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Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glucose Sensor
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 1 focused on measuring Glucose Monitoring System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent obtained after being advised of the nature of the study
  • Male or female aged ≥18 years
  • Type 1 diabetes for at least 6 months according to the World Health Organization (WHO) definition
  • Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months
  • Body Mass Index (BMI) < 35 kg/m²
  • Willing and able to wear 5 CGM devices for the duration of the study and undergo all study procedures.
  • HbA1c ≤ 86 mmol/mol

Exclusion Criteria:

  • Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
  • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
  • Any mental condition rendering the subject incapable of giving his consent
  • Subject is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
  • Subject may not use acetaminophen (paracetamol) while participating in the study
  • Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study.
  • Subject is actively enrolled in another clinical trial
  • Known adrenal gland problem, pancreatic tumour, or insulinoma
  • Inability of the subject to comply with all study procedures
  • Inability of the subject to understand the patient information.
  • Subject donated blood in the last 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Glucose Sensor

    Arm Description

    Continuous subcutaneous glucose monitoring using four different CGM systems in parallel will be performed throughout the study. Insulin therapy will be performed by the subjects themselves, as under daily life conditions. For the hypoglycaemia experiment an increased insulin bolus will be administered with meals (180% of the subject's calculated mealtime dose).

    Outcomes

    Primary Outcome Measures

    Percentage of Test-to-Reference Measurement Pairs With an Absolute Relative Difference (ARD) ≤15%
    The primary outcome measure was overall sensor accuracy determined using ISO 15197:2013, which is percentage (%) of sensor values that are within ±0.8 mmol/L of the reference value at glucose concentrations <5.6 mmol/L and within ±15% at glucose concentrations ≥5.6 mmol/L. The sensor values were obtained using three different glucose monitoring systems, i.e. Abbott, Dexcom and Medtronic, in patients with T1D over a 12-hour period in standardized conditions. The reference values were obtained by analysis of venous plasma glucose samples.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 24, 2015
    Last Updated
    May 2, 2023
    Sponsor
    Medical University of Graz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02614768
    Brief Title
    Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions
    Official Title
    Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (Actual)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess accuracy and reliability of the SPIDIMAN continuous glucose monitoring (CGM) sensor system with regard to values as measured by Super GL and compare these results with similar evaluations of the Medtronic MiniMed 640G system, the Abbott FreeStyle Libre Flash Sensor and the DexCom G4 Platinum Sensor in patients with type 1 Diabetes.
    Detailed Description
    The study is a single-center open-label study in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) therapy. The study will include a total of 12 subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 1
    Keywords
    Glucose Monitoring System

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glucose Sensor
    Arm Type
    Experimental
    Arm Description
    Continuous subcutaneous glucose monitoring using four different CGM systems in parallel will be performed throughout the study. Insulin therapy will be performed by the subjects themselves, as under daily life conditions. For the hypoglycaemia experiment an increased insulin bolus will be administered with meals (180% of the subject's calculated mealtime dose).
    Intervention Type
    Device
    Intervention Name(s)
    Glucose Sensor
    Intervention Description
    The investigational intervention is CGM monitoring using four different CGM systems. Three of the four CGM devices which are used will be CGM systems which have received conformité européenne (CE) certification (Dexcom G4 Platinum, Medtronic MiniMed 640G system, Abbott FreeStyle Libre Flash). The SPIDIMAN sensor will be used for the first time in human subjects, does not yet have received CE certification and will be given an identifying label in addition to being labelled "for investigative use only".
    Primary Outcome Measure Information:
    Title
    Percentage of Test-to-Reference Measurement Pairs With an Absolute Relative Difference (ARD) ≤15%
    Description
    The primary outcome measure was overall sensor accuracy determined using ISO 15197:2013, which is percentage (%) of sensor values that are within ±0.8 mmol/L of the reference value at glucose concentrations <5.6 mmol/L and within ±15% at glucose concentrations ≥5.6 mmol/L. The sensor values were obtained using three different glucose monitoring systems, i.e. Abbott, Dexcom and Medtronic, in patients with T1D over a 12-hour period in standardized conditions. The reference values were obtained by analysis of venous plasma glucose samples.
    Time Frame
    36 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Informed consent obtained after being advised of the nature of the study Male or female aged ≥18 years Type 1 diabetes for at least 6 months according to the World Health Organization (WHO) definition Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months Body Mass Index (BMI) < 35 kg/m² Willing and able to wear 5 CGM devices for the duration of the study and undergo all study procedures. HbA1c ≤ 86 mmol/mol Exclusion Criteria: Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods Any mental condition rendering the subject incapable of giving his consent Subject is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration Subject may not use acetaminophen (paracetamol) while participating in the study Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study. Subject is actively enrolled in another clinical trial Known adrenal gland problem, pancreatic tumour, or insulinoma Inability of the subject to comply with all study procedures Inability of the subject to understand the patient information. Subject donated blood in the last 3 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julia Mader, Prof. Dr.
    Organizational Affiliation
    Medical University of Graz
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions

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