Insulin Pump Therapy in Moslem Patients with Type 1 Diabetes During Ramadan Fasting: An Observational Report

Introduction

Fasting during the daytime of Ramadan (the ninth lunar month) is a compulsory obligation for all adult Moslems. The definition of adulthood here encompasses adolescent boys and girls who have entered puberty. ¹ During Ramadan, eating and drinking are prohibited between dawn and sunset. Specific groups exempted from fasting are travelers, the elderly, pregnant and nursing women, and people who are sick. Sickness that qualifies for exemption is that in which the “condition may worsen” or “healing may be delayed” by fasting. ²

Ramadan fasting has many medical ramifications that have been reviewed extensively elsewhere, ³ and diabetes during Ramadan has been extensively studied. ^4,5 Although Moslem patients with diabetes may be able to avail themselves of the exemption from fasting during Ramadan, many do choose to observe the fast. ⁶ The role of the treating physician is to “establish feasibility and safety and to empower the patient so that he can make an informed choice.” ⁷ There are widely accepted criteria on when to advise patients to refrain from fasting during Ramadan, with minor variations between different working groups. ^{7 –11} These criteria are based on the principles of “risk reduction” deduced from expert opinions provided by physicians caring for Moslem patients. ^{6 –9} Many therapeutic regimens have been described on how to adjust the type, dose, and timing of insulin in those treated with insulin injections ^{8 –12} for those in whom fasting was deemed to be safe. These regimens represent the collective clinical opinion and many observational and/or interventional studies fully appraised elsewhere. ^4,5,9,10 However, despite the increasing use of insulin pump therapy worldwide, including many of the Arab and Muslim nations, ^12,13 there are few data on insulin pump therapy during Ramadan fasting despite the theoretical potential benefits. ¹⁴

We have therefore conducted this observational study on type 1 diabetes patients on insulin pumps during Ramadan 2008. Patients' glycemic control and adjustments made by patients in their insulin pump regimen were assessed with the view (1) to establish the feasibility and safety of fasting on pump therapy and (2) to understand the most appropriate changes needed in the insulin pump protocol.

Patients and Methods

A total of 63 patients were evaluated during the month prior to Ramadan. Forty-nine patients chose to fast, and 14 elected not to fast. Those who fasted were 24 males and 25 females (Table 1). All patients were stable on their insulin pump and were deemed to be fully educated in insulin pump self-management and carbohydrate counting. Patients used the Medtronic (Northridge, CA) MiniMed 722 model and had been using pump therapy for an average of 20 ± 10 months.

Patients were contacted 2 weeks before Ramadan. Forty-nine out of the 63 patients declared they will be fasting. The baseline insulin doses were documented. No specific instructions were given to them regarding the dose of insulin. Patients were instructed to break their fast should hypoglycemia develop. Patients adjusted their bolus insulin as per their usual carbohydrate counting practices. They were reassessed 2 weeks after the end of Ramadan. In an unselected subgroup of patients (n = 12), serum fructosamine was measured before and after Ramadan.

Outcome measures were (1) number of “full fasted days” that were completed during the month, (2) hypoglycemia (defined for the purposes of this study as low blood glucose level leading to breaking the fast, and if patients needed a third-party intervention, it is defined as severe hypoglycemia), (3) unusual hyperglycemia (identified as well above patients' own usual glycemic ranges: fasting >150 mg/dL and random >240 mg/dL), and (4) emergency hospital visit for diabetes-related problems.

The study was approved by the Research Ethics Committee of Sheikh Khalifa Medical City, Abu Dhabi, UAE, and patients gave informed consent to participate in the study. There were no financial implications in the study as it was performed as a practice examination exercise.

Results

Thirty patients (61.2%) fasted the whole month with no problems, whereas 19 (38.7%) fasted between 23 and 28 days (Table 2). Nearly half of the patients decreased their basal insulin rate by 5–50%; median reduction was 14% (Table 3). Seventeen patients had hypoglycemia necessitating breaking their fast. Fasting was broken on 55 out of 1,450 potential fasting days (3.8%).

No severe hypoglycemia (as defined above) was reported by any patient. Unusual hyperglycemia was reported in nine patients (18%). Hospital visits were reported for only one patient for hyperglycemia (a 16-year-old girl who disconnected her pump). Twelve patients (24%) had serum fructosamine levels measured both before and immediately after Ramadan: the pre-Ramadan fructosamine level was 4.0 ± 0.6 mmol/L, and that post-Ramadan was 3.6 ± 0.6 mmol/L (P = 0.007) (normal range, 1.6–2.7 mmol/L).

