Validation of the new IDF-DAR risk assessment tool for Ramadan fasting in patients with diabetes in a primary healthcare setting.

doi:10.21203/rs.3.rs-3640308/v1

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Validation of the new IDF-DAR risk assessment tool for Ramadan fasting in patients with diabetes in a primary healthcare setting.

https://doi.org/10.21203/rs.3.rs-3640308/v1

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Background:

In diabetic patients intending to fast, Ramadan, risk assessment, and stratification are essential for an individualized treatment plan. The new IDF-DAR risk stratification tool (International Diabetes Federation - Diabetes and Ramadan Alliance) is becoming the primary tool. This study aims to validate this tool in the Abu Dhabi population.

Method

IDF-DAR risk stratification assessment was done before Ramadan, followed by assessing any significant outcome after Ramadan. Patients were included if the attending physicians used the tool in the risk assessment of the patients within six weeks before Ramadan 1444, 2022, in the AHS healthcare center. After Ramadan, assessment was done through tele-interview and Electronic Medical Records review.

Results

Patients included in the study were 435, excluding 21 patients with type 1 Diabetes. Half of the patients were in the low-risk category of the IDF-DAR risk stratification tool (51.7%), 28.5% in the moderate-risk category, and 19.8% in the higher-risk category. Most of those patients fasted all of Ramadan, 81.3%, and the remaining 28.7% attempted to fast but had to break their fast; among them, only 17 (3.9%)did not fast for 15 days or more.

The lower-risk group was younger, with an average age of 56.3 years, compared to the moderate and high-risk risk, who had an average age of 59 and 64.5 years, respectively. Diabetes control was progressively worse with increasing the DAR risk category with an average HbA1C of 7.18, 8.2, and 9 for the low, moderate, and high-risk categories. From all the sample, 14 (3.8%) were admitted at least once, and 56 (12.9%) had at least one significant event, including admission to the hospital.

Using logistic regression, the determinant factor of not having an adverse event was fasting more days, B=-0.08 OR=0.92 (0.86-0.99) p value=0.023. Another independent risk factor was being in the low-risk category of the DAR risk assessment tool B=-1.2, OR= 0.29 (0.09-0.95)p value=0.042 and having a higher frailty score was the third independent risk factor, B=0.4, OR=1.5 (1-2.02-1.86) p value=0.039.

Conclusion

Diabetic patients in the Low-risk category, according to the IDF-DAR risk assessment, had a better outcome than the Moderate or high-risk categories during Ramadan regarding significant adverse events. Another independent risk factor is if the patient is Frail, according to the FRAIL scoring.

Diabetes Mellitus

Ramadan

Fasting

Adverse events

risk assessment

The health effects of changes in diet and lifestyle of diabetic patients during Ramadan are of rising interest to estimate possible risks and benefits for better-informing management guidelines, including recommending exemptions from fasting and optimal medication adjustments. For the whole month of Ramadan, Muslims must abstain from eating and drinking from dawn to sunset, and these fasting hours are accompanied by a change of sleep and primary meals timings. The accumulating evidence, including a recent systematic review, confirms that the incidences of complications during Ramadan are minimally higher than at other times of the year in high-risk diabetic patients (1). But the ability of patients’ bodies to adjust to these changes is variable and many factors, such as comorbidities and diabetic complications, may influence it. Therefore, many international societies have issued guidelines to guide physicians and patients to save the fasting of Ramadan (2).

In diabetic patients, risk assessment and stratification are essential for an individualized treatment plan. The new IDF-DAR risk stratification tool (International Diabetes Federation - Diabetes and Ramadan Alliance) is becoming the primary tool used. It was developed based on available evidence and a consensus of experts who included factors thought or found to increase the risk of adverse events in diabetic patients. A score is generated as collective points given to the different factors if present (2). It was found to be valid in predicting both the ability to fast during Ramadan as well as the likelihood of getting hypoglycemia, hyperglycemia, or significant adverse events (3) (4) (5) (6) (7). Validating this calculator in different settings will facilitate more perception and applicability of the tool.

For a few years, Ambulatory Healthcare Services had an initiative to counsel and adjust the care plan for patients with chronic diseases who intend to fast during Ramadan. The IDF-DAR practical guidelines, including the IDF-DAR risk stratification tool published in 2021, were used to assess risk and assist in decision-making for diabetics. The tool was built into the Electronic Medical Records EMR system. Physicians were encouraged to use it to help stratify diabetic patients and guide their counselling on decisions regarding fasting. This study aimed to validate the IDF-DAR risk stratification by comparing the patients' outcomes after Ramadan to the assessed baseline, the before Ramadan, IDF-DAR risk stratification score.

