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

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®
  1. Glucose monitoring by OptiScanner® for 48 h
  2. Glucose lowering intervention (insulin) guided by OptiScanner®
Other: Blinded continuous glucose monitoring
Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements
  1. Glucose monitoring by OptiScanner® for 48 h
  2. Glucose lowering intervention (insulin) guided by OptiScanner®

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

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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