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

April 27, 2021 updated by: King Abdullah International Medical Research Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemia incidence
Time Frame: 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.
Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose variability
Time Frame: 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
Through study completion, an average of 3 months
Days fast broken
Time Frame: 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
Through study completion, an average of 3 months
Glycemic control
Time Frame: 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
Through study completion, an average of 3 months
Hyperglycemia
Time Frame: 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)
Through study completion, an average of 3 months
Acute diabetes complications
Time Frame: 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)
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah International Medical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 28, 2020

Primary Completion (ACTUAL)

August 31, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

May 10, 2020

First Posted (ACTUAL)

May 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ19/175/J

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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