- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03107806
Monitoring Glucose Levels in Patients With Myocardial Infarction (COMGAMI)
August 14, 2019 updated by: Lars Ryden
COMGAMI Continuous Monitoring of Glucose in Acute Myocardial Infarction
To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Methodology Part a) Explorative Part b) Randomised, parallel-group design
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Stockholm, Sweden, 17176
- Karolinska University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Glucose monitoring by OptiScanner®
Glucose monitoring and intervention guided by OptiScanner®
|
|
Other: Blinded continuous glucose monitoring
Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of glucose values derived by the new equipment vs. standard lab recordings
Time Frame: 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.
|
During the first part of the study, up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose variability
Time Frame: Hospitalization, through study completion, an average of 1 year
|
Glucose variability
|
Hospitalization, through study completion, an average of 1 year
|
Number of episodes of Hypoglycemia
Time Frame: 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.
|
Hospitalization, through study completion, an average of 1 year
|
Number of episodes of Hyperglycemia
Time Frame: Hospitalization, through study completion, an average of 1 year
|
No of episodes of hyperglycemia >12 mmol/L
|
Hospitalization, through study completion, an average of 1 year
|
Work load in nursing staff
Time Frame: Hospitalization, through study completion, an average of 1 year
|
Work load in nursing staff, questionnaire
|
Hospitalization, through study completion, an average of 1 year
|
Time in targeted glucose values
Time Frame: 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.
|
Next step after the completion of the first and ongoing part. through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Camilla Hage, PhD, Karolinska Institutet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2013
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
April 16, 2013
First Submitted That Met QC Criteria
April 4, 2017
First Posted (Actual)
April 11, 2017
Study Record Updates
Last Update Posted (Actual)
August 15, 2019
Last Update Submitted That Met QC Criteria
August 14, 2019
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/1446-31/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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