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Oral Carbohydrates for Hypoglycemia in Type 1 Diabetes (REMODAL Trial)

N/A

Waitlist Available

Led By Remi Rabasa-Lhoret

Research Sponsored by Institut de Recherches Cliniques de Montreal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently treated with multiple daily insulin injections (MDI), continuous subcutaneous insulin infusion (CSII), or automated insulin delivery (AID) systems

Clinical diagnosis of Type 1 diabetes for at least 1 year

Must not have

Gastroparesis

Significant cardiac rhythm abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10, 15, 20, 30, and 60 minutes

Summary

"This trial is testing a new way to treat mild low blood sugar in people with Type 1 diabetes using continuous glucose monitoring technology. The study wants to see if treating low blood sugar early with smaller amounts

Who is the study for?

This trial is for individuals with Type 1 Diabetes who regularly monitor their blood sugar using CGM. It's designed to find better ways to prevent and treat low blood sugar episodes. Participants should be willing to try different carbohydrate amounts when their sugar levels drop.

What is being tested?

The REMODAL trial is testing if taking a smaller amount of carbohydrates at an earlier sign of dropping blood sugar (5.0 mmol/L) can help avoid hypoglycemia more effectively than the usual method of waiting until it falls below 4.0 mmol/L.

What are the potential side effects?

Since this study involves oral carbohydrate intake, side effects may include changes in blood sugar levels such as potential rebound hyperglycemia or insufficient treatment leading to persistent hypoglycemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently managing my diabetes with insulin injections or an insulin pump.

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I have been diagnosed with Type 1 diabetes for over a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have gastroparesis.

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I have serious heart rhythm problems.

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I have been diagnosed with epilepsy.

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I have serious kidney issues or severe eye problems due to diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10, 15, 20, 30, and 60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10, 15, 20, 30, and 60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10, 15, 20, 30, and 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Hypoglycemia Prevention with 16g CHO at 5.0 mmol/L

Secondary study objectives

CGM Interstitial Glucose Levels Post-CHO Intake

Incidence of Rebound Hyperglycemia (≥ 10.0 mmol/L)

Lowest CGM Glucose Value Post-CHO Intake

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 8g CHO at 5.0 mmol/L (Proactive Approach)Experimental Treatment1 Intervention

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.

Group II: 16g CHO at 5.0 mmol/L (Proactive Approach)Experimental Treatment1 Intervention

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.

Group III: 16g CHO at < 4.0 mmol/L (Reactive Approach)Placebo Group1 Intervention

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.

0 / 6Eligibility criteria met