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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Fast-acting insulin aspart; Drug: Rapid-acting insulin analogues (insulin aspart or insulin lispro)

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.

• Study Type: Observational
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 54246
    • Aristotle University of Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Faster aspart (FIAsp); Children and adolescents with type 1 diabetes mellitus using insulin pump therapy who received faster-acting insulin aspart.	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.
Aspart/Lispro; Children and adolescents with type 1 diabetes mellitus using insulin pump therapy receiving rapid-acting insulin analogues (insulin aspart or lispro).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Weeks 1 to 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Half-hour glucose levels on Fiasp	ost-prandial 1/2-hour glucose levels on Fiasp® when used in the MiniMed	Weeks 1 to 4
Half-hour glucose levels on Novorapid	ost-prandial 1/2-hour glucose levels on Novorapid® when used in the MiniMed	Weeks 1 to 4
2 hours glucose levels on Fiasp	ost-prandial 2-hours glucose levels on Fiasp® when used in the MiniMed	Weeks 1 to 4
2 hours glucose levels on Novorapid	ost-prandial 2-hours glucose levels on Novorapid® when used in the MiniMed	Weeks 1 to 4
Time in Range in Fiasp	Percent of time spent within 70-180 mg/dl during Fiasp® use	Weeks 1 to 4
Time in Range in Novorapid	Percent of time spent within 70-180 mg/dl during Novorapid® use	Weeks 1 to 4
Hypoglycemia in Fiasp	Percent of time spent below 70mg mg/dl during Fiasp® use	Weeks 1 to 4
Hypoglycemia in Novorapid	Percent of time spent below 70mg mg/dl during Novorapid® use	Weeks 1 to 4
Total Daily Dose in Fiasp	Units of insulin used per day during Fiasp® use	Weeks 1 to 4
Total Daily Dose in Novorapid	Units of insulin used per day during Novorapid® use	Weeks 1 to 4
Basal/Bolus in Fiasp	Units of insulin used per basal/bolus day during Fiasp® use	Weeks 1 to 4
Basal/Bolus in Novorapid	Units of insulin used per basal/bolus day during Novorapid® use	Weeks 1 to 4
eHbA1c in Fiasp	Estimated HbA1c levels during Fiasp® use	Weeks 1 to 4
eHbA1c in Novorapid	Estimated HbA1c levels during Novorapid® use	Weeks 1 to 4
Incidence of infusion sites reactions in Fiasp	Number of reactions involving infusion sites during Fiasp® use	Weeks 1 to 4
Incidence of infusion sites reactions in Novorapid	Number of reactions involving infusion sites during Fiasp® use	Weeks 1 to 4
Occlusion events in Fiasp	Number of occlusion events during Fiasp® use	Weeks 1 to 4
Occlusion events in Novorapid	Number of occlusion events during Novorapid® use	Weeks 1 to 4

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki

Publications and helpful links

General Publications

• Stamati A, Sotiriou G, Dimitriadou M, Christoforidis A. 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. J Diabetes Complications. 2023 Sep;37(9):108587. doi: 10.1016/j.jdiacomp.2023.108587. Epub 2023 Aug 15.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: October 26, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulins; Pancreatic Hormones; Insulin, Short-Acting; Insulin Aspart; Insulin Lispro
• Other Study ID Numbers: AUTH-AC-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No