Introduction: A novel clinical calculator was developed to assist physicians in classifying the risk for individuals with diabetes planning to observe fasting during the holy month of Ramadan. The aim of this study was to evaluate the necessity to use this approach. Methods: A survey with twenty-six clinical scenario questions was developed. All cases were pre-scored using the proposed Diabetes and Ramadan Risk Calculator. The survey was sent to 350 reputable practicing physicians with considerable expertise in managing patients with diabetes. The survey sought expert opinion on patients’ risk classification during Ramadan fasting. Quantitative methods were used for data analysis. Results: Responses of 312 participants were valid for analysis. There was a wide variation in evaluating patients’ risk, particularly in moderate-risk cases. Overall, responses to case scenarios were classified correctly with 33–85% variation in correct response. Geographical and inter-specialty differences were noted. Conclusion: There is a broad variation among physicians on how to estimate the risk for patients with diabetes planning to fast during the month of Ramadan. A practical method using many variables might help physicians in the decision making.

Risk stratification for people with diabetes planning to fast during the month of Ramadan is an integral part of all diabetes and Ramadan international guidelines. Recommendations have evolved from the 4-tier categories in the 2005 and 2010 American Diabetes Association [1] for 2010 to the three-tier traffic light system in the IDF-DAR guidelines in 2016 [2] and several other groups [3, 4]. Existing guidelines, however, depend largely on expert opinions with limited scientific evidence [5]. Many critical considerations, including relevant aspects of illness and personal circumstances, are often not taken into account (Table 1) [6].

Table 1.

Recognized factors that may influence the development of personalized care for diabetes during Ramadan fasting

 Recognized factors that may influence the development of personalized care for diabetes during Ramadan fasting
 Recognized factors that may influence the development of personalized care for diabetes during Ramadan fasting

In general, health care professionals recognized these recommendations as their primary source of guidance [7]. However, many experts in the field believe that existing risk stratification may be too rigid, particularly in view of the evolving evidence about the safety of fasting for certain high-risk groups [8].

People with type 1 diabetes are a clear example of this scenario, where almost all guidelines categorize them as a high- or very high-risk population, but recent studies have shown that some, who are supported with all the necessary tools, are able to fast the entire month of Ramadan safely without development of extreme hypo- or hyperglycemia that might require emergency department visits or hospital admissions [9, 10]. Indeed, individuals with diabetes and stable cardiovascular disease or early stages of chronic kidney disease are considered by different recommendations as high-risk populations and are usually advised against fasting. However, many observe fasting. Certainly, there is very limited evidence to support either approach [11, 12].

Prior to this review, the IDF-DAR Guidelines for 2021 writing group developed a risk score tool based on the limited available evidence. Although not constantly supported by evidence, the risk calculation represents the best judgment of the makers of the calculator after many deliberations with the guideline group and other experts in the field.

Many variables were considered in the development of the risk calculator including age, type and duration of diabetes, diabetes control, incidence of hypoglycemia, presence of chronic micro- and macrovascular complications, type of treatment, appropriate use of glucose monitoring, history of acute diabetes complications within the preceding year, patients’ physical and cognitive functions, type of work, duration of fasting, and past Ramadan experience [12]. Risk factors were graded as not likely to cause any harm with a score of zero or potentially harmful depending on their clinical significance (Table 2). Patients were classified as low risk for fasting if they score 0–3 points, moderate risk if they score 3.5–6, or high risk when they score >6 (Table 3).

Table 2.

Elements for risk calculation and suggested risk score

 Elements for risk calculation and suggested risk score
 Elements for risk calculation and suggested risk score
Table 3.

Risk score and risk categories

 Risk score and risk categories
 Risk score and risk categories

In this analysis, we wanted to find out the risk category for twenty-six hypothetical clinical scenarios as estimated by participating physicians and to compare that with the calculated risk score using the new tool. In this paper, the risk calculator was considered as “gold standard” against which the responses were judged. Matching answers were considered the correct ones.

We used Survey Monkey® (SVMK Inc., San Mateo, CA, USA) to build, deliver, and analyze data. The survey was launched in September 2020. The survey was sent to 350 experienced physicians from 15 countries across the world including East Mediterranean, North Africa, Gulf region, Indian subcontinent, Southeast Asia, and Western countries. Participants were selected from specialized groups and authors’ contacts.

The survey included twenty-six hypothetical clinical scenarios of patients with diabetes presenting to the pre-Ramadan diabetes clinic. Each case included details of patient’s age, type of diabetes, duration of diabetes, history of hypoglycemia, presence of diabetic related chronic or acute complications, diabetes treatment, self-monitoring of blood glucose, hemoglobin A1c level, physical and cognitive status, duration of fasting, type of work, and past Ramadan fasting experience. Survey is available in the appendix.

The risk category for each case scenario was provided by all authors using the newly developed risk score calculator where patients are classified as low risk for fasting if they score 0–3 points, moderate risk if they score 3.5–6, and high risk when they score >6, respectively. Providers invited to participate in this survey were asked to classify each patient’s risk as low, moderate, or high based on their own clinical judgment. Responses were collected and stored electronically and anonymously. We calculated the percentages of answers for each case scenario. We subanalyzed data according to respondents’ geographical region, case diagnosis, risk level, and medical specialty.

Circulated hypothetical clinical scenarios included 8 cases of patients with type 1 diabetes, eight cases of women with hyperglycemia during pregnancy, and 10 cases of type 2 diabetes patients. Using the new risk calculator, there were thirteen high-risk, eight moderate-risk, and five low-risk cases included in the case scenarios.

