Recruiting

Preventive Guidelines

Sponsor:

Institut de Recherches Cliniques de Montreal

Code:

NCT06683391

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment

Study Details

Brief summary:

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

Type 1 Diabetes

Study ID

NCT06683391

Start date

Feb 6, 2025

Status verified date

Feb, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: 16g CHO at < 4.0 mmol/L (Reactive Approach)

Participants receive 16 grams of carbohydrate only when their CGM reading falls below 4.0 mmol/L, in line with the traditional "reactive" approach. This arm serves as a control, reflecting current hypoglycemia treatment guidelines, allowing comparison to proactive interventions.

experimental: 8g CHO at 5.0 mmol/L (Proactive Approach)

Participants receive 8 grams of carbohydrate when their CGM reading reaches a proactive threshold of 5.0 mmol/L. This arm tests whether a lower amount of CHO, administered at a higher glucose level, can effectively prevent hypoglycemia with minimal caloric intake.

experimental: 16g CHO at 5.0 mmol/L (Proactive Approach)

Participants receive 16 grams of carbohydrate at the proactive threshold of 5.0 mmol/L. This arm examines if a slightly higher dose of CHO at the same proactive threshold provides additional preventive benefits compared to 8 grams, while still aiming to avoid hypoglycemia and limit subsequent glucose fluctuations.

Interventions

Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment

The intervention in the REMODAL trial involves administering specific amounts of oral carbohydrates (CHO) at different glucose thresholds to evaluate the effectiveness of proactive versus reactive hypoglycemia management strategies in adults with Type 1 diabetes using continuous glucose monitoring (CGM). Participants will undergo three distinct interventions, each designed to test a different amount and timing of CHO intake.

Primary outcome measure

  • Percentage of Hypoglycemia Prevention with 16g CHO at 5.0 mmol/L [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

Valérie Boudreau, PhD

514-987-5643valerie.boudreau@ircm.qc.ca

Corinne Suppere

514-987-5597corinne.suppere@ircm.qc.ca

Locations

Institut de recherches cliniques de Montréal

Recruiting

Montreal, Quebec, Canada, H2W 1R7

Principal Investigator:

Rémi Rabasa-Lhoret

Montreal Clinical Research Institute

Recruiting

Montreal, Quebec, Canada, H2W1R7

Contacts

Rémi Rabasa-Lhoret

1-514-987-5762remi.rabasa-lhoret@ircm.qc.ca

More Information

Sponsor

Institut de Recherches Cliniques de Montreal

Last update posted

Feb 25, 2025

Last verified

Feb, 2025

Keywords

  • type 1 diabetes
  • hypoglycemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Institut de Recherches Cliniques de Montreal on 2025-02-25.