Continuous Glucose Monitoring System: Accuracy and Progno... | NCT07108179

Studies
Continuous Glucose Monitoring System: Accuracy and Prognostic Value in Critically Ill Patients

NCT07108179

Sponsor

Sinocare

Status

Enrolling by invitation

Last Update Posted

Aug 6, 2025Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Critically Ill Patients

Interventions

Continuous Glucose Monitoring (CGM) System

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2025Actual

Primary Completion Date

Aug 2025Estimated

Completion Date

Sep 2025Estimated

First Submitted Date

Jul 25, 2025

First Submission Date that Met QC Criteria

Jul 31, 2025

First Posted Date

Aug 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2025

Last Update Posted Date

Aug 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Whether diabetic or non-diabetic patients, blood glucose management during ICU hospitalization is essential. This study aims to evaluate the accuracy of the iCan Continuous Glucose Monitoring (CGM) System for detecting blood glucose levels in ICU patients, as well as its value in prognostic evaluation, to provide reference for blood glucose management in critically ill patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous Glucose Monitoring (CGM) System	Device	Continuous Glucose Monitoring (CGM) System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy	"Comparison between arterial blood gas analysis glucose values and CGM values at the same time"	Up to eight days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years; gender not limited.
Expected ICU (Intensive Care Unit) stay ≥ 48 hours.
Patients requiring frequent blood gas monitoring in the ICU.

Exclusion Criteria:

The patient or their family refuses to use CGM for blood glucose monitoring.
Patients with adverse skin conditions (such as rash, active inflammation, etc.) in the device placement area, or those requiring emergency surgical intervention in that area.
Patients who need to undergo computed tomography (CT), X-ray, or magnetic resonance imaging (MRI) scans on the device placement area during the study period.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Continuous glucose monitoring system		Changsha	changsha		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000095583	Continuous Glucose Monitoring
D016503	Drug Delivery Systems

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided