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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical patients | Adult patients admitted for major abdominal-, orthopedic or arterial vascular surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous vital signs and glucose monitoring | Other | The patients will have the following parameters and vital signs continuously monitored using wireless equipment:
|
| 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) |
| 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 |
| 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 |
Inclusion Criteria:
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:
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Adult patients admitted for major abdominal-, orthopedic or arterial vascular surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Eske K Aasvang, MD, DMSc | Rigshospitalet, Centre for Cancer and Organ Diseases | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Danmark | 2100 | Denmark | ||
| Bispebjerg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35129526 | Derived | Carlsson CJ, Norgaard K, Oxboll AB, Sogaard MIV, Achiam MP, Jorgensen LN, Eiberg JP, Palm H, Sorensen HBD, Meyhof CS, Aasvang EK. Continuous Glucose Monitoring Reveals Perioperative Hypoglycemia in Most Patients With Diabetes Undergoing Major Surgery: A Prospective Cohort Study. Ann Surg. 2023 Apr 1;277(4):603-611. doi: 10.1097/SLA.0000000000005246. Epub 2021 Oct 8. |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
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) |
| 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) |
| 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 |
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) |
| Copenhagen |
| Danmark |
| 2400 |
| Denmark |