Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes
REMODAL
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
1 other identifier
interventional
32
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
February 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 25, 2025
February 1, 2025
1.9 years
November 6, 2024
February 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Hypoglycemia Prevention with 16g CHO at 5.0 mmol/L
The primary outcome will measure the percentage of hypoglycemic episodes prevented when participants consume 16 grams of carbohydrate (CHO) at a proactive threshold of 5.0 mmol/L, as indicated by continuous glucose monitoring (CGM) readings. Prevention is defined by the avoidance of any CGM interstitial glucose reading below 4.0 mmol/L following the CHO intake. Measured for each intervention visit within 60 minutes after CHO ingestion.
60 minutes
Secondary Outcomes (8)
CGM Interstitial Glucose Levels Post-CHO Intake
10, 15, 20, 30, and 60 minutes
Lowest CGM Glucose Value Post-CHO Intake
60 minutes
Time Spent in Hypoglycemia Following CHO Intake
60 minutes
Percentage of Episodes Corrected by CHO at Specific Time Intervals
10, 15, 20, and 30 minutes
Number of Episodes Requiring Additional CHO Treatment
60 minutes
- +3 more secondary outcomes
Study Arms (3)
16g CHO at < 4.0 mmol/L (Reactive Approach)
PLACEBO COMPARATORParticipants 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.
8g CHO at 5.0 mmol/L (Proactive Approach)
EXPERIMENTALParticipants 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.
16g CHO at 5.0 mmol/L (Proactive Approach)
EXPERIMENTALParticipants 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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Anticipated treatment changes during the trial period
- Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7, Canada
Montreal Clinical Research Institute
Montreal, Quebec, H2W1R7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Remi Rabasa-Lhoret
IRCM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- open-label masking
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President clinic and clinical research, Professor
Study Record Dates
First Submitted
November 6, 2024
First Posted
November 12, 2024
Study Start
February 6, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
February 25, 2025
Record last verified: 2025-02