Early Versus Late Administration of Insulin Glargine in T1DM During Fasting Ramadan
NCT ID: NCT04383990
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
185 participants
INTERVENTIONAL
2020-02-28
2020-11-30
Brief Summary
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Detailed Description
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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:
1. To estimate the difference between the two groups in glucose variability
2. To estimate the difference between the two groups in number of days they needed to brake their fast
3. To assess the difference in glycemic control between the two groups
4. To estimate the difference between the two groups in overnight and daytime hyperglycemia.
5. 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:
1. Patient's demographics including (age, gender, type and duration of diabetes), and baseline measurements (weight, height,BMI, …).
2. Rate of Hypoglycemic events (as per SMBG records and CGM) in both groups
3. Number of days fasting was broken in both groups
4. Rate of severe hyperglycemic episodes (BG\>250mg/dl) or DKA in both groups
5. 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.
6. Mean 24-hour blood glucose as measured by a continuous glucose monitoring devise in both groups.
7. Mean fasting blood glucose for the month period as calculated from patients home blood sugar measurements in both groups.
8. Mean 2-hour post-prandial blood glucose for the as calculated from patients home blood sugar measurements in both groups.
9. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early Glargine
To take insulin Glargine at 6-7 pm
Timing of taking insulin
To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)
Late Glargine
To take insulin Glargine at 10-12 pm
Timing of taking insulin
To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)
Interventions
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Timing of taking insulin
To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)
Eligibility Criteria
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Inclusion Criteria
2. Age \> 14 years
3. Diagnosis of type 1 DM of more than 6 months.
4. Committed to do SMBG
Exclusion Criteria
2. Adrenal insufficiency
3. Pregnancy
4. Alcohol consumption
5. Any diagnosed psychiatric disease
14 Years
ALL
No
Sponsors
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King Abdullah International Medical Research Center
OTHER
Responsible Party
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Locations
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KingAbullahIMRC
Jeddah, , Saudi Arabia
Countries
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Other Identifiers
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RJ19/175/J
Identifier Type: -
Identifier Source: org_study_id
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