الفهرس 
IntroductionOnly 14 pages are availabe for public view
 |  | from | 39 |  |  |
| | | from | 39 | | |
Abstract
Ramadan fasting is fundamental to the Islamic way of life both spiritually and socially. Although there are clear religious exemptions from fasting for patients with chronic diseases, people with diabetes feel inclined to fast as other members of the community. A large number of these patients use insulin-based therapies. The available guidelines on how to adjust insulin regimens during Ramadan from many associations and societies all came from updated position statements and expert recommendations. There are no large scale studies examining the effects of these adjustments on different parameters.
Our study was an open-label randomized prospective trial (INSULIN REGIMENS IN RAMADAN - IRIR).The study aims to compare the adjustments of different regimens of insulin adopted by patients according to the current guidance, while fasting the holy month of Ramadan.
This study included 400 T2DM patients receiving insulin therapy on different regimens and was stratified into two groups:
group I: included 300 patients on premixed insulin, further divided equally into 2 arms:
(a) IA(pre-dawn dose (sohour) was be reduced by 50%) and,
(b) IB the pre-dawn dose (sohour) was be reduced by 25%). Both arms maintained the same pre-sunset (iftar) dose as the pre-Ramadan morning premixed dose.
group II: included 100 Patients on a Basal-bolus insulin regimen and further divided equally into two arms:
(a) IIA: Basal insulin dose was be reduced by 20%, while the pre-dawn dose (sohour) dose was be reduced by 50%,
(b) IIB: Basal insulin dose was kept the same as the pre-Ramadan dose, while the pre-dawn dose (sohour) was be reduced by 50% from the pre-Ramadan evening dose. Both arms maintained the same pre-sunset (iftar) dose as the pre-Ramadan morning premixed dose.
Our study was different from other previously published studies since it aimed primarily to compare insulin regimens in terms of outcomes. Hence, trying to find a regimen that allows patients to fast safely, and at the same time, to fast as many days during Ramadan as possible. This is intended to gain the spiritual benefits and wellbeing that will in turn reflect positively on their health and quality of life overall.
The patients had 6 visits to follow up: pre-Ramadan visit, 4 once-weekly visits during Ramadan and a post-Ramadan visit (within 1 month after Ramadan).
Our findings were the following:
1. Decreasing premixed Insulin suhoor doses by 50% resulted in the same incidence of hypoglycemia compared to decreasing the dose by 25%. This change also showed worsening of HbA1c. Decreasing the insulin suhoor dose by 50% also caused a higher incidence of breaking the fast due to hyperglycemia and worse renal functions. All these factors drive us to conclude that reducing premixed insulin suhoor doses by 50% is not recommended.
2. Renal function was slightly affected by Ramadan fast in both arms of group 1, but we observed a more significant worsening of serum creatinine levels and albuminurea in the group where suhoor insulin was reduced by 50%.
3. There were no cases of severe hypoglycemia reported in either groups. Interestingly, both hyperglycemic and hypoglycemic events clustered in the first week, decreasing as Ramadan goes on, pointing to the importance of close follow up and wise, appropriate, and individualized dose modifications.
4. Higher baseline HbA1c led to higher incidence of hypoglycemia, hyperglycemia and fast breaking.
5. Our study showed that the main reason for breaking the fast was hyperglycemia (69.7%) compared to hypoglycemia (30.3%), meaning that the excessive reduction of insulin doses is not recommended.
We recommend that a large number of patients can fast safely with wise and appropriate dose adjustments after ensuring that proper education and clinical assessments are done. Close follow up during Ramadan is essential regardless of age, duration of diabetes, and the presence of complications.
We need not forget that maximizing the spiritual benefits and satisfying our patients improves their overall quality of life and should be the main focus and end point of all Ramadan-based studies, not just focus on preventing acute complications.