Monitoring Glucose Levels in Patients With Myocardial Infarction

NCT03107806 | Terminated

• 1 other identifier: 2011/1446-31/1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes

Conditions

Acute Coronary Syndromes; Hyperglycemia; Hypoglycemia

Keywords

acute coronary syndromes; hyperglycemia; hypoglycemia; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Glucose variability

  Hospitalization, through study completion, an average of 1 year

• Number of episodes of Hypoglycemia

  Hospitalization, through study completion, an average of 1 year

• Number of episodes of Hyperglycemia

  Hospitalization, through study completion, an average of 1 year

• Work load in nursing staff

  Hospitalization, through study completion, an average of 1 year

• Time in targeted glucose values

  Next step after the completion of the first and ongoing part. through study completion, an average of 1 year

Study Arms (2)

Glucose monitoring by OptiScanner®

OTHER

Glucose monitoring and intervention guided by OptiScanner®

Device: OptiScanner®

Blinded continuous glucose monitoring

OTHER

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

Device: OptiScanner®

Interventions

OptiScanner® DEVICE

1. Glucose monitoring by OptiScanner® for 48 h 2. Glucose lowering intervention (insulin) guided by OptiScanner®

Blinded continuous glucose monitoring; Glucose monitoring by OptiScanner®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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).

Sponsors & Collaborators

• Lars Ryden: lead
• Karolinska Institutet: collaborator
• Swedish Heart Lung Foundation: collaborator

Study Sites (1)

Karolinska University hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Camilla Hage, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior professor

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 11, 2017
• Study Start: April 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 15, 2019

Record last verified: 2017-04

Locations

SE (1)