Clinical trial NCT04430608: Remote Continues Glucose Monitoring During the COVID-19 Pandemic in Quarantined Hospitalized Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Covid-19
Infection
Keywords: endocrinology
diabetes
quarentine
isolation
CGM
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized 1:1 to either CGM or Fingerprick group
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Time In Range (TIR) for blood glucose
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Saved patient-personnel contacts related to blood glucose measurements.
timeFrame: 1-2 weeks
measure: Glucose variations during hospitalization
timeFrame: 1-2 weeks
measure: Blood glucose lowering interventions
timeFrame: 1-2 weeks
measure: CGM sensor performance
timeFrame: 1-2 weeks
measure: Course of hospital stay.
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
Study officials:
affiliation: Nordsjællands Hospital
name: Peter L. Kristensen, MD, ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klarskov CK, Windum NA, Olsen MT, Dungu AM, Jensen AK, Lindegaard B, Pedersen-Bjergaard U, Kristensen PL. Telemetric Continuous Glucose Monitoring During the COVID-19 Pandemic in Isolated Hospitalized Patients in Denmark: A Randomized Controlled Exploratory Trial. Diabetes Technol Ther. 2022 Feb;24(2):102-112. doi: 10.1089/dia.2021.0291. Epub 2022 Jan 4.
citation: Klarskov CK, Lindegaard B, Pedersen-Bjergaard U, Kristensen PL. Remote continuous glucose monitoring during the COVID-19 pandemic in quarantined hospitalized patients in Denmark: A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Nov 25;21(1):968. doi: 10.1186/s13063-020-04872-4.