Ramadan is the ninth month of the Islamic lunar calendar, during which Muslims abstain from food and fluid intake from dawn until sunset. Depending on geographical location and season, the fasting period can last from 12 to 20 hours daily for approximately 29-30 consecutive days [1]. This form of intermittent fasting represents a significant shift in meal timing and frequency, posing unique challenges for individuals with diabetes, particularly those with Type 1 Diabetes (T1D) who require exogenous insulin administration [2].

T1D is an autoimmune condition characterized by pancreatic beta-cell destruction leading to absolute insulin deficiency [3]. Management of T1D involves a delicate balance of insulin administration, dietary intake, and physical activity to maintain optimal glycemic control and prevent both acute and chronic complications [4]. The altered eating pattern during Ramadan can significantly impact this balance, potentially increasing the risk of hypoglycemia, hyperglycemia, and diabetic ketoacidosis (DKA) [5].

While religious obligations are important for many individuals with T1D, Islamic teachings provide exemptions from fasting for those with medical conditions, including diabetes, where fasting might pose health risks [6]. Nevertheless, many individuals with T1D choose to fast during Ramadan due to personal, spiritual, or social factors [7, 8]. Understanding the impact of Ramadan fasting on individuals with T1D is therefore critical for healthcare providers to offer appropriate guidance.

Several studies have examined the effects of Ramadan fasting in people with T1D, with varying results. The landmark EPIDIAR study reported an increased frequency of severe hypoglycemia during Ramadan compared to other months (0.14 vs. 0.03 episodes/month) in individuals with T1D [9]. Subsequent studies have shown that with proper education, insulin adjustments, and glucose monitoring, many individuals with T1D can fast during Ramadan with reduced risks [10, 11,12]. However, most of these studies have been conducted in the Middle East and Western countries, with limited data from the Indian subcontinent, particularly from Northern India. A systematic review conducted by Rahul Garg showed potential benefits of various fasting regimens including Ramadan fasting, time-restricted eating, and prolonged fasting protocols [13].

Uttar Pradesh, located in Northern India, is home to a significant Muslim population who observe Ramadan fasting. The hot climate, particularly during summer months when Ramadan has occurred in recent years, may exacerbate the risks of dehydration and related complications during fasting. Furthermore, socioeconomic factors, healthcare access, and diabetes management practices may differ from those in previously studied populations.

This study aims to evaluate the effects of Ramadan fasting on glycemic control, metabolic parameters, and complications in patients with T1D attending a tertiary care center in Uttar Pradesh, India. The findings will help in developing region-specific guidelines for the management of T1D during Ramadan, facilitating safe fasting practices for those who choose to observe this religious obligation.

Study Design and Setting

This prospective observational study was conducted at the Department of Medicine at a tertiary care center in Uttar Pradesh, India. The study was approved by the Institutional Ethics Committee and written informed consent was obtained from all participants or their guardians (for participants <18 years). The study was conducted during and post Ramadan (March-May 2024).

Study Population

Fifty patients with T1D who expressed intent to fast during Ramadan were enrolled in the study. The diagnosis of T1D was based on American Diabetes Association criteria [14].

Inclusion criteria:

1. Confirmed diagnosis of T1D for at least one year
2. Age ≥12 years
3. Intention to fast for at least 15 days during Ramadan
4. Willingness to comply with the study protocol and follow-up visits

Exclusion criteria:

1. Pregnancy or breastfeeding
2. Recent hospitalization for DKA or severe hypoglycemia (within 3 months before Ramadan)
3. Presence of advanced micro or macrovascular complications of diabetes
4. Acute concurrent illness
5. Psychiatric conditions affecting compliance
6. HbA1c >11% within 3 months before Ramadan

Pre-Ramadan Assessment and Education

All participants attended a structured education program before Ramadan, which included:

1. Information about the risks and benefits of fasting with T1D
2. Recognition and management of hypoglycemia and hyperglycemia
3. Insulin adjustment strategies during fasting
4. Meal planning and nutrition during Ramadan
5. The importance of adequate hydration and physical activity modifications
6. Guidelines for breaking the fast in case of medical necessity

Participants were stratified into risk categories based on International Diabetes Federation and Diabetes and Ramadan (IDF-DAR) guidelines [15], with modifications for T1D as suggested by Hussain et al. [8]:

