CGM in Acute Ischemic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIsala
About this trial
The goal of this randomized clinical trial is to evaluate whether continuous glucose monitoring (CGM) can be used to guide glucose management in patients with type 2 diabetes who are admitted with an acute ischemic stroke and undergo endovascular therapy. Hyperglycemia frequently occurs during hospitalization in stroke and is associated with worse neurological and clinical outcomes. In current clinical practice, glucose levels are monitored using intermittent point-of-care testing (POCT) with finger-prick measurements, which may miss clinically relevant glucose fluctuations. CGM provides continuous glucose measurements and may allow earlier detection of hyperglycemia and more timely glucose management.
This study is designed as a non-inferiority randomized controlled trial comparing CGM-guided glucose management with standard POCT-guided glucose management. The primary objective is to determine whether CGM-guided glucose management is non-inferior to POCT-guided management in terms of percentage time spent in hyperglycemia (glucose \>10 mmol/L) during the first 72 hours of hospitalization.
Researchers will compare CGM-guided glucose management to POCT-guided glucose management to evaluate whether CGM can be used as an alternative strategy to guide glucose control in hospitalized stroke patients.
Participants will:
* Be randomly assigned to either CGM-guided glucose management or standard POCT-guided glucose management * Have their glucose levels continuously monitored (blinded in the POCT-guided group) during hospitalization * Receive glucose management according to the assigned monitoring strategy, based on the hospital insulin protocol
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Acute ischemic stroke treated with endovascular therapy (EVT)
documented diagnosis of type 2 diabetes mellitus
use of glucose-lowering medication
Disqualifiers
Current pregnancy
Extensive skin infections or dermatological conditions at the intended sensor site
Hypotension defined as a systolic blood pressure <100 mmHg at 30 and 60 minutes after admission
Dialysis treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous Glucose Monitoring
DeviceContinuous glucose monitoring using the FreeStyle Libre systems (Abbott Diabetes Care) to measure interstitial glucose levels through a subcutaneous sensor that continuously records glucose concentrations during hospitalization.
Point-of-Care Testing
Diagnostic testIntermittent glucose monitoring using point-of-care finger-prick capillary blood glucose measurements according to the hospital glucose management protocol.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: CGM-guided glucose managementExperimental treatment 1 intervention
Group B: POCT-guided glucose managementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time spent in hyperglycemia (>10 mmol/L)
Percentage of time during hospitalization with glucose levels above 10 mmol/L measured using continuous glucose monitoring.
Time frame
During the first 72 hours of hospitalizationSecondary outcomes
1
Duration of hyperlgycemic episodes (>10 mmol/L)
Duration of hyperglycemic episodes (\>10 mmol/L) measured using continuous glucose monitoring.
Time frame
During the first 72 hours of hospitalization2
Duration of hypoglycemic episodes (<3.9 mmol/L)
Duration of hypoglycemic episodes (\<3.9 mmol/L) measured using continuous glucose monitoring.
Time frame
During the first 72 hours of hospitalization3
Time in normoglycemia (3.9-10.0 mmol/L)
Percentage of time with glucose levels between 3.9-10.0 mmol/L measured using continuous glucose monitoring.
Time frame
During the first 72 hours of hospitalization4
Time in hypoglycemia (<3.9 mmol/L)
Percentage of time with glucose levels \<3.9 mmol/L measured using continuous glucose monitoring
Time frame
During the first 72 hours of hospitalizationLocations
Source ClinicalTrials.gov
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