Monitoring Glucose Levels in Patients With Myocardial Infarction

Not Applicable

Terminated

• Conditions: Acute Coronary Syndromes; Hyperglycemia; Hypoglycemia
• Interventions: Device: OptiScanner®

• Registration Number: NCT03107806
• Lead Sponsor: Lars Ryden

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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-16
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-11
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucose monitoring by OptiScanner®	OptiScanner®	Glucose monitoring and intervention guided by OptiScanner®
Blinded continuous glucose monitoring	OptiScanner®	Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
Glucose variability	Hospitalization, through study completion, an average of 1 year	Glucose variability
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.

Trial Locations

Locations (1)

Karolinska University hospital; 🇸🇪 Stockholm, Sweden