Status:
COMPLETED
Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring
Lead Sponsor:
University Hospital Bispebjerg and Frederiksberg
Collaborating Sponsors:
Rigshospitalet, Denmark
Conditions:
Hypoglycemia
Perioperative Complication
Eligibility:
All Genders
18+ years
Brief 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 vita...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04473001
Start Date
June 26 2020
End Date
February 28 2021
Last Update
March 29 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Rigshospitalet
Copenhagen, Danmark, Denmark, 2100
2
Bispebjerg Hospital
Copenhagen, Danmark, Denmark, 2400