Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study

Diabetes Mellitus Clinical Trial

Official title:

Validation of the Accuracy of Continuous Glucose Monitoring Using the Dexcom G7 in Patients With Diabetes in Situations With Circulatory Impairment. A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297850
• Other study ID #: WARD-Glucose Validation v.2.2
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: Casper Pedersen, MD
• Phone: 004526712696
• Email: casper.pedersen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment.

The main questions it aims to answer are:

• Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment?

Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days.

Description:

This is a prospective observational study on patients living with diabetes who a) undergo surgery at the Department of Vascular Surgery, Rigshospitalet, Denmark and the Surgical Department and Department of Orthopedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital, Denmark, or b) are admitted to the intensive care unit (ICU) at Bispebjerg and Frederiksberg Hospital with circulatory impairment.

The study aim is to investigate the accuracy of the Dexcom G7 CGM in patients with diabetes undergoing surgery and in patients at the ICU with circulatory impairment. The glucose readings will be compared to standard practice with POC blood glucose measurements.

Included patients will be asked to wear the CGM device Dexcom G7 for up 10 days.

The study will include 60 patients

This study is part of an overall project that aims to investigate the use of CGM and continuous wireless monitoring of vital signs in patients with diabetes undergoing major surgery. Using this technology, postoperative complications including dysglycaemia can potentially be detected and treated earlier thus improving the perioperative care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Medical history with diabetes mellitus requiring antidiabetic drugs

• Age =18 years

• Surgery with estimated surgery time =45 minutes with expected stay for at least one night in hospital postoperatively OR

• Admission to the ICU with Circulatory impairment defined as need of vasopressors to maintain a mean arterial pressure (MAP) =65 mmHg and peripheral perfusion index <1.5

Exclusion Criteria:

• Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area

• Contraindications to skin puncture (arteriovenous fistula for dialysis, post-mastectomy lymphoedema etc)

• Known allergy to plaster used in the CGM device

Related Conditions & MeSH terms

• Circulatory; Complications
• Diabetes Mellitus
• Dysglycemia
• Perioperative Complication

Intervention

Device:
• Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)
A CGM device placed on the posterior aspect of the upper arm in which a sensor placed in the skin registers glucose values. Via Bluetooth, these readings are sent to a receiver near the patient every 5 minutes. The CGM system can alert when deviating glucose levels, but will for this observational study be blinding to patients and clinical staff. Thus, the patients' diabetic care will rely on standard practice.

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital	Copenhagen	The Capital Region Of Denmark
Denmark	Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet	Copenhagen	The Capital Region Of Denmark
Denmark	Department of Orthopaedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital	Copenhagen	The Capital Region Of Denmark
Denmark	Surgical department, Bispebjerg and Frederiksberg Hospital,	Copenhagen	The Capital Region Of Denmark

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg	Rigshospitalet, Denmark, Steno Diabetes Center Copenhagen, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse clinical outcomes	Occurrence and severity of adverse clinical outcomes until 30 days postoperatively according to a set of predefined diagnoses and/or definitions, assessed by physicians at the research unit	30 days postoperative
Other	Readmission	Occurrence of readmission until 6 months postoperatively, assessed by physicians at the research unit	6 months postoperatively
Other	Mortality	Occurrence of death until 6 months postoperatively, assessed by physicians at the research unit	6 months postoperatively
Primary	Agreement between glucose	Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements (matched pairs within 5 minutes) in the perioperative setting	Perioperatively
Secondary	Agreement between glucose readings when at low glucose levels	Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at low glucose levels (<3.9 mmol/l in the POC blood glucose measurement)	Perioperatively
Secondary	Agreement between glucose readings when at normal glucose levels	Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at normal glucose levels (>3.9-10.0 mmol/l in the POC blood glucose measurement)	Perioperatively
Secondary	Agreement between glucose readings when at high glucose levels	Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at high glucose levels (>10.0 mmol/l in the POC blood glucose measurement)	Perioperatively