Sahoor Meal Regimen for Patients With Type1 Diabetes

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864483
• Other study ID #: RJ20/446/J,
• Status: Completed
• Phase: N/A
• Start date: March 21, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: April 2022
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 30, 2021
• Est. primary completion date: June 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Fasting Hypoglycemia
• Hypoglycemia
• Type1diabetes

Intervention

Other:
• Meal timing in relation to time of starting the fast
as described

Locations

Country	Name	City	State
Saudi Arabia	KingAbullahIMRC	Jeddah	Western

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hyperglycemia incidence during fasting	To estimate the difference between the two regimen in daytime hyperglycemia	1 month
Secondary	Blood sugar control	To assess the difference in glycemic control between the two regimens using estimated A1c	1 month
Secondary	Incidence of complications	To estimate the difference between the two groups in rate of severe hyperglycemia and /or DKA	1 month
Secondary	Glucose variability	To estimate the difference between the two regimens in glucose variability	1 month
Secondary	Patient satisfaction and preference	To estimate the difference between the two regimens in patients' preferences	1 month