Clinical trial NCT04383990: Early Versus Late Administration of Insulin Glargine in T1DM During Fasting Ramadan
Official title: Comparison of Early Versus Late Administration of Insulin Glargine in Patients With type1 Diabetes During Fasting Ramadan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Fasting
Insulin
Keywords: Type1 Diabetes
Fasting
Insulin Glargine
Ramadan
Hypoglycemia
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 185
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label Randomized
Primary purpose: TREATMENT

Brief 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.

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:

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.

Eligibility criteria: Inclusion Criteria:

1. DM type 1
2. Age \> 14 years
3. Diagnosis of type 1 DM of more than 6 months.
4. Committed to do SMBG

Exclusion Criteria:

1. Renal and hepatic impairment
2. Adrenal insufficiency
3. Pregnancy
4. Alcohol consumption
5. Any diagnosed psychiatric disease

Primary outcomes:
measure: Hypoglycemia incidence
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Glucose variability
timeFrame: Through study completion, an average of 3 months
measure: Days fast broken
timeFrame: Through study completion, an average of 3 months
measure: Glycemic control
timeFrame: Through study completion, an average of 3 months
measure: Hyperglycemia
timeFrame: Through study completion, an average of 3 months
measure: Acute diabetes complications
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: KingAbullahIMRC
Study officials:
References: