people with both type 1 and 2 diabetes, and did not require a specific number of each diabetes type. There is, therefore, a much lower number of participants with type 1 than type 2 diabetes. This is not unexpected as the proportion of the adult population with type 2 diabetes is higher than that with type 1 diabetes, but it does mean that this analysis is based on a small number of participants. Secondly, only those who believe that they are fit enough actually fast, and only a proportion of those are able to fast for the whole of the holy month. The results are, therefore, not representative of the entire type 1 diabetes population. While the analysis suggests that fasting during Ramadan is safe, this cannot be extrapolated to the whole of the type 1 diabetes population. Lastly, it is important to note that hypoglycemia, particularly symptomatic confirmed hypoglycemia, which was based on patient self-assessment, could potentially be under-reported as a result of impaired awareness of hypoglycemia or reluctance to measure SMPG levels. It is possible that participants perceived symptoms of hypoglycemia but did not assess SMPG levels; rather, they may have simply stopped activities and waited for symptoms to subside, as they may not have wanted to interrupt their fasting. Therefore, it was difficult to capture all hypoglycemic episodes and their severity. Ideally, the results of the current study would be validated in a future study based on continuous glucose monitoring.