To investigate the discrepancy between CGM and POC measurements in insulin-dependent ICU patients and to study whether these potential discrepancies between CGM and POC vary across patient-related factors, like gender, age, comorbidities, medication…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The first main study parameter is the discrepancy, in exact values, between
glucose levels measured with CGM and POC in insulin-dependent ICU patients. The
other main study parameter is the variation of the potential difference in
glucose levels between CGM and POC among different patient-related factors
Secondary outcome
Six secundary study parameters are defined:
1. The difference in absolute discrepancy between the glucose levels measured
with CGM and POC when the CGM sensor is placed in the abdomen versus the upper
arm.
2. The reported adverse events, such as infections, bleeding, and decubitus,
linked to the CGM. In case of a suspected infection originating from the CGM or
decubitus, the CGM will be removed.
3. The number and percentage of hypo- and hyperglycemia episodes shown by the
CGM which were not detected by POC interval measurements will be recorded. A
hypoglycemia in this study is defined as a glucose level < 4,0 mmol/L and a
hyperglycemia is defined as a glucose level > 10,0 mmol/L.
4. The time between the onset of a hypo- or hyperglycemia and its detection via
POC testing. The time is described in minutes between the first CGM measurement
below 4,0 mmol/L or above 10,0 mmol/L and the time of the POC testing below 4,0
mmol/L or above 10,0 mmol/L.
5. The duration of time, in minutes, it takes for the CGM to reliably measure
after the sensor is inserted. Duration of time, in hours, the CGM reliably
measures after the sensor is inserted.
6. The difference in discrepancy between the glucose levels measured with CGM
and POC after radiologic procedure.
Background summary
Hyperglycaemia is present in up to 50% of patients admitted to an intensive
care unit (ICU) and is strongly associated with elevated morbidity and
mortality rates. Therefore, it is important to monitor glucose levels closely.
In the ICU, glucose monitoring primarily relies on periodic measurements
through point-of-care (POC) meters, which involve invasive blood sampling from
venous or arterial lines. To maintain blood glucose concentrations better
within acceptable ranges a possible improvement is continuous glucose
monitoring (CGM), which is now used to manage glucose levels in diabetic
patients in general settings and has shown significant benefits. Studies on the
use of CGM in ICU setting are limited. If CGM is reliably measuring glucose
levels in critically ills patients, it enables earlier intervention and might
help to predict hypo- or hyperglycemia based on measurement trends.
Study objective
To investigate the discrepancy between CGM and POC measurements in
insulin-dependent ICU patients and to study whether these potential
discrepancies between CGM and POC vary across patient-related factors, like
gender, age, comorbidities, medication use, disease severity scores, treatment
in ICU.
Study design
Prospective, multi-centre, single-arm intervention, exploratory study.
All study participants receive one CGM sensor to monitor glucose levels. A
second CGM sensor will only be applied if the first CGM sensor needed to be
replaced within 8 days after insertion. The measurements will be blinded to all
except the research team.
Study burden and risks
The risks of participation in this trial are considered to be negligible. The
CGM sensor is a minimally invasive tool and there are no serious risks foreseen
of placing and carrying the CGM sensor. Participation in the study will not
interfere with the usual care and the gold standard for glucose control (POC
interval measures) will be used for insulin therapy. Part of the study
population might be critically ill, incapacitated patients. Especially these
patients will be insulin depended and fulfil the inclusion criteria. The
required data for the study is recorded as part of standard medical care for
patients admitted to the ICU (e.g. blood pressure) and no additional tests are
needed. Participants will not benefit from this trial because the CGM values
will be blinded to the treatment team.
Nico Bolkesteinlaan 75
Deventer 7416 SE
NL
Nico Bolkesteinlaan 75
Deventer 7416 SE
NL
Listed location countries
Age
Inclusion criteria
- Patients admitted to the ICU
- Insulin-dependent as defined in local protocol
- Age: >= 18 y
- Expected length of stay in ICU > 2 days
Exclusion criteria
- Pregnancy
- No informed consent
- Therapeutic hypothermia (<34 degrees celsius)
- Platelet count < 50,000/µL at time of inclusion
- Use of hydroxyurea
- Use of acetaminophen >4 g/day
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87243.100.24 |