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

ELIAS Emergency University Hospital

Status and phase

Enrolling

Phase 4

Conditions

Diabetes Mellitus, Type 1

Treatments

Device: Switching to the Medtronic 780G insulin pump

Study type

Interventional

Funder types

Other

Identifiers

NCT06326489

105122023-1/05.12.2023

ERP-2023-13520 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

7 to 17 years old

Volunteers

No Healthy Volunteers

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)