Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864483
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2021-04-26
Brief Title:
Sahoor Meal Regimen for Patients With Type1 Diabetes
Sponsor:
King Abdullah International Medical Research Center
Organization:
King Abdullah International Medical Research Center
Study Overview
Official Title:
Sahoor Meal Regimen for Patients With Type1 Diabetes Randomized Cross Over Design of Two Regimens
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hasnt 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None