Updating guidelines for treating mild hypoglycemia in Type 1 diabetes
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut de Recherches Cliniques de Montreal Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT06683391 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with significant cardiac rhythm abnormalities, severe hypoglycemic episodes recently, or clinically significant microvascular complications may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Montreal, Quebec and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.