Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus
Sponsor: ELIAS Emergency University Hospital
Summary
The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G). Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores.
Key Details
Gender
All
Age Range
7 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-03-11
Completion Date
2025-07-08
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Switching to the Medtronic 780G insulin pump
Patients using a Medtronic 740G insulin pump will receive the 780G model for three months
Locations (1)
Elias University Emergency Hospital
Bucharest, Sector 1, Romania