Characteristics of Blood Glucose Variability in Patients With Type 2 Diabetes Mellitus and COVID-19

November 24, 2023 updated by: kuanxiao Tang, Qilu Hospital of Shandong University

Characteristics of Blood Glucose Variability in Patients With Type 2 Diabetes Mellitus Complicated With COVID-19 and Its Effect on the Prognosis of the Disease

using intermittently scanned continuous glucose monitoring (isCGM) to clarify the characteristics of blood glucose variability parameters in T2DM patients with NCP, guide the formulation of reasonable clinical treatment measures and make timely and reasonable adjustments, improve the prognosis of patients, shorten the length of hospital stay, and reduce medical costs.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patients with T2DM all had moderate or severe cases and were diagnosed according to the guidelines issued by the World Health Organization (WHO), meeting at least the following criteria: positive COVID-19 RNA PCR and characteristic imaging manifestations of novel coronavirus pneumonia.

Description

Inclusion Criteria:

  1. All patients met the diagnostic criteria of type 2 diabetes mellitus in "Chinese Guidelines for the Prevention and treatment of type 2 Diabetes Mellitus (2020 edition)" formulated by the Chinese Diabetes Society of the Chinese Medical Association, and were previously diagnosed with type 2 diabetes mellitus and newly diagnosed with type 2 diabetes mellitus after admission
  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:

  1. Cases with incomplete data
  2. Non-NCP and non-T2DM patients
  3. Patients who did not receive CGM or peripheral blood glucose monitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The composite adverse outcomes
Time Frame: Up to 3 weeks
The composite adverse outcomes were defined as either a >20-day length of stay16 intensive care unit admission, mechanical ventilation use, or death.
Up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Principal Investigator: Kuanxiao Tang, M.D., Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

November 24, 2023

First Posted (Estimated)

December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kuanxiao Tang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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