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

NCT06683391 · Institut de Recherches Cliniques de Montreal
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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
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Gastroparesis * Significant cardiac rhythm abnormalities * Clinically significant microvascular complications such as nephropathy (eGFR \< 40 ml/min) or severe proliferative retinopathy * Diagnosis of epilepsy * Pregnancy or currently breastfeeding * Severe hypoglycemic episode within 1 month prior to inclusion * Macrovascular events or uncorrected hypokalemia (K+ \< 3.5 mmol/L) within 3 months prior to inclusion * Anticipated treatment changes during the trial period * Inability to provide informed consent
Study design
Enrollment target: 32 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-06
Estimated completion: 2027-12-31
Last updated: 2025-02-25
Interventions
Behavioral: Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment
Primary outcomes
  • Percentage of Hypoglycemia Prevention with 16g CHO at 5.0 mmol/L (60 minutes)
Sponsor
Institut de Recherches Cliniques de Montreal · other
Contacts & investigators
ContactValérie Boudreau, PhD · contact · valerie.boudreau@ircm.qc.ca · 514-987-5643
ContactCorinne Suppere · contact · corinne.suppere@ircm.qc.ca · 514-987-5597
InvestigatorRemi Rabasa-Lhoret · principal_investigator, IRCM
All locations (2)
Institut de recherches cliniques de MontréalRecruiting
Montreal, Quebec, Canada
Montreal Clinical Research InstituteRecruiting
Montreal, Quebec, Canada
Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes · TrialPath