Remote Continues Glucose Monitoring During the COVID-19 Pandemic in Quarantined Hospitalized Patients

Not Applicable

Completed

• Conditions: Infection; Diabetes; Covid-19

• Registration Number: NCT04430608
• Lead Sponsor: Nordsjaellands Hospital

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.

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 Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-25
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-12
• Primary Completion: 2021-02-25
• Study Completion: 2021-04-25
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Glucose variations during hospitalization	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.
Saved patient-personnel contacts related to blood glucose measurements.	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.
Blood glucose lowering interventions	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.
CGM sensor performance	1-2 weeks	Number of techincal errors during the sensors lifetime.
Course of hospital stay.	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).

Trial Locations

Locations (1)

Nordsjællands Hospital; 🇩🇰 Hillerød, Denmark