Sahoor Meal Regimen for Patients With Type1 Diabetes

Study Overview
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Brief Summary
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To examine effects of two approaches to sahoor meal consumption during Ramadan on blood sugar control and incidence of early day hypoglycemic episodes requring the discontinuation of fasting.

Detailed Description
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Most studies and guidelines regarding insulin dose adjustments have focused on basal insulin modification rather than boluses or timing of meals. There hasn't been so far any study that examines a specific dose reduction or timing that is best to avoid early day (post Suhoor) hypo or hyperglycemia, and the advised dose reductions are based on expert opinion with small observational studies that used certain dose changes. The timing of sleep and meals are different during Ramadan and therefore have a direct impact on blood glucose levels, we demonstrated in a previous prospective cohort of 156 T1DM patients contrary to other studies, the post suhoor and early day period had the highest incidence time for hypoglycemia in the Saudi population. It is therefore necessary to understand how adjustments to the timing of the meals and their doses can achieve better glycemic control during fastin Ramadan. Current guidelines recomend that the Suhoor meal is delayed as much as possible in order to reduce the fasting duration to be taken with a claculated insulin dose. However, the concern is that this would not allow patients to correct the hypoglycemic or hyperglycemic events related to miscalculation of Suhoor insulin dose if they occur as the fasting time begins and they must break their fast to correct their blood glucose levels. Many people with T1DM do not count meal carbohydrates correctly, therefore, there is a need for an approach that allows patients to correct their blood glucose levels after having a large meal that requires insulin administration without having to break their fast, as well as the ability to have a snack or a late Suhoor without the need for insulin administration to minimize the fasting period and insure that the blood glucose is in range before starting to fast. The approach that we are proposing will allow patients to do that by having the Suhoor meal with its bolus at least two hours before fasting begins, and having a low carbohydrate snack - late suhoor- just before starting to fast without the need for insulin administration (regimen 1). It is going to be compared with having the Suhoor with its insulin bolus just before the start of fasting (regimen 2).

Official Title
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Sahoor Meal Regimen for Patients With Type1 Diabetes; Randomized Cross Over Design of Two Regimens

Conditions
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Type1diabetes, Fasting Hypoglycemia

Intervention / Treatment
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* Other: Meal timing in relation to time of starting the fast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DM type 1 Age > 14 years Diagnosis of type 1 DM of more than 6 months. Committed to do SMBG or on CGM On Multiple Daily Injections or insulin pumps On carbohydrate counting for meal dosing Have previously fasted Ramadan Are willing to fast this year Well educated about requirements for fasting Ramadan Exclusion Criteria: Cognitive impairment or learning disability Renal and hepatic impairment Adrenal insufficiency Pregnancy Alcohol consumption Any diagnosed psychiatric disease

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized cross over design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early sahoor with predawn snack<br>To take the Sahoor meal 1:30-2 hours before dawn with insulin dose then a pre-dawn snack with no insulin (Sahoor is the latest meal before starting the fast at dawn during the month of Ramadan. The intervention is meal timing in relation to start of fast and does not involve any medications). | Other: Meal timing in relation to time of starting the fast<br>* as described<br>|
| Experimental: Late Sahoor meal (within 30 minjted of dawn) with insulin dose<br>To take sahoor meal as late as possi le with usual insulin dose (Sahoor is the latest meal before starting the fast at dawn during the month of Ramadan. The intervention is meal timing in relation to start of fast and does not involve any medications). | Other: Meal timing in relation to time of starting the fast<br>* as described<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of early day hypoglycemia | To determine if taking insulin dose suhoor meal 90 minutes before dawn plus a predawn high protein snack is associated with less rates of hypoglycemia -(we will consider glucose level of 70 mg/dl ( 3.9 mmol/l) and below as the level of hypoglycemia - compared to taking insulin dose suhoor meal 15-30 minutes before dawn during fasting Ramadan in patietnts with T1DM on MDI or insulin pump | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days fasting discontinued | To estimate the difference between the two regimens in number of days they needed to brake their fast | 1 month | 
| Hyperglycemia incidence during fasting | To estimate the difference between the two regimen in daytime hyperglycemia | 1 month | 
| Blood sugar control | To assess the difference in glycemic control between the two regimens using estimated A1c | 1 month | 
| Incidence of complications | To estimate the difference between the two groups in rate of severe hyperglycemia and /or DKA | 1 month | 
| Glucose variability | To estimate the difference between the two regimens in glucose variability | 1 month | 
| Patient satisfaction and preference | To estimate the difference between the two regimens in patients' preferences | 1 month |