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

NCT ID: NCT04124302

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IPF

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).

Group Type ACTIVE_COMPARATOR

Insulin Glulisine

Intervention Type DRUG

A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.

Insulin Aspart

Intervention Type DRUG

A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.

Insulin Lispro

Intervention Type DRUG

A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.

30%IC

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).

Group Type EXPERIMENTAL

Insulin Glulisine

Intervention Type DRUG

A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.

Insulin Aspart

Intervention Type DRUG

A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.

Insulin Lispro

Intervention Type DRUG

A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.

Interventions

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Insulin Glulisine

A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.

Intervention Type DRUG

Insulin Aspart

A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.

Intervention Type DRUG

Insulin Lispro

A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.

Intervention Type DRUG

Other Intervention Names

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Apidra NovoRapid Humalog, Liprolog

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Warsaw Medical University

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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Mixed Meal Bolus

Identifier Type: -

Identifier Source: org_study_id

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