Skip to main content
OpenTrials
Completed

NCT Number: NCT04473001

Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring

The applicant and research team partners have over the last years developed the WARD project (Wireless Assessment of Respiratory and circulatory Distress), using wireless continuous monitoring of vital signs in high-risk patients undergoing major abdominal surgery. An important perioperative indicator not currently included in the WARD project is continuous glucose monitoring (CGM), which may not only predict and identify hypo- and hyperglycemia, but also utilize the information from variations in blood glucose in combination with other changes in vital signs to predict surgical complications in all patients.

The current study involves the inclusion of 80 patients, scheduled for major abdominal, orthopedic or vascular surgery, to be monitored with CGM in addition to the currently measured vital signs. The project is a prospective, observational, clinical study, describing and analyzing variations in perioperative blood glucose levels and vital signs, and the relation to adverse clinical outcomes.

Patients scheduled for elective surgery will preferentially be recruited at the preoperative assessment at a maximum of 30 days before surgery. CGM and monitoring of the remaining vital sign modalities will commence on the day of surgery. Patients admitted for acute surgery will be recruited preoperatively and CGM as well monitoring of the remaining vital sign modalities will commence as soon as possible. The patients will be monitored with CGM for up to 10 days and with the remaining modalities for up to 5 days or for all modalities until discharge or withdrawal of consent.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoglycemia 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

Bispebjerg Hospital, Copenhagen, Danmark, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (≥18 years) admitted to Rigshospitalet or Bispebjerg Hospital for major abdominal surgery (e.g. colonic resections, gastrectomy, hepatic resection etc.) or major orthopedic surgery (e.g. hip-fracture, hip and knee-arthroplasty) or major arterial vascular surgery (e.g. aortic aneurysm, iliac or femoral bypass etc.)
  • Estimated duration of surgery ≥1 hour and at least one expected overnight stay postoperatively

AND

● Type 1 diabetes (Clinically defined: insulin initiated at diabetes onset and treatment with multiple doses of insulin or continuous subcutaneous insulin infusion) (n=20)

OR

● Type 2 diabetes treated with insulin (Clinically defined: treatment with diet or oral antidiabetic drugs for at least 6 months before insulin was started) (n =20)

OR

● Type 2 diabetes treated with oral antihyperglycemic drugs and/or GLP-1 analogs (n=20)

OR

● No diabetes mellitus (excluded by an admission HbA1c <48 mmol/mol) (n=20)

Exclusion criteria

  • Patient expected not to cooperate with study procedures.
  • Patient allergic to plaster or silicone.
  • Patients with impaired cognitive function (assessed by a Mini Mental State Examination [MMSE] score <24)
  • Patients admitted for palliative care only.
  • Previous or currently scheduled for pancreatectomy (complete or partial)
  • Patients with pacemaker or implantable cardioverter defibrillator (ICD) device

Treatment and study plan

Continuous vital signs and glucose monitoring

Other

The patients will have the following parameters and vital signs continuously monitored using wireless equipment:

  • Glucose measurements (quasi-continuous, every 5 minutes)
  • Heart rate
  • Heart rhythm (single-lead ECG; quasi-continuous, 10 seconds every minute)
  • Signs of cardiac ischemia (single-lead ECG; quasi-continuous, 10 seconds every minute)
  • Respiration rate
  • Oxygen saturation of arterial hemoglobin (%SpO2)
  • Perfusion index (ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue)
  • Blood pressure (quasi-continuous; every 30-60 minutes)
  • Skin temperature
  • Electrodermal activity
  • Ambulatory activity (accelerometry)

Primary outcomes

  1. Hypoglycemia

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    Duration of glucose levels < 3.9 mmol/L as measured by continuous glucose monitoring (CGM)

Secondary outcomes

  1. Active CGM

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    % of study time with active CGM and data stored on the secure server

  2. Glycemic variability

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    Glycemic variability (%CV, SD)

  3. Mean glucose

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    Mean glucose (mmol/L).

  4. Number of hypoglycemic events

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    Median number of hypoglycemic events per patient per day; glucose < 3.9 mmol/L, >15 minutes

  5. Number of severe hypoglycemic events

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    Median number of severe hypoglycemic events per patient per day; glucose < 3.0 mmol/L, >15 minutes

  6. Number of fasting hypoglycemia events

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    Median number of hypoglycemia events during perioperative fasting; glucose < 3.9 mmol/L, >15 minutes

  7. Duration of fasting hypoglycemia events

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    Duration of hypoglycemia events during perioperative fasting, glucose < 3.9 mmol/L

  8. % of readings and time below range (TBR)

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    • % of readings and time in range 3.0-3.8 mmol/L
    • % of readings and time <3.0 mmol/L

  9. % of readings and time in range (TIR)

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    ○ % of readings and time in range 3.9-10.0 mmol/L.

  10. % of readings and time above range (TAR)

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    • % of readings and time in range 10.1-13.9 mmol/L.
    • % of readings and time >13.9 mmol/L.

  11. Adverse clinical outcomes

    Time frame: Until 30 days after monitoring is commenced

    Occurrence and severity of a range of predefined adverse clinical outcomes.

  12. Readmission or death

    Time frame: Until 6 months after monitoring is commenced

    Occurrence of readmission and/or death.

Other outcomes

  1. Agreement between CGM and plasma glucose (PG)

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    Level of agreement between CGM and concomitant PG measurements.

  2. Duration of hypoglycemia as measured by PG

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    Duration of glucose levels < 3.9 mmol/L as measured by plasma glucose (defined as time from first measurement < 3.9 mmol/L, until first measurement > 3.9 mmol/L).

  3. Number of PG measurements

    Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

    Median number of bedside PG measurements.

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

Continuous Glucose Measurements to Detect Hypoglycemia in Patients Undergoing Major Surgery

Acronym: WARD-CGM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2020
Registry last updated
Mar 29, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.