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Type 1 DiabetesNCT04149262

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

An observational study of Type 1 Diabetes, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Fast-acting insulin aspart and Rapid-acting insulin analogues (insulin aspart or insulin lispro)
How many people
44 participants
Where
1 siteGreece
Study dates
15 Nov 2019to 15 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

  • Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies
  • Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within 30 days before screening
  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Aristotle University of Thessaloniki

    Thessaloniki, 54246

Other trials in Greece

About this study

Official title: 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

Read the 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
Being tested
Fast-acting insulin aspart, Rapid-acting insulin analogues (insulin aspart or insulin lispro)
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fast-acting insulin aspartDrug

    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 (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.

Study groups in NCT04149262
Study groupRoleWhat they receive
Faster aspart (FIAsp)Children and adolescents with type 1 diabetes mellitus using insulin pump therapy who received faster-acting insulin aspart.
Receives: Drug: Fast-acting insulin aspart
Aspart/LisproChildren and adolescents with type 1 diabetes mellitus using insulin pump therapy receiving rapid-acting insulin analogues (insulin aspart or lispro).
Receives: Drug: Rapid-acting insulin analogues (insulin aspart or insulin lispro)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Weeks 1 to 4

  2. 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.

    Measured: Weeks 1 to 4

Secondary outcomes (18)

  1. Half-hour glucose levels on Fiasp

    ost-prandial 1/2-hour glucose levels on Fiasp® when used in the MiniMed

    Measured: Weeks 1 to 4

  2. Half-hour glucose levels on Novorapid

    ost-prandial 1/2-hour glucose levels on Novorapid® when used in the MiniMed

    Measured: Weeks 1 to 4

  3. 2 hours glucose levels on Fiasp

    ost-prandial 2-hours glucose levels on Fiasp® when used in the MiniMed

    Measured: Weeks 1 to 4

  4. 2 hours glucose levels on Novorapid

    ost-prandial 2-hours glucose levels on Novorapid® when used in the MiniMed

    Measured: Weeks 1 to 4

  5. Time in Range in Fiasp

    Percent of time spent within 70-180 mg/dl during Fiasp® use

    Measured: Weeks 1 to 4

  6. Time in Range in Novorapid

    Percent of time spent within 70-180 mg/dl during Novorapid® use

    Measured: Weeks 1 to 4

  7. Hypoglycemia in Fiasp

    Percent of time spent below 70mg mg/dl during Fiasp® use

    Measured: Weeks 1 to 4

  8. Hypoglycemia in Novorapid

    Percent of time spent below 70mg mg/dl during Novorapid® use

    Measured: Weeks 1 to 4

  9. Total Daily Dose in Fiasp

    Units of insulin used per day during Fiasp® use

    Measured: Weeks 1 to 4

  10. Total Daily Dose in Novorapid

    Units of insulin used per day during Novorapid® use

    Measured: Weeks 1 to 4

  11. Basal/Bolus in Fiasp

    Units of insulin used per basal/bolus day during Fiasp® use

    Measured: Weeks 1 to 4

  12. Basal/Bolus in Novorapid

    Units of insulin used per basal/bolus day during Novorapid® use

    Measured: Weeks 1 to 4

  13. eHbA1c in Fiasp

    Estimated HbA1c levels during Fiasp® use

    Measured: Weeks 1 to 4

  14. eHbA1c in Novorapid

    Estimated HbA1c levels during Novorapid® use

    Measured: Weeks 1 to 4

  15. Incidence of infusion sites reactions in Fiasp

    Number of reactions involving infusion sites during Fiasp® use

    Measured: Weeks 1 to 4

  16. Incidence of infusion sites reactions in Novorapid

    Number of reactions involving infusion sites during Fiasp® use

    Measured: Weeks 1 to 4

  17. Occlusion events in Fiasp

    Number of occlusion events during Fiasp® use

    Measured: Weeks 1 to 4

  18. Occlusion events in Novorapid

    Number of occlusion events during Novorapid® use

    Measured: Weeks 1 to 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2019
  2. Study start15 Nov 2019
  3. Primary completion31 Mar 2020
  4. Study completion15 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04149262
Sponsor's protocol ID
AUTH-AC-1
Status last verified
Mar 2026
First submitted
26 Oct 2019
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 37597378

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-hour glucose levels on Fiasp (time frame: Weeks 1 to 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04149262, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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