Early versus later sugar treatment for mild low blood sugar in type 1 diabetes
Tests early sugar treatment for mild low blood sugar in adults with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes
Key facts
- Where
- Montreal, CanadaSee the 2 sites
Where in Canada
- Institut de Recherches Cliniques de MontrealMontreal, CanadaTaking people
- Montreal Clinical Research InstituteMontreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut de Recherches Cliniques de Montreal
- Trial code
- NCT06683391
- Record updated
- 25 February 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Severe hypoglycemic episode within 1 month prior to inclusion; Significant cardiac rhythm abnormalities; Diagnosis of epilepsy; Clinically significant microvascular complications such as nephropathy (eGFR < 40 ml/min) or severe proliferative retinopathy; Macrovascular events or uncorrected hypokalemia (K+ < 3.5 mmol/L) within 3 months prior to inclusion; Gastroparesis; Pregnancy or currently breastfeeding; Anticipated treatment changes during the trial period; Inability to provide informed consent.