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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Glargine | Active Comparator | To take insulin Glargine at 6-7 pm |
|
| Late Glargine | Active Comparator | To take insulin Glargine at 10-12 pm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing of taking insulin | Other | To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose variability | To estimate the difference between the two groups in glucose variability as measured by standard deviation on glucose monitoring | Through study completion, an average of 3 months |
| Days fast broken |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KingAbullahIMRC | Jeddah | Saudi Arabia |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| D007333 | Insulin Resistance |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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Open label Randomized
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To estimate the difference between the two groups in number of days they needed to brake their fast
| 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 | 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) | 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) | Through study completion, an average of 3 months |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |