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Glycaemic Load and Pre-meal Insulin Doses in Type 1 Diabetes Patients (GLUT)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal
Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Type 1 diabetes treated by insulin pump

Exclusion Criteria:

  • Preganncy

  • HbA1c > 9%

    • Any serious acute or chronic illness a part diabetes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Glycaemic load

    Carbohydrates content

    Arm Description

    Outcomes

    Primary Outcome Measures

    daily plasma glucose excursion
    mean plasma glucose concentrations

    Secondary Outcome Measures

    postprandial plasma glucose concentrations

    Full Information

    First Posted
    November 1, 2013
    Last Updated
    November 1, 2013
    Sponsor
    Federico II University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01978704
    Brief Title
    Glycaemic Load and Pre-meal Insulin Doses in Type 1 Diabetes Patients
    Acronym
    GLUT
    Official Title
    Use of the Glycemic Load for the Adjustment of the Dose of Preprandial Insulin in Patients With Type 1 Diabetes Mellitus in Insulin Pump Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federico II University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to compare the feasibility and the efficacy on short-term glucose control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of the carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with insulin pump

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glycaemic load
    Arm Type
    Experimental
    Arm Title
    Carbohydrates content
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal
    Intervention Type
    Other
    Intervention Name(s)
    Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal
    Primary Outcome Measure Information:
    Title
    daily plasma glucose excursion
    Time Frame
    1 week
    Title
    mean plasma glucose concentrations
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    postprandial plasma glucose concentrations
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Eligibility Criteria
    Inclusion Criteria: Type 1 diabetes treated by insulin pump Exclusion Criteria: Preganncy HbA1c > 9% Any serious acute or chronic illness a part diabetes

    12. IPD Sharing Statement

    Learn more about this trial

    Glycaemic Load and Pre-meal Insulin Doses in Type 1 Diabetes Patients

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