drugset / Trial / NCT04876079

Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes

NCT04876079

Completed 30 enrolled Montreal Clinical Research Institute
RandomizedCrossoverOpen-labelTreatment

Summary

According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose \< 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy. In practice, only 32-50% of patients follow the current guidelines. In addition, recent studies suggest that under current intensive insulin therapies, an initial correction with 15g of oral glucose may be insufficient to rapidly correct mild-to-moderate hypoglycemia. With the development and increasing usage of newer glucose monitoring technologies, the community is witnessing a shift in hypoglycemia management, from a reactive to a proactive approach (e.g., prevent imminent episodes rather than treating established episodes).

Timeline

Start
2021-06-01
Primary completion
2023-06-01
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic Subcutaneous