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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Dysglycemia; Perioperative Complication; Circulatory; Complications
• Intervention / Treatment: Device: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Casper Pedersen, MD; Phone Number: 004526712696; Email: casper.pedersen@regionh.dk
• Study Contact Backup: Name: Eske K Aasvang, MD, DmSci; Phone Number: 004535450802; Email: eske.kvanner.aasvang.01@regionh.dk

Study Locations

• Denmark
  • The Capital Region Of Denmark
    • Copenhagen, The Capital Region Of Denmark, Denmark, 2100
      • Recruiting
      • Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet
      • Contact: Eske K Aasvang, MD, DMSc; Email: eske.kvanner.aasvang.01@regionh.dk
    • Copenhagen, The Capital Region Of Denmark, Denmark, 2400
      • Recruiting
      • Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital
      • Contact: Christian S Meyhoff, MD, PhD; Email: christian.sylvest.meyhoff@regionh.dk
    • Copenhagen, The Capital Region Of Denmark, Denmark, 2400
      • Recruiting
      • Department of Orthopaedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital
      • Contact: Henrik Palm, MD, DMSc; Email: henrik.palm@regionh.dk
    • Copenhagen, The Capital Region Of Denmark, Denmark, 2400
      • Not yet recruiting
      • Surgical department, Bispebjerg and Frederiksberg Hospital,
      • Contact: Lars N Jørgensen, MD, DMSc; Email: lars.nannestad.joergensen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

To the answer of our two research questions, we include both patients with diabetes undergoing surgery, and patients with diabetes admitted to the intensive care unit with circulatory impariment, as described in the criteria above.

We aim to exclude only patients with direct contraindications to the wear of the CGM.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Readmission	Occurrence of readmission until 6 months postoperatively, assessed by physicians at the research unit	6 months postoperatively
Mortality	Occurrence of death until 6 months postoperatively, assessed by physicians at the research unit	6 months postoperatively

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: Zealand University Hospital; Rigshospitalet, Denmark; Steno Diabetes Center Copenhagen
• Investigators: Study Director: Eske K Aasvang, MD, DmSci, Dept. of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Continuous glucose monitoring; Medical devices
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: WARD-Glucose Validation v.2.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan making individual patient data available to researchers outside the study group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes