Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring

Study Overview
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Brief Summary
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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.

Official Title
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Continuous Glucose Measurements to Detect Hypoglycemia in Patients Undergoing Major Surgery

Conditions
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Hypoglycemia, Perioperative Complication

Intervention / Treatment
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* Other: Continuous vital signs and glucose monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical patients<br>Adult patients admitted for major abdominal-, orthopedic or arterial vascular surgery. | Other: Continuous vital signs and glucose monitoring<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia | Duration of glucose levels < 3.9 mmol/L as measured by continuous glucose monitoring (CGM) | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active CGM | % of study time with active CGM and data stored on the secure server | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 
| Glycemic variability | Glycemic variability (%CV, SD) | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 
| Mean glucose | Mean glucose (mmol/L). | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 
| Number of hypoglycemic events | Median number of hypoglycemic events per patient per day; glucose < 3.9 mmol/L, >15 minutes | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 
| Number of severe hypoglycemic events | Median number of severe hypoglycemic events per patient per day; glucose < 3.0 mmol/L, >15 minutes | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 
| Number of fasting hypoglycemia events | Median number of hypoglycemia events during perioperative fasting; glucose < 3.9 mmol/L, >15 minutes | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 
| Duration of fasting hypoglycemia events | Duration of hypoglycemia events during perioperative fasting, glucose < 3.9 mmol/L | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 
| % of readings and time below range (TBR) | % of readings and time in range 3.0-3.8 mmol/L % of readings and time <3.0 mmol/L | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 
| % of readings and time in range (TIR) | ○ % of readings and time in range 3.9-10.0 mmol/L. | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 
| % of readings and time above range (TAR) | % of readings and time in range 10.1-13.9 mmol/L. % of readings and time >13.9 mmol/L. | Through the monitoring period (up to 5 days after monitoring is commenced or until discharge) | 
| Adverse clinical outcomes | Occurrence and severity of a range of predefined adverse clinical outcomes. | Until 30 days after monitoring is commenced | 
| Readmission or death | Occurrence of readmission and/or death. | Until 6 months after monitoring is commenced |