Responses of 312 participants were valid for analysis, and a total of 8,112 responses were evaluated. Participants’ geographical regions and specialties are illustrated in Table 4. Overall, 53% of the case scenarios were classified correctly with a 33–85% variation. Regional variations in classifying patients were noted, ranging from 48 to 58% in the Indian subcontinent and Gulf States, respectively (Fig. 1).

Table 4.

Characteristics

 Characteristics
 Characteristics
Fig. 1.

Average percentages of correct answers by region.

Fig. 1.

Average percentages of correct answers by region.

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Patients with T1DM and hyperglycemia in pregnancy were less likely to be scored differently compared to type 2 patients’ case scenarios. Matching answer was more likely in cases of pregnancy followed by type 1 diabetes and lastly by cases with type 2 DM 55%, 53%, 49%, respectively (Fig. 2).

Fig. 2.

Average percentages of correct answers by diagnosis.

Fig. 2.

Average percentages of correct answers by diagnosis.

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Data analysis based on calculated risk levels showed that participants rated 66% of high-risk cases and 47% of low-risk cases correctly. Conversely, only 38% of moderate-risk cases were classified as such (Fig. 3).

Fig. 3.

Average percentages of correct answers by risk level.

Fig. 3.

Average percentages of correct answers by risk level.

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Finally, providers’ specialties were a factor in classifying moderate- and high-risk cases. For instance, endocrinologists were able to make the correct classification of such cases in 54, 62% versus 46, 51% when compared to other specialties. Additionally, endocrinologists were more likely to make the correct risk classification based on diagnosis (Fig. 4, 5).

Fig. 4.

Average matching classification by risk level and specialty.

Fig. 4.

Average matching classification by risk level and specialty.

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Fig. 5.

Correct classification by diagnosis and specialty.

Fig. 5.

Correct classification by diagnosis and specialty.

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In order to direct management decisions, most available guidelines advise clinicians to estimate the risk for patients with diabetes planning to fast during the month of Ramadan. Multiple variables are used to classify patients into low-, moderate-, and high-risk group categories. These variables merit special attention in the personalized management of diabetes during Ramadan. Perhaps the most critical issue is the understanding that care must be highly individualized and that the management plan can vary for each patient. In addition, it is essential for patients to have the means to monitor their blood glucose levels many times daily. This is particularly important in patients with diabetes treated with sulfonylureas and/or insulin [13].

Most regional and international guidelines agree on the major aspects of diabetes care such as targets for glycemic control, blood pressure, and lipid targets. However, Ramadan fasting seems to lack that level of harmony, perhaps due to limited evidence-based medicine, lack of validated scoring systems, providers’ personal medical experience and religious views, inadequate agreement between medical and religious opinions, and cultural variations. Physicians might weigh same risk factors differently [14, 15] and that would consequently lead to inconsistent risk stratification.

A recent survey of approximately 8,000 persons with diabetes showed that fasting rate in people with type 1 diabetes was reported to be 12% in Turkey and 90% in Saudi Arabia [10]. A relatively similar pattern was seen in T2DM patients where 42.6% fasted in Morocco while 97% fasted in Saudi Arabia [13]. These regional variations were also noted earlier in CREED study [16]. Similarly, variations in fasting practices were noted in the DAR Global surveys even within countries of comparable medical, environmental, and cultural aspects such as the UAE and Saudi Arabia [13]. The results of our current survey confirm these differences among physicians even when evaluating clear-cut case scenarios that provide specific clinical information. Unexpectedly, the wide variation existed even in the same geographical distribution and at similar levels of medical expertise.

While variation reflects the religious and cultural attitudes toward taking fasting exemption which are very variable between the different regions, it can instigate work-related stress for physicians as well as increased liability risk. Certainly, this could confuse patients, leading to reduced patient confidence, impaired patient-doctor relationships, and, most importantly, jeopardized patients’ safety. This was obvious from the fact that many patients elect to fast against medical advice [15].

The wide differences among surveyed physicians to the clinical case scenarios match the differences seen in previous studies. Certainly, the regional variations are similar to those seen in CREED study or in the recent DAR Global Survey of 2020 [13, 16].

While there is no one plan that fits all case scenarios, risk score calculation can minimize inappropriate patient categorization and empower medical personnel in making the appropriate decisions regarding fasting in patients with diabetes during Ramadan. Hence, there is a need to establish a unified tool that measures different risk factors with some degree of flexibility [6, 17].

To our knowledge, the Diabetes and Ramadan Risk Calculator is the first flexible clinical scoring system designed to help quantify potential risk, aid physicians and patients in decision making in order to minimize fasting risk. This can help unify fasting risk assessment, particularly among non-specialists or those with less expertise on Ramadan fasting. Similarly, we believe that other steps to achieve better harmony among physicians in fasting risk assessment should include improving documentation, improving communication, increasing physician and patients’ knowledge, applying latest guidelines, and unifying risk assessment approach.

High level of variation exists among physicians when classifying the risk of patients with diabetes during Ramadan fasting. Risk categorization should be customized taking into account multiple physical, personal, spiritual, and social factors to empower physicians to stratify each individual patient accordingly. Further research to establish the validity of using the risk calculator tool will be appropriate. Indeed, stronger evidence-based medicine in the field of diabetes and Ramadan fasting could help harmonize the view of treating physicians.

As this is a survey of the opinion of physicians, no ethical approval was required.

The authors have no conflict of interest to disclose.

No funding was required.

Bachar Afandi and Mohamed Hassanein are considered both as first authors as they have equallly contributed to the design of the work, review and interpretation of data and writting up of manuscript. Mouniar Alarouj and Shehla Sheikh contributed to the review of data and manuscript. Gamal Ibrahim did the statistical analysis.

Data are available upon reasonable request.

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