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 - Trial NCT06326489
Access comprehensive clinical trial information for NCT06326489 through Pure Global AI's free database. This Phase 4 trial is sponsored by ELIAS Emergency University Hospital and is currently Recruiting. The study focuses on Diabetes Mellitus, Type 1. Target enrollment is 30 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
ELIAS Emergency University Hospital
Timeline & Enrollment
Phase 4
Mar 11, 2024
Nov 30, 2024
Primary Outcome
Variations in HbA1c
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06326489
Device Trial