Randomized Transition to Gla-300 in Pediatric Type 1 Diabetes: CGM-Derived Outcomes

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

Continuous glucose monitoring data were used to compare glucose control and hypoglycemia before and after the switch.

It had two arms (groups): one (active comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Continuous glucose monitoring data obtained before and after the switch were used to evaluate early changes in glycemic control, including time in range, time above range, and time below range, with particular attention to nighttime glucose control and hypoglycemia.

A subset of participants with adequate continuous glucose monitoring data was also followed at 3 and 6 months to evaluate longer-term glycemic outcomes, insulin requirements, and changes in anthropometric measures.

Who Took Part

Enrollment: 71 actual participants took part.

It was open to people of any sex aged from 6 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Children and adolescents aged 6-18 years with type 1 diabetes mellitus. Treatment with insulin glargine U-100 as basal insulin before study enrollment. Use of a continuous glucose monitoring (CGM) system with sufficient sensor data for assessment of glycemic outcomes. Written informed consent from the parent/legal guardian and assent from the participant, when applicable.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: acute diabetic complications or severe intercurrent illness at enrollment; inadequate cgm data for assessment of study outcomes; inability or unwillingness of the participant or family to comply with the study procedures.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2025-05-01 with completion listed for 2025-11-01.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Early glycemic outcomes after switching from insulin glargine U-100 to U-300 (time frame: 2 weeks before and 2 weeks after switching from insulin glargine U-100 to U-300).

It also tracked 1 secondary outcome, for example Long-term glycemic outcomes after switching to insulin glargine U-300.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 71 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.