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

NCT04149262 | Completed

• 1 other identifier: AUTH-AC-1
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Half-hour glucose levels on Fiasp

  Weeks 1 to 4

• Half-hour glucose levels on Novorapid

  Weeks 1 to 4

• 2 hours glucose levels on Fiasp

  Weeks 1 to 4

• 2 hours glucose levels on Novorapid

  Weeks 1 to 4

• Time in Range in Fiasp

  Weeks 1 to 4

Study Arms (2)

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

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)

Interventions

Fast-acting insulin aspart DRUG

Faster-acting insulin aspart used in insulin pump therapy in children and adolescents with type 1 diabetes mellitus during routine clinical care.

Faster aspart (FIAsp)

Rapid-acting insulin analogues (insulin aspart or insulin lispro) DRUG

Rapid-acting insulin analogues used in insulin pump therapy in children and adolescents with type 1 diabetes mellitus during routine clinical care.

Aspart/Lispro

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Informed consent obtained by parents or legal caregivers before any trial-related activities.
• Any age, age ≥ 2 years and age \<18 years at the time of signing informed consent
• Documented diagnoses of T1DM ≥ 3 months prior to the beginning of the study
• 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.
• Ability and willingness to use the same insulin infusion sets throughout the trial
• Using the same insulin for at least 30 days prior to screening
• HbA1c \< 9.0% as assessed by local laboratory at screening
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, 54246, Greece

Location

Related Publications (1)

• 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.

  PMID: 37597378 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Pediatric Endocrinology

Study Record Dates

• First Submitted: October 26, 2019
• First Posted: November 4, 2019
• Study Start: November 15, 2019
• Primary Completion: March 31, 2020
• Study Completion: February 15, 2023
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)