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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

NCT06326489 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-26

No results posted yet for this study

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

DEVICE

Switching to the Medtronic 780G insulin pump

Patients using a Medtronic 740G insulin pump will receive the 780G model for three months

Sponsors & Collaborators

  • ELIAS Emergency University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2024-08-30
Completion
2024-11-30

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06326489 on ClinicalTrials.gov