DiabetesNCT03629704
Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients
An observational study of Diabetes, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
This study is to evaluate the glycemic variation using Continuous Glucose Monitoring System in patients in the intensive care unit, find out the occult hypoglycemia, and investigate the relationship between glycemic variation, especially the incidence of hypoglycemia and prognosis of patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- What is being tested?
- Continuous Glucose Monitoring System
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 3 Aug 2018to 31 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted into care unit of Nanjing First Hospital.
Who may be able to join
- Patients with history of diabetes;
- Patients without history of diabetes, but their random blood glucose≧7.8mmol/L or fast blood glucose≧5 mmol/L;
- The patients hospitalized in care unit (ICU or CCU) for more than 48 hours.
Who cannot join
- Patient had history of mental illness;
- Patient was not suitable for using the CGMS;
- blood glucose > 22.2 mmol/L at admission.
Trial locations and contacts
No sites are listed yet.
About this study
This study is to evaluate the glycemic variation using Continuous Glucose Monitoring System in patients in the intensive care unit, find out the occult hypoglycemia, and investigate the relationship between glycemic variation, especially the incidence of hypoglycemia and prognosis of patients. Meanwhile, the inflammatory factors were measured and the relationship between inflammatory factors and glycemic variation.
- Conditions
- Diabetes
- Being tested
- Continuous Glucose Monitoring System
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring SystemDiagnostic test
Continuous Glucose Monitoring System for 72 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day prognosis
Case-fatality at 28 days
Measured: 0-28 days
Secondary outcomes (5)
Acute Physiology and Chronic Health Evaluation II score
Acute Physiology and Chronic Health Evaluation II score
Measured: 0-28 days
Global registry of acute coronary events risk score
Global registry of acute coronary events risk score
Measured: 0-28 days
Twenty-four-hour mean blood glucose
Twenty-four-hour mean blood glucose assessed by CGM
Measured: 1-4 days
Mean amplitude of glycemic excursion every 24 h
Mean amplitude of glycemic excursion every 24 h assessed by CGM
Measured: 1-4 days
Incidence of hypoglycemia
Incidence of hypoglycemia
Measured: 1-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start3 Aug 2018 (estimated)
- Primary completion29 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianhua Ma, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629704
- Sponsor's protocol ID
- KY20170904-06
- Status last verified
- Jun 2018
- First submitted
- 18 Jun 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03629704
- Acronym / sponsor ID
- KY20170904-06
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 3 Aug 2018 (estimated)
- Primary completion
- 29 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 14 Aug 2018 (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.
This study is to evaluate the glycemic variation using Continuous Glucose Monitoring System in patients in the intensive care unit, find out the occult hypoglycemia, and investigate the relationship between glycemic variation, especially the incidence of hypoglycemia and prognosis of patients. Meanwhile, the inflammatory factors were measured and the relationship between inflammatory factors and glycemic variation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted into care unit of Nanjing First Hospital.
Key inclusion criteria (3 listed)
- Patients with history of diabetes;
- Patients without history of diabetes, but their random blood glucose≧7.8mmol/L or fast blood glucose≧5 mmol/L;
- The patients hospitalized in care unit (ICU or CCU) for more than 48 hours.
Key exclusion criteria (3 listed)
- Patient had history of mental illness;
- Patient was not suitable for using the CGMS;
- blood glucose > 22.2 mmol/L at admission.
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 |
|---|---|---|
| Continuous Glucose Monitoring SystemContinuous Glucose Monitoring System for 72 hours | Diagnostic test | – |
Primary outcome
28 day prognosis
Time frame: 0-28 days
Case-fatality at 28 days
5 secondary outcomes
Acute Physiology and Chronic Health Evaluation II score
Time frame: 0-28 days
Global registry of acute coronary events risk score
Time frame: 0-28 days
Twenty-four-hour mean blood glucose
Time frame: 1-4 days
Mean amplitude of glycemic excursion every 24 h
Time frame: 1-4 days
Incidence of hypoglycemia
Time frame: 1-4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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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.
Jianhua Ma, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Nanjing First Hospital, Nanjing Medical University.
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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Huiqin Li, MD (+8625-5288-7090, lihuiqin496@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day prognosis (time frame: 0-28 days). 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 14 Aug 2018.