Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring (NCT04473001) | Clinical Trial Compass
CompletedNot Applicable
Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring
Denmark70 participantsStarted 2020-06-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hypoglycemia
Timeframe: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Trial details
NCT IDNCT04473001
SponsorUniversity Hospital Bispebjerg and Frederiksberg