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 ID: NCT06326489

Interventional - Phase 4 - Completed

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

• Switching to the Medtronic 780G insulin pump

Eligibility

Inclusion criteria

• Age 7 years or older at baseline
• Diagnosis of type 1 diabetes
• Current use of a predictive low glucose suspend insulin pump (740G)
• At least 30% of subjects must have an HbA1c \> 7,5% (58 mmol/mol)

Exclusion criteria

• Age \< 7 years or ≥ 18 years at baseline
• Diabetes duration \< 1 year at baseline
• HbA1c ≤ 7% (53 mmol/mol)
• Not meeting the Romanian national standards for closed-loop insulin pump therapy
• Other criteria deemed inappropriate by the principal investigator (to be documented)

Sponsor

ELIAS Emergency University Hospital

Source: ClinicalTrials.gov

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