Type1diabetesNCT04864483
Sahoor Meal Regimen for Patients With Type1 Diabetes
A study testing Meal timing in relation to time of starting the fast in people with Type1diabetes and Fasting Hypoglycemia, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Type1diabetes, Fasting Hypoglycemia
- What is being tested?
- Meal timing in relation to time of starting the fast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 21 Mar 2021to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Have previously fasted Ramadan
- Are willing to fast this year
- Well educated about requirements for fasting Ramadan
Who cannot join
- Cognitive impairment or learning disability
- Renal and hepatic impairment
- Adrenal insufficiency
- Pregnancy
- Alcohol consumption
- Any diagnosed psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sahoor Meal Regimen for Patients With Type1 Diabetes; Randomized Cross Over Design of Two Regimens
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.
Read the 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).
- Conditions
- Type1diabetes, Fasting Hypoglycemia
- Being tested
- Meal timing in relation to time of starting the fast
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal timing in relation to time of starting the fastOther
as described
| Study group | Role | What they receive |
|---|---|---|
| Early sahoor with predawn snack | Experimental | 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). Receives: Other: Meal timing in relation to time of starting the fast |
| Late Sahoor meal (within 30 minjted of dawn) with insulin dose | Experimental | 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). Receives: Other: Meal timing in relation to time of starting the fast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (6)
number of days fasting discontinued
To estimate the difference between the two regimens in number of days they needed to brake their fast
Measured: 1 month
Hyperglycemia incidence during fasting
To estimate the difference between the two regimen in daytime hyperglycemia
Measured: 1 month
Blood sugar control
To assess the difference in glycemic control between the two regimens using estimated A1c
Measured: 1 month
Incidence of complications
To estimate the difference between the two groups in rate of severe hyperglycemia and /or DKA
Measured: 1 month
Glucose variability
To estimate the difference between the two regimens in glucose variability
Measured: 1 month
Patient satisfaction and preference
To estimate the difference between the two regimens in patients' preferences
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start21 Mar 2021
- Primary completion27 Jun 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross over design
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mohammad Alamoudi, King Abdullah International Medical Research Center
- Investigators
- Reem M Alamoudi, Principal investigator, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864483
- Sponsor's protocol ID
- RJ20/446/J,
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2021
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sahoor Meal Regimen for Patients With Type1 Diabetes; Randomized Cross Over Design of Two Regimens
- ClinicalTrials.gov ID
- NCT04864483
- Acronym / sponsor ID
- RJ20/446/J,
- Conditions
- Type1diabetes, Fasting Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 27 Jun 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cross over design
| Arm | Type | Receives |
|---|---|---|
| Early sahoor with predawn snack | Experimental | Other: Meal timing in relation to time of starting the fastTo 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). |
| Late Sahoor meal (within 30 minjted of dawn) with insulin dose | Experimental | Other: Meal timing in relation to time of starting the fastTo 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). |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- Cognitive impairment or learning disability
- Renal and hepatic impairment
- Adrenal insufficiency
- Pregnancy
- Alcohol consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal timing in relation to time of starting the fastas described | Other | Early sahoor with predawn snack, Late Sahoor meal (within 30 minjted of dawn) with insulin dose |
Primary outcome
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
6 secondary outcomes
number of days fasting discontinued
Time frame: 1 month
Hyperglycemia incidence during fasting
Time frame: 1 month
Blood sugar control
Time frame: 1 month
Incidence of complications
Time frame: 1 month
Glucose variability
Time frame: 1 month
Patient satisfaction and preference
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem M Alamoudi principal investigator
King Abdullah International Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal timing in relation to time of starting the fast in people with Type1diabetes and Fasting Hypoglycemia, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of early day hypoglycemia (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.