We aim to assess the feasibility of continuous glucose monitoring with CGM in patients with acute ischemic stroke who are eligible for endovascular treatment. In addition, we will assess the evolution of glucose levels in these patients.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of using CGM in the acute phase will be the main parameter in the
pilot study. In this stage we will consider if it is logistically feasible to
implant the CGM in this acute setting. In addition, the accuracy of CGM in
acute ischemic stroke will be tested.
1. logistical feasibility will be defined as number of patients who complete 24
hours of glucose monitoring. There will be concluded that CGM is feasible when
monitoring is successful for 24 hours in 75% of the included patients. Delay in
start of of endovascular treatment due to implantation (5 minutes delay is
determined as reasonable) and adverse events will be specifically assessed..
2. accuracy of CGM, will be determined by parallel capillary finger prick at
10.00 AM and 12.00; 14.00; 16.00; 18.00 and 20.00 PM. Glucose values will also
be determined by venous measurements at 08.00 AM (fasting glucose); 10.00 AM
and 15.00 PM. According to previous literature the point accuracy of CGM versus
interstitial based glucose values was determined with the Parkes error grid
analysis. Values in zones A and B are described as clinically acceptable.
Values in zones C,D and E are determined as inaccurate. CGM is accurate when
95% of the CGM measurements are in zones A and B.
Secondary outcome
Secondary study outcome consist of stroke severity assessed with NIHSS-score
and core and penumbra volume on admission CT-perfusion respectively
Background summary
Hyperglycemia on admission is common in patients with acute ischemic stroke.
Increased glucose levels have been associated with larger infarct volume and
worse functional outcome after both intravenous thrombolysis and endovascular
treatment. Hence, glucose lowering therapy might be an effective therapeutic
target in acute ischemic stroke patients. However, several studies showed no
effect of lowering glucose on infarct size or functional outcome. None of these
studies focused on recanalization treatment and the majority started with the
glucose lowering intervention outside the acute window of ischemic stroke.
Also, they failed to realise target glucose levels in the intervention group
and capillary plasma glucose monitoring was appeared to be difficult. By using
continuous glucose monitoring, glucose levels can be assessed continuously and
an intervention can be adjusted to current glucose values.
Our aim is to assess the feasibility of continuous glucose monitoring in acute
ischemic stroke with continuous glucose monitoring devices (CGM) in patients
who are eligible for endovascular treatment. In addition, we will assess the
temporal profile of hyperglycemia in these patients.
Study objective
We aim to assess the feasibility of continuous glucose monitoring with CGM in
patients with acute ischemic stroke who are eligible for endovascular
treatment. In addition, we will assess the evolution of glucose levels in these
patients.
Study design
This study will be an exploratory intervention study and will be conducted in
two phases. During a pilot phase, the feasibility of continuously measuring
glucose in the acute phase of stroke will be observed. When this is feasible,
during phase 2, the evolution of glucose during the first 24 hours after acute
stroke will be assessed. A separate application or an amendment will then be
submitted for this.
Study burden and risks
Using the information generated in this study, a future glucose lowering
intervention can be more specified for example in terms of the most effective
window of the intervention. Also, by using continuously monitoring during a
glucose lowering, this intervention can be adapted to current glucose levels.
Other possible variables that must be taken into account include pre-existing
diabetes, age and the type and degree of recanalization. Because this
knowledge, a future glucose lowering intervention could provide smaller infarct
volumes and better functional outcome after ischemic stroke.
During comparable studies, except for some moderate skin reactions, no patients
adverse events were reported. Safe and accurately use of CGM in the acute
setting has also been shown in the context of treatment on the intensive care
unit. Hence, significant knowledge can be gained while patients undergo their
regular treatment without added risks due to CGM.
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
Acute ischemic stroke
18 years or over
Intracranial occlusion
Eligible for endovascular treatment
Exclusion criteria
No specific
Design
Recruitment
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 | NL78000.075.21 |