Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring

Hypoglycemia Clinical Trial

— WARD-CGM  

Official title:

Continuous Glucose Measurements to Detect Hypoglycemia in Patients Undergoing Major Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473001
• Other study ID #: H-20002220
• Status: Completed
• Start date: June 26, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoglycemia
• Perioperative Complication

Intervention

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)

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Danmark
Denmark	Rigshospitalet	Copenhagen	Danmark

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	Glycemic variability	Glycemic variability (%CV, SD)	Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Secondary	Mean glucose	Mean glucose (mmol/L).	Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	% 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)
Secondary	% 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)
Secondary	% 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)
Secondary	Adverse clinical outcomes	Occurrence and severity of a range of predefined adverse clinical outcomes.	Until 30 days after monitoring is commenced
Secondary	Readmission or death	Occurrence of readmission and/or death.	Until 6 months after monitoring is commenced