NCT03629704

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 3, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 14, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

June 18, 2018

Last Update Submit

August 12, 2018

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • 28 day prognosis

    Case-fatality at 28 days

    0-28 days

Secondary Outcomes (5)

  • Acute Physiology and Chronic Health Evaluation II score

    0-28 days

  • Global registry of acute coronary events risk score

    0-28 days

  • Twenty-four-hour mean blood glucose

    1-4 days

  • Mean amplitude of glycemic excursion every 24 h

    1-4 days

  • Incidence of hypoglycemia

    1-4 days

Interventions

Continuous Glucose Monitoring SystemDIAGNOSTIC_TEST

Continuous Glucose Monitoring System for 72 hours

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted into care unit of Nanjing First Hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient had history of mental illness;
  • Patient was not suitable for using the CGMS;
  • blood glucose \> 22.2 mmol/L at admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Jianhua Ma, MD

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqin Li, MD

CONTACT

+8625-5288-7090lihuiqin496@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

August 14, 2018

Study Start

August 3, 2018

Primary Completion

December 29, 2018

Study Completion

December 31, 2018

Last Updated

August 14, 2018

Record last verified: 2018-06