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Continuous Glucose Monitorization in Hospitalized Patients With COVID-19

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)
Overall Status
Recruiting
CT.gov ID
NCT05096858
Collaborator
(none)
120
Enrollment
1
Location
31
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

DM2 is a major comorbidity of COVID-19. It has been observed that subjects with DM2 require more medical interventions, have a significantly higher mortality (7.8% versus 2.7%) and injuries of multiple organs that the individuals not diabetics.

In situations of glycemic variability, phenomena of oxidative stress and activation of protein kinase C can be initiated , through the release of pro-inflammatory cytosines , which could induce microvascular damage .Patients with diabetes and COVID-19 were shown to be more likely to develop serious or critical illness with more complications, and to have higher incidence rates of antibiotic therapy, non-invasive and invasive mechanical ventilation, and death (11.1% vs. 4.1%).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of the Effect of Continuous Glucose Monitorization on Glycemic Variability and Insulin's Prescription in Hospitalized Patients With COVID-19
    Actual Study Start Date :
    Jun 1, 2020
    Anticipated Primary Completion Date :
    Aug 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Glucose variability [For up to two weeks, during hospitalization]

      Percentage of time within the ADA recommended range

    2. Insulin use [For up two weeks, during hospitalization]

      Average daily UI of insulin per patient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Confirmed COVID-19 pneumonia

    • Diabetes mellitus

    Exclusion Criteria:
    • Less than 3 days of hospital care

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institute of Medical Sciences and Nutrition Salvador Zubiran Mexico City Mexico 14080

    Sponsors and Collaborators

    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Investigators

    • Principal Investigator: ALFONSO GULIAS HERRERO, INCMNSZ

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    ClinicalTrials.gov Identifier:
    NCT05096858
    Other Study ID Numbers:
    • 3066
    First Posted:
    Oct 27, 2021
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jun 8, 2022