Characteristics of Blood Glucose Variability in Patients With Type 2 Diabetes Mellitus and COVID-19
NCT ID: NCT06156137
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-08-01
2024-08-31
Brief Summary
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The goal of this observational study is to investigate the characteristics of blood glucose variability in patients with type 2 diabetes mellitus (T2DM) complicated with novel coronavirus pneumonia (NCP) and its effect on disease progression and prognosis.
The main question it aims to answer is:After fully lifting coronavirus disease 2019 (COVID-19) pandemic control measures in mainland China in 12/2022, the incidence of COVID-19 has increased markedly, making it difficult to meet the general time-in-range (TIR) requirement. Therefore, the investigators investigated a more clinically practical TIR threshold and examined its association with the prognosis of COVID-19 patients with type-2 diabetes.
participant population/health conditions：Participants were equipped with isCGM sensors on admission.
According to the outcome, the patients were divided into favorable outcome group and composite outcome group.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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adverse outcomes
The composite adverse outcomes are defined as either a \>20-day length of stay intensive care unit admission, mechanical ventilation use, or death.
Glucose variability
A retrospective cohort study was conducted in hospitalized T2DM patients with NCP who were discharged or died. Clinical data and blood glucose variability parameters were collected by computer blood glucose monitoring technology (CGM). Time in range (TIR), time above target range (TAR), time below target range (TBR), mean amplitude of glycemic excursions (MAGE), absolute mean daily difference (MODD) and other indicators were used.
favorable outcomes
favorable outcomes the patient are defined as discharged with improvement and hospitalization less than 20 days.
Glucose variability
A retrospective cohort study was conducted in hospitalized T2DM patients with NCP who were discharged or died. Clinical data and blood glucose variability parameters were collected by computer blood glucose monitoring technology (CGM). Time in range (TIR), time above target range (TAR), time below target range (TBR), mean amplitude of glycemic excursions (MAGE), absolute mean daily difference (MODD) and other indicators were used.
Interventions
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Glucose variability
A retrospective cohort study was conducted in hospitalized T2DM patients with NCP who were discharged or died. Clinical data and blood glucose variability parameters were collected by computer blood glucose monitoring technology (CGM). Time in range (TIR), time above target range (TAR), time below target range (TBR), mean amplitude of glycemic excursions (MAGE), absolute mean daily difference (MODD) and other indicators were used.
Eligibility Criteria
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Inclusion Criteria
2. Patients with mild, moderate, severe and critical COVID-19 in accordance with the guidelines of "Diagnosis and Treatment of novel coronavirus Infection (Trial version 10)"
3. Patients receiving CGM or peripheral blood glucose monitoring during hospitalization
Exclusion Criteria
2. Non-NCP and non-T2DM patients
3. Patients who did not receive CGM or peripheral blood glucose monitoring
18 Years
100 Years
ALL
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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kuanxiao Tang
chief physician
Principal Investigators
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Kuanxiao Tang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Locations
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Qilu hospital of shandong university
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Kuanxiao Tang, M.D.
Role: primary
Other Identifiers
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kuanxiao Tang
Identifier Type: -
Identifier Source: org_study_id