RecruitingPhase 4NCT06326489

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

Enrollment

30 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

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.

Eligibility

Min Age: 7 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether upgrading to an advanced hybrid closed-loop insulin pump system improves blood sugar control and quality of life for Romanian children with type 1 diabetes. A hybrid closed-loop system (also called an artificial pancreas) automatically adjusts insulin delivery based on continuous glucose readings, reducing the burden of manual management. **You may be eligible if...** - You are between 7 and 17 years old (at least 7 at study start, under 18) - You have type 1 diabetes - You currently use a specific insulin pump (the 740G model) - You have had diabetes for at least 1 year **You may NOT be eligible if...** - You are under 7 or 18 and older at the start of the study - Your HbA1c (a measure of average blood sugar) is very well controlled (at or below 7%) - You do not meet Romanian national standards for closed-loop pump therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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