Actively Recruiting
Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes
Led by Institut de Recherches Cliniques de Montreal · Updated on 2025-02-25
32
Participants Needed
2
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Clinical diagnosis of Type 1 diabetes for at least 1 year
- Currently treated with multiple daily insulin injections, continuous subcutaneous insulin infusion, or automated insulin delivery systems
- HbA1c level below 9.0%
- Equal distribution of male and female participants, as well as different insulin delivery methods
You will not qualify if you...
- Gastroparesis
- Significant cardiac rhythm abnormalities
- Clinically significant microvascular complications such as nephropathy with eGFR below 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+ below 3.5 mmol/L) within 3 months prior to inclusion
- Anticipated treatment changes during the trial period
- Inability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7
Actively Recruiting
2
Montreal Clinical Research Institute
Montreal, Quebec, Canada, H2W1R7
Actively Recruiting
Research Team
V
Valérie Boudreau, PhD
CONTACT
C
Corinne Suppere
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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