Type1diabetesNCT04383990
Early Versus Late Administration of Insulin Glargine in T1DM During Fasting Ramadan
A study testing Timing of taking insulin in people with Type1diabetes and Fasting, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial summary
To compare different timing of insulin Glargine administration (early-6 pm versus standard bedtime-10 pm) as part of standard of care in patients with type1 diabetes who wish to fast the month of Ramadan. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Type1diabetes, Fasting, Insulin
- What is being tested?
- Timing of taking insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 28 Feb 2020to 30 Nov 2020
- 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 years and older
- 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
Who cannot join
- 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: Comparison of Early Versus Late Administration of Insulin Glargine in Patients With type1 Diabetes During Fasting Ramadan
To compare different timing of insulin Glargine administration (early-6 pm versus standard bedtime-10 pm) as part of standard of care in patients with type1 diabetes who wish to fast the month of Ramadan.
Read the detailed description
The investigators aim to compare the effectiveness and safety of two management strategies currently used in basal insulin adjustment for treatment of Type1 diabetes (T1DM) during fasting the holy month of Ramadan.
Primary Objective:
To determine if taking basal insulin Glargine at 6 pm 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 bedtime timing (10-12pm) during fasting Ramadan in patients with T1DM
Secondary Objectives:
- To estimate the difference between the two groups in glucose variability
- To estimate the difference between the two groups in number of days they needed to brake their fast
- To assess the difference in glycemic control between the two groups
- To estimate the difference between the two groups in overnight and daytime hyperglycemia.
- To estimate the difference between the two groups in rate of severe hyperglycemia and /or DKA
It is a multi-center open label randomized study that will take place in the diabetes/Endocrine clinics at National Guards Hospitals in four cities (Jeddah, Riyadh, Alhasa, and Dammam)
Variables to be Assessed:
- Patient's demographics including (age, gender, type and duration of diabetes), and baseline measurements (weight, height,BMI, …).
- Rate of Hypoglycemic events (as per SMBG records and CGM) in both groups
- Number of days fasting was broken in both groups
- Rate of severe hyperglycemic episodes (BG>250mg/dl) or DKA in both groups
- Mean blood glucose for the month of Ramadan as calculated from sum of each patient's 7-point blood sugar home measurements in both groups.
- Mean 24-hour blood glucose as measured by a continuous glucose monitoring devise in both groups.
- Mean fasting blood glucose for the month period as calculated from patients home blood sugar measurements in both groups.
- Mean 2-hour post-prandial blood glucose for the as calculated from patients home blood sugar measurements in both groups.
- Fructosamine and HbA1c level before and after Ramadan in both groups
Results of this study will help fill a current gap of knowledge and may also contribute to the development of future guidelines for the management of type1DM during Ramadan.
- Conditions
- Type1diabetes, Fasting, Insulin
- Being tested
- Timing of taking insulin
- Keywords
- Type1 Diabetes, Fasting, Insulin Glargine, Ramadan, Hypoglycemia
- Medical subject headings
- Fasting, Insulin Resistance, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of taking insulinOther
To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)
| Study group | Role | What they receive |
|---|---|---|
| Early Glargine | Active comparator | To take insulin Glargine at 6-7 pm Receives: Other: Timing of taking insulin |
| Late Glargine | Active comparator | To take insulin Glargine at 10-12 pm Receives: Other: Timing of taking insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia incidence
To determine if taking basal insulin Glargine at 6 pm 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 bedtime timing (10-12pm) during fasting Ramadan in patients with T1DM.
Measured: Through study completion, an average of 3 months
Secondary outcomes (5)
Glucose variability
To estimate the difference between the two groups in glucose variability as measured by standard deviation on glucose monitoring
Measured: Through study completion, an average of 3 months
Days fast broken
To estimate the difference between the two groups in number of days they needed to brake their fast
Measured: Through study completion, an average of 3 months
Glycemic control
To assess the difference in glycemic control between the two groups as measured by hbA1c and frucosamine before and after Ramadan
Measured: Through study completion, an average of 3 months
Hyperglycemia
To estimate the difference between the two groups in overnight and daytime rates of hyperglycemia (BG > 250 mg/dl)
Measured: Through study completion, an average of 3 months
Acute diabetes complications
To estimate the difference between the two groups in rate of severe hyperglycemia (hypoglycemia associated with need for outside assisstance) and /or presentation to ER with Diabetic Keto-acidosis (DKA)
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start28 Feb 2020
- Primary completion31 Aug 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- Open label Randomized
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383990
- Sponsor's protocol ID
- RJ19/175/J
- Status last verified
- May 2020
- First submitted
- 14 Apr 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alamoudi R, Alqarni A, Alsubaiee M, Khogeer G, Saleh Y, Aljawharji A, Zarif H, Alaidarous S, Khashwayn S, Hassanein M. Timing of Insulin Glargine Administration During Intermittent Ramadan Fasting in patients With Type1 Diabetes: A Randomized Controlled Trial (GLARIF). J Diabetes Sci Technol. 2026 Oct 17:19322968261493574. doi: 10.1177/19322968261493574. Online ahead of print.
