drugset / Trial / NCT04664764

Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

NCT04664764

Phase 4 Unknown 60 enrolled Ain Shams University
RandomizedParallel-groupOpen-labelTreatment

Summary

Background: Achieving glycemic control without risking hypoglycemia imposes a major challenge in the management of toddlers and preschool children with Type 1 diabetes(T1D). Optimal insulin therapy for young children with T1D should provide effective glycemic control while minimizing the risk of hypoglycemia and hyperglycemia. Despite the advantages of the basal-bolus insulin regimens, hypoglycemia still presents a major barrier in achieving desirable glycemic control. Objectives: To compare the effectiveness of insulin degludec to insulin glargine and NPH in toddlers and preschool children with T1D in terms of glycosylated hemoglobin(HbA1C) and frequency of hypoglycemic episodes.

Timeline

Start
2019-02-21
Primary completion
2021-02-28
Completion
2021-03-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Degludec Protein / enzyme biologic
Comparator Insulin Protein / enzyme biologic
Comparator insulin glargine Protein / enzyme biologic