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

• Sponsor: King Abdullah International Medical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04383990
• Collaborator: (none)
• Enrollment: 185
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.1
• Patients Per Site Per Month: 20.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type1diabetes; Fasting; Insulin	Other: Timing of taking insulin	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 185 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Open label RandomizedOpen label Randomized
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Early Versus Late Administration of Insulin Glargine in Patients With type1 Diabetes During Fasting Ramadan
• Actual Study Start Date: Feb 28, 2020
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Early Glargine To take insulin Glargine at 6-7 pm	Other: Timing of taking insulin; To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)
Active Comparator: Late Glargine To take insulin Glargine at 10-12 pm	Other: Timing of taking insulin; To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)

Outcome Measures

Primary Outcome Measures

1. Hypoglycemia incidence [Through study completion, an average of 3 months]

   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 Outcome Measures

1. Glucose variability [Through study completion, an average of 3 months]

   To estimate the difference between the two groups in glucose variability as measured by standard deviation on glucose monitoring

2. Days fast broken [Through study completion, an average of 3 months]

   To estimate the difference between the two groups in number of days they needed to brake their fast

3. Glycemic control [Through study completion, an average of 3 months]

   To assess the difference in glycemic control between the two groups as measured by hbA1c and frucosamine before and after Ramadan

4. Hyperglycemia [Through study completion, an average of 3 months]

   To estimate the difference between the two groups in overnight and daytime rates of hyperglycemia (BG > 250 mg/dl)

5. Acute diabetes complications [Through study completion, an average of 3 months]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KingAbullahIMRC	Jeddah		Saudi Arabia

Sponsors and Collaborators

• King Abdullah International Medical Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: King Abdullah International Medical Research Center
• ClinicalTrials.gov Identifier: NCT04383990
• Other Study ID Numbers: RJ19/175/J
• First Posted: May 12, 2020
• Last Update Posted: Apr 28, 2021
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by King Abdullah International Medical Research Center: Type1 Diabetes; Fasting; Insulin Glargine; Ramadan; Hypoglycemia
• Additional relevant MeSH terms: Diabetes Mellitus, Type 1; Insulin

Study Results

No Results Posted as of Apr 28, 2021