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

NCT06683391 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-02-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Institut de Recherches Cliniques de Montreal

    lead OTHER

Principal Investigators

  • Remi Rabasa-Lhoret · IRCM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06683391 on ClinicalTrials.gov