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

Inclusion Criteria4

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 Criteria5

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)