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

Qualifiers

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

Treatments tested in this trial

  • Continuous Glucose Monitoring
  • Point-of-Care Testing

Treatment groups

82 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators