Continuous Glucose Monitoring in the Intensive Care Unit | NCT06190808

Studies
Continuous Glucose Monitoring in the Intensive Care Unit

NCT06190808

Sponsor

University of Massachusetts, Worcester

Status

Completed

Last Update Posted

Jul 31, 2025Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Dexcom G7 Continuous Glucose Monitor

Countries

United States

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

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2024Actual

Primary Completion Date

Jul 25, 2025Actual

Completion Date

Jul 25, 2025Actual

First Submitted Date

Dec 7, 2023

First Submission Date that Met QC Criteria

Dec 19, 2023

First Posted Date

Jan 5, 2024Actual

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 28, 2025

Last Update Posted Date

Jul 31, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the proposed clinical trial is to study the use of the Dexcom G7 continuous glucose monitor (CGM) within the intensive care unit (ICU) environment. The overall goal is to validate the accuracy and practicality of the Dexcom G7 when used to assess glycemia in critically ill patients.

Detailed Description

The specific goals are 1) to work with intensive care unit (ICU) staff, in a respiratory ICU setting, to determine how best to place and maintain Dexcom G7 continuous glucose monitors (CGMs) on patients and how to place recording devices and chargers in that environment, 2) download CGM readings to the Dexcom Dashboard in an analyzable format, and 3) to compare simultaneous CGM readings with glucose measurements obtained in the course of routine care as recorded in the electronic medical record. The primary analytical goal is the correlation of CGM glucose measurements with those obtained in the course of routine care. A secondary goal is to determine the frequency of device malfunctions that occur either as a result of device failure (e.g. it falls off) or adverse events (e.g. removal due to skin irritation).

Study subjects will be patients admitted to the 6-ICU UMass Memorial Medical Center (UMMMC) University Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized. All enrolled volunteers will have a Dexcom G7 CGM place on the skin according to manufacturer's specifications. The devices will remain in place for 10 days or until discharge from the ICU

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	All members of the arm will have a CGM place and glucose concentration downloaded.	Diagnostic Test: Dexcom G7 Continuous Glucose Monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexcom G7 Continuous Glucose Monitor	Diagnostic Test	Continuous glucose monitor	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clarke Error Grid	Traditional comparison of glucose concentration results obtained by standard test methods and by newer method	6 months
Mean Absolute Relative Difference (MARD).	Concordance of glucose concentration results obtained by standard test methods with those obtained by a continuous glucose monitoring device	6 months

Secondary Outcomes

Measure	Description	Time Frame
Unplanned event frequency	Number of occurrences per patient of device failure or or unforeseen device removal	6 months
Adverse event nature and frequency	Number of occurrences per patient of device-associated infection, pain, or skin irritation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Campus medical intensive care unit for any reason who have known diabetes or who are hyperglycemic (blood glucose concentration ≥200 mg/dL) with diabetes that was previously undiagnosed or unrecognized.

Persons with either type 1 or type 2 diabetes.
Persons of either sex.
Persons of any age over 18.
Persons able to give informed consent or cognitively impaired adults whose legally authorized representative (LAR) can give informed consent.
English or Spanish speaking adults.

Exclusion Criteria:

Persons unable to provide informed consent.
Cognitively impaired persons whose LAR declines to provide informed consent.
Patients receiving hydroxyurea, which interferes with sensor function.
Patients receiving high dose acetaminophen (> 4 gm/day), which interferes with sensor function.
Anasarca affecting preferred areas for device placement (arm, upper buttocks, or thigh), which may interfere with sensor accuracy.
Severe cachexia with absence of subcutaneous fat at preferred sensor placement sites, which might interfere with sensor accuracy.
Persons who are pregnant.
Prisoners.

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
John P Mordes, MD	UMass Chan Medical School	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UMass Memorial Medical Center		Worcester	Massachusetts	01605	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study design and deidentified aggregate glucose concentration data will be shared. No individual patient data will be shared.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

One year

Access Criteria

Publication

URL

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 5, 2026			May 29, 2026	4

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D007003	Hypoglycemia

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

Intervention Model Description

Hyperglycemic patients admitted to an intensive care unit will have blood glucose concentration measured using current standard-of-care tests (fingerstick determinations and laboratory assays). Study participants will bel be asked to volunteer to permit concurrent glucose measurement using a Dexcom G7 continuous glucose monitor in order to determine the accuracy and feasibility of the latter. Only standard glucose measurements will be used for patient management.