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

NCT06297850 | Completed FDA Device

• 1 other identifier: WARD-Glucose Validation v.2.2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Diabetes Mellitus; Dysglycemia; Perioperative Complication; Circulatory; Complications

Keywords

Diabetes Mellitus; Continuous glucose monitoring; Medical devices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Agreement between glucose readings when at low glucose levels

  Perioperatively

• Agreement between glucose readings when at normal glucose levels

  Perioperatively

• Agreement between glucose readings when at high glucose levels

  Perioperatively

Other Outcomes (3)

• Adverse clinical outcomes

  30 days postoperative

• Readmission

  6 months postoperatively

• Mortality

  6 months postoperatively

Interventions

Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) DEVICE

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.

Also known as: Dexcom G7

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Rigshospitalet, Denmark: collaborator
• Steno Diabetes Center Copenhagen: collaborator
• Zealand University Hospital: collaborator

Study Sites (4)

Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet

Copenhagen, The Capital Region of Denmark, 2100, Denmark

Location

Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital

Copenhagen, The Capital Region of Denmark, 2400, Denmark

Location

Department of Orthopaedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital

Copenhagen, The Capital Region of Denmark, 2400, Denmark

Location

Surgical department, Bispebjerg and Frederiksberg Hospital,

Copenhagen, The Capital Region of Denmark, 2400, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• Eske K Aasvang, MD, DmSci

  Dept. of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, principal investigator

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 7, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)