NCT06683391

Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes

Updating pReventive and Treatment guidelinEs for Mild hypOglycemia in Individuals Living With Type 1 Diabetes During the erA of Continuous gLucose Monitoring: The REMODAL Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Institut de Recherches Cliniques de Montreal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The REMODAL trial is a randomized crossover study aiming to update treatment guidelines for mild hypoglycemia in people with Type 1 diabetes using continuous glucose monitoring (CGM) technology. The study will assess whether treating mild hypoglycemia proactively (at a glucose threshold of 5.0 mmol/L) with lower doses of carbohydrate (CHO) is more effective than the traditional reactive approach (treatment at \< 4.0 mmol/L). The goal is to reduce hypoglycemia frequency and improve quality of life, while minimizing caloric intake and rebound hyperglycemia.

Detailed description

The REMODAL trial explores an individualized, proactive approach to treat mild hypoglycemia in individuals with Type 1 diabetes (T1D) who use CGM. Traditional guidelines, established in the 1980s, recommend the "15g/15min rule" - consuming 15g of CHO every 15 minutes for glucose levels below 4.0 mmol/L. However, these guidelines may no longer be optimal with the advancements in insulin therapies and CGM, which provide real-time glucose data and predict glucose trends. In this study, 32 adult participants with T1D will receive three interventions to test different amounts and timing of CHO intake under real-life conditions. These are as follows: 1. 8g of CHO at a threshold of 5.0 mmol/L (proactive approach). 2. 16g of CHO at a threshold of 5.0 mmol/L (proactive approach). 3. 16g of CHO at a threshold of \< 4.0 mmol/L (traditional reactive approach). The primary outcome is the prevention rate of hypoglycemic episodes under each intervention, with additional measures on glucose levels, time spent in hypoglycemia, and rebound hyperglycemia. The study also considers differences in glucose management between multiple daily injections, continuous subcutaneous insulin infusion, and automated insulin delivery systems, which may affect CHO needs. This study hopes to redefine effective hypoglycemia management in the modern era of diabetes care, providing personalized recommendations to improve glycemic control and overall quality of life.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment	The intervention in the REMODAL trial involves administering specific amounts of oral carbohydrates (CHO) at different glucose thresholds to evaluate the effectiveness of proactive versus reactive hypoglycemia management strategies in adults with Type 1 diabetes using continuous glucose monitoring (CGM). Participants will undergo three distinct interventions, each designed to test a different amount and timing of CHO intake.

Timeline

• Start date: 2025-02-06
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-11-12
• Last updated: 2025-02-25

Locations

2 sites across 1 country: Canada