Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes

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.

Eligibility

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

Conditions2

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