This is an exploratory, single-center retrospective cohort real-world study comparing safety and efficacy of Fiasp® versus NovoRapid® when used in the Medtronic MiniMed 640G system in pediatric subjects with Type 1 Diabetes Mellitus

This study evaluates the effectiveness and safety of faster-acting insulin aspart (Fiasp®) compared with rapid-acting insulin analogues (insulin aspart or insulin lispro) in children and adolescents with type 1 diabetes mellitus using insulin pump therapy.

The study is a single-center retrospective cohort study including real-world clinical data from pediatric patients followed at the Pediatric Diabetes Outpatient Clinic of the 1st Pediatric Department of the Aristotle University of Thessaloniki, at Ippokratio General Hospital.

Clinical and continuous glucose monitoring data were collected from medical records during routine clinical follow-up. Patients were treated with continuous subcutaneous insulin infusion using insulin pumps equipped with continuous glucose monitoring systems.

The primary objective was to evaluate glycemic control using continuous glucose monitoring metrics, with particular emphasis on time in range (70-180 mg/dL). Secondary outcomes included time spent in hypoglycemia (<70 mg/dL), time spent in hyperglycemia (>180 mg/dL and >250 mg/dL), glycemic variability, total daily insulin dose, basal and bolus insulin distribution, and other pump-related parameters.

Comparisons were performed between patients receiving faster-acting insulin aspart and those receiving rapid-acting insulin analogues during routine clinical care.

Inclusion Criteria:

1. Informed consent obtained by parents or legal caregivers before any trial-related activities.
2. Any age, age ≥ 2 years and age <18 years at the time of signing informed consent
3. Documented diagnoses of T1DM ≥ 3 months prior to the beginning of the study
4. Using the Medtronic MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter for at least 30 days prior to beginning of the study and willing to continue using the system throughout the trial.
5. Ability and willingness to use the same insulin infusion sets throughout the trial
6. Using the same insulin for at least 30 days prior to screening
7. HbA1c < 9.0% as assessed by local laboratory at screening
8. Ability and willingness to adhere to the protocol including performing SMBG (Self Monitoring Blood Glucose) profiles, attending visits, uploading pump and sensor data to the CareLink platform

Exclusion Criteria:

1. Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies
2. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within 30 days before screening
3. Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial
4. Any diabetic complication including renal disease, retinopathy, etc
5. History of hospitalization for ketoacidosis ≤ 3 months prior to the day of screening
6. Any condition which, in the opinion of the Investigator, might influence patient's safety or compliance with the protocol

Children and adolescents with type 1 diabetes mellitus receiving care at the Pediatric Diabetes Outpatient Clinic of the 1st Pediatric Department of Aristotle University of Thessaloniki at Ippokratio General Hospital. The study population includes patients treated with continuous subcutaneous insulin infusion (insulin pump therapy) with available continuous glucose monitoring data during routine clinical follow-up.