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Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes
Sponsor: Institut de Recherches Cliniques de Montreal
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-02-06
Completion Date
2027-12-31
Last Updated
2025-02-25
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (2)
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
Montreal Clinical Research Institute
Montreal, Quebec, Canada