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

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ClinicalTrials.gov Identifier: NCT04385862
Recruitment Status : Withdrawn (Sponsor problem of delivering material)
First Posted : May 13, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Study Description
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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.


Condition or disease
Continuous Glucose Monitoring

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Use of a Continuous Glucose Monitoring System (Dexcom G6) in Hospitalized Patients for Acute Care
Estimated Study Start Date : July 27, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 11, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To assess the validity of the Dexcom G6 CGM system measurements in IV insulin therapy patients hospitalized in the intensive care unit of the CHUM compared to the blood glucose measurements made using the Accuchek Inform II glucometer [ Time Frame: 3-10 days ]

Secondary Outcome Measures :
  1. To assess the validity of the Dexcom G6 CGM system measurements compared to the different methods of glucose measurement and different blood sources in intensive care [ Time Frame: 3-10 days ]

    Comparing the Dexcom G6 CGM system measurements to the different methods of glucose measurement and different blood sources in intensive care:

    Portable glucometer, on capillary blood, Portable glucometer, on venous or arterial blood, Central laboratory analyzes on venous or arterial blood


  2. Assess the validity of the Dexcom G6 CGM system measurements compared to the glucometer, according to the glucose concentrations measured: <4.0 mmol / L 4.0 - 10.0 mmol / L > 10.0 mmol / L [ Time Frame: 3-10 days ]
  3. To assess the validity of the Dexcom G6 CGM system measurements compared to the glucometer, according to the rate of change of glucose. [ Time Frame: 3-10 days ]
  4. Measure the influence of the patient's clinical characteristics (age, sex, weight, presence of diabetes, septic state and need for organ supports), and biochemical (hematocrit, acidosis, renal function) on the validity of CGM values. [ Time Frame: 3-10 days ]
  5. Assess the obstacles to the integration of the use of the CGM in the intensive care unit, namely the technical problems encountered and remote data management. [ Time Frame: 3-10 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults hospitalized at the intensive care of the Centre hospitalier de l'Université de Montréal (CHUM), receiving an intravenous insulin infusion for more than 72 hours.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385862


Locations
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Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Canada
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD Institut de recherches cliniques de Montréal
More Information
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04385862    
Other Study ID Numbers: CGM-SI
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Continuous glucose monitoring
Intravenous insulin
Diabetes
Insulin
Glucose measurements