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

NCT04430608 | Completed DMC FDA Device

• 1 other identifier: H-20025305
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Covid-19; Infection

Keywords

endocrinology; diabetes; quarentine; isolation; CGM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Saved patient-personnel contacts related to blood glucose measurements.

  1-2 weeks

• Glucose variations during hospitalization

  1-2 weeks

• Blood glucose lowering interventions

  1-2 weeks

• CGM sensor performance

  1-2 weeks

• Course of hospital stay.

  1-2 weeks

Study Arms (2)

Fingerprick glucose

OTHER

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

Device: Dexcom G6

Open continous glucose monitoring (CGM)

EXPERIMENTAL

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

Device: Dexcom G6

Interventions

Dexcom G6 DEVICE

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.

Fingerprick glucose; Open continous glucose monitoring (CGM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A documented clinically relevant history of diabetes or newly discovered during hospitalization.
• Written informed consent obtained before any trial related procedures are performed.
• Male or female aged over 18 years of age.
• Must be able to communicate with the study personnel.
• The subject must be willing and able to comply with trial protocol.

You may not qualify if:

• \. Known hypersensitivity to the band-aid of the Dexcom G6 sensors

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (2)

• 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.

  PMID: 34524009 DERIVED

• 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.

  PMID: 33239100 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; COVID-19; Infections

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Peter L. Kristensen, MD, ph.D

  Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomized 1:1 to either CGM or Fingerprick group

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 12, 2020
• Study Start: May 25, 2020
• Primary Completion: February 25, 2021
• Study Completion: April 25, 2021
• Last Updated: April 5, 2024

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)