Updating guidelines for treating mild hypoglycemia in Type 1 diabetes
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
Run by Institut de Recherches Cliniques de Montreal · NCT06683391 · Data updated 2026-11-12
This study is testing whether treating mild low blood sugar earlier with smaller amounts of carbs can help people with Type 1 diabetes have fewer low blood sugar episodes and feel better overall.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Institut de Recherches Cliniques de Montreal Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Status | Recruiting |
| Started | February 6, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | February 25, 2025 |
| Trial ID | NCT06683391 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a clinical diagnosis of Type 1 diabetes for at least one year, currently treated with insulin therapies.
✕Probably not a fit
Patients with significant cardiac rhythm abnormalities, severe hypoglycemic episodes recently, or clinically significant microvascular complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The REMODAL trial is a randomized crossover study designed to update treatment guidelines for mild hypoglycemia in individuals with Type 1 diabetes using continuous glucose monitoring (CGM) technology. It compares a proactive approach of treating mild hypoglycemia at a glucose threshold of 5.0 mmol/L with lower doses of carbohydrate to the traditional reactive approach of treating at levels below 4.0 mmol/L. The study will involve 32 adult participants who will receive different interventions to assess the effectiveness of these approaches in reducing hypoglycemia frequency and improving quality of life while minimizing caloric intake. The primary outcome will focus on the prevention rate of hypoglycemic episodes and additional measures related to glucose management.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hypoglycemia in Type 1 diabetes, enhancing patient quality of life and glycemic control.
How similar studies have gone: While traditional guidelines have been established for decades, this proactive approach using CGM technology is relatively novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada Recruiting -
Montreal Clinical Research Institute
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Remi Rabasa-Lhoret — Ircm
- Study coordinator: Valérie Boudreau, PhD
- Email: valerie.boudreau@ircm.qc.ca
- Phone: 514-987-5643
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Next Generation Extended Wear Sensors in Type 1 and Type 2 Diabetes
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This study tests whether teaching mealtime insulin dosing using CGM data helps adults with Type 1 diabetes who don’t usually count carbs.
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Safety and effectiveness of GLP-1 receptor agonists and SGLT inhibitors added to insulin in adults with type 1 diabetes
This registry will see if adding GLP-1RA or SGLTi therapies to insulin helps adults with type 1 diabetes over one year.
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Think-Find-Solve activities for insulin self-management in children with type 1 diabetes
A behavior-change activity book is tested with children aged 8–12 with type 1 diabetes and their parents to see if it improves daily insulin self-management.
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Near-sensor insulin delivery with CGM in people with type 1 diabetes
A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.