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
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged 18 years and older

• Clinical diagnosis of Type 1 diabetes for at least 1 year

• Currently treated with multiple daily insulin injections (MDI), continuous subcutaneous insulin infusion (CSII), or automated insulin delivery (AID) systems

• HbA1c level below 9.0%

• Equal distribution of male and female participants, as well as MDI/CSII and AID users

Locations
Other Locations
Canada
Institut de recherches cliniques de Montréal
RECRUITING
Montreal
Montreal Clinical Research Institute
RECRUITING
Montreal
Contact Information
Primary
Valérie Boudreau, PhD
valerie.boudreau@ircm.qc.ca
514-987-5643
Backup
Corinne Suppere
corinne.suppere@ircm.qc.ca
514-987-5597
Time Frame
Start Date: 2025-02-06
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 32
Treatments
Placebo_comparator: 16g CHO at < 4.0 mmol/L (Reactive Approach)
Participants receive 16 grams of carbohydrate only when their CGM reading falls below 4.0 mmol/L, in line with the traditional reactive approach. This arm serves as a control, reflecting current hypoglycemia treatment guidelines, allowing comparison to proactive interventions.
Experimental: 8g CHO at 5.0 mmol/L (Proactive Approach)
Participants receive 8 grams of carbohydrate when their CGM reading reaches a proactive threshold of 5.0 mmol/L. This arm tests whether a lower amount of CHO, administered at a higher glucose level, can effectively prevent hypoglycemia with minimal caloric intake.
Experimental: 16g CHO at 5.0 mmol/L (Proactive Approach)
Participants receive 16 grams of carbohydrate at the proactive threshold of 5.0 mmol/L. This arm examines if a slightly higher dose of CHO at the same proactive threshold provides additional preventive benefits compared to 8 grams, while still aiming to avoid hypoglycemia and limit subsequent glucose fluctuations.
Related Therapeutic Areas
Sponsors
Leads: Institut de Recherches Cliniques de Montreal

This content was sourced from clinicaltrials.gov