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

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383990
• Other study ID #: RJ19/175/J
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: May 2020
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: November 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Fasting
• Insulin
• Type1diabetes

Intervention

Other:
• Timing of taking insulin
To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)

Locations

Country	Name	City	State
Saudi Arabia	KingAbullahIMRC	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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