Monitoring Glucose Levels in Patients With Myocardial Infarction

Lars Ryden14 enrolled

Overview

To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes

Methodology Part a) Explorative Part b) Randomised, parallel-group design

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Acute Coronary Syndromes Hyperglycemia Hypoglycemia

Interventions

OptiScanner®DEVICE

1. Glucose monitoring by OptiScanner® for 48 h 2. Glucose lowering intervention (insulin) guided by OptiScanner®

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute coronary syndrome according to the joint recommendations by the European Society of Cardiology (48, 49) * Signed written informed consent consistent with Helsinki declaration and local legislations prior to participation in the trial. Exclusion Criteria: * \<18 years old. * Congestive heart failure. * Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: alcohol or drug abuse, psychiatric disorder).

Locations (1)

Karolinska University hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

Accuracy of glucose values derived by the new equipment vs. standard lab recordings

The above specified part of the study is ongoing. Preliminary data confirms accuracy of recorded glucose values but there is a problem with venous access over the intended time of 48 hours. A new type of venous access will be tested and ethics approval has just been accomplished.

Time frame: During the first part of the study, up to 6 months

Secondary Outcomes

Glucose variability

Time frame: Hospitalization, through study completion, an average of 1 year

Number of episodes of Hypoglycemia

No of episodes of hypoglycaemia defined as glucose \<3.0 mmol/L with or without symptoms.

Time frame: Hospitalization, through study completion, an average of 1 year

Number of episodes of Hyperglycemia

No of episodes of hyperglycemia \>12 mmol/L

Time frame: Hospitalization, through study completion, an average of 1 year

Work load in nursing staff

Work load in nursing staff, questionnaire

Time frame: Hospitalization, through study completion, an average of 1 year

Time in targeted glucose values

Targets for plasma glucose are defined and the personnel will have support of the new equipment allowing continuous monitoring of glucose levels when adjusting glucose lowering therapy. This will be compared to monitoring with standard, intermittent glucose measuring.

Time frame: Next step after the completion of the first and ongoing part. through study completion, an average of 1 year

Data from ClinicalTrials.gov

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