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Electronic Platform for Diabetic Patients Activation (INSULINCOM)

Primary Purpose

Hypoglycemia, Hypoglycemia Acute

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ti.care
Sponsored by
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypoglycemia

Eligibility Criteria

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

Inclusion Criteria:

  • Aged over 17 years
  • Patients with type 2 diabetes diagnosis
  • Patients who start insulin treatment or with intensification of treatment
  • Patients who sign informed consent

Exclusion Criteria:

  • Patients with type 1 diabetes diagnosis
  • Life expectancy less than one year
  • Pregnancy
  • Patients with dementia
  • Patients with treatment different to insulin
  • Patients who, in the opinion of the researcher, cannot follow the recommendations of the self-care health education plan.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Usual care and usual communication with health professional

    They will be trained to use the ti.care platform and will be able to use it as a communication channel for any questions or clarification they require during the time elapsed between routine control visits. This platform will be a complement to the visits, but in no case will it replace them or be used as a diagnostic or therapeutic method. The platform does not have any treatment algorithm and only aims to facilitate communication between the patient at home and the health professional, both the doctor and the nurse educator. It will be used in a preventive and advisory manner for the patient for follow-up. In no case it will be used for emergencies. Daily during working hours from Monday to Friday, health professionals will review patient requests and respond to them.

    Outcomes

    Primary Outcome Measures

    Change from HbA1c level at 3 months
    Change from HbA1c level at 3 months
    Change from basal capillary blood glucose at 3 months
    Change from basal capillary blood glucose at 3 months
    Change from postprandial blood glucose at 3 months
    Change from postprandial blood glucose at 3 months
    Change from nocturnal blood glucose at 3 months
    Change from nocturnal blood glucose at 3 months
    Total hypoglycemia
    Number of total hypoglycemia events
    Number of nocturnal hypoglycemia events
    Number of nocturnal hypoglycemia events
    Number of inadvertent hypoglycemia events
    Number of inadvertent hypoglycemia events

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2020
    Last Updated
    March 18, 2021
    Sponsor
    Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04595383
    Brief Title
    Electronic Platform for Diabetic Patients Activation
    Acronym
    INSULINCOM
    Official Title
    Efficacy of an Electronic Communication Platform to Activate Diabetic Patients Treated With Insulin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    May 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    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
    The purpose of this study is to assess the efficacy of an electronic platform for doctor-patient communication in order to reduce severe and non-severe hypoglycemia events as well as inadvertent hypoglycemia events.
    Detailed Description
    This is an open randomized clinical trial without drugs. Patients with type 2 diabetes and treated with insulin will be included. Patients allocated in the intervention group will use the electronic platform as a communication channel with their health provider during the time between visits. The name of the platform is ti.care (https://ti.care/es) and it will be a complement of the control visits to resolve doubts through chats, email or video call. Health providers will answer the patient requests.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoglycemia, Hypoglycemia Acute

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    106 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Usual care and usual communication with health professional
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    They will be trained to use the ti.care platform and will be able to use it as a communication channel for any questions or clarification they require during the time elapsed between routine control visits. This platform will be a complement to the visits, but in no case will it replace them or be used as a diagnostic or therapeutic method. The platform does not have any treatment algorithm and only aims to facilitate communication between the patient at home and the health professional, both the doctor and the nurse educator. It will be used in a preventive and advisory manner for the patient for follow-up. In no case it will be used for emergencies. Daily during working hours from Monday to Friday, health professionals will review patient requests and respond to them.
    Intervention Type
    Device
    Intervention Name(s)
    ti.care
    Intervention Description
    Electronic platform for doctor-patient communication
    Primary Outcome Measure Information:
    Title
    Change from HbA1c level at 3 months
    Description
    Change from HbA1c level at 3 months
    Time Frame
    Baseline and at 3 months
    Title
    Change from basal capillary blood glucose at 3 months
    Description
    Change from basal capillary blood glucose at 3 months
    Time Frame
    Baseline and at 3 months
    Title
    Change from postprandial blood glucose at 3 months
    Description
    Change from postprandial blood glucose at 3 months
    Time Frame
    Baseline and at 3 months
    Title
    Change from nocturnal blood glucose at 3 months
    Description
    Change from nocturnal blood glucose at 3 months
    Time Frame
    Baseline and at 3 months
    Title
    Total hypoglycemia
    Description
    Number of total hypoglycemia events
    Time Frame
    At 3 months
    Title
    Number of nocturnal hypoglycemia events
    Description
    Number of nocturnal hypoglycemia events
    Time Frame
    At 3 months
    Title
    Number of inadvertent hypoglycemia events
    Description
    Number of inadvertent hypoglycemia events
    Time Frame
    At 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged over 17 years Patients with type 2 diabetes diagnosis Patients who start insulin treatment or with intensification of treatment Patients who sign informed consent Exclusion Criteria: Patients with type 1 diabetes diagnosis Life expectancy less than one year Pregnancy Patients with dementia Patients with treatment different to insulin Patients who, in the opinion of the researcher, cannot follow the recommendations of the self-care health education plan.

    12. IPD Sharing Statement

    Learn more about this trial

    Electronic Platform for Diabetic Patients Activation

    We'll reach out to this number within 24 hrs