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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Insulin Glulisine
Insulin Aspart
Insulin Lispro
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring diabetes type 1, insulin bolus, prandial insulin requirement, postprandial glycemia, insulin pump therapy, mixed meal

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    IPF

    30%IC

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Glucose Area Under the Curve (AUC)
    Measurements based on Continuous Glucose Monitoring System (CGMS)
    The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)
    Measurements based on SMBG
    Hypoglycemia Episodes
    Hypoglycemia defined as a plasma glucose concentration below 70mg/dl with or without symptoms

    Full Information

    First Posted
    August 23, 2019
    Last Updated
    October 10, 2019
    Sponsor
    Medical University of Warsaw
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04124302
    Brief Title
    The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2019 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    August 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Warsaw

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 1
    Keywords
    diabetes type 1, insulin bolus, prandial insulin requirement, postprandial glycemia, insulin pump therapy, mixed meal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IPF
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    30%IC
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin Glulisine
    Other Intervention Name(s)
    Apidra
    Intervention Description
    A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin Aspart
    Other Intervention Name(s)
    NovoRapid
    Intervention Description
    A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin Lispro
    Other Intervention Name(s)
    Humalog, Liprolog
    Intervention Description
    A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
    Primary Outcome Measure Information:
    Title
    Postprandial glycemia
    Description
    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
    Time Frame
    60 minutes after meal
    Title
    Postprandial glycemia
    Description
    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
    Time Frame
    120 minutes after meal
    Title
    Postprandial glycemia
    Description
    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
    Time Frame
    180 minutes after meal
    Title
    Postprandial glycemia
    Description
    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
    Time Frame
    210 minutes after meal
    Title
    Postprandial glycemia
    Description
    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
    Time Frame
    240 minutes after meal
    Title
    Postprandial glycemia
    Description
    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
    Time Frame
    270 minutes after meal
    Title
    Postprandial glycemia
    Description
    Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).
    Time Frame
    300 minutes after meal
    Secondary Outcome Measure Information:
    Title
    Glucose Area Under the Curve (AUC)
    Description
    Measurements based on Continuous Glucose Monitoring System (CGMS)
    Time Frame
    5 hours study period
    Title
    The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)
    Description
    Measurements based on SMBG
    Time Frame
    5 hours study period
    Title
    Hypoglycemia Episodes
    Description
    Hypoglycemia defined as a plasma glucose concentration below 70mg/dl with or without symptoms
    Time Frame
    5 hours study period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Magdalena Dymińska, MD
    Phone
    +48 223179538
    Email
    m.dyminska91@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Agnieszka Szypowska, Prof.
    Phone
    +48 223179539
    Email
    agnieszka.szypowska@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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