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New treatment option for Type 1 Diabetes
Official title Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes
ClinicalTrials.gov ID: NCT06683391
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)...
- HbA1c level below 9.0%
- Equal distribution of male and female participants, as well as MDI/CSII and AID users
You likely can't join 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
- Severe hypoglycemic episode within 1 month prior to inclusion
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.