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Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eversense
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring eversense, type 1 diabetes

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or Female diagnosed with type 1 diabetes mellitus
  2. Age > 18
  3. Insulin treatment for at least 1 year (Either MDI of CSII)
  4. HbA1c < 11%
  5. Signing informed consent and willing to apply with study procedure

Exclusion Criteria:

  1. History of severe hypoglycaemia in the last 3 months
  2. History of DKA in the last 3 months
  3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition
  4. Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
  5. Any condition that require MRI imaging or planned MRI during the trial period
  6. Known topical or local anaesthetic allergy
  7. Known allergy to glucocorticoids
  8. History of hepatitis B, hepatitis C or HIV
  9. Any Bleeding disorder or taking anticoagulant medication
  10. Participation in other clinical trial
  11. Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    single arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    changes in quality of life evaluated questionnaires (DTSQ)

    Secondary Outcome Measures

    Change in HBA1C
    CGM Time In Range (70-180 mg/dl)
    CGM Time in hypoglycaemia below 70 mg/dl
    CGM Time in hypoglycaemia below 54 mg/dl
    CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit]
    Change in HFS-ii (hypoglycaemia fear survey II)
    Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT)
    Any adverse event related to study device

    Full Information

    First Posted
    November 10, 2019
    Last Updated
    November 18, 2019
    Sponsor
    Meir Medical Center
    Collaborators
    DYN Diagnostic LTD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04161651
    Brief Title
    Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
    Official Title
    Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2019 (Anticipated)
    Primary Completion Date
    October 2020 (Anticipated)
    Study Completion Date
    October 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Meir Medical Center
    Collaborators
    DYN Diagnostic LTD

    4. Oversight

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

    5. Study Description

    Brief Summary
    Evaluation of Long-Term Implanted Sensor in Patients on Quality of life
    Detailed Description
    Assess satisfaction and acceptance of long-term implanted single sensor use (eversense XL) for up to 6 months in type 1 insulin-using patients

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single arm
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    eversense
    Intervention Description
    eversense CGM
    Primary Outcome Measure Information:
    Title
    changes in quality of life evaluated questionnaires (DTSQ)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change in HBA1C
    Time Frame
    3 / 6 months
    Title
    CGM Time In Range (70-180 mg/dl)
    Time Frame
    3 / 6 months
    Title
    CGM Time in hypoglycaemia below 70 mg/dl
    Time Frame
    3 / 6 months
    Title
    CGM Time in hypoglycaemia below 54 mg/dl
    Time Frame
    3 / 6 months
    Title
    CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit]
    Time Frame
    3 / 6 months
    Title
    Change in HFS-ii (hypoglycaemia fear survey II)
    Time Frame
    6 months
    Title
    Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT)
    Time Frame
    6 months
    Title
    Any adverse event related to study device
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or Female diagnosed with type 1 diabetes mellitus Age > 18 Insulin treatment for at least 1 year (Either MDI of CSII) HbA1c < 11% Signing informed consent and willing to apply with study procedure Exclusion Criteria: History of severe hypoglycaemia in the last 3 months History of DKA in the last 3 months Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study Any condition that require MRI imaging or planned MRI during the trial period Known topical or local anaesthetic allergy Known allergy to glucocorticoids History of hepatitis B, hepatitis C or HIV Any Bleeding disorder or taking anticoagulant medication Participation in other clinical trial Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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