Use of Continuous Glucose Monitors in Coronavirus Disease 2019 ICU and Potential Inpatient Settings

NCT05343624 | Completed Results FDA Device

• 1 other identifier: 20200558
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to improve glycemic control in inpatient/ICU settings using real- time continuous glucose monitors (CGM) data for insulin titration. It may help reduce Coronavirus disease 2019 patient contact with healthcare workers as well.

Conditions

Covid19; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Time in Range

  Percentage of time spent in target glucose range of 140-180mg/dL

  14 days

Secondary Outcomes (2)

• Number of Days CGM Worn

  14 days

• Hypoglycemia

  14 days

Study Arms (1)

CGM Arm

OTHER

continuous glucose meter is placed on the abdomen

Device: continuous glucose monitoring

Interventions

continuous glucose monitoring DEVICE

Use of continuous glucose monitoring in inpatient and ICU settings

CGM Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronavirus disease 2019 tested positive patient
• Age over 18 years
• Admitted to Coronavirus disease 2019 specific ICU, with possible transfer to inpatient unit when stable
• Patients with known or acquired Type 1 or Type 2 Diabetes requiring insulin therapy during admission

You may not qualify if:

• In state of active diabetic ketoacidosis (DKA) at time of enrollment
• Two or more vasopressors in use at time of sensor placement
• Unable to use at predetermined sensor site based on assessment of skin health

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

COVID-19; Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Dr. Tanureet Arora
• Organization: University Hospitals Cleveland Medical Center

Tanureet.Arora@UHhospitals.org

(440)892-6424

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: April 25, 2022
• Study Start: June 18, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 10, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)