Diabetes Mellitus, Type 1Phase 4NCT04124302

The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.

A Phase 4 study testing Insulin Glulisine, Insulin Aspart and Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Medical University of Warsaw at 1 site in Poland.

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

The aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus. Read more about this study

Who is it for?: Ages 10 to 18 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Insulin Glulisine, Insulin Aspart and Insulin Lispro
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 sitePoland
Study dates: 1 Oct 2019to 31 Dec 2024
Phase: Phase 4
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 10 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

duration of type 1 diabetes longer than 12 months
insulin pump therapy longer than 3 months
treated by the same type of insulin longer than 3 months
written informed consent by patients and parents

Who cannot join

celiac disease
diabetes related complications (e.g. nephropathy)
any disease judged by the investigator to affect the trial
withdrawal of consent to participate in the study

Trial locations and contacts

1 site in 1 country.

Poland1 site

Warsaw Medical University
Warsaw

Other trials in Poland

About this study

Official title: The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.

The aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus.

Conditions: Diabetes Mellitus, Type 1
Being tested: Insulin Glulisine, Insulin Aspart, Insulin Lispro
Keywords: diabetes type 1, insulin bolus, prandial insulin requirement, postprandial glycemia, insulin pump therapy, mixed meal
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.

Insulin GlulisineDrug
Also called Apidra
A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
Insulin AspartDrug
Also called NovoRapid
A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
Insulin LisproDrug
Also called Humalog, Liprolog
A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.

Study groups in NCT04124302
Study group	Role	What they receive
IPF	Active comparator	Total meal bolus will consist of insulin for carbohydrates (IC) and insulin for proteins and fats (IPF) based on individual insulin-to-carbohydrate ratio (ICR). Dual bolus will be given 15 minutes before the mixed meal (toast with cheese). Receives: Drug: Insulin Glulisine; Drug: Insulin Aspart; Drug: Insulin Lispro
30%IC	Experimental	Total meal bolus will consist of insulin for carbohydrates (IC) calculated based on individual insulin-to-carbohydrate ratio (ICR) and insulin for proteins and fats (IPF) estimated as 30% of IC. Dual bolus will be given 15 minutes before the mixed meal (toast with cheese). Receives: Drug: Insulin Glulisine; Drug: Insulin Aspart; Drug: Insulin Lispro

What is being measured

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

Postprandial glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Measured: 30 minutes after meal
Postprandial glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Measured: 60 minutes after meal
Postprandial glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Measured: 90 minutes after meal
Postprandial glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Measured: 120 minutes after meal
Postprandial glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Measured: 150 minutes after meal
Postprandial glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Measured: 180 minutes after meal
Postprandial glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Measured: 210 minutes after meal
Postprandial glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Measured: 240 minutes after meal
Postprandial glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Measured: 270 minutes after meal
Postprandial glycemia
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Measured: 300 minutes after meal

Secondary outcomes (4)

Glucose Area Under the Curve (AUC)
Measurements based on Continuous Glucose Monitoring System (CGMS)
Measured: 5 hours study period
The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)
Measurements based on SMBG
Measured: 5 hours study period
Hypoglycemia Episodes
Hypoglycemia defined as a plasma glucose concentration below 70mg/dl with or without symptoms
Measured: 5 hours study period
Time in target postprandial glycemia
Time spent in the target range between 70 and 180 mg/dL based on CGMS
Measured: 5 hours study period

Timeline

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

1 Oct 201931 Dec 2024

First posted11 Oct 2019
Study start1 Oct 2019
Primary completion27 Mar 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by Medical University of WarsawThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04124302
Sponsor's protocol ID: Mixed Meal Bolus
Status last verified: Mar 2024
First submitted: 23 Aug 2019
Last updated: 18 Nov 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.
ClinicalTrials.gov ID: NCT04124302
Acronym / sponsor ID: Mixed Meal Bolus
Conditions: Diabetes Mellitus, Type 1
Keywords: diabetes type 1, insulin bolus, prandial insulin requirement, postprandial glycemia, insulin pump therapy, mixed meal
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Medical University of WarsawUniversity, hospital or other
Study start: 1 Oct 2019 (actual)
Primary completion: 27 Mar 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 11 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
IPF	Active comparator	Drug: Insulin Glulisine, Drug: Insulin Aspart, Drug: Insulin LisproTotal meal bolus will consist of insulin for carbohydrates (IC) and insulin for proteins and fats (IPF) based on individual insulin-to-carbohydrate ratio (ICR). Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).
30%IC	Experimental	Drug: Insulin Glulisine, Drug: Insulin Aspart, Drug: Insulin LisproTotal meal bolus will consist of insulin for carbohydrates (IC) calculated based on individual insulin-to-carbohydrate ratio (ICR) and insulin for proteins and fats (IPF) estimated as 30% of IC. Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

duration of type 1 diabetes longer than 12 months
insulin pump therapy longer than 3 months
treated by the same type of insulin longer than 3 months
written informed consent by patients and parents

Key exclusion criteria (4 listed)

celiac disease
diabetes related complications (e.g. nephropathy)
any disease judged by the investigator to affect the trial
withdrawal of consent to participate in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin GlulisineAlso: ApidraA kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.	Drug	30%IC, IPF
Insulin AspartAlso: NovoRapidA kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.	Drug	30%IC, IPF
Insulin LisproAlso: Humalog, LiprologA kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.	Drug	30%IC, IPF

Primary outcome

Postprandial glycemia
Time frame: 30 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Postprandial glycemia
Time frame: 60 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Postprandial glycemia
Time frame: 90 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Postprandial glycemia
Time frame: 120 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Postprandial glycemia
Time frame: 150 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Postprandial glycemia
Time frame: 180 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Postprandial glycemia
Time frame: 210 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Postprandial glycemia
Time frame: 240 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Postprandial glycemia
Time frame: 270 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
Postprandial glycemia
Time frame: 300 minutes after meal
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

4 secondary outcomes

Glucose Area Under the Curve (AUC)
Time frame: 5 hours study period
The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)
Time frame: 5 hours study period
Hypoglycemia Episodes
Time frame: 5 hours study period
Time in target postprandial glycemia
Time frame: 5 hours study period

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin Glulisine, Insulin Aspart and Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Medical University of Warsaw at 1 site in Poland.

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 4 inclusion and 4 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 18 Nov 2025. 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 Poland. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Postprandial glycemia (time frame: 30 minutes after meal). The study lists 10 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 NCT04124302.

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 18 Nov 2025.