Accuracy of CGM in the ICU, Compared to Standard of Care | NCT04352907

Studies
Accuracy of CGM in the ICU, Compared to Standard of Care

NCT04352907

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

Jun 2, 2022Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Diabetes

Interventions

Continuous Glucose Sensor

Countries

Canada

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2020Actual

Primary Completion Date

Sep 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Apr 15, 2020

First Submission Date that Met QC Criteria

Apr 15, 2020

First Posted Date

Apr 20, 2020Actual

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

May 31, 2022

Last Update Posted Date

Jun 2, 2022Actual

Name	Class
DexCom, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

To determine the performance of the Dexcom CGM device in comparison to arterial glucose samples.

Detailed Description

The performance of the Dexcom continuous glucose sensor will be compared with the current standard of care which is arterial glucose samples analyzed on a glucose meter. Subjects will be ICU patients receiving intravenous insulin infusions.

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

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous Glucose Sensor	Device	Continuous glucose sensor results will be compared with arterial glucose samples

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Continous Glucose Sensor values (CGM)	CGM will be compared with arterial glucose values	3 to 7 consecutive days

Secondary Outcomes

Measure	Description	Time Frame
Vasopressor Use	10 of the 20 subjects will be on vasopressors and large volume fluid resuscitation	3 to 7 consecutive days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

minimum age 18 years
anticipated to be on an insulin infusion for 3-7 consecutive days
10 of these subjects will be on vasopressors who will be receiving large volume fluid resuscitation

Exclusion Criteria:

subjects not on insulin infusion

Accepts Healthy Volunteers

Yes

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

Subjects in the Intensive Care Unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David M Thompson, MD	Contact	604 875 5996		david.thompson@vch.ca
Barbara J Allan, MHA	Contact	604 875 5997		barbara.allan@vch.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vancouver General Hospital	Recruiting	Vancouver	British Columbia	V5Z 1M9	Canada

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

Type	Date	Date Unknown
Release	Oct 12, 2023
Reset	Apr 11, 2024

Submission Tracking

Estimated Results First Submitted Date

Oct 12, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 12, 2023			Apr 11, 2024

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided