Remote Continues Glucose Monitoring During the COVID-19 Pandemic in Quarantined Hospitalized Patients (CGM-ISO)

April 4, 2024 updated by: Nordsjaellands Hospital

Remote Glucose Monitoring of Patients With Diabetes Quarantined During the COVID-19 Pandemic - a Hospital-Based Randomized Controlled Trial of the Effect of Remote Continuous Glucose Monitoring Compared to Usual Glucose Monitoring

This is a randomized controlled trial of isolated patients with diabetes admitted to Nordsjællands Hospital with or without COVID-19-pneumonia. A continuous glucose monitoring (CGM) based system with transmission of glucose data to a central system is used for remote monitoring of glucose levels and compared to standard finger-prick glucose. Blinded (to patients) CGM is mounted in the finger-prick group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epidemics and pandemics are a constant threat to health care systems globally. This stresses the importance of preparedness for a large amount of hospitalized quarantined patients in isolation, with the extra challenges it brings. The COVID-19 pandemic challenges the Danish health care system in many aspects: An increased number of citizens are expected to be admitted to hospital due to COVID-19 infected pneumonia and this will demand extra workforce resources, extra use of protective equipment (gowns, masks, gloves, etc) and extra time used for taking protective equipment on and off. In concert these extra demands will drain the health care system and any initiative to reduce these challenges is needed.

In this randomized controlled trial, isolated patients with diabetes will be randomized to either standard care fingerprick glucose + blinded CGM or Dexcom G6 only.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hillerød, Denmark, 3400
        • Nordsjællands Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Hospitalized with confirmed COVID-19 infection by real-time PCR or another validated method OR hospitalized with a non-COVID-19 diagnosis AND in isolation at time of inclusion.
  2. A documented clinically relevant history of diabetes or newly discovered during hospitalization.
  3. Written informed consent obtained before any trial related procedures are performed.
  4. Male or female aged over 18 years of age.
  5. Must be able to communicate with the study personnel.
  6. The subject must be willing and able to comply with trial protocol.

Exclusion Criteria:

1. Known hypersensitivity to the band-aid of the Dexcom G6 sensors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fingerprick glucose
Standard care with fingerprick glucose + blinded CGM stratification on COVID-19 status
Device: Dexcom G6

The investigational device is a CGM Dexcom G6. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The device-system consists of a sensor, the Dexcom G6 device/sender, and connects to a smart device like a cellphone. The Dexcom G6 CGM system is probably the most precise system on the market and with no need for daily calibration with finger prick glucose. The Dexcom G6 sensor can last for 10 days without calibration and is approved for diabetes treatment decision making. Dexcom G6 has been extensively tested and is safe and approved even for pregnant women.

The CE Marking confirms that the G6 system meets the Essential Requirements of the Medical Device Directive MDD 93/42/EEC as amended by 2007/47/EC.
Experimental: Open continous glucose monitoring (CGM)
Standard care with fingerprick glucose + un-blinded CGM stratification on COVID-19 status
Device: Dexcom G6

The investigational device is a CGM Dexcom G6. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The device-system consists of a sensor, the Dexcom G6 device/sender, and connects to a smart device like a cellphone. The Dexcom G6 CGM system is probably the most precise system on the market and with no need for daily calibration with finger prick glucose. The Dexcom G6 sensor can last for 10 days without calibration and is approved for diabetes treatment decision making. Dexcom G6 has been extensively tested and is safe and approved even for pregnant women.

The CE Marking confirms that the G6 system meets the Essential Requirements of the Medical Device Directive MDD 93/42/EEC as amended by 2007/47/EC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time In Range (TIR) for blood glucose
Time Frame: 1-2 weeks
TIR is presented in percent of time in which the participants' glucose values are in different glucose ranges.
1-2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saved patient-personnel contacts related to blood glucose measurements.
Time Frame: 1-2 weeks
Saved patient-personnel contacts related to blood glucose measurements, incl. time healthcare providers spent on diabetes related tasks and PPE related tasks, during the patients' hospitalization.
1-2 weeks
Glucose variations during hospitalization
Time Frame: 1-2 weeks
Additional glucose outcomes based on data from Dexcom G6 are for example Time Above Range (TAR), Time Below Range (TBR), average glucose, variance in glucose (CV), etc.
1-2 weeks
Blood glucose lowering interventions
Time Frame: 1-2 weeks
That is: Tablet-based and insulin-based regimens and number of times that sliding scale insulin (including dose of insulin) has been administered for each patient.
1-2 weeks
CGM sensor performance
Time Frame: 1-2 weeks
Number of techincal errors during the sensors lifetime.
1-2 weeks
Course of hospital stay.
Time Frame: 1-2 weeks
Hospital death (yes/no), length of stay at hospital, need for respiratory support (yes/no) and intensive care (yes/no), recovered vs. fatal (death within 60 days from admission).
1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordsjaellands Hospital

Investigators

  • Principal Investigator: Peter L. Kristensen, MD, ph.D, Nordsjællands Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2020

Primary Completion (Actual)

February 25, 2021

Study Completion (Actual)

April 25, 2021

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20025305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Undecided, will be updated

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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