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.
Study Type
OBSERVATIONAL
Enrollment
44
Faster-acting insulin aspart used in insulin pump therapy in children and adolescents with type 1 diabetes mellitus during routine clinical care.
Rapid-acting insulin analogues used in insulin pump therapy in children and adolescents with type 1 diabetes mellitus during routine clinical care.
Aristotle University of Thessaloniki
Thessaloniki, Greece
1-hour glucose levels on Fiasp
ost-prandial 1-hour glucose levels on Fiasp® when used in the MiniMed 640G pump in children with type 1 diabetes.
Time frame: Weeks 1 to 4
1-hour glucose levels on Novorapid
ost-prandial 1-hour glucose levels on Novorapid® when used in the MiniMed 640G pump in children with type 1 diabetes.
Time frame: Weeks 1 to 4
Half-hour glucose levels on Fiasp
ost-prandial 1/2-hour glucose levels on Fiasp® when used in the MiniMed
Time frame: Weeks 1 to 4
Half-hour glucose levels on Novorapid
ost-prandial 1/2-hour glucose levels on Novorapid® when used in the MiniMed
Time frame: Weeks 1 to 4
2 hours glucose levels on Fiasp
ost-prandial 2-hours glucose levels on Fiasp® when used in the MiniMed
Time frame: Weeks 1 to 4
2 hours glucose levels on Novorapid
ost-prandial 2-hours glucose levels on Novorapid® when used in the MiniMed
Time frame: Weeks 1 to 4
Time in Range in Fiasp
Percent of time spent within 70-180 mg/dl during Fiasp® use
Time frame: Weeks 1 to 4
Time in Range in Novorapid
Percent of time spent within 70-180 mg/dl during Novorapid® use
Time frame: Weeks 1 to 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hypoglycemia in Fiasp
Percent of time spent below 70mg mg/dl during Fiasp® use
Time frame: Weeks 1 to 4
Hypoglycemia in Novorapid
Percent of time spent below 70mg mg/dl during Novorapid® use
Time frame: Weeks 1 to 4
Total Daily Dose in Fiasp
Units of insulin used per day during Fiasp® use
Time frame: Weeks 1 to 4
Total Daily Dose in Novorapid
Units of insulin used per day during Novorapid® use
Time frame: Weeks 1 to 4
Basal/Bolus in Fiasp
Units of insulin used per basal/bolus day during Fiasp® use
Time frame: Weeks 1 to 4
Basal/Bolus in Novorapid
Units of insulin used per basal/bolus day during Novorapid® use
Time frame: Weeks 1 to 4
eHbA1c in Fiasp
Estimated HbA1c levels during Fiasp® use
Time frame: Weeks 1 to 4
eHbA1c in Novorapid
Estimated HbA1c levels during Novorapid® use
Time frame: Weeks 1 to 4
Incidence of infusion sites reactions in Fiasp
Number of reactions involving infusion sites during Fiasp® use
Time frame: Weeks 1 to 4
Incidence of infusion sites reactions in Novorapid
Number of reactions involving infusion sites during Fiasp® use
Time frame: Weeks 1 to 4
Occlusion events in Fiasp
Number of occlusion events during Fiasp® use
Time frame: Weeks 1 to 4
Occlusion events in Novorapid
Number of occlusion events during Novorapid® use
Time frame: Weeks 1 to 4