NCT06683391Recruiting
Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With 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
Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 6 Nov 2024
- Start date
- 6 Feb 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Diseases
- Type 1 diabetes
- NCT number
- NCT06683391
What you commit to
- Study type: Interventional
- Planned participants: 32
- From 6 Feb 2025 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe hypoglycemic episode within 1 month prior to inclusion
Other illness
- Significant cardiac rhythm abnormalities
- Diagnosis of epilepsy
Lab values
- 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
Other
- Gastroparesis
- Pregnancy or currently breastfeeding
- Anticipated treatment changes during the trial period
- Inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montreal Clinical Research Institute Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Institut de Recherches Cliniques de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.