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

Nordsjaellands Hospital

Status: Completed

Conditions: Infection; Diabetes; Covid-19

Treatments: Device: Dexcom G6

Study type: Interventional

Funder types: Other

Identifiers

NCT04430608

H-20025305

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Fingerprick glucose

Other group

Description:

Standard care with fingerprick glucose + blinded CGM stratification on COVID-19 status

Treatment:

Device: Dexcom G6

Open continous glucose monitoring (CGM)

Experimental group

Description:

Standard care with fingerprick glucose + un-blinded CGM stratification on COVID-19 status

Treatment:

Device: Dexcom G6