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

Covid-19 Clinical Trial

— CGM-ISO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430608
• Other study ID #: H-20025305
• Status: Completed
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: April 25, 2021

Study information

• Verified date: May 2020
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Diabetes
• Infection

Intervention

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.

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time In Range (TIR) for blood glucose	TIR is presented in percent of time in which the participants' glucose values are in different glucose ranges.	1-2 weeks
Secondary	Saved patient-personnel contacts related to blood glucose measurements.	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
Secondary	Glucose variations during hospitalization	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
Secondary	Blood glucose lowering interventions	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
Secondary	CGM sensor performance	Number of techincal errors during the sensors lifetime.	1-2 weeks
Secondary	Course of hospital stay.	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