Optimization of Basal Insulin During Ramadan Fasting in Type 2 Diabetic Patients: Comparison Between DAR Recommendations and the Carbohydrate Fasting Test & Metabolic and Inflammatory Consequences

Ramadan, a fasting period observed by many Muslim patients, poses a significant challenge for glycemic management in diabetics. During this month, abstinence from food, water, and medication from dawn to dusk leads to significant glycemic fluctuations. Inadequate insulin dose management can cause acute complications such as hypoglycemia, hyperglycemia, ketosis, or hyperosmolar states. In 2021, the Diabetes and Ramadan (DAR) guidelines provided recommendations for adjusting insulin doses, taking into account changes in circadian rhythms and patients' dietary habits. However, these standardized recommendations may not be suitable for everyone. A personalized alternative, the Carbohydrate Fasting Test (CFT), allows for the assessment of individual basal insulin needs through a controlled fast excluding carbohydrates for 24 hours. Comparing these two approaches could provide valuable insights into their relative effectiveness, particularly in terms of safety and quality of life for patients.

Moreover, diabetes can be influenced by fasting, with potentially beneficial effects on inflammation and metabolism.

This study aims to determine which of these two methods optimizes glycemic control and to assess the variations of inflammation markers before and after Ramadan fasting. The results could be integrated into future clinical practices to improve diabetes management during Ramadan. We aim to compare the effectiveness and safety of basal insulin dose adjustments according to DAR 2021 guidelines versus the Carbohydrate Fasting Test (CFT) and to analyze the impact on the quality of life of diabetic patients. This is a prospective, longitudinal, randomized, interventional study including 60 Type 2 diabetic patients, aged 18 to 70 years old, on insulin therapy for at least 6 months. All participants intend to fast during Ramadan and are at low to moderate risk according to the IDF-DAR score (≤6).

Eligible patients will be randomly assigned into two groups:

DAR Group: Insulin dose adjustments according to DAR 2021 recommendations. CFT Group: Personalized insulin adjustments based on a Carbohydrate Fasting Test conducted before Ramadan.

Protocol:

Initial assessment will be Clinical ( Weight, BMI, blood pressure) and biological (Fasting glucose, HbA1c, fructosamine and inflammatory markers ( Interleukin 6 and TNF alfa)).

During Ramadan, weekly glycemic monitoring will be conducted to track blood sugar levels. Any complications will be recorded, and insulin dose adjustments will be made remotely if necessary to ensure optimal glycemic control.

In the last week of Ramadan, a final clinical assessment will be performed, including measurements of weight, BMI, and blood pressure. A biological assessment will also be conducted to measure fructosamine levels and inflammatory markers ( Interleukin 6 and TNF alfa).

Two months after Ramadan, fasting glucose and HbA1c levels will be re-evaluated to assess long-term glycemic control. The study will also analyze the impact on glycemic regulation, anthropometric parameters, and overall quality of life using the SF-12 questionnaire.

In conclusion, this project aims to identify the most effective method for adjusting basal insulin doses during Ramadan, contributing to optimal Type 2 diabetes management and to assess the variations of inflammation markers before and after Ramadan fasting.

Study Overview

• Status: Active, not recruiting
• Conditions: Fasting, Intermittent; Inflammatory Markers; Diabetes Mellitus, Type 2 Treated With Insulin; Ramadan Fasting
• Intervention / Treatment: Drug: Adjustment of insulin doses DAR; Drug: Adjustment of insulin doses CFT

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1000
    • La Rabta Hospital , Endocrinology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 to 70 years with Type 2 diabetes on a basal insulin regimen (NPH, Detemir, or Glargine) with or without 1 to 2 boluses of rapid-acting insulin.
• Diabetes duration of at least 2 years and insulin therapy for at least 6 months.
• Patients wishing to fast during Ramadan and having provided informed consent.
• Low risk of complications according to the IDF-DAR 2021 risk score or moderate risk for patients who insist on fasting.

