Clincosm LogoSign in Get a demo

Analysis of Relevant Influencing Factors of Glycemic Control in Patients With Diabetes

Sponsor
Nanjing First Hospital, Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05854862
Collaborator
(none)
10,000
Enrollment
1
Location
125
Anticipated Duration (Months)
80
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims at the analysis of relevant influencing factors of glycemic control in patients with diabetes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Analysis of Relevant Influencing Factors of Glycemic Control in Patients With Diabetes
    Actual Study Start Date :
    Aug 1, 2013
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. HbA1c [day 1]

      the glycosylated hemoglobin level of patients

    2. TIR [day 1-14]

      time in range observed using continuous glucose monitoring

    Secondary Outcome Measures

    1. MBG [day 1-14]

      mean blood glucose

    2. MAGE [day 1-14]

      Mean amplitude of glycemic excursion assessed by continuous glucose monitoring

    3. SD [day 1-14]

      the standard deviation of mean glucose

    4. Incidence of hypoglycemia [day 1-14]

      Incidence of hypoglycemia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients aged 18-90 years with diabetes and the diagnostic criteria of diabetes is according to the World Health Organization in 1999.

    Exclusion Criteria:

    Patients with stress hyperglycaemia. Patients with severe systemic disease. Patients treated with systemic glucocorticoids within the last three months. Patients without any records about HbA1c, CGM and SMBG.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanjing First hospital Nanjing Jiangsu China 210006

    Sponsors and Collaborators

    • Nanjing First Hospital, Nanjing Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nanjing First Hospital, Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT05854862
    Other Study ID Numbers:
    • KY20220124-01
    First Posted:
    May 11, 2023
    Last Update Posted:
    May 11, 2023
    Last Verified:
    Jan 1, 2023
    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

    Study Results

    No Results Posted as of May 11, 2023