Continuous glucose monitoring in acute ischemic stroke: a prospective study of the feasibility of continuous glucose monitoring and evolution of glucose in acute ischemic stroke patients suitable for endovascular treatment

Continuous glucose monitoring in acute ischemic stroke: a prospective study of the feasibility of continuous glucose monitoring and evolution of glucose in acute ischemic stroke patients suitable for endovascular treatment - Continuous glucose monitoring in acute ischemic stroke (GASP-study)

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52090

Enrollment

Registered

2021-11-04

Start date

2022-02-07

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Acute ischemic stroke 18 years or over Intracranial occlusion Eligible for endovascular treatment

Exclusion criteria

Exclusion criteria: No specific

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Secondary study outcome consist of stroke severity assessed with NIHSS-score and core and penumbra volume on admission CT-perfusion respectively	—

Countries

Netherlands

Outcome results