Type 1 DiabetesREMODALNCT06683391
Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes
A study testing Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- 6 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
Corinne Suppère
Rémi Rabasa-Lhoret
- Recruiting
Montreal Clinical Research Institute
Montreal, Quebec, H2W1R7
Rémi Rabasa-Lhoret, 1-514-987-5762, remi.rabasa-lhoret@ircm.qc.ca
About this study
Official title: 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.
Read the detailed description
The REMODAL trial explores an individualized, proactive approach to treat mild hypoglycemia in individuals with Type 1 diabetes (T1D) who use CGM. Traditional guidelines, established in the 1980s, recommend the "15g/15min rule" - consuming 15g of CHO every 15 minutes for glucose levels below 4.0 mmol/L. However, these guidelines may no longer be optimal with the advancements in insulin therapies and CGM, which provide real-time glucose data and predict glucose trends.
In this study, 32 adult participants with T1D will receive three interventions to test different amounts and timing of CHO intake under real-life conditions. These are as follows:
- 8g of CHO at a threshold of 5.0 mmol/L (proactive approach).
- 16g of CHO at a threshold of 5.0 mmol/L (proactive approach).
- 16g of CHO at a threshold of < 4.0 mmol/L (traditional reactive approach).
The primary outcome is the prevention rate of hypoglycemic episodes under each intervention, with additional measures on glucose levels, time spent in hypoglycemia, and rebound hyperglycemia. The study also considers differences in glucose management between multiple daily injections, continuous subcutaneous insulin infusion, and automated insulin delivery systems, which may affect CHO needs. This study hopes to redefine effective hypoglycemia management in the modern era of diabetes care, providing personalized recommendations to improve glycemic control and overall quality of life.
- Conditions
- Type 1 Diabetes
- Being tested
- Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment
- Keywords
- type 1 diabetes, hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 16g CHO at < 4.0 mmol/L (Reactive Approach) | Placebo comparator | 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. Receives: Behavioral: Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment |
| 8g CHO at 5.0 mmol/L (Proactive Approach) | Experimental | 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. Receives: Behavioral: Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment |
| 16g CHO at 5.0 mmol/L (Proactive Approach) | Experimental | 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. Receives: Behavioral: Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Secondary outcomes (8)
CGM Interstitial Glucose Levels Post-CHO Intake
Continuous glucose monitoring will be used to measure interstitial glucose values at intervals of 10, 15, 20, 30, and 60 minutes after the initial CHO intake. This will assess the glucose response and stability following different CHO dosages and thresholds. Measured post-CHO ingestion during each intervention.
Measured: 10, 15, 20, 30, and 60 minutes
Lowest CGM Glucose Value Post-CHO Intake
This outcome will record the lowest CGM glucose reading within 60 minutes following the initial CHO intake for each intervention. This helps determine the effectiveness of the intervention in preventing deep hypoglycemia. Measured within 60 minutes of CHO ingestion during each intervention.
Measured: 60 minutes
Time Spent in Hypoglycemia Following CHO Intake
The duration, in minutes, spent in hypoglycemia (CGM readings < 4.0 mmol/L) within 60 minutes after the initial CHO ingestion will be recorded. This will assess how well each intervention prevents prolonged hypoglycemia. Measured within 60 minutes post-CHO ingestion during each intervention.
Measured: 60 minutes
Percentage of Episodes Corrected by CHO at Specific Time Intervals
The proportion of hypoglycemic episodes (CGM readings < 4.0 mmol/L) corrected at 10, 15, 20, and 30 minutes after CHO intake will be measured to evaluate the effectiveness of each CHO intervention. Measured at 10, 15, 20, and 30 minutes after CHO ingestion for each intervention.
Measured: 10, 15, 20, and 30 minutes
Number of Episodes Requiring Additional CHO Treatment
The number of hypoglycemic episodes that require additional CHO intake after the initial dose will be recorded. This assesses whether the initial CHO intake was sufficient to correct hypoglycemia. Measured within 60 minutes post-CHO ingestion during each intervention.
Measured: 60 minutes
Incidence of Rebound Hyperglycemia (≥ 10.0 mmol/L)
The occurrence of rebound hyperglycemia (CGM reading ≥ 10.0 mmol/L) within 60 minutes following the initial CHO intake will be documented to assess the risk of overcorrection leading to hyperglycemia. Measured within 60 minutes post-CHO ingestion during each intervention.
