Clinical trial NCT04864483: Sahoor Meal Regimen for Patients With Type1 Diabetes
Official title: Sahoor Meal Regimen for Patients With Type1 Diabetes; Randomized Cross Over Design of Two Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Fasting Hypoglycemia
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 44
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross over design
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: Inclusion Criteria:

1. DM type 1
2. Age \> 14 years
3. Diagnosis of type 1 DM of more than 6 months.
4. Committed to do SMBG or on CGM
5. On Multiple Daily Injections or insulin pumps
6. On carbohydrate counting for meal dosing
7. Have previously fasted Ramadan
8. Are willing to fast this year
9. Well educated about requirements for fasting Ramadan

Exclusion Criteria:

1. Cognitive impairment or learning disability
2. Renal and hepatic impairment
3. Adrenal insufficiency
4. Pregnancy
5. Alcohol consumption
6. Any diagnosed psychiatric disease

Primary outcomes:
measure: Incidence of early day hypoglycemia
timeFrame: 1 month
Secondary outcomes:
measure: number of days fasting discontinued
timeFrame: 1 month
measure: Hyperglycemia incidence during fasting
timeFrame: 1 month
measure: Blood sugar control
timeFrame: 1 month
measure: Incidence of complications
timeFrame: 1 month
measure: Glucose variability
timeFrame: 1 month
measure: Patient satisfaction and preference
timeFrame: 1 month
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: KingAbullahIMRC
state: Western
Study officials:
affiliation: King Abdullah International Medical Research Center
name: Reem M Alamoudi
role: PRINCIPAL_INVESTIGATOR
References: