Acute Coronary Syndromes, Hyperglycemia, Hypoglycemia
Conditions
Keywords
acute coronary syndromes, hyperglycemia, hypoglycemia, continuous glucose monitoring
Brief summary
To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes
Detailed description
Methodology Part a) Explorative Part b) Randomised, parallel-group design
Interventions
DEVICEOptiScanner®
1. Glucose monitoring by OptiScanner® for 48 h 2. Glucose lowering intervention (insulin) guided by OptiScanner®
Sponsors
Karolinska Institutet
Swedish Heart Lung Foundation
Lars Ryden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of glucose values derived by the new equipment vs. standard lab recordings | During the first part of the study, up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose variability | Hospitalization, through study completion, an average of 1 year | Glucose variability |
| Number of episodes of Hypoglycemia | Hospitalization, through study completion, an average of 1 year | No of episodes of hypoglycaemia defined as glucose \<3.0 mmol/L with or without symptoms. |
| Number of episodes of Hyperglycemia | Hospitalization, through study completion, an average of 1 year | No of episodes of hyperglycemia \>12 mmol/L |
| Work load in nursing staff | Hospitalization, through study completion, an average of 1 year | Work load in nursing staff, questionnaire |
| Time in targeted glucose values | Next step after the completion of the first and ongoing part. through study completion, an average of 1 year | 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. |
Countries
Sweden
Outcome results
None listed