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

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06156137
Collaborator
(none)
200
1
12
16.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Glucose variability

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The composite adverse outcomes [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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qilu hospital of shandong university Jinan Shandong China 250012

Sponsors and Collaborators

  • Qilu Hospital of Shandong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
kuanxiao Tang, chief physician, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT06156137
Other Study ID Numbers:
  • kuanxiao Tang
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Nov 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2023