Ambulatory Healthcare Services has structured chronic disease clinics, and within these clinics, an annual initiative was targeting chronic disease patients to counsel them and adjust their care plan in preparation for fasting Ramadan if appropriate medically. Integrating Ramadan fasting-related counselling in chronic disease patient visits is preceded by an educational event targeting physicians on new updates in this area. The IDF-DAR practical guidelines were included in the educational event, including the IDF-DAR risk stratification tool published in 2021. The AHS team requested to use the tool within the EMR system, which was built internally within CERNER EMR. The training was conducted, and physicians were encouraged to use it to help stratify diabetic patients and guide their counselling on decisions regarding fasting.

Data collection

No data was collected before Ramadan. After Ramadan, data was extracted from the EMR that included all patients who had their risk assessed by the EMR form. Therefore, patients from the AHS centers assessed as part of their routine visits who were included after their data was extracted from the EMR. Family medicine residents collected data through tele-interview. They called the patients, and if they consented to participate, data was collected regarding fasting and significant history during Ramadan. Additional clinical data after Ramadan was collected from the EMR. In addition to demographics and clinical data, fasting status, significant health events, and time of admission into care were collected after Ramadan. Only events occurring during Ramadan were considered in this study and for those who did fast after their fast. The start of surveillance was from the first day of Ramadan to the end of the holy month. Frailty assessment was done for patients who are 60 years or older, and the FRAIL tool was used. It is a validated tool that includes five questions that demonstrated strong evidence in predicting clinical outcomes (8–10) (11). The five questions were related to fatigue, resistance or climbing stairs, Ambulation, i.e., walking a couple of blocks, number of chronic illnesses, and losing weight by more than 5%.

Data Analysis

Patients with diabetes who fasted all Ramadan days or attempted to fast were included (20 were excluded). Type I DM patients were excluded (a total of 27 patients). Data analysis was done using SPSS v27.

The IDF-DAR risk assessment score was done for 610 diabetic patients type 2. The patients were approached by telephone, and 134 were either unreachable (no response) or refused to participate. Out of the remaining 476, 20 patients did not attempt to fast Ramadan and were excluded. Patients included in the study were 456. Most of those patients fasted all of Ramadan, 81.3%, and the remaining 28.7% attempted to fast but had to break their fast, among them, only 17 (3.9%)did not fast for 15 days or more.

The lower-risk group was younger, with an average age of 56.3 years, compared to the moderate and high-risk risk, who had an average age of 59 years and 64.5 years, respectively. Table (1) shows the patients' demographics, with almost two-thirds of them in the age group 50 years or above 16.1% of them above the age of 70 years. Those between 40 and 50 were 18.4%. More older patients were in the higher risk category as per the DAR stratification, for example, nearly one-quarter of them were in the higher risk group in the age groups above 50 years compared to 2.3% and 11.6% in the age groups 31to 40 years and 41 to 50 years. Males were 43.4% and UAE nationals were the majority ( 74.5%) of the total sample. The duration of diabetes was more than ten years in 57% of included patients.

Diabetes control was progressively worse with increasing the DAR risk category with an average HbA1C of 7.18, 8.2, and 9 for the low, moderate, and high-risk categories. Regarding co-morbidities, microvascular diseases were absent in 78.9% of the patients. Other comorbidities were 8.1% had ischemic heart diseases, 1.4% had stroke, 62.3% were hypertensive, and 9.9% had chronic kidney diseases (CKD). The CKD stages were 89.2 had an eGFR above 60 ml/min, 5.7% had an eGFR between 45 and 60 ml/min, 4.1% had an eGFR between 30 and 45 ml/min, and only 0.9% had an eGFR < 30ml/min. Oral hypoglycemic agents were 55.6 used GLP-1 receptor agonist, 73.9% DPP-4inhibitor, 65.3% SGLT2, TZDs 52.9%, and 79.1% Sulfonylurea.

From all the sample, 14 (3.8%) were admitted at least once, and 56 (12.9%) had at least one significant event, including admission to hospital. This was progressive among the three risk groups as per the DAR tool with 2 (1.1%),3(2.7%),9(12%) admissions in the low moderate and high groups, respectively, and 18(8%), 21(16.9%), 17(19.8%) among low moderate and high groups respectively.