• Very high risk: T1D with poor glycemic control (HbA1c >9%), history of severe hypoglycemia/DKA within 3 months, hypoglycemia unawareness, advanced complications, or multiple comorbidities
• High risk: T1D with moderate glycemic control (HbA1c 7.5-9%), no severe hypoglycemia/DKA within 3 months, good hypoglycemia awareness, minimal complications, and stable comorbidities
• Moderate risk: Well-controlled T1D (HbA1c <7.5%), no severe hypoglycemia/DKA within 6 months, good hypoglycemia awareness, no complications, and stable comorbidities, with access to advanced glucose monitoring/insulin delivery systems

Insulin Adjustment Protocol

Participants were provided with individualized insulin adjustment recommendations based on their pre-Ramadan insulin regimen, risk category, and glycemic patterns. General guidelines included:

1. Basal insulin:

• Once-daily long-acting analogues (glargine, degludec): Reduce dose by 15-30% and administer at iftar (sunset meal)
• Twice-daily long-acting analogues or NPH insulin: Reduce morning/pre-dawn (suhoor) dose by 30-50% and evening/sunset (iftar) dose by 0-20%

1. Bolus insulin:

• Suhoor (pre-dawn meal): Calculate dose based on carbohydrate content and reduce correction factor by 20-30%
• Iftar (sunset meal): Calculate dose based on carbohydrate content, with usual correction factor
• Additional meal before sleep (if taken): Calculate dose based on carbohydrate content with usual correction factor

1. Insulin pump users:

• Reduce basal rates by 20-40% during fasting hours
• Maintain or slightly increase basal rates during night/early morning
• Use normal bolus calculations for meals with possible reduction in insulin-to-carbohydrate ratio for suhoor

Monitoring Protocol

Participants were instructed to monitor capillary blood glucose at least 4-7 times daily:

1. Pre-suhoor (pre-dawn meal)
2. Mid-morning
3. Mid-day
4. Mid-afternoon
5. Pre-iftar (pre-sunset meal)
6. 2 hours post-iftar
7. Before sleep

Continuous glucose monitoring (CGM) was used for 31 participants (62%) who had access to this technology. All participants maintained detailed diaries of glucose readings, insulin doses, meals, physical activity, and any symptoms of hypoglycemia or hyperglycemia.

Participants were advised to break their fast immediately if:

1. Blood glucose <70 mg/dL (3.9 mmol/L)
2. Blood glucose >300 mg/dL (16.7 mmol/L)
3. Symptoms of hypoglycemia, even if glucose monitoring was not immediately available
4. Signs of dehydration, DKA, or other acute illness

Study Assessments

Participants were evaluated at four time points:

1. Baseline (1-2 weeks before Ramadan)
2. Mid-Ramadan (day 14-16)
3. End of Ramadan (day 28-30)
4. Post-Ramadan (4 weeks after Ramadan)

At each visit, the following assessments were performed:

1. Clinical examination including weight, blood pressure, and hydration status
2. Review of glucose monitoring data and hypoglycemia/hyperglycemia episodes
3. Assessment of insulin requirements and adjustments
4. Laboratory investigations (as outlined below)
5. Evaluation of adverse events and complications

Laboratory investigations included:

• Fasting and 2-hour postprandial glucose (at iftar meal during Ramadan)
• HbA1c (baseline and post-Ramadan)
• Fructosamine (all visits)
• Lipid profile (baseline, end of Ramadan, and post-Ramadan)
• Renal function tests (baseline and end of Ramadan)
• Urine ketones (when indicated by symptoms or high glucose values)

Outcome Measures

Primary outcomes:

1. Frequency of hypoglycemia (categorized as Level 1: <70 mg/dL but ≥54 mg/dL; Level 2: <54 mg/dL; Level 3: severe, requiring assistance)
2. Frequency of hyperglycemia (>250 mg/dL)
3. Incidence of DKA
4. Number of days fasted

Secondary outcomes:

1. Changes in HbA1c and fructosamine levels
2. Changes in body weight
3. Changes in lipid profile
4. Changes in insulin requirements
5. Quality of life and experiences during fasting (assessed through a structured questionnaire)

Statistical Analysis

Sample size calculation: Based on previous studies suggesting a hypoglycemia rate of approximately 0.14 episodes/month during Ramadan [9], a sample size of 50 participants was determined to provide 80% power to detect a 50% change in hypoglycemia frequency with a significance level of 0.05.

