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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• Institut de recherches cliniques de Montréal, Montreal, Quebec, Canada
• Montreal Clinical Research Institute, Montreal, Quebec, Canada

Who to contact

Valérie Boudreau, PhD · 514-987-5643 · valerie.boudreau@ircm.qc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06683391.