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Monitoring Glucose Levels in Patients With Myocardial Infarction (COMGAMI)

Primary Purpose

Acute Coronary Syndromes, Hyperglycemia, Hypoglycemia

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
OptiScanner®
Sponsored by
Lars Ryden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Coronary Syndromes focused on measuring acute coronary syndromes, hyperglycemia, hypoglycemia, continuous glucose monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Karolinska University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Glucose monitoring by OptiScanner®

Blinded continuous glucose monitoring

Arm Description

Glucose monitoring and intervention guided by OptiScanner®

Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Glucose variability
Glucose variability
Number of episodes of Hypoglycemia
No of episodes of hypoglycaemia defined as glucose <3.0 mmol/L with or without symptoms.
Number of episodes of Hyperglycemia
No of episodes of hyperglycemia >12 mmol/L
Work load in nursing staff
Work load in nursing staff, questionnaire
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.

Full Information

First Posted
April 16, 2013
Last Updated
August 14, 2019
Sponsor
Lars Ryden
Collaborators
Karolinska Institutet, Swedish Heart Lung Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03107806
Brief Title
Monitoring Glucose Levels in Patients With Myocardial Infarction
Acronym
COMGAMI
Official Title
COMGAMI Continuous Monitoring of Glucose in Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Blood withdrawal problems despite use of different catheters.
Study Start Date
April 2013 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Ryden
Collaborators
Karolinska Institutet, Swedish Heart Lung Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes, Hyperglycemia, Hypoglycemia
Keywords
acute coronary syndromes, hyperglycemia, hypoglycemia, continuous glucose monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose monitoring by OptiScanner®
Arm Type
Other
Arm Description
Glucose monitoring and intervention guided by OptiScanner®
Arm Title
Blinded continuous glucose monitoring
Arm Type
Other
Arm Description
Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements
Intervention Type
Device
Intervention Name(s)
OptiScanner®
Intervention Description
Glucose monitoring by OptiScanner® for 48 h Glucose lowering intervention (insulin) guided by OptiScanner®
Primary Outcome Measure Information:
Title
Accuracy of glucose values derived by the new equipment vs. standard lab recordings
Description
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.
Time Frame
During the first part of the study, up to 6 months
Secondary Outcome Measure Information:
Title
Glucose variability
Description
Glucose variability
Time Frame
Hospitalization, through study completion, an average of 1 year
Title
Number of episodes of Hypoglycemia
Description
No of episodes of hypoglycaemia defined as glucose <3.0 mmol/L with or without symptoms.
Time Frame
Hospitalization, through study completion, an average of 1 year
Title
Number of episodes of Hyperglycemia
Description
No of episodes of hyperglycemia >12 mmol/L
Time Frame
Hospitalization, through study completion, an average of 1 year
Title
Work load in nursing staff
Description
Work load in nursing staff, questionnaire
Time Frame
Hospitalization, through study completion, an average of 1 year
Title
Time in targeted glucose values
Description
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.
Time Frame
Next step after the completion of the first and ongoing part. through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilla Hage, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

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Monitoring Glucose Levels in Patients With Myocardial Infarction

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