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NCT06326489

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

ELIAS Emergency University Hospital·Phase 4·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Diabetes Mellitus, Type 1
Drug/Device/Intervention
Switching to the Medtronic 780G insulin pump
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
ELIAS Emergency University Hospital
Location
Bucharest, Romania
Timeline & enrollment
Phase
Phase 4
Start date
Mar 11, 2024
End date
Nov 30, 2024
Enrollment
30 participants
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
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06326489
Type
Device Trial
About this record

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.