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OpenTrials
Completed

NCT Number: NCT04864483

Sahoor Meal Regimen for Patients With Type1 Diabetes

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.

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Key information

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KingAbullahIMRC

Jeddah, Western, 21423, Saudi Arabia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal timing in relation to time of starting the fast

Other

as described

Primary outcomes

  1. Incidence of early day hypoglycemia

    Time frame: 1 month

    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

Secondary outcomes

  1. number of days fasting discontinued

    Time frame: 1 month

    To estimate the difference between the two regimens in number of days they needed to brake their fast

  2. Hyperglycemia incidence during fasting

    Time frame: 1 month

    To estimate the difference between the two regimen in daytime hyperglycemia

  3. Blood sugar control

    Time frame: 1 month

    To assess the difference in glycemic control between the two regimens using estimated A1c

  4. Incidence of complications

    Time frame: 1 month

    To estimate the difference between the two groups in rate of severe hyperglycemia and /or DKA

  5. Glucose variability

    Time frame: 1 month

    To estimate the difference between the two regimens in glucose variability

  6. Patient satisfaction and preference

    Time frame: 1 month

    To estimate the difference between the two regimens in patients' preferences

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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