Discussion

The use of insulin pump therapy is ever increasing in clinical practice. Several professional bodies recommend use of insulin pump therapy because of the dual advantages of achieving adequate glycemic control coupled with reduced risk of hypoglycemia. Currently, it is recommended as an option when choosing an insulin delivery method by several reputable organizations such as the National Institute of Clinical Excellence in the United Kingdom, the American Diabetes Association, and the European Association for the Study of Diabetes. ^{17 –21} These recommendations are embraced in most parts of the world. It has been suggested that cultural diversity and social support systems may play a role in the success rate of this technology in the Middle East. ^13,14 The Sheikh Khalifa Medical City Center for Diabetes and Endocrinology now has nearly 200 patients in its insulin pump therapy program. The Center's team designed adequate preparation and continued education for patients enrolled in the insulin pump program. These measures helped to sustain a satisfactory level of self-management and to enable patients to adjust the doses appropriately during this study.

During Ramadan fasting, patients abstain from carbohydrate and calorie intake during the daytime. On the other hand, it is not uncommon for people to indulge in food consumption during the nighttime period to overcompensate for the daytime fasting. This eating pattern predictably creates two contrasting metabolic profiles in the daytime and nighttime. The two major metabolic problems feared during Ramadan are the potential daytime hypoglycemia due to deprivation of calorie intake and unopposed insulin action and possible hyperglycemia after the breaking of the fast in the evening due to compensatory overeating. Theoretically, the paradoxically combined risks of hypoglycemia from prolonged daytime fasting and hyperglycemia from excessive nighttime eating can be better managed by an insulin pump-based regimen than by multiple insulin dose injection therapy. Hypoglycemia can be aborted, reduced, prevented, and even more readily treated in pump-treated patients by timely downward adjustments or even totally stopping of insulin delivery from the pump. Such an advantage is not available to those treated with a conventional insulin injection where insulin continues to be released from the site of injection throughout its predetermined duration of action. Any excess insulin action can only be counteracted by intake of carbohydrate.

Although there are limited data on the use of insulin pump therapy during Ramadan, three different anecdotal opinions have been expressed. ^{9 –11} A group of professionals convened in 2004 argued strongly for discouraging insulin pump-treated patients from fasting and branded the use of insulin pump as an “absolute contraindication” for fasting. ⁹ A second group thought that “subcutaneous insulin pump management is an appealing alternative strategy”; however, they were more concerned about that fact “it is more expensive and still requires frequent blood glucose monitoring.” ¹⁰ Interestingly, a third group without any supporting evidence suggested that “Patients using insulin pumps (continuous subcutaneous insulin infusion, CSII) should adjust their infusion rates carefully according to results of frequent home blood glucose monitoring. Most will need to reduce their basal infusion rate whilst increasing the bolus doses to cover the pre-dawn and sunset meals.” ¹¹ Therefore, it was timely that this study was conducted with the increased usage of insulin pumps in the affluent countries of the Middle East. ^13,14

This report describes an initial observational experience with type 1 diabetes patients on insulin pumps during Ramadan 2008 (29 days). Patients' glycemic control and changes made by patients in their insulin pump regimen were assessed in “real life” situation. Patients were allowed to adjust the doses as they would do under normal circumstances. From first principles and our observation, the most crucial change is the reduction of the basal insulin rates during the fasting period of the day. However, we have noticed that the reduction varied widely among patients. Crude assessment could not relate the change in insulin dose and risk of hypoglycemia. Patients adjusted the bolus insulin doses by intake of carbohydrate as per their usual practice guided by their previous experiences, and patients were deemed adequately capable of making such adjustments. We conclude that the present study established the feasibility and safety of fasting of patients with type 1 diabetes on pump therapy provided they are fully educated on the use of the insulin pump and are otherwise metabolically stable and free from any acute illnesses. This exercise was based on normal clinic practice and is limited by the lack of detailed documentation of the basis and extent of dose adjustment and the precise relationship between dose adjustments and glycemic control. Other factors influencing glycemic control such as diet and exercise were not evaluated.

There are obvious limitations of this study. Lack of adequate documentation in “control” groups is noteworthy. One group that could have been used as controls, namely, patients on multiple dose insulin regimens who are observing the fast, to evaluate the advantages of pump therapy under these circumstances. Another group are those patients on pump therapy who did not fast.

We suggest that future studies consider evaluating all these variables before and during Ramadan fasting. Continuous glucose monitoring has been used before and could be used in a such study too. ²²

In conclusion, fasting during Ramadan is feasible for patients with type 1 diabetes on insulin pumps with adequate counseling and support. Further detailed and carefully designed studies are needed to confirm these observations using downloaded blood glucose measurements to verify reported hypoglycemic symptoms and to establish the best adjustments in their pump protocols.