Does the Use of Fiasp vs. Asp Lead to the Prolonged TIR in Children With Type 1 Diabetes?

February 22, 2021 updated by: Medical University of Warsaw

Does the Use of Faster Insulin Aspart vs. Aspart Lead to the Prolonged Glycemic Time in Range in Children Suffering From Type 1 Diabetes Who Use Continuous Glucose Monitoring?

The aim of the study is to assess whether the implementation of faster insulin aspart in children with Type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using Real Time Continuous Glucose Monitoring (RT-CGM) systems leads to prolonged time in range (TIR) compared to insulin aspart.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥1 year of a history of type 1 diabetes;
  • treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, CSII) ≥3 months;
  • using continuous glucose monitoring system for at least 1 month;
  • HbA1c<8%;
  • consent to participate in the study obtained from the parent and the patient (>16 years of age).

Exclusion Criteria:

  • diabetes treated with multiple insulin injections with insulin pens (Multiple Daily Injections, MDI);
  • concomitant medical problems which might significantly affect glucose levels;
  • the withdrawal of the consent to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Insulin Aspart
Patients will use the continuous subcutaneous insulin infusion of insulin aspart (Novo Rapid, Novo Nordisk) and RT-CGM for 4 weeks.
Drug: Insulin faster aspart (Fiasp, Novo Nordisk)

Duration of the study: 10 weeks.

It is assumed that the patients will attend 4 visits in Pediatric Diabetology Clinic, and 3 telephone consultations.

W0: The study will start with a 2-week run-in period in order to normalize glycemia.

W1: RT-CGM will be inserted. Subsequently, the participants will be randomly assigned to one of two groups (Fa-A or A-Fa), basing on which the order of insulin use will be determined.

W2: after 2 weeks, diabetology telephone consultation (washout period).

W3: after 2 weeks, diabetology consultation. Changing insulin type according to the allocation.

W4: after 2 weeks, diabetology telephone consultation (washout period).

W5: after 2 weeks, diabetology telephone consultation.

W6: the results obtained throughout the study will be discussed with the patient and the parent.

Other Names:
  • Insulin aspart (Novo Rapid, Novo Nordisk)
Experimental: Insulin Fiasp
Patients will use the continuous subcutaneous insulin infusion of insulin faster aspart (Fiasp, Novo Nordisk) and RT-CGM for 4 weeks.
Drug: Insulin faster aspart (Fiasp, Novo Nordisk)

Duration of the study: 10 weeks.

It is assumed that the patients will attend 4 visits in Pediatric Diabetology Clinic, and 3 telephone consultations.

W0: The study will start with a 2-week run-in period in order to normalize glycemia.

W1: RT-CGM will be inserted. Subsequently, the participants will be randomly assigned to one of two groups (Fa-A or A-Fa), basing on which the order of insulin use will be determined.

W2: after 2 weeks, diabetology telephone consultation (washout period).

W3: after 2 weeks, diabetology consultation. Changing insulin type according to the allocation.

W4: after 2 weeks, diabetology telephone consultation (washout period).

W5: after 2 weeks, diabetology telephone consultation.

W6: the results obtained throughout the study will be discussed with the patient and the parent.

Other Names:
  • Insulin aspart (Novo Rapid, Novo Nordisk)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Glycaemia difference in time in range (TIR) 70-180mg/dl
Time Frame: at week 4 of the study
at week 4 of the study
Glycaemia difference in time in range (TIR) 70-180mg/dl
Time Frame: at week 8 of the study
at week 8 of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Glycaemia difference in time below range (TBR)
Time Frame: at weeks 4 and 8 of the study
at weeks 4 and 8 of the study
Glycaemia difference in time above range (TAR)
Time Frame: at weeks 4 and 8 of the study
at weeks 4 and 8 of the study
Glycaemia difference in the coefficient of variation (CV)
Time Frame: at weeks 4 and 8 of the study
at weeks 4 and 8 of the study
Difference in the average glycemia levels + standard deviation
Time Frame: at weeks 4 and 8 of the study
at weeks 4 and 8 of the study
Difference in Total Daily Dose (TDD) of insulin
Time Frame: at weeks 4 and 8 of the study
at weeks 4 and 8 of the study
Difference in the basal rate of insulin
Time Frame: at weeks 4 and 8 of the study
at weeks 4 and 8 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Warsaw

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Agnieszka Szypowska, Prof., Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital of the Medical University of Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TIR: Fiasp vs. Asp

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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