RecruitingNot ApplicableNCT06683391

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

Sponsor

Institut de Recherches Cliniques de Montreal

Enrollment

32 participants

Start Date

Feb 6, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study aims to update guidelines for preventing and treating low blood sugar (hypoglycemia) in adults with Type 1 diabetes, by studying people who use insulin therapy. **You may be eligible if...** - You are 18 years or older - You have had a Type 1 diabetes diagnosis for at least 1 year - You use multiple daily insulin injections, an insulin pump, or an automated insulin delivery system - Your HbA1c (a measure of blood sugar control over 3 months) is below 9.0% **You may NOT be eligible if...** - You have gastroparesis (a condition where the stomach empties too slowly) - You have significant heart rhythm problems - You have serious kidney problems (eGFR below 40) or severe eye disease from diabetes - You have epilepsy - You are pregnant or breastfeeding - You had a severe low blood sugar episode in the past month - You had a heart attack or stroke in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALOral 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.