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NCT Number: NCT04383990

Early Versus Late Administration of Insulin Glargine in T1DM 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.

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Key information

Conditions

Type1diabetes Behavior Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Insulin Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KingAbullahIMRC

Jeddah, Saudi Arabia

About this study

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:

  • To estimate the difference between the two groups in glucose variability
  • To estimate the difference between the two groups in number of days they needed to brake their fast
  • To assess the difference in glycemic control between the two groups
  • To estimate the difference between the two groups in overnight and daytime hyperglycemia.
  • 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:

  • Patient's demographics including (age, gender, type and duration of diabetes), and baseline measurements (weight, height,BMI, …).
  • Rate of Hypoglycemic events (as per SMBG records and CGM) in both groups
  • Number of days fasting was broken in both groups
  • Rate of severe hyperglycemic episodes (BG>250mg/dl) or DKA in both groups
  • 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.
  • Mean 24-hour blood glucose as measured by a continuous glucose monitoring devise in both groups.
  • Mean fasting blood glucose for the month period as calculated from patients home blood sugar measurements in both groups.
  • Mean 2-hour post-prandial blood glucose for the as calculated from patients home blood sugar measurements in both groups.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DM type 1
  • Age > 14 years
  • Diagnosis of type 1 DM of more than 6 months.
  • Committed to do SMBG

Exclusion criteria

  • Renal and hepatic impairment
  • Adrenal insufficiency
  • Pregnancy
  • Alcohol consumption
  • Any diagnosed psychiatric disease

Treatment and study plan

Timing of taking insulin

Other

To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 12, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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