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

Recruiting

• Conditions: Type2diabetes; COVID-19 Pneumonia
• Interventions: Other: Glucose variability

• Registration Number: NCT06156137
• Lead Sponsor: Qilu Hospital of Shandong University

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.

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 Timeline

• Study Start: 2023-08-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-11-24
• Last Update Submitted: 2023-11-24
• Study First Posted: 2023-12-05
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adverse outcomes	Glucose variability	The composite adverse outcomes are defined as either a \>20-day length of stay intensive care unit admission, mechanical ventilation use, or death.
favorable outcomes	Glucose variability	favorable outcomes the patient are defined as discharged with improvement and hospitalization less than 20 days.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Qilu hospital of shandong university; 🇨🇳 Jinan, Shandong, China