Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients

Diabetes Clinical Trial

Official title:

Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03629704
• Other study ID #: KY20170904-06
• Status: Not yet recruiting
• Start date: August 3, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2018
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Huiqin Li, MD
• Phone: +8625-5288-7090
• Email: lihuiqin496[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Meanwhile, the inflammatory factors were measured and the relationship between inflammatory factors and glycemic variation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2018
• Est. primary completion date: December 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with history of diabetes;

2. Patients without history of diabetes, but their random blood glucose?7.8mmol/L or fast blood glucose?5 mmol/L;

3. The patients hospitalized in care unit (ICU or CCU) for more than 48 hours.

Exclusion Criteria:

1. Patient had history of mental illness;

2. Patient was not suitable for using the CGMS;

3. blood glucose > 22.2 mmol/L at admission.

Related Conditions & MeSH terms

• Critical Illness
• Diabetes

Intervention

Diagnostic Test:
• Continuous Glucose Monitoring System
Continuous Glucose Monitoring System for 72 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 day prognosis	Case-fatality at 28 days	0-28 days
Secondary	Acute Physiology and Chronic Health Evaluation II score	Acute Physiology and Chronic Health Evaluation II score	0-28 days
Secondary	Global registry of acute coronary events risk score	Global registry of acute coronary events risk score	0-28 days
Secondary	Twenty-four-hour mean blood glucose	Twenty-four-hour mean blood glucose assessed by CGM	1-4 days
Secondary	Mean amplitude of glycemic excursion every 24 h	Mean amplitude of glycemic excursion every 24 h assessed by CGM	1-4 days
Secondary	Incidence of hypoglycemia	Incidence of hypoglycemia	1-4 days