Monitoring Glucose Levels in Patients With Myocardial Infarction

Hyperglycemia Clinical Trial

— COMGAMI  

Official title:

COMGAMI Continuous Monitoring of Glucose in Acute Myocardial Infarction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03107806
• Other study ID #: 2011/1446-31/1
• Status: Terminated
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Hyperglycemia
• Hypoglycemia
• Infarction
• Myocardial Infarction

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