NCT07872475CompletedPhase 4
Randomized Transition to Gla-300 in Pediatric Type 1 Diabetes: CGM-Derived Outcomes
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 71 (actual)
- First submitted
- 7 Oct 2026
- Start date
- 1 May 2025
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Marmara University
- Diseases
- Type 1 diabetes
- NCT number
- NCT07872475
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 71
- From 1 May 2025 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of a significant chronic disease other than type 1 diabetes that could affect glycemic control or insulin requirements.
- Acute diabetic complications or severe intercurrent illness at enrollment.
Lab values
- Use of medications known to significantly affect glucose metabolism.
Other
- Inadequate CGM data for assessment of study outcomes.
- Inability or unwillingness of the participant or family to comply with the study procedures.
Who the study is looking for
- 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.
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Marmara University School of Mecidine Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.