Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring (WARD-CGM)

Continuous Glucose Measurements to Detect Hypoglycemia in Patients Undergoing Major Surgery

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.

Study Overview

• Status: Completed
• Conditions: Hypoglycemia; Perioperative Complication
• Intervention / Treatment: Other: Continuous vital signs and glucose monitoring

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Denmark
  • Danmark
    • Copenhagen, Danmark, Denmark, 2100
      • Rigshospitalet
    • Copenhagen, Danmark, Denmark, 2400
      • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted for major abdominal-, orthopedic or arterial vascular surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Surgical patients; Adult patients admitted for major abdominal-, orthopedic or arterial vascular surgery.

Other: Continuous vital signs and glucose monitoring; 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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between CGM and plasma glucose (PG)	Level of agreement between CGM and concomitant PG measurements.	Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Duration of hypoglycemia as measured by PG	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).	Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Number of PG measurements	Median number of bedside PG measurements.	Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: Rigshospitalet, Denmark
• Investigators: Study Director: Eske K Aasvang, MD, DMSc, Rigshospitalet, Centre for Cancer and Organ Diseases

Publications and helpful links

General Publications

• Carlsson CJ, Norgaard K, Oxboll AB, Sogaard MIV, Achiam MP, Jorgensen LN, Eiberg JP, Palm H, Sorensen HBD, Meyhoff CS, Aasvang EK. Continuous Glucose Monitoring Reveals Perioperative Hypoglycemia in Most Patients With Diabetes Undergoing Major Surgery: A Prospective Cohort Study. Ann Surg. 2021 Oct 8. doi: 10.1097/SLA.0000000000005246. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2020
• Primary Completion (ACTUAL): February 28, 2021
• Study Completion (ACTUAL): February 28, 2021

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (ACTUAL): July 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: H-20002220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No