Monitoring Glucose Levels in Patients With Myocardial Infarction

NCT ID: NCT03107806

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-01-31

Brief Summary

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

Detailed Description

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Methodology Part a) Explorative Part b) Randomised, parallel-group design

Conditions

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Acute Coronary Syndromes Hyperglycemia Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Glucose monitoring by OptiScanner®

Glucose monitoring and intervention guided by OptiScanner®

Group Type OTHER

OptiScanner®

Intervention Type DEVICE

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

Blinded continuous glucose monitoring

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

Group Type OTHER

OptiScanner®

Intervention Type DEVICE

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

Interventions

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OptiScanner®

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Swedish Heart Lung Foundation

OTHER

Sponsor Role collaborator

Lars Ryden

OTHER

Sponsor Role lead

Responsible Party

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Lars Ryden

Senior professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Camilla Hage, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska University hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2011/1446-31/1

Identifier Type: -

Identifier Source: org_study_id

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