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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04430608
Recruitment Status : Unknown
Verified May 2020 by Nordsjaellands Hospital.
Recruitment status was:  Recruiting
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Nordsjaellands Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Covid-19 Infection Device: Dexcom G6 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized 1:1 to either CGM or Fingerprick group
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : April 25, 2021
Estimated Study Completion Date : May 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. CGM sensor performance [ Time Frame: 1-2 weeks ]
    Number of techincal errors during the sensors lifetime.

  5. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04430608


Contacts
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Contact: Carina Klarskov, MD 004548294829 carina.kirstine.klarskov@regionh.dk
Contact: Peter L. Kristensen, MD, ph.D 004548294829 peter.lommer.kristensen.01@regionh.dk

Locations
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Denmark
Nordsjællands Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Peter L. Kristensen, MD, ph.D    004548294829    peter.lommer.kristensen.01@regionh.dk   
Contact: Carina Klarskov, MD    004548284829    carina.kirstine.klarskov@regionh.dk   
Sponsors and Collaborators
Nordsjaellands Hospital
Investigators
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Principal Investigator: Peter L. Kristensen, MD, ph.D Nordsjællands Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT04430608    
Other Study ID Numbers: H-20025305
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Undecided, will be updated

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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
Keywords provided by Nordsjaellands Hospital:
endocrinology
diabetes
quarentine
isolation
CGM
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases