Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients

Charles University, Czech Republic

Status: Completed

Conditions: Cardiac Surgery; Hyperglycemia

Treatments: Other: Intensive insulin therapy using standard protocol; Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00996099

CGM-eMPC

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective cardiac surgery

Exclusion criteria

• insulin allergy
• mental incapacity
• language barrier

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

CGM-eMPC

Active Comparator group

Treatment:

Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment

Control

Other group

Treatment:

Other: Intensive insulin therapy using standard protocol

Sponsor of this trial

Lead Sponsor

Charles University, Czech Republic