Measured: 60 minutes
Total CHO Consumption per Intervention
The cumulative amount of CHO consumed per intervention will be recorded to analyze CHO requirements and efficiency across different intervention arms.
Measured: 60 minutes
Safety Endpoint - Plasma Glucose and CGM Lag-Time Analysis
Plasma glucose levels at specified intervals (5, 10, 15, 20, and 30 minutes after CHO intake) will be compared to CGM readings to assess the lag time between plasma and interstitial glucose during hypoglycemia correction. Measured at 5, 10, 15, 20, and 30 minutes post-CHO ingestion for each intervention.
Measured: 5, 10, 15, 20, and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start6 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Remi Rabasa-Lhoret, Principal investigator, IRCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683391
- Sponsor's protocol ID
- 2025-1295
- Acronym
- REMODAL
- Status last verified
- Feb 2025
- First submitted
- 6 Nov 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06683391
- Acronym / sponsor ID
- REMODAL / 2025-1295
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, hypoglycemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The REMODAL trial explores an individualized, proactive approach to treat mild hypoglycemia in individuals with Type 1 diabetes (T1D) who use CGM. Traditional guidelines, established in the 1980s, recommend the "15g/15min rule" - consuming 15g of CHO every 15 minutes for glucose levels below 4.0 mmol/L. However, these guidelines may no longer be optimal with the advancements in insulin therapies and CGM, which provide real-time glucose data and predict glucose trends.
In this study, 32 adult participants with T1D will receive three interventions to test different amounts and timing of CHO intake under real-life conditions. These are as follows:
- 8g of CHO at a threshold of 5.0 mmol/L (proactive approach).
- 16g of CHO at a threshold of 5.0 mmol/L (proactive approach).
- 16g of CHO at a threshold of < 4.0 mmol/L (traditional reactive approach).
The primary outcome is the prevention rate of hypoglycemic episodes under each intervention, with additional measures on glucose levels, time spent in hypoglycemia, and rebound hyperglycemia. The study also considers differences in glucose management between multiple daily injections, continuous subcutaneous insulin infusion, and automated insulin delivery systems, which may affect CHO needs. This study hopes to redefine effective hypoglycemia management in the modern era of diabetes care, providing personalized recommendations to improve glycemic control and overall quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 16g CHO at < 4.0 mmol/L (Reactive Approach) | Placebo comparator | Behavioral: Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and TreatmentParticipants 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) | Experimental | Behavioral: Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and TreatmentParticipants 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) | Experimental | Behavioral: Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and TreatmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and TreatmentThe 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. | Behavioural | 16g CHO at 5.0 mmol/L (Proactive Approach), 16g CHO at < 4.0 mmol/L (Reactive Approach), 8g CHO at 5.0 mmol/L (Proactive Approach) |
Primary outcome
Percentage of Hypoglycemia Prevention with 16g CHO at 5.0 mmol/L
Time frame: 60 minutes
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.
8 secondary outcomes
CGM Interstitial Glucose Levels Post-CHO Intake
Time frame: 10, 15, 20, 30, and 60 minutes
Lowest CGM Glucose Value Post-CHO Intake
Time frame: 60 minutes
Time Spent in Hypoglycemia Following CHO Intake
Time frame: 60 minutes
Percentage of Episodes Corrected by CHO at Specific Time Intervals
Time frame: 10, 15, 20, and 30 minutes
Number of Episodes Requiring Additional CHO Treatment
Time frame: 60 minutes
Incidence of Rebound Hyperglycemia (≥ 10.0 mmol/L)
Time frame: 60 minutes
Total CHO Consumption per Intervention
Time frame: 60 minutes
Safety Endpoint - Plasma Glucose and CGM Lag-Time Analysis
Time frame: 5, 10, 15, 20, and 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Remi Rabasa-Lhoret principal investigator
IRCM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Carbohydrate (CHO) Administration for Hypoglycemia Prevention and Treatment in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie Boudreau, PhD (514-987-5643, valerie.boudreau@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Hypoglycemia Prevention with 16g CHO at 5.0 mmol/L (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.