COVID-19 PneumoniaNCT06156137
Characteristics of Blood Glucose Variability in Patients With Type 2 Diabetes Mellitus and COVID-19
An observational study of COVID-19 Pneumonia and Type2diabetes, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19 Pneumonia, Type2diabetes
- What is being tested?
- Glucose variability
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- 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)"
- Patients receiving CGM or peripheral blood glucose monitoring during hospitalization
Who cannot join
- Cases with incomplete data
- Non-NCP and non-T2DM patients
- Patients who did not receive CGM or peripheral blood glucose monitoring
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hospital of shandong university
Jinan, Shandong, 250012
Kuanxiao Tang, M.D., 18560082261, tangkx_ql@hotmail.com
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- COVID-19 Pneumonia, Type2diabetes
- Being tested
- Glucose variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose variabilityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Glucose variability | |
| favorable outcomes | favorable outcomes the patient are defined as discharged with improvement and hospitalization less than 20 days. Receives: Other: Glucose variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite adverse outcomes
The composite adverse outcomes were defined as either a >20-day length of stay16 intensive care unit admission, mechanical ventilation use, or death.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Aug 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kuanxiao Tang, Qilu Hospital of Shandong University
- Investigators
- Kuanxiao Tang, M.D., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156137
- Sponsor's protocol ID
- kuanxiao Tang
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06156137
- Acronym / sponsor ID
- kuanxiao Tang
- Conditions
- COVID-19 Pneumonia, Type2diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adverse outcomes | – | Other: Glucose variabilityThe composite adverse outcomes are defined as either a >20-day length of stay intensive care unit admission, mechanical ventilation use, or death. |
| favorable outcomes | – | Other: Glucose variabilityfavorable outcomes the patient are defined as discharged with improvement and hospitalization less than 20 days. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
- 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)"
- Patients receiving CGM or peripheral blood glucose monitoring during hospitalization
Key exclusion criteria (3 listed)
- Cases with incomplete data
- Non-NCP and non-T2DM patients
- Patients who did not receive CGM or peripheral blood glucose monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose variabilityA 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. | Other | adverse outcomes, favorable outcomes |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuanxiao Tang, M.D. principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Type2diabetes, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuanxiao Tang, M.D. (18560082261, tangkx_ql@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite adverse outcomes (time frame: Up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.