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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03107806
Other study ID # 2011/1446-31/1
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date January 2018

Study information

Verified date April 2017
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

Device:
OptiScanner®
Glucose monitoring by OptiScanner® for 48 h Glucose lowering intervention (insulin) guided by OptiScanner®

Locations

Country Name City State
Sweden Karolinska University hospital Stockholm

Sponsors (3)

Lead Sponsor Collaborator
Lars Ryden Karolinska Institutet, Swedish Heart Lung Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Glucose variability Glucose variability Hospitalization, through study completion, an average of 1 year
Secondary 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
Secondary Number of episodes of Hyperglycemia No of episodes of hyperglycemia >12 mmol/L Hospitalization, through study completion, an average of 1 year
Secondary Work load in nursing staff Work load in nursing staff, questionnaire Hospitalization, through study completion, an average of 1 year
Secondary 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
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