Performance Study Using the OptiScanner on Healthy Diabetics

June 2, 2010 updated by: Profil Institut für Stoffwechselforschung GmbH
This study is designed to demonstrate the accuracy of the OptiScanner glucose measurement. The accuracy of the test device will be determined using plasma samples collected directly from Type 1 and Type 2 Diabetics using the OptiScanner. Blood samples will simultaneously be collected and measured on YSI 2300 STAT PLUS (YSI) made by YSI Incorporated. These results will be compared to the OptiScanner's glucose measurement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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

  • Germany
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Have signed an Informed Consent Form for this study approved by the Institutional Review Board (IRB)
  2. Have a documented onset of diabetes ³ 1 year prior to this study
  3. Have Type 1 or Type 2 diabetes according to the American Diabetes Association diagnostic criteria
  4. Be currently treated with insulin (all regimens) for ³ 1 year and able (as judged by Investigator) and willing to undergo a hypoglycemic challenge and a hyperglycemic challenge; oral diabetes medication in combination with insulin is allowed
  5. Be at least 18 but no more than 65 years of age
  6. Be willing and able to comply with the requirements of the protocol
  7. Be willing to refrain from participating in any other investigational study while enrolled in this study
  8. For Female Subjects: Be post-menopausal, sterilized or not of child-bearing potential, or have a negative pregnancy test and have no intention of becoming pregnant between Visit 1 and Visit 2, and be using contraceptive devices or drugs (risk of pregnancy must be lower than 1%).

Exclusion Criteria:

  1. Recurrent major hypoglycemia (as judged by the Investigator) or hypoglycemia requiring hospitalization within the last 12 months
  2. Have a history of hypoglycemic seizure within the last year
  3. Impaired hepatic function measured as AST/ALT ³ two and a half times the upper reference limit or total bilirubin two and a half times the upper reference limit based on analysis from the local laboratory, or at the Investigator's discretion
  4. Impaired renal function measured as creatinine ³ 1.5 (females) mg/dL, ³ 1.7 (males) mg/dL based on analysis from the local laboratory, or at the Investigator's discretion
  5. Haematocrit or electrolytes (sodium, potassium) outside of normal limits based on analysis from the local laboratory, or at the investigator's discretion.
  6. Have Uric Acid > 10 mg/dL based on analysis from the local laboratory
  7. HIV positive, or Hepatitis B or C positive (blood test required). A viral load test will be done at the local laboratory for subjects with a positive Hepatitis result.
  8. New York Heart Association (NYHA) Class III or IV congestive heart failure
  9. Have a history of angina requiring hospitalization or a myocardial infarction within the last 12 months
  10. Evidence of intermittent or sustained ventricular or supra-ventricular arrhythmias such as ventricular tachycardia, atrial fibrillation, etc. Holter monitoring may be performed to exclude arrhythmias at the discretion of the investigator.
  11. Uncontrolled treated/untreated hypertension (systolic blood pressure ³ 160 mmHg and/or diastolic blood pressure ³ 100 mmHg)
  12. Have active diabetic proliferative retinopathy (undergoing treatment)
  13. Have active significant recurring skin infections or adhesive allergies, at the Investigator's discretion
  14. Have given more than 150 mL of blood within 8 weeks prior to enrollment in this study
  15. Currently taking anticoagulants, e.g. Coumadin (warfarin), Marcumar (phenprocoumon). Patients with prolonged activated PTT will not be included in this study.
  16. Have received any investigational product or been treated with an invasive device within the past 30 days
  17. Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
  18. Any chronic illness that, in the judgment of the Investigator, may hinder or confuse compliance with the protocol
  19. Any condition (may include clinically significant screening laboratory assessments) which, in the judgement of the Investigator, may increase the risk to the subject or decrease the likelihood of achieving the objectives of the study
  20. Pregnancy or breastfeeding

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: Diagnostic
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in otherwise healthy diabetic subjects when compared to blood glucose levels simultaneously measured on the YSI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
The secondary objective of the study is to demonstrate a blood glucose measurement range of 60 to 500 mg/dL at the hematocrit levels referenced as normal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Profil Institut für Stoffwechselforschung GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
OptiScan Biomedical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1003106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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