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.
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.
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.
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
Nordsjællands Hospital
Hillerød, Denmark
Investigator: Peter L. Kristensen, MD, ph.D
Contact: 004548294829
peter.lommer.kristensen.01@regionh.dk
Carina Klarskov, MD
004548294829
carina.kirstine.klarskov@regionh.dk
Peter L. Kristensen, MD, ph.D
004548294829
peter.lommer.kristensen.01@regionh.dk
Peter L. Kristensen, MD, ph.D, Principal Investigator
Nordsjællands Hospital