A Randomized Control Trial in People With Type 1 Diabetes Mellitus Who Will Fast Ramadan: Does Insulin Timing and Dose Matter?

INTRODUCTION/BACKGROUND

Diabetes and Ramadan (DAR) and IDF international collaboration created the IDF-DAR guidelines which include the practical recommendations for HCP to better manage people with diabetes who plan to fast Ramadan. The National Institute for Health and Clinical Excellence has recommended implementation of structured education programs to help individuals enhance their knowledge about diabetes and improve their management techniques. The educational program needs to ensure that patients can cope with specific situations such as exercise, illness which should extend to religious fasting.

We have developed and adopted a 5-day educational program widely used in the UK for delivery in Kuwait. The course trains adults with Type 1 Diabetes in the UK to manage their condition more effectively using multiple injections. As part of our course, DAFNE graduates receive yearly Ramadan diabetes educational specific session (separate from the main 5-day course) and all DAFNE graduates are invited. During the 6 hours session, we seek patients' views, willingness to fast and introduced to the specific food that commonly consumed during Ramadan. Previous personal experiences of fasting and problems encountered are collected. Patients who are intending to fast and whom we deem safe to undertake this, receive clear and practical guidance on safe fasting during Ramadan.

Current Gaps in the Literature

Most intervention studies up to date have been performed in controlled conditions, using a small number of participants and with a short duration of intervention, ie not closely related to real-life. The variability of insulin regimens, dietary patterns and physical activity levels and the complexity of ways in which they are tested make it difficult to identify the individual effects of each component on diabetes outcomes. As a result, further research is needed to help expand the currently available knowledge regarding the management of diabetes and its associated complications when fasting during Ramadan. We believe that large, randomized, controlled intervention trials are necessary to broaden our understanding of the implications of fasting and evaluate guidance without bias. Further research into the effect of fasting during Ramadan on both high (measured by SMBG and HbA1C) and low glucose (measured by the incidence of hypoglycemia) is required. Robust evaluation of evidence-based guidelines will lead to useful practical assistance for patients who can fulfill religious obligations despite the additional burden of insulin-treated diabetes. This pilot study builds on an educational program, DAFNE which includes many of the elements of flexible eating and insulin dose adjustment which should permit patients to fast safely.