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NCT Number: NCT06297850

Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. 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.

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Key information

Conditions

Diabetes Mellitus Circulatory; Complications Dysglycemia Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Perioperative Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital, Copenhagen, The Capital Region of Denmark, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Dexcom G7

Primary outcomes

  1. Agreement between glucose

    Time frame: Perioperatively

    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

Secondary outcomes

  1. Agreement between glucose readings when at low glucose levels

    Time frame: Perioperatively

    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)

  2. Agreement between glucose readings when at normal glucose levels

    Time frame: Perioperatively

    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)

  3. Agreement between glucose readings when at high glucose levels

    Time frame: Perioperatively

    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)

Other outcomes

  1. Adverse clinical outcomes

    Time frame: 30 days postoperative

    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

  2. Readmission

    Time frame: 6 months postoperatively

    Occurrence of readmission until 6 months postoperatively, assessed by physicians at the research unit

  3. Mortality

    Time frame: 6 months postoperatively

    Occurrence of death until 6 months postoperatively, assessed by physicians at the research unit

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Collaborators

  • Rigshospitalet, Denmark
  • Steno Diabetes Center Copenhagen
  • Zealand University Hospital

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 7, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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