NCT04124302

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 18, 2025

Status Verified

March 1, 2024

Enrollment Period

4.5 years

First QC Date

August 23, 2019

Last Update Submit

November 14, 2025

Conditions

Diabetes Mellitus, Type 1

Keywords

diabetes type 1insulin bolusprandial insulin requirementpostprandial glycemiainsulin pump therapymixed meal

Outcome Measures

Primary Outcomes (10)

  • Postprandial glycemia

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

    30 minutes after meal

  • Postprandial glycemia

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

    60 minutes after meal

  • Postprandial glycemia

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

    90 minutes after meal

  • Postprandial glycemia

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

    120 minutes after meal

  • Postprandial glycemia

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

    150 minutes after meal

  • Postprandial glycemia

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

    180 minutes after meal

  • Postprandial glycemia

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

    210 minutes after meal

  • Postprandial glycemia

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

    240 minutes after meal

  • Postprandial glycemia

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

    270 minutes after meal

  • Postprandial glycemia

    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).

    300 minutes after meal

Secondary Outcomes (4)

  • Glucose Area Under the Curve (AUC)

    5 hours study period

  • The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)

    5 hours study period

  • Hypoglycemia Episodes

    5 hours study period

  • Time in target postprandial glycemia

    5 hours study period

Study Arms (2)

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).

Drug: Insulin GlulisineDrug: Insulin AspartDrug: 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).

Drug: Insulin GlulisineDrug: Insulin AspartDrug: Insulin Lispro

Interventions

Insulin GlulisineDRUG

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

Also known as: Apidra
30%ICIPF
Insulin AspartDRUG

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

Also known as: NovoRapid
30%ICIPF
Insulin LisproDRUG

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

Also known as: Humalog, Liprolog
30%ICIPF

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warsaw Medical University

Warsaw, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisineInsulin AspartInsulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

October 11, 2019

Study Start

October 1, 2019

Primary Completion

March 27, 2024

Study Completion

December 31, 2024

Last Updated

November 18, 2025

Record last verified: 2024-03

Locations

PL(1)