PubMed 42891564
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Versus Late Administration of Insulin Glargine in Patients With type1 Diabetes During Fasting Ramadan
- ClinicalTrials.gov ID
- NCT04383990
- Acronym / sponsor ID
- RJ19/175/J
- Conditions
- Type1diabetes, Fasting, Insulin
- Keywords
- Type1 Diabetes, Fasting, Insulin Glargine, Ramadan, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 12 May 2020 (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 compare different timing of insulin Glargine administration (early-6 pm versus standard bedtime-10 pm) as part of standard of care in patients with type1 diabetes who wish to fast the month of Ramadan.
Detailed description
The investigators aim to compare the effectiveness and safety of two management strategies currently used in basal insulin adjustment for treatment of Type1 diabetes (T1DM) during fasting the holy month of Ramadan.
Primary Objective:
To determine if taking basal insulin Glargine at 6 pm 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 bedtime timing (10-12pm) during fasting Ramadan in patients with T1DM
Secondary Objectives:
- To estimate the difference between the two groups in glucose variability
- To estimate the difference between the two groups in number of days they needed to brake their fast
- To assess the difference in glycemic control between the two groups
- To estimate the difference between the two groups in overnight and daytime hyperglycemia.
- To estimate the difference between the two groups in rate of severe hyperglycemia and /or DKA
It is a multi-center open label randomized study that will take place in the diabetes/Endocrine clinics at National Guards Hospitals in four cities (Jeddah, Riyadh, Alhasa, and Dammam)
Variables to be Assessed:
- Patient's demographics including (age, gender, type and duration of diabetes), and baseline measurements (weight, height,BMI, …).
- Rate of Hypoglycemic events (as per SMBG records and CGM) in both groups
- Number of days fasting was broken in both groups
- Rate of severe hyperglycemic episodes (BG>250mg/dl) or DKA in both groups
- Mean blood glucose for the month of Ramadan as calculated from sum of each patient's 7-point blood sugar home measurements in both groups.
- Mean 24-hour blood glucose as measured by a continuous glucose monitoring devise in both groups.
- Mean fasting blood glucose for the month period as calculated from patients home blood sugar measurements in both groups.
- Mean 2-hour post-prandial blood glucose for the as calculated from patients home blood sugar measurements in both groups.
- Fructosamine and HbA1c level before and after Ramadan in both groups
Results of this study will help fill a current gap of knowledge and may also contribute to the development of future guidelines for the management of type1DM during Ramadan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label Randomized
| Arm | Type | Receives |
|---|---|---|
| Early Glargine | Active comparator | Other: Timing of taking insulinTo take insulin Glargine at 6-7 pm |
| Late Glargine | Active comparator | Other: Timing of taking insulinTo take insulin Glargine at 10-12 pm |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- DM type 1
- Age > 14 years
- Diagnosis of type 1 DM of more than 6 months.
- Committed to do SMBG
Key exclusion criteria (5 listed)
- Renal and hepatic impairment
- Adrenal insufficiency
- Pregnancy
- Alcohol consumption
- Any diagnosed psychiatric disease
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 |
|---|---|---|
| Timing of taking insulinTo take insulin Glargine early (6-7pm) or late (bedtime-10-12pm) | Other | Early Glargine, Late Glargine |
Primary outcome
Hypoglycemia incidence
Time frame: Through study completion, an average of 3 months
To determine if taking basal insulin Glargine at 6 pm 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 bedtime timing (10-12pm) during fasting Ramadan in patients with T1DM.
5 secondary outcomes
Glucose variability
Time frame: Through study completion, an average of 3 months
Days fast broken
Time frame: Through study completion, an average of 3 months
Glycemic control
Time frame: Through study completion, an average of 3 months
Hyperglycemia
Time frame: Through study completion, an average of 3 months
Acute diabetes complications
Time frame: Through study completion, an average of 3 months
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 28 Apr 2021.
- Derived from this study: PubMed 42891564Alamoudi R, Alqarni A, Alsubaiee M, Khogeer G, Saleh Y, Aljawharji A, Zarif H, Alaidarous S, Khashwayn S, Hassanein M. Timing of Insulin Glargine Administration During Intermittent Ramadan Fasting in patients With Type1 Diabetes: A Randomized Controlled Trial (GLARIF). J Diabetes Sci Technol. 2026 Oct 17:19322968261493574. doi: 10.1177/19322968261493574. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of taking insulin in people with Type1diabetes and Fasting, 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 4 inclusion and 5 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 28 Apr 2021. 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?
Hypoglycemia incidence (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383990, which also lists 1 linked publication.
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 28 Apr 2021.