Clinical Research Directory
Browse clinical research sites, groups, and studies.
Randomized Transition to Gla-300 in Pediatric Type 1 Diabetes: CGM-Derived Outcomes
Sponsor: Marmara University
Summary
This study evaluated two different starting dose strategies when switching children and adolescents with type 1 diabetes from insulin glargine U-100 to insulin glargine U-300. Participants were randomly assigned to start insulin glargine U-300 either at the same basal insulin dose they had been using or at a 20% higher dose. Continuous glucose monitoring data were used to compare glucose control and hypoglycemia before and after the switch. Participants were also followed to evaluate longer-term changes in glucose control and insulin requirements
Official title: Optimizing the Transition to Insulin Glargine U-300 in Children and Adolescents With Type 1 Diabetes: A Randomized Study of Initial Dose Strategies and Longitudinal CGM-Derived Glycemic Outcomes
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2025-05-01
Completion Date
2026-05-01
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Insulin glargine U-300
Insulin glargine U-300 was administered once daily as basal insulin. Participants switched from insulin glargine U-100 to insulin glargine U-300 using either the same basal insulin dose or an initial dose 20% higher than their previous U-100 dose, according to randomized group assignment. Subsequent dose adjustments were made according to glycemic control.
Locations (1)
Marmara University School of Mecidine
Istanbul, Maltepe, Turkey (Türkiye)