Data were analyzed using SPSS version 26.0 (IBM Corp., Armonk, NY, USA). Continuous variables were presented as mean ± standard deviation or median (interquartile range) depending on the normality of distribution. Categorical variables were presented as frequencies and percentages. Paired t-tests or Wilcoxon signed-rank tests were used to compare continuous variables before, during, and after Ramadan. McNemar's test was used for paired categorical data. Repeated measures ANOVA or Friedman's test was used for parameters measured at all-time points. Subgroup analyses were performed based on age groups, gender, diabetes duration, insulin regimen, and risk category. A p-value <0.05 was considered statistically significant.

Baseline Characteristics

The baseline characteristics of the study population are presented in Table 1. The mean age was 24.6 ± 7.8 years, with 52% being male. The mean duration of T1D was 8.3 ± 5.6 years. Thirty-seven participants (74%) were on multiple daily injections (MDI) with basal-bolus regimens, while 13 (26%) used insulin pumps. Mean baseline HbA1c was 8.6 ± 1.4%.

Table 1: Baseline characteristics of study participants (n=50)

SMBG: Self-monitoring of blood glucose; CGM: Continuous glucose monitoring; MDI: Multiple daily injections; SD: Standard deviation

Fasting Outcomes

Of the 50 participants who intended to fast, 37 (74%) completed at least 15 days of fasting, while 22 (44%) fasted for all 29 days of Ramadan. The mean number of fasting days was 19.7 ± 9.3. Thirteen participants (26%) broke their fast due to medical reasons, primarily hypoglycemia (n=7), hyperglycemia/ketosis (n=4), and acute illness (n=2).

The fasting outcomes stratified by risk category are presented in Table 2 and Figure 1. Participants in the very high-risk category completed significantly fewer fasting days compared to those in moderate risk and high-risk categories (p<0.01).

 Table 2: Fasting outcomes stratified by risk category

Glycemic Control

Frequency of glycemic events during Ramadan have been shown in Figure 2.

Hypoglycemia

The frequency of hypoglycemia increased significantly during Ramadan compared to the pre-Ramadan period (0.16 vs. 0.05 episodes/patient/day, p<0.01). A total of 205 hypoglycemic episodes were reported during Ramadan, of which 157 (76.6%) were Level 1 (54-69 mg/dL), 44 (21.5%) were Level 2 (<54 mg/dL), and 4 (2.0%) were Level 3 (severe, requiring assistance). The timing of hypoglycemic events showed a bimodal distribution, with peaks in the mid-afternoon (14:00-16:00) and pre-dawn period (03:00-05:00) (Figure 3).

Hyperglycemia

Hyperglycemia (>250 mg/dL) was more common than hypoglycemia during Ramadan (0.24 vs. 0.16 episodes/patient/day, p<0.05). A total of 301 hyperglycemic episodes were recorded, with the highest frequency observed during the post-iftar period (20:00-23:00). Two participants developed DKA requiring hospitalization, both from the very high-risk category.

Glycemic Variability

Among participants using CGM (n=31), glycemic variability as measured by coefficient of variation (CV) increased during Ramadan compared to the pre-Ramadan period (42.8 ± 8.6% vs. 36.5 ± 7.9%, p<0.01). Time in range (70-180 mg/dL) decreased slightly but not significantly during Ramadan compared to pre-Ramadan (56.3 ± 12.7% vs. 61.2 ± 13.4%, p=0.07).

HbA1c and Fructosamine

Fructosamine levels decreased significantly during Ramadan compared to baseline (317.2 ± 48.5 vs. 342.6 ± 51.3 μmol/L, p<0.05) and returned toward baseline values at 4-weeks post-Ramadan (332.4 ± 50.1 μmol/L). HbA1c showed a modest but non-significant reduction post-Ramadan compared to baseline (8.2 ± 1.3% vs. 8.6 ± 1.4%, p=0.06).

