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HypoglycemiaWARD-CGMNCT04473001

Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring

An observational study of Hypoglycemia and Perioperative Complication, run by University Hospital Bispebjerg and Frederiksberg at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypoglycemia, Perioperative Complication
What is being tested?
Continuous vital signs and glucose monitoring
How many people
70 participants
Where
2 sitesDenmark
Study dates
26 Jun 2020to 28 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Rigshospitalet

    Copenhagen, Danmark, 2100

  • Bispebjerg Hospital

    Copenhagen, Danmark, 2400

Other trials in Denmark

About this study

Official title: 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.

Being tested
Continuous vital signs and glucose monitoring
Medical subject headings
Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous vital signs and glucose monitoringOther

    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)
Study groups in NCT04473001
Study groupRoleWhat they receive
Surgical patientsAdult patients admitted for major abdominal-, orthopedic or arterial vascular surgery.
Receives: Other: Continuous vital signs and glucose monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypoglycemia

    Duration of glucose levels < 3.9 mmol/L as measured by continuous glucose monitoring (CGM)

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

Secondary outcomes (12)

  1. Active CGM

    % of study time with active CGM and data stored on the secure server

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

  2. Glycemic variability

    Glycemic variability (%CV, SD)

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

  3. Mean glucose

    Mean glucose (mmol/L).

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

  4. Number of hypoglycemic events

    Median number of hypoglycemic events per patient per day; glucose < 3.9 mmol/L, >15 minutes

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

  5. Number of severe hypoglycemic events

    Median number of severe hypoglycemic events per patient per day; glucose < 3.0 mmol/L, >15 minutes

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

  6. Number of fasting hypoglycemia events

    Median number of hypoglycemia events during perioperative fasting; glucose < 3.9 mmol/L, >15 minutes

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

  7. Duration of fasting hypoglycemia events

    Duration of hypoglycemia events during perioperative fasting, glucose < 3.9 mmol/L

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

  8. % 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

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

  9. % of readings and time in range (TIR)

    ○ % of readings and time in range 3.9-10.0 mmol/L.

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

  10. % 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.

    Measured: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

  11. Adverse clinical outcomes

    Occurrence and severity of a range of predefined adverse clinical outcomes.

    Measured: Until 30 days after monitoring is commenced

  12. Readmission or death

    Occurrence of readmission and/or death.

    Measured: Until 6 months after monitoring is commenced

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2020
  2. Study start26 Jun 2020
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04473001
Sponsor's protocol ID
H-20002220
Acronym
WARD-CGM
Status last verified
Mar 2021
First submitted
30 Jun 2020
Last updated
29 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35129526

Questions about this trial

What is this clinical trial studying?

An observational study of Hypoglycemia and Perioperative Complication, run by University Hospital Bispebjerg and Frederiksberg at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypoglycemia (time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04473001, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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