Early Versus Late Administration of Insulin Glargine in T1DM During Fasting Ramadan

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Early Versus Late Administration of Insulin Glargine in Patients With type1 Diabetes During Fasting Ramadan

Conditions
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Insulin, Type1diabetes, Fasting

Intervention / Treatment
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* Other: Timing of taking insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DM type 1 Age > 14 years Diagnosis of type 1 DM of more than 6 months. Committed to do SMBG Exclusion Criteria: Renal and hepatic impairment Adrenal insufficiency Pregnancy Alcohol consumption Any diagnosed psychiatric disease

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Glargine<br>To take insulin Glargine at 6-7 pm | Other: Timing of taking insulin<br>* To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)<br>|
| Active Comparator: Late Glargine<br>To take insulin Glargine at 10-12 pm | Other: Timing of taking insulin<br>* To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type1 Diabetes, Fasting, Insulin Glargine, Ramadan, Hypoglycemia