Non-Inclusion Criteria:

• High-risk patients according to IDF-DAR 2021 score >6, including those with:
• Severe renal impairment
• Cognitive dysfunction or frailty
• Unrecognized hypoglycemia
• Unstable cardiovascular disease
• Pregnancy
• Type 1 diabetes
• Type 2 diabetes patients on sulfonylureas or related medications

Exclusion Criteria:

• Patients who did not follow the study protocol regarding insulin dose adjustments and capillary blood glucose (CBG) self-monitoring.
• Fasting discontinuation without medical advice.
• Severe complications requiring fasting cessation.
• Patients who withdrew their informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DAR Group; The basal insulin doses will be adjusted in accordance with the recommendations published by DAR in 2021 for diabetic patients during Ramadan.	Drug: Adjustment of insulin doses DAR; Patients will be hospitalized at La Rabta Hospital from February 15 to February 28, 2025 for clinical (weight, BP, SF-12), biological (HbA1c, lipid profile) assessments and inflammatory markers (Interleukin 6 and TNF alfa) DAR Group: Insulin will be adjusted per DAR 2021 guidelines. Patients will track insulin doses, glycemic cycles, hypoglycemia episodes, fasting interruptions, and hospital visits in a dedicated log. They will receive weekly calls for insulin adjustments and continuous support. During the last week of Ramadan, clinical and biological data including inflammatory markers will be collected. Two months post-Ramadan, HbA1c, fasting glucose, and lipid profile will be reassessed to evaluate glycemic control.
Active Comparator: CFT Group; The basal insulin doses will be adjusted after a carbohydrate fasting test to assess individual insulin needs during fasting periods.	Drug: Adjustment of insulin doses CFT; Patients will be hospitalized at La Rabta Hospital from February 15 to February 28, 2025 for clinical (weight, BP, SF-12) and biological (HbA1c, lipid profile) assessments and inflammatory markers (Interleukin 6 and TNF alfa) . CFT Group: Insulin adjusted after a Carbohydrate Fasting Test. Patients will track insulin doses, glycemic cycles, hypoglycemia episodes, fasting interruptions, and hospital visits in a dedicated log. They will receive weekly calls for insulin adjustments and continuous support. During the last week of Ramadan, clinical and biological data including inflammatory markers will be collected. Two months post-Ramadan, HbA1c, fasting glucose, and lipid profile will be reassessed to evaluate glycemic control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fructosamine levels	Fructosamine variation 15 days before & the last week of Ramadan	up to 6 weeks
Interleukin-6 levels	variation during the fast of Ramadan 15 dayd before and at the Last week of Ramadan	up to 6 weeks
Hypoglycemia	Frequency of hypoglycemic episodes	up to one month
glycemic auto-monitoring	Percentage of blood glucose values meeting target levels during the month of Ramadan	up to one month
HbA1c levels	HbA1c variation before and after Ramadan 15 days before & 2 months after Ramadan	up to 6 weeks
TNF-alfa levels	Variation during fasting Ramadan 15 days before and at the Last week of Ramadan	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Body mass index variation : Before and at the Last week of Ramadan	up to 6 weeks
Quality of life of patients	Quality of life of patients assessed using the Medical Outcomes Study Short-Form General Health Survey (SF-12) questionnaire in its validated Tunisian dialect version. Before and at at the last week of Ramadan Higher score means a better quality of life.	up to 6 weeks
waist circumference	variation of waist circumference: Before and at the Last week of Ramadan	up to 6 weeks
Blood pressure	Variation of blood pressure : Before and at the Last week of Ramadan	up to 6 weeks

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Collaborators: Hopital La Rabta

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 9, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Behavior; Nutritional and Metabolic Diseases; Feeding Behavior; Fasting; Diabetes Mellitus; Intermittent Fasting; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: RE001

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