Metabolic Parameters

Body Weight

Mean body weight decreased significantly from baseline to the end of Ramadan (59.7 ± 11.3 vs. 57.9 ± 10.8 kg, p<0.01), with a mean weight loss of 1.8 ± 1.1 kg. By 4 weeks post-Ramadan, mean body weight had increased to 59.2 ± 11.1 kg, which was not significantly different from baseline (p=0.14).

Lipid Profile

Changes in lipid parameters are presented in Table 3 and Figure 4. Total cholesterol and LDL-cholesterol increased significantly during Ramadan (p<0.05), while HDL-cholesterol showed a small but significant increase (p=0.03). Triglyceride levels did not change significantly. By 4 weeks post-Ramadan, lipid parameters had returned toward baseline values.

 Table 3: Changes in lipid parameters during the study period

*p-value for comparison between baseline and end of Ramadan

Insulin Requirements

Total daily insulin requirements decreased significantly during Ramadan compared to baseline (0.65 ± 0.16 vs. 0.74 ± 0.18 units/kg/day, p<0.01). The reduction was more pronounced for basal insulin (25.3 ± 8.7%) compared to bolus insulin (13.6 ± 7.2%). By 4 weeks post-Ramadan, insulin requirements had returned to near-baseline levels (0.72 ± 0.17 units/kg/day), as shown in Figure 5.

Quality of Life and Experiences

Based on the structured questionnaire administered at the end of Ramadan, 82% of participants reported satisfaction with their fasting experience. Common challenges included thirst (68%), fatigue (56%), difficulty with glycemic control (52%), and hunger (48%). Facilitators for successful fasting included family support (76%), healthcare provider guidance (72%), flexible insulin regimens (68%), and CGM use (62% of CGM users).

Among those who successfully completed at least 15 days of fasting, 92% expressed intention to fast during the next Ramadan. Of those who broke their fast due to medical reasons, 62% still expressed intention to attempt fasting in the future with better preparation and management strategies.

Predictors of Successful Fasting

Multivariate logistic regression analysis identified several independent predictors of successful fasting (completion of ≥15 days):

1. Lower baseline HbA1c (OR 0.72, 95% CI 0.56-0.92, p=0.01)
2. CGM use (OR 3.45, 95% CI 1.72-6.94, p<0.01)
3. Insulin pump therapy (OR 2.86, 95% CI 1.38-5.92, p=0.02)
4. Previous Ramadan fasting experience (OR 3.12, 95% CI 1.54-6.31, p<0.01)
5. Younger age at diagnosis (OR 0.93, 95% CI 0.87-0.99, p=0.04)

This prospective observational study evaluated the impact of Ramadan fasting on 50 individuals with T1D at a tertiary care center in Uttar Pradesh, India. Our findings indicate that while Ramadan fasting is feasible for many individuals with T1D, it is associated with increased risk of glycemic excursions, particularly hypoglycemia and hyperglycemia. However, with appropriate pre-Ramadan education, insulin adjustments, and glucose monitoring, 74% of participants were able to fast for at least 15 days, and 44% completed the entire month of fasting.

The increased frequency of hypoglycemia during Ramadan (0.16 vs. 0.05 episodes/patient/day) is consistent with previous studies. Salti et al. reported a significant increase in severe hypoglycemia during Ramadan compared to other months (0.14 vs. 0.03 episodes/month) in the EPIDIAR study [9]. Similarly, Hassanein et al. found that 60.7% of individuals with T1D experienced hypoglycemia during Ramadan fasting [16]. In our study, the timing of hypoglycemic events showed a bimodal distribution, with peaks in the mid-afternoon and pre-dawn period, highlighting the need for targeted insulin adjustments during these vulnerable periods.

Interestingly, hyperglycemia was more common than hypoglycemia in our cohort (0.24 vs. 0.16 episodes/patient/day), consistent with findings by Alfadhli, who reported a higher rate of hyperglycemia than hypoglycemia during Ramadan fasting in patients with uncontrolled T1D [17]. This may reflect the tendency to reduce insulin doses excessively due to fear of hypoglycemia or the influence of larger meals with higher carbohydrate content consumed during non-fasting hours.

The two cases of DKA occurred in participants categorized as very high risk, emphasizing the importance of risk stratification and individualized recommendations. Fernández-Cardona et al. reported a case of DKA triggered by intermittent fasting in a patient with previously stable T1D, highlighting the potential risks in vulnerable individuals [18].

