Monitoring Glucose Levels in Patients With Myocardial Infarction

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

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

Official Title
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COMGAMI Continuous Monitoring of Glucose in Acute Myocardial Infarction

Conditions
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Acute Coronary Syndromes, Hyperglycemia, Hypoglycemia

Intervention / Treatment
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* Device: OptiScanner®


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Glucose monitoring by OptiScanner®<br>Glucose monitoring and intervention guided by OptiScanner® | Device: OptiScanner®<br>* Glucose monitoring by OptiScanner® for 48 h Glucose lowering intervention (insulin) guided by OptiScanner®<br>|
| Other: Blinded continuous glucose monitoring<br>Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements | Device: OptiScanner®<br>* Glucose monitoring by OptiScanner® for 48 h Glucose lowering intervention (insulin) guided by OptiScanner®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the first part of the study, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose variability | Glucose variability | 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. | Hospitalization, through study completion, an average of 1 year | 
| Number of episodes of Hyperglycemia | No of episodes of hyperglycemia >12 mmol/L | Hospitalization, through study completion, an average of 1 year | 
| Work load in nursing staff | Work load in nursing staff, questionnaire | 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. | Next step after the completion of the first and ongoing part. through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute coronary syndromes, hyperglycemia, hypoglycemia, continuous glucose monitoring