Overall, those who did not fast had an 8(42.1%) event rate compared to 56 (12.9%) among those who fasted or attempted to fast. Figure 1

Using logistic regression, the determinant factors of the occurrence of adverse event was more days not fasted B=-0.08 OR = 0.92 (0.86–0.99) p value = 0.023, being in the low-risk category of the DAR risk assessment tool B=-1.2, OR = 0.29 (0.09–0.95)p value = 0.042 and a higher frailty score B = 0.4, OR = 1.5 (1.02–1.86) p value = 0.039. Figure 2

Another important outcome is the incidence of hypoglycemia, with 46 patients reporting hypoglycemic episodes during the month of Ramadan (11.7%). The high-risk group, as per the DAR stratification tool, had ten patients experiencing these episodes during Ramadan (12.7% of the high-risk patients), moderate risk had 18 (15.8%), and the low-risk category had 18 episodes(9%) Table (2). These episodes of hypoglycemia were more likely to be among those who needed to break their fast, which was the only significant determinant of hypoglycemia as per logistic regression, B = -0.11 C.I.(0.85–0.94), S.E. =0.027, P-value < 0.001. Figure 3

Patients in the Low-risk category, as per the DAR risk assessment tool, who fasted all Ramadan or attempted to fast had a significantly better outcome than those in the Moderate or high-risk categories during Ramadan regarding the occurrence of significant adverse events. They were at 70% less risk of developing an adverse event than moderate or high-risk categories. Moderate and high-risk categories were nearly close to each other in predicting the patients' outcomes during fasting. As well, there was a noticeable increase in the risk of adverse events with increasing IDF-DAR risk category scores from low to moderate and to high. This study reported more adverse events than a similar study in the same period in a diabetes center in Abu Dhabi-AlAin (3). Mohammad et al. study reported outcomes related to mainly hypoglycemic and hyperglycemic episodes. Only one patient in their cohort had been admitted. Therefore, this study adds an outcome that matters, which is fewer hospitalizations in the lower-risk group as well as the incidence of illness, which was more in this study than Mohammad et al.. Surprisingly, hypoglycemic episodes were more in their study than in this study, 15% compared to 9.6%, respectively, although the other variables were not that much different between the two cohorts to explain this difference, such as diabetes control, insulin use, or diabetes duration. Such differences between cohorts are an area for study to investigate possible influencing factors on outcome. The hypoglycemia risk may be related to other factors such as healthcare setting, health literacy, and self-management, not related to the risk profile of the patient.

In another similar study to validate the DAR risk assessment tool in Bangladesh, Kamrul-Hasan et al. found that hypoglycemia and hyperglycemia risks were 3.74-fold and 3.86-fold higher in the high-risk group than in the low-risk group (5). Similar to this study, the episodes of hypoglycemia were lower than Mohammed et al. and this study, 3.5%.

This study supports Mohammad et al. and Kamrul-Hasan et al. that the DAR Risk assessment tool is helpful in stratifying the risk of diabetic patients intending to fast during Ramadan. Two additional independent risk factors were identified, the previous fasting experience and the frailty of the patients. The more days the patients did not fast, the more the occurrence of adverse events, which may indicate that they were unable to complete all the days due to poor health, and those who completed fasting they are in a better health status. This highlights the importance of patients' previous fasting experience validating the DAR risk assessment tool question.

Frailty is found in this study as another independent risk factor. No study used the FRAIL score in assessing the outcome of fasting during Ramadan, and therefore, this is an important addition that is discussed in another part of this study.

The main limitation of this study is the possible variation among physicians who performed the clinical judgment and utilized the risk estimation calculator. This was found to be true in a study by Afandi et al., where classifying the risk of patients with diabetes during Ramadan fasting was found to be with wide variation. (12) They used case scenarios presented in a survey distributed to physicians and asked to evaluate patients’ risk utilizing the same DAR calculator. The variation was particularly more in moderate-risk cases. Investigators attributed this to factors other than clinical judgment, such as personal, spiritual, and social factors, and recommended that risk categorization should be customized to empower physicians to stratify each individual patient. Nevertheless, these factors, although important, in support of this risk assessment tool is the significant prediction of key outcomes that support the physicians' judgment. It is empirical to recommend that validating this tool in different cultures and geographical regions will strengthen the prediction of outcomes.

Ethical approval and consent to participate:

The study was approved by the Ambulatory Healthcare Services- Abu Dhabi IRB. All methods were carried out under relevant guidelines and regulations.

Consent statement in the Ethics approval and consent to participate:

Informed consent was obtained from all subjects, and data was anonymized at analysis.

Competing interests:

All authors declare no conflicts of interest.
Funding: No funding was used in this study.
Authors' contributions: LB conceptualized, analyzed data, and wrote the manuscript. NN assisted in statistical analysis and reviewed the manuscript. BA participated in conceptualization and reviewed the manuscript, MH reviewed the manuscript, HA, RN, MS, FB, NB, AA, NM, AK, SM collected data and reviewed the manuscript.

Acknowledgments: None

Consent to publish: Not Applicable.

Availability of data and materials: Data is available on request sent to the corresponding author.

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Table 1 Study subjects' characteristics.

		Low Risk	Moderate Risk	High Risk	All
AGE GROUPS	<=30	2	1	0	3
		0.90%	0.80%	0.00%	0.70%
	31-40	16	8	2	26
		7.10%	6.50%	2.30%	6.00%
	41-50	49	21	10	80
		21.80%	16.90%	11.60%	18.40%
	51-60	74	30	22	126
		32.90%	24.20%	25.60%	29.00%
	61-70	60	47	23	130
		26.70%	37.90%	26.70%	29.90%
	>70	24	17	29	70
		10.70%	13.70%	33.70%	16.10%
GENDER	Female	130	64	52	246
		57.80%	51.60%	60.50%	56.60%
	Male	95	60	34	189
		42.20%	48.40%	39.50%	43.40%
Nationality	Non UAE	53	29	29	111
		23.60%	23.40%	33.70%	25.50%
	UAE	172	95	57	324
		76.40%	76.60%	66.30%	74.50%
DURATION OF DIABETES YEARS	A duration of < 10	140	35	12	187
		62.20%	28.20%	14.00%	43.00%
	A duration of >= 10	85	89	74	248
		37.80%	71.80%	86.00%	57.00%
RENAL COMPLICATIONS COMORBIDITIES	eGFR < 30 mL/min	0	0	4	4
		0.00%	0.00%	4.70%	0.90%
	eGFR >60 mL/min	222	110	56	388
		98.70%	88.70%	65.10%	89.20%
	eGFR 30-45 mL/min	0	3	15	18
		0.00%	2.40%	17.40%	4.10%
	eGFR 45-60 mL/min	3	11	11	25
		1.30%	8.90%	12.80%	5.70%
MVD COMPLICATIONS COMORBIDITIES		1	1	0	2
		0.40%	0.80%	0.00%	0.50%
	No MVD	213	92	38	343
		94.70%	74.20%	44.20%	78.90%
	Stable MVD	11	31	40	82
		4.90%	25.00%	46.50%	18.90%
	Unstable MVD	0	0	8	8
		0.00%	0.00%	9.30%	1.80%
PRESENCE OF HYPOGLYCAEMIA	Hypoglycemia less than 1	13	8	19	40
		5.80%	6.50%	22.10%	9.20%
	Hypoglycemia unawareness	0	1	3	4
		0.00%	0.80%	3.50%	0.90%
	Multiple weekly hypoglycemia	0	1	6	7
		0.00%	0.80%	7.00%	1.60%
	No hypoglycemia	212	114	57	383
		94.20%	91.90%	66.30%	88.00%
	Recent Severe hypoglycemia	0	0	1	1
		0.00%	0.00%	1.20%	0.20%
PREGNANCY	No	142	72	56	270
		100.00%	97.30%	98.20%	98.90%
	Yes	0	2	1	3
		0.00%	2.70%	1.80%	1.10%
FRAILTY AND COGNITIVE FUNCTION as assessed by physicians	>70 years old with no home support	0	5	10	15
		0.00%	4.00%	11.60%	3.40%
	Impaired cognitive function or Frail	0	0	10	10
		0.00%	0.00%	11.60%	2.30%
	No frailty or loss in cognitive function	224	118	66	408
		99.60%	95.20%	76.70%	93.80%
HbA1C	<7.5	144.00	38.00	20.00	202.00
		72.00	34.00	26.00	57.00
	7.5-9	41.00	44.00	25.00	110.00
		20.00	0.39	0.33	28.00
	>9	16.00	31.00	32.00	79.00
		8.00	27.00	42.00	20.00
PHYSICAL LABOUR		0	1	0	1
		0.00%	0.80%	0.00%	0.20%
	Moderate Intense P	14	24	12	50
		6.20%	19.40%	14.00%	11.50%
	No physical labor	211	99	74	384
		93.80%	79.80%	86.00%	88.30%
SELFMONITORING OF BLOOD GLUCOSE	Conducted as indicated	162	62	32	256
		72.00%	50.00%	37.20%	58.90%
	Indicated but conducted sub-opt	53	46	32	131
		23.60%	37.10%	37.20%	30.10%
	Indicated but not conducted	9	16	22	47
		4.00%	12.90%	25.60%	10.80%
FASTING HOURS	< 16 hours	206	108	74	388
		91.60%	87.10%	86.00%	89.20%
	>= 16 hours	19	16	12	47
		8.40%	12.90%	14.00%	10.80%
Ischemic Heart Diseases	No IHD	218	110	67	395
		97.80%	90.20%	78.80%	91.90%
	IHD	5	12	18	35
		2.20%	9.80%	21.20%	8.10%
Stroke	No Stroke	222	121	82	425
		99.60%	98.40%	96.50%	98.60%
	Stroke	1	2	3	6
		0.40%	1.60%	3.50%	1.40%
Hypertension	No Hypertension	96	45	20	161
		43.60%	36.60%	23.80%	37.70%
	Hypertension	124	78	64	266
		56.40%	63.40%	76.20%	62.30%
GLP-1 receptor agonist	Not On GLP-1 receptor agonist	117	50	26	193
		52.00%	40.30%	30.20%	44.40%
	On GLP-1 receptor agonist	108	74	60	242
		48.00%	59.70%	69.80%	55.60%
DPP-4 inhibitor	Not on DPP-4 inhibitor	74	26	17	117
		32.90%	21.00%	19.80%	26.90%
	On DPP-4 inhibitor	151	98	69	318
		67.10%	79.00%	80.20%	73.10%
SGLT2 inhibitor	Not on SGLT2 inhibitor	96	38	17	151
		42.70%	30.60%	19.80%	34.70%
	On SGLT2 inhibitor	129	86	69	284
		57.30%	69.40%	80.20%	65.30%
Sulfonylurea	Not on Sulfonylurea	95	33	18	146
		42.20%	26.60%	20.90%	33.60%
	On Sulfonylurea	130	91	68	289
		57.80%	73.40%	79.10%	66.40%
Insulin	Not on Insulin	125	48	11	184
		55.60%	38.70%	12.80%	42.30%
	On Insulin	100	76	75	251
		44.40%	61.30%	87.20%	57.70%
TZDs	Not on TZDs	122	54	29	205
		54.20%	43.50%	33.70%	47.10%
	On TZDs	103	70	57	230
		45.80%	56.50%	66.30%	52.90%
CKD	No CKD	221	109	62	392
		98.20%	87.90%	72.10%	90.10%
	CKD	4	15	24	43
		1.80%	12.10%	27.90%	9.90%
DAYS NOT FASTED CODED	Did fast all days	202	105	69	376
		89.80%	84.70%	80.20%	86.40%
	-1 to -4	10	10	7	27
		4.40%	8.10%	8.10%	6.20%
	-5 to -9	5	3	3	11
		2.20%	2.40%	3.50%	2.50%
	-10 to -14	2	1	1	4
		0.90%	0.80%	1.20%	0.90%
	-15 to -19	2	3	3	8
		0.90%	2.40%	3.50%	1.80%
	-20 to -24	1	0	1	2
		0.40%	0.00%	1.20%	0.50%
	-25 to -30	3	2	2	7
		1.30%	1.60%	2.30%	1.60%
Admitted to hospital	No	184	107	66	357
		98.90%	97.30%	88.00%	96.20%
	Yes	2	3	9	14
		1.10%	2.70%	12.00%	3.80%
Significant event or Admitted to hospital	No	207	103	69	379
		92.00%	83.10%	80.20%	87.10%
	Yes	18	21	17	56
		8.00%	16.90%	19.80%	12.90%
Frail cat	Robust	47	29	19	95
		52.80%	45.30%	36.50%	46.30%
	Prefrail	38	33	19	90
		42.70%	51.60%	36.50%	43.90%
	Frail	4	2	14	20
		4.50%	3.10%	26.90%	9.80%
Total		225	124	86	435
		51.7%	28.5%	19.8%	100.00%

Table 2 Incidence of hypoglycemia

Hypoglycemia incidence distributed by the IDF Risk assessment Score
		Low Risk	Moderate Risk	High Risk	Total
	No Hypoglycemia	183	96	69	348
		91.00%	84.20%	87.30%	88.30%
	Hypoglycemia	18	18	10	46
		9.00%	15.80%	12.70%	11.70%
	Total	201	114	79	394
		100.00%	100.00%	100.00%	100.00%

No competing interests reported.

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Validation of the new IDF-DAR risk assessment tool for Ramadan fasting in patients with diabetes in a primary healthcare setting.

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