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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: ELIAS Emergency University Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Switching to the Medtronic 780G insulin pump	Patients using a Medtronic 740G insulin pump will receive the 780G model for three months

Timeline

• Start date: 2024-03-11
• Primary completion: 2024-08-30
• Completion: 2024-11-30
• First posted: 2024-03-22
• Last updated: 2024-03-26

Locations

1 site across 1 country: Romania