Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan

Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan: Safety and Efficacy

All healthy Muslim adults are required to observe the Ramadan fast, which is one of Islam's five pillars. People with Type 2 Diabetes Mellitus(T2DM). frequently fast throughout Ramadan. However, many Muslim patients insist on fasting in spite of medical warning. So, the investigators aim in the current study to assess safety and efficacy of our hybrid method using of low-ratio premixed insulin take at Iftar and short acting insulin take at Suhoor compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting.

Study Overview

• Status: Completed
• Conditions: Continous Blood Glucose Monitoring; Calculation of Body Mass Index; Measurment of Blood Pressure

Detailed Description

All healthy Muslim adults are required to observe the Ramadan fast, which is one of Islam's five pillars. People with Type 2 Diabetes Mellitus(T2DM). frequently fast throughout Ramadan.

Although fasting during Ramadan is said to have positive effects on diabetes patients, such as a reduction in excess body weight and an improvement in lipid profile, it can be linked to a slight increased risk for metabolic complications that need immediate attention, such as hypoglycemia and hyperglycemia, dehydration, and diabetic ketoacidosis (DKA)

Similarly, an increase in hyperglycemic episodes was also noted in another study conducted by the Benghazi Diabetes and Endocrine Centre (BDEC) on 493 T2DM patients fasting during Ramadan where 10.7% experienced hyperglycemia. Therefore, appropriate treatment adjustments including insulin regimen are necessary to avoid both hypo and hyperglycemia during Ramadan fasting.

T2DM patients well-controlled on premixed insulin or multiple doses injections should not fast, and they have the legitimate exemption for this. However, many Muslim patients insist on fasting inspite of medical warning. So, the investigators aim in the current study to assess safety and efficacy of our hybrid method using of low-ratio premixed insulin take at Iftar and short acting insulin take at Suhoor compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

This study will carry out on Muslim type 2 DM patients willing to fast Ramadan during the year 2024 attending outpatient clinic, Sohag faculty of medicine, Sohag university, Egypt.

Description

Inclusion Criteria:

• Egyptian male and female Muslim patients,With T2DM, willing to fast Ramadan

  • . age ≥ 18 years old.
  • . type 2 diabetic patients treated with premixed insulin alone or combined with oral antidiabetic drugs (metformin, sulfonylurea: gliclazide, dipeptidyl peptidase 4 Inhibitor: sitagliptin or vildagliptin or thiazolidinediones/glitazones).

Exclusion Criteria:

• type 1 diabetic patients
• uncontrolled type 2 diabetics (HbA1c > 9; but they were included if insisting on fasting despite the detailed medical advice very high-risk diabetics (according to IDF 2021 classification)9
• newly diagnosed as diabetics (< 3 months)
• patients with previous ketoacidosis or hyperosmolar hyperglycemic states, recurrent or severe hypoglycemia within the past 2 months
• type 2 diabetic patients with hypoglycemic unawareness.
• Hospitalized patients, besides pregnant and lactating females

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1; type 2 diabetic patients take normal breakfast dose at Iftar and take 50% of dinner dose as short acting insulin at Suhoor with giving metformin dose after Suhoor even if giving once per day.
Group 2; patients on regmin as recommendations of IDF take normal breakfast dose at Iftar and Reduce Suhoor dose by 20-50% of dinner premixed dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of hyprid method of insulin in type 2 diabetic patients during fasting in ramadan	This is a study aiming to assess the safety and efficacy of our hybrid method compare to last recommendation of IDF guideline of using low-ratio premix insulin regimens in type 2 diabetic patients who insist on Ramadan fasting. and this done by measurement of blood glucose level 7 times daily to detect control of blood glucose during fasting in ramadan .then will measure fasting and postprandial blood glucose level after ramadan	4 weeks after ramadan

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Chair: sara Kasem Abdelal, lecturer, Sohag University .Faculty of Medicine; Study Chair: Ahmed Faysal El_Rawy, lecturer, Sohag University .Faculty of Medicine; Study Chair: Marwa zanaty Elsayed, lecturer, Sohag University .Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): June 15, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: type 2 DM.fasting in ramadan .insulin therapy
• Other Study ID Numbers: Soh-Med-24-05--02PD.

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