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

Launched by UNIVERSITY TUNIS EL MANAR · Feb 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best way to adjust insulin doses for people with Type 2 diabetes during Ramadan, a month when many Muslims fast from dawn until dusk. Fasting can make it challenging to manage blood sugar levels, and improper insulin dosing can lead to serious health issues. The trial compares two methods: the Diabetes and Ramadan (DAR) guidelines, which provide general recommendations for insulin adjustments, and a personalized approach called the Carbohydrate Fasting Test (CFT), which determines individual insulin needs through a controlled fast without carbohydrates for 24 hours. The goal is to find out which method helps keep blood sugar stable and improves the quality of life for patients during Ramadan.

To participate, individuals must be between 18 and 70 years old, have Type 2 diabetes, and have been using insulin for at least six months. They should intend to fast during Ramadan and be at low to moderate risk for complications. Throughout the study, participants will have regular check-ups to monitor their blood sugar levels and overall health during Ramadan, and follow-up assessments will take place two months after Ramadan to evaluate long-term effects. This research aims to improve diabetes care during Ramadan and understand how fasting impacts inflammation in the body.

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Eligibility criteria

• 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.