Our study demonstrated the benefits of technology in facilitating safer fasting during Ramadan. Participants using CGM experienced fewer hypoglycemic events compared to those using SMBG alone (0.13 vs. 0.21 episodes/patient/day, p=0.02). Similarly, insulin pump therapy was associated with reduced hypoglycemia risk compared to MDI (0.11 vs. 0.18 episodes/patient/day, p=0.03). These findings are consistent with Elbarbary and Ismail, who demonstrated improved glycemic control and reduced hypoglycemia with advanced hybrid closed-loop systems during Ramadan fasting [12].

The significant decrease in fructosamine levels during Ramadan (342.6 ± 51.3 vs. 317.2 ± 48.5 μmol/L, p<0.05) suggests short-term improvement in glycemic control, similar to findings by El-Hawary et al., who observed a decrease in fructosamine and HbA1c in children with T1D during Ramadan fasting [19]. The modest but non-significant reduction in HbA1c post-Ramadan (8.6 ± 1.4% vs. 8.2 ± 1.3%, p=0.06) may reflect the relatively short duration of fasting and variable adherence.

The observed weight loss during Ramadan (mean 1.8 ± 1.1 kg) is consistent with previous studies [19,20] and likely reflects reduced overall caloric intake despite changes in meal timing. However, most participants regained weight by 4 weeks post-Ramadan, suggesting that the weight loss effects are temporary.

Changes in lipid parameters during Ramadan, including increases in total cholesterol and LDL-cholesterol, align with findings by El-Hawary et al. [19]. These changes may be attributed to alterations in dietary patterns, with potentially higher consumption of fried and fatty foods during iftar meals. The small increase in HDL-cholesterol is consistent with some studies on intermittent fasting [21] and may reflect metabolic adaptations to altered meal timing.

The reduction in insulin requirements during Ramadan (0.74 ± 0.18 vs. 0.65 ± 0.16 units/kg/day, p<0.01), particularly basal insulin, is consistent with recommendations for insulin adjustment during fasting [8,15]. Al-Khawari et al. similarly reported the safety of a 10-20% reduction in basal insulin for adolescents fasting during Ramadan [22].

A systematic review conducted by Rahul Garg revealed that some research indicates potential benefits including improved insulin sensitivity, better metabolic parameters, and reduced glucose variability when properly managed, others highlight significant risks of hypoglycemia, hyperglycemia, and diabetic ketoacidosis. Ramadan fasting is the most extensively studied IF form, with improved outcomes noted when using structured education and advanced monitoring. Successful implementation requires personalized approaches, comprehensive education, insulin adjustments, and close medical supervision. The review concludes that IF for T1D patients demands careful individualization, with further research needed on long-term effects and optimal protocols.[13]

Our multivariate analysis identified several predictors of successful fasting, including lower baseline HbA1c, CGM use, insulin pump therapy, previous fasting experience, and younger age at diagnosis. These findings can help in developing targeted interventions for individuals with specific risk factors.

The satisfaction reported by 82% of participants with their fasting experience, despite the challenges encountered, highlights the importance of supporting individuals with T1D who choose to fast during Ramadan. The high intention to fast again (92% among successful fasters) underscores the personal and spiritual significance of this practice.

Limitations of the study

Our study has some limitations. The single-center design limits generalizability, although the tertiary care setting provided access to patients from diverse socioeconomic backgrounds. The observational nature precludes causal inferences. The study duration was limited to one Ramadan period, and long-term effects were not assessed. Additionally, the sample size, while adequate for primary outcomes, may have limited power for subgroup analyses.

This study provides valuable insights into the impact of Ramadan fasting on individuals with T1D in Uttar Pradesh, India. While fasting is associated with increased risk of hypoglycemia and hyperglycemia, many individuals can fast safely with appropriate preparation, education, and monitoring. The benefits of technology, including CGM and insulin pumps, in facilitating safer fasting are evident. Pre-Ramadan risk stratification and individualized management plans are essential for optimizing outcomes. Future research should focus on larger multicenter studies, the development and validation of risk assessment tools specific for T1D, the role of advanced technologies like hybrid closed-loop systems, and the long-term impact of annual Ramadan fasting on metabolic health and diabetes-related complications.

CONFLICT OF INTEREST

The authors declare no conflicts of interest.

FUNDING

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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