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

King Abdullah International Medical Research Center

Status: Completed

Conditions: Insulin; Fasting; Type1diabetes

Treatments: Other: Timing of taking insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT04383990

RJ19/175/J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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185 participants in 2 patient groups

Early Glargine

Active Comparator group

Description:

To take insulin Glargine at 6-7 pm

Treatment:

Other: Timing of taking insulin

Late Glargine

Active Comparator group

Description:

To take insulin Glargine at 10-12 pm

Treatment:

Other: Timing of taking insulin