The Use of a Continuous Glucose Monitoring System (Dexcom G6) in Hospitalized Patients for Acute Care

NCT ID: NCT04385862

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2021-01-11

Brief Summary

The state of a coronavirus disease pandemic (COVID-19) was declared by the World Health Organization on March 11, 2020. Hospitalized patients receiving intravenous (IV) insulin therapy have been identified in the hospital setting as a group that places health care workers at high risk of contamination. Indeed, the many capillary blood glucose measurements required to adjust the IV insulin doses involve direct contact with the patient. It is generally recommended to measure blood sugar every 1 to 2 hours with an IV insulin infusion. Ensuring a working method allowing optimal monitoring of patients' blood sugar levels while limiting the risk of contamination of health professionals is therefore to be preferred.

Continuous Glucose Monitoring (CGM) systems are minimally invasive devices that allow you to get a blood glucose measurement every 5 to 15 minutes, and some devices allow you to access your blood sugar profile without having to be in contact with the patients. These devices are approved, validated, and widely used in diabetic ambulatory populations. The principle is based on a measurement of glucose in the interstitial fluid under the skin.

DEXCOM G6 is the only device currently approved in Canada that does not require calibration using a capillary blood glucose level or contact with the patient for remote data transmission. A sensor installed on the skin makes it possible to measure blood sugar from the interstitial fluid. A transmitter installed on the sensor sends the data to a receiver which can be remote from the patient (up to 6 meters). Its use in an acute care setting, however, is not approved in Canada. However, Health Canada issued an emergency order on April 25, 2020 allowing the use of Dexcom G6 in hospitals during the COVID-19 pandemic.

The CGM offers several potential advantages compared to the capillary glycemia currently used to ensure the follow-up of insulin-treated patients thanks to the real-time measurement of the glycemia and their transmission at a distance. In intensive care the SGC has the potential:

• For staff to limit contact with patients infected with COVID-19 (reduction in the use of personal protective equipment and contamination) while ensuring close monitoring of blood glucose levels for the adjustment of insulin therapy.
• For patients to reduce the discomfort related to multiple capillary blood sugar levels and possibly better detection of hypoglycaemia

This study is the first step in a 2-phase research program, the ultimate goal of which is to use a CGM to replace capillary blood glucose in hospitals to adjust intravenous (IV) insulin therapy.

The objective of the first study presented in this protocol is to validate the use of a continuous glucose monitoring system (CGM) for glycemic monitoring in patients hospitalized in intensive care.

Conditions

Continuous Glucose Monitoring

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥ 18 years old) admitted to intensive care at the CHUM
• IV insulin infusion scheduled for a planned duration of at least 72 hours.

Exclusion Criteria

• Magnetic resonance imaging planned, which would require removing the sensor less than 72 hours after installation;
• Patient whose death is expected within the next 72 hours.
• Patient included in the LOVIT study due to the theoretical risk of interference with blood glucose measurements with the CMS device

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rémi Rabasa-Lhoret, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de recherches cliniques de Montréal

Locations

Centre Hospitalier de l'Université de Montréal

Montreal, , Canada

Countries

Canada

Other Identifiers

CGM-SI

Identifier Type: -

Identifier Source: org_study_id