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Blood withdrawal problems despite use of different catheters.
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Swedish Heart Lung Foundation | OTHER |
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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
Methodology Part a) Explorative Part b) Randomised, parallel-group design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose monitoring by OptiScanner® | Other | Glucose monitoring and intervention guided by OptiScanner® |
|
| Blinded continuous glucose monitoring | Other | Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OptiScanner® | Device |
|
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camilla Hage, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University hospital | Stockholm | 17176 | Sweden |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 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 |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |