NCT04149262

Fiasp® Versus NovoRapid® in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor

Efficacy and Safety of Faster Aspart in Insulin Pumps in Children and Adolescents With Type 1 Diabetes Mellitus: A Single-center Study With Real-world Data

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Fast-acting insulin aspart	Faster-acting insulin aspart used in insulin pump therapy in children and adolescents with type 1 diabetes mellitus during routine clinical care.
DRUG	Rapid-acting insulin analogues (insulin aspart or insulin lispro)	Rapid-acting insulin analogues used in insulin pump therapy in children and adolescents with type 1 diabetes mellitus during routine clinical care.

Timeline

• Start date: 2019-11-15
• Primary completion: 2020-03-31
• Completion: 2023-02-15
• First posted: 2019-11-04
• Last updated: 2026-03-11

Locations

1 